VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1453692
Sex: F
Age:
State: CT

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: blood clot after taking the first dose; This is a spontaneous report from a Pfizer sponsored program. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021, as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced blood clot after taking the first dose and was just advised to take the second dose by her Doctor. Caller wanted to make an appointment for the patient's second dose. Caller refused to be transferred and will talk to his friend and Doctor first. The outcome of the event was unknown. Follow up attempts are needed. Information about batch/lot number has been requested. Follow-up (21Jun2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1453693
Sex: F
Age:
State: NY

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: extreme dizziness, to the point I had to hold on to furniture to be able to walk; intense ear pressure; My arm that received the injection has a rash, there is a different kind of rash on my other arm; my legs and feet were freezing intermittently to the point I had to wear 6 pairs of socks; worse at fingers and toes/pain in all my extremities/I started having pain in all my extremities; Joint pain; muscle pain; Severe headache; ringing in ears; numb/tingling/itchy face and head; numb/tingling/itchy face and head/I continue to have high sensitivity feelings like numbness in both sides of my face, scalp and both sides of my head and through my jawline; numb/tingling/itchy face and head; lupus "flare up."; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in arm right on 06Apr2021 13:45 (at the age of 58-year-old) as single dose for COVID-19 immunisation. The patient's medical history included systemic lupus erythematosus, breast cancer, mastectomy, autoimmune disorder from an unknown date and unknown if ongoing I had rashes before because of autoimmune disorder. The patient's concomitant medications were not reported. Patient had allergy to sulfa drugs. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Apr2021, patient experienced zapping shooting pain in limbs, worse at fingers and toes/pain in all my extremities, joint pain, muscle pain, severe headache, ringing in ears, numb/tingling/itchy face and head, continue to have high sensitivity feelings like numbness in both sides of my face, scalp and both sides of my head and through my jawline, legs and feet were freezing intermittently to the point patient had to wear 6 pairs of socks. On an unknown date, patient experienced lupus flare up, extreme dizziness, to the point patient had to hold on to furniture to be able to walk, intense ear pressure, arm that received the injection had a rash, there is a different kind of rash on patient's other arm. Doctor had advised the patient not to receive the 2nd Pfizer vaccine dose. On 06May2021, patient experienced pain in all extremities. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on 25Apr2021 Blood test. Therapeutic measures were taken as a result of lupus flare up included steroids. patient stated that could not finish the 5 days of steroids because the steroids were exacerbating that sensitive, underlying speeding up feeling I was having all the time, like the feeling you get when you are about to sneeze is the only way can describe the feeling. The outcome of the events zapping shooting pain in limbs, worse at fingers and toes/pain in all my extremities, joint pain, muscle pain, severe headache, ringing in ears, numb/tingling/itchy face and head, continue to have high sensitivity feelings like numbness in both sides of my face, scalp and both sides of my head and through my jawline were not recovered. The outcome of the events lupus flare up, extreme dizziness, to the point patient had to hold on to furniture to be able to walk, intense ear pressure, arm that received the injection had a rash, there is a different kind of rash on patient's other arm, pain in all extremities were unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1453694
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: tested positive for covid one week past her second Pfizer shot; tested positive for covid one week past her second Pfizer shot; This is a spontaneous report from a Non- contactable consumer. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. It was reported that someone in a local group posted that on an unspecified date, the patient (her nanny) has tested positive for COVID one week past her second Pfizer shot. The reporter stated that in the group, the poster mentioned that the patient has been asymptomatic and was tested as part of routing testing in the household and was tested twice and both tests were positive, so the poster did not think it's a false positive. The reporter was reporting this as a potential efficacy issue for the Pfizer Biontech Vaccine. On an unspecified date, the patient underwent lab tests and procedures which included covid-19 test which result showed tested positive for COVID. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1453695
Sex: F
Age:
State: MD

Vax Date: 04/07/2021
Onset Date: 04/08/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: walking to her bed, and started to see stars, and felt like she was starting to faint; had trouble breathing, along with chest pain.; her daughter had the same thing happen again, but it was worse.; had trouble breathing, and some other side effects, like a sore throat, and nasal congestion; had trouble breathing, and some other side effects, like a sore throat, and nasal congestion; had trouble breathing, and some other side effects, like a sore throat, and nasal congestion; This is a spontaneous report from a contactable consumer (patient's mother). A 27-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0138), dose 1 via an unspecified route of administration on 07Apr2021 at 17:30 (at the age of 27 years old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she she was calling on behalf of her daughter who had her first Pfizer COVID-19 Vaccine dose on 07Apr2021 at 5:30PM. She said her daughter woke up with a jolt at 1:00AM (08Apr2021), and had trouble breathing, and some other side effects, like a sore throat, and nasal congestion. She said her daughter had a COVID-19 Virus test done and the test was negative. Stated She said 5 days later, out of the blue, her daughter had the same thing happen again, but it was worse. She said her daughter was in the shower and had trouble breathing, along with chest pain. She said her daughter was walking to her bed, and started to see stars, and felt like she was starting to faint. She said her daughter sat down on the bed, and put her head between her knees, and was able to stop herself from fainting. The reporter stated her daughter was worried her symptoms were a side effect of the COVID-19 Vaccine. She said she hadn't read anywhere of that kind of side effect. She said the first time her daughter had trouble breathing, her daughter thought it was definitely a side effect of the COVID-19 Vaccine. She said for the same thing to happen to her daughter 5 days later had both her and her daughter wondering if what she had experienced was a side effect, or an allergic reaction to the COVID-19 Vaccine. The reporter said she was calling to find out if her daughter could get the second COVID-19 Vaccine after what she had experienced with the first COVID-19 Vaccine dose. The reporter stated that she had provided the Pfizer Pharmacist with the wrong COVID-19 Vaccine Lot Number yesterday (EW0138). She would like to find out if her daughter could get the second COVID-19 Vaccine after what she had experienced with the first COVID-19 Vaccine dose. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. Reported her daughter received her COVID-19 Vaccine at the . She said she believed that the was a federal COVID-19 Vaccination site. No further details provided. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1453696
Sex: F
Age:
State: CA

Vax Date: 05/03/2021
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Neck was chocking I feel like that I have taken a pill and it stuck in a throat; My breaths starts to close in I couldn't breathe; I have a lot of trouble in breathing; I couldn't eat; I couldn't sleep; I was very dizzy; I had a lot of vomiting; I couldn't even swallow; My neck was really getting swollen; I had fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: 5EW0182), via an unspecified route of administration on 03May2021 (at the age of 22-years-old) as a single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her shot right in, "my breaths starts to close in I couldn't breathe", "I couldn't eat", "I couldn't sleep", "I was very dizzy", "I had a lot of vomiting" and it was basically not good. Then she went to the urgent care because "I couldn't even swallow", "my neck was really getting swollen" and "neck was chocking I feel like that I have taken a pill and it stuck in a throat" and then "I had fever", chills and a lot of hard time. When paraphrased the above concern, the patient stated, and then "I have a lot of trouble in breathing". She received the second dose on 24May2021. The patient stated, the only thing that they gave her was Ibuprofen because they say, that's the only thing that they could give her. The outcome of all the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1453697
Sex: F
Age:
State: NY

Vax Date: 04/26/2021
Onset Date: 04/01/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: He had a bad flare up; This is a spontaneous report from a contactable nurse. A 63-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 26Apr2021 (at the age of 63-years-old) as a single dose for covid-19 immunization. Medical history included rheumatoid arthritis. Concomitant medication(s) included tofacitinib citrate (XELJANZ XR) taken for rheumatoid arthritis from 2019 to an unspecified stop date. It was unknown, whether the patient was pregnant at the time of event. On an unspecified date, in April 2021, patient stated "I had to hold my xeljanz when I received my covid vaccines per my doctor. She had to stop Xeljanz a week Before, the week of and the week after both vaccines. Last vaccine was 26Apr2021". She had a bad flare up and Had to go to doctor to get a shot to help. She has appointment to go back and see doctor next week." doctor aware. Outcome of the event was unknown. Information on the Lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of rheumatoid arthritis flare up. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: Xeljanz XR

Current Illness:

Date Died: 03/01/2021

ID: 1453698
Sex: M
Age:
State: PA

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Tinnitus; Committed suicide; Fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 05Mar2021 11:15 and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: ER8730), on 26Mar2021 10:30; both via an intramuscular route of administration, administered in Arm left (left shoulder), as single dose, for covid-19 immunization. Medical history included multiple sclerosis (MS) from 07Jul2002 and ongoing. Patient's prior vaccination was none. The patient's concomitant medications were not reported. Caller reported the side effects after the administration of the Covid-19 vaccine. On unknown date in Mar2021, after the first shot his tinnitus started and he was also fatigued; and he committed suicide eventually. The caller went to a specialist and was told that he had heard about that symptom before from 6 patients who reported the same thing. Later the reporter mentioned he didn't know the guy other than he was a founder of one organization (name no provided) and he committed suicide. Had spoken with one of his friends who knew of a friend who also had tinnitus shortly after getting Covid and it was serious because the guy committed suicide. The guy was about his age and he ended up committing suicide and he had similar symptoms. This all happened around the same time in March when he had his vaccine and it's kind of eerie. It stated on the guy's obituary he had covid and tinnitus, but caller unable to clarify if guy had covid virus or vaccine. He didn't know the guy, but his other friend who have friends that were doctors said that you could go crazy. No further details provided for this person or other persons. This was the report two of three. Upon receipt of the follow up, it was stated that approximately 1-2 days after just vaccine, the patient started with hissing second on both ears which stated was diagnosed as tinnitus. As of today, 12Jun2021, the "hissins" was consistent or worse than the start and it fall day and night. On an unspecified date in Mar2021, the patient died, and the autopsy was not performed. The outcome of the events committed suicide and tinnitus was fatal while the outcome of the event fatigue was unknown. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Tinnitus; committed suicide

Other Meds:

Current Illness: MS

ID: 1453699
Sex: M
Age:
State: RI

Vax Date: 02/12/2021
Onset Date: 05/19/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: tachycardia; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; Sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160 / 110.; This is a spontaneous report from a contactable other hcp reporting for himself. A 60-years-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9262; Expiration date was not reported), intramuscular, administered in Deltoid Left on 12Feb2021 15:15 (at the age of 60-years-old) as single dose for COVID-19 immunization. Medical history included spinal stenosis, spinal laminectomy from Jun2003 and ongoing, intervertebral disc operation from Jun2003 and ongoing, intervertebral disc operation from an unknown date and unknown if ongoing Failed L3-4 LAMI Discectomy, seroma from 2003 to an unknown date, intervertebral disc protrusion, HNP L4-L5 Protrusions, back pain (Back spasms), reduced inflammation from an unknown date and unknown if ongoing. It was reported that the patient had laminectomy discectomy approximately from June 2003 and not fully remedied, ongoing; pertinent details: L3-L4 laminectomy/ discectomy in 2003 with infection with difficile large seroma. family history: copd. Concomitant medications included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) taken for intervertebral disc operation, spinal laminectomy, intervertebral disc protrusion from 2021 and ongoing; diazepam (DIAZEPAM) taken for back pain; lidocaine (LIDOCAINE) taken for impaired work ability from 2013 and ongoing; curcuma longa (TURMERIC [CURCUMA LONGA]) taken for inflammation from 2020 and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL3247), via intramuscular route in left deltoid on 22Jan2021 at 15:15 for covid-19 immunization. The patient previously took penicillin and had known allergy. Other vaccine in four weeks, covid prior vaccination, prior vaccinations (within 4weeks) included none. Vaccine was administered at hospital and not administered at military facility. The patient experienced sudden onset diaphoresis, 2 dry heaves, sudden elevation of blood pressure to 160/110 on 19May2021 11:30. Patient received treatment with portable B/P monitor and reduced duty in Radiology. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 22Apr2021 Nasal Swab test. Other Relevant tests included none. It was reported that patient experienced tachycardia on 22May2021 11:30. Reporter considered the event seriousness criteria as important medical event. AE required patient a visit to Physician Office and patient received no treatment for tachycardia. Outcome of tachycardia was not recovered, and other events were recovered with lasting effects on unspecified date in 2021. Reporter considered that the Pfizer product had a causal effect to the adverse events.

Other Meds: HYDROCODONE/ACETAMINOPHEN; DIAZEPAM; LIDOCAINE; TURMERIC [CURCUMA LONGA]

Current Illness: Discectomy; Laminectomy spinal

ID: 1453700
Sex: F
Age:
State: NY

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: I started to feel a deep tingling and burning sensation on my upper lip; Entire body is in hives/it is hives all over her body; she really wants to itch herself and she is trying not to/ lot of itching; her body feels like she has chicken pox; rash/On her legs it's like patches.; lips still burning; This is a spontaneous report received from a contactable other healthcare professional (Dental receptionist reported for self). A 31-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179), first dose via an unspecified route of administration, administered in left arm on 04May2021 at 18:00 (at the age of 31-year-old), as a single for COVID-19 immunisation administered at other facility. Medical history included asthma, two mini strokes (it's been 2 or 3 years, she does not have that information), chicken pox, Patient stated she is allergic to all to medications. Her doctor does not prescribed medications to her at all. This included acetaminophen, ibuprofen, aspirin and all NSAID medications. There were no concomitant medications. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. It was reported that, on 04May2021, patient went to (withheld) to get her first dose of the Pfizer vaccine. Patient's vaccination was scheduled for 04May2021 at 18:00. Patient's allergist recommended that she wait another 15 minutes just to be sure. She had nothing in her bloodstream when she arrived because she was allergic to all over-the-counter drugs, including acetmetaphine, ibuprofen, naproxen, aspirin, and other NSAIDs. Since she had asthma and wanted to make sure this vaccine was right for her, she saw both her PCP and an allergist specialist before getting the vaccine. Suggested to her that it would be useful to her. The shot was administered to her on her left arm, on 04May2021, and shortly after receiving the vaccine on 04May2021 at 18:15, she started to feel a deep tingling and burning sensation on her upper lip, which spread progressively across the bottom of her lower lip. She told the on-duty nurse. She said it had nothing to do with the vaccine. She then led her to the seating room, instructing another nurse present to keep an eye on patient, for the first. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the event tingling lips and burning sensation. She stated she also called in to Pfizer the same day after sending it online because she missed that it said it would be taking like a week. She did this on the 22May2021. She was at her general doctor's office so she can give him an understanding of what happened. She has only taken her first dose and she was not comfortable taking her second dose after this reaction. Patient said she was not sure if all of that information was shared on her previous report. Verified that patient was referring to the Pfizer Covid-19 vaccine. She wanted to know if there was a way, she can get a call back, because the doctor may be coming in soon and she may have to disconnect the phone call. She gave a brief summary as to what she did. She did not know what she was supposed to do. She was calling to see when the follow-up was and what was her next step. She stated her body feels like she has chicken pox. She has already had chicken pox before so it's just like her entire body was in hives. She cannot wear jeans anymore, because if she wears anything tight fitting, her body goes into hives. Constant hive mode. She was sitting in her doctor's office and she really wants to itch herself and she was trying not to. At night it was ten times worse. She wanted information, but she really wants to report want her incident was. She has never been in this situation before. Her allergist even wrote out a prescription saying that nothing would happen to her. So, she needs to do a follow up with him. It has been a month in her system. She knew it was going to take like 3 weeks for the vaccine to run its course, so she gave it time. She took the vaccine on 04May2021 and it is now 06Jun2021. So, it has been a month in her system, and it was still not going away. She wants to know if there is a way, she can reverse this. She wants to know if she should go and take Moderna. Should she take Johnson and Johnson. She did not know what to do at this point. She definitely wants the vaccine in her body, but she did not want to be allergic to it. She would like a call back on Tuesday if possible. She does not have the lot number for the vaccine with her to provide. She had it on the paper and she did that online. She does not have NDC or expiration with her right now either. The rash happened right away on 04May2021. There was a lot of itching and her lips are still burning. The itching was everywhere, not just one place. It feels like she was not quite sure, if it's shingles or chicken pox. It is constantly itching. She has taken Benadryl, Zyrtec and Allegra and they have all stopped working. Nothing was working. Patient does not have medications with her at time of call and cannot provide, NDC, Lot and Expiry. She tried them a week apart, for like a week each because it has been 3 weeks. Benadryl worked for 3 days and then it stopped. Then she tried Zyrtec, which worked for a day and then nothing. It worked for like a couple hours. Allegra worked for maybe 3 hours and then it stopped. If she wears tight jeans and a t-shirt on top and then if she takes them off a couple hours later, it was hives all over her body. On her legs it's like patches. She does not know how to stop this itching. Since the issue started, it was the same. there was no improvement. Normally when she was allergic to medications, she takes Benadryl because that helps her soothe it down and within a day it was gone out of her system, but now that the vaccine was in her system and none of these medications are working. She did not know what to do. It was reported that there is a product complaint to report. She was at her general doctor's office so she can give him an understanding of what happened. She has only taken her first dose and she is not comfortable taking her second dose. Complaint regarding Benadryl, Zyrtec, and Allegra: It is constantly itching. She has taken Benadryl, Zyrtec and Allegra and they have all stopped working. Nothing was working. She tried them a week apart. Benadryl worked for 3 days and then it stopped. Then she tried Zyrtec, which worked for a day and then nothing. It worked for like a couple hours. Allegra worked for maybe 3 hours and then it stopped. Allegra and Zyrtec were the small count bottles and Benadryl was a box of 8, 9 or 10. Patient did not have medications with her at time of call and cannot provide, NDC, Lot and Expiry. Is a sample of the product available to be returned, if requested reported as yes for all products and packaging sealed and intact was reported as yes for all products. She did not know what she was supposed to do. She was calling to see when the follow-up was and what was her next step. She wanted to know if there was a way, she can reverse this on her. She wanted to know if she should go and take Moderna or not and should she take Johnson and Johnson. She did not know what to do at this point. She would like a call back on Tuesday if possible. patient notified to call back on specific day was not guaranteed. Patient was given with Covid-19 phone number to call back. The outcome of the events was reported as not resolved and for rash outcome was reported as unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is eva

Other Meds:

Current Illness:

ID: 1453701
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: feeling light headed; sinus pressure; reports nausea; has slowed down & still constipated".; still constipated; bending down; weak and tired; This is a spontaneous report from a contactable consumer (patient herself) from a Pfizer sponsored program Pharmacy Sutent and assistance Program. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation; palbociclib (IBRANCE), via oral route from 04Mar2021 (Batch/Lot number was not reported) and was ongoing, at 75 mg every other day (21 days on/7 days off) for breast cancer. The recommended dose was 125mg daily, 21 days on/7 days off as per the prescribing information. The patient's medical history included breast cancer and had problems with sinuses in the past. Concomitant medication(s) included fulvestrant (FULVESTRANT). On an unknown date, the patient was feeling lightheaded, a little dizzy when position changes, sinus pressure, nausea, has slowed down, still constipated, bending down. All the events were considered to be medically significant. Patient reports about a month ago, feeling very exhausted, real weak and tired. The patient went to the emergency room and was given 1pint of blood. Doctor instructed patient to restart current ibrance cycle 04Mar2021, 75mg every other day (ten tablets) + one week off to see if it improves red counts. Patient reports feeling "improved energy levels. The doctor was aware of dosing history of ibrance: 100mg dose on 18Nov2020-Jan2021; 75mg dose 21 days on/7 days off 04Feb2021. The patient underwent lab tests which included on an unknown date, blood test which was found to be low and oxygen saturation was low and on 22Mar2021, the results of red blood cells were pending. The outcome of all the events was unknown. Information about batch/ lot number has been requested.

Other Meds: FULVESTRANT

Current Illness:

ID: 1453702
Sex: M
Age:
State: MT

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 07/07/2021
Hospital:

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Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: bleeding; sore throat; sickness; raw blisters; joint pain early morning; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a 37-year-old male patient in response to Non-HCP letter sent in cross referenced case that included: A 37-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration in Arm left on 10Mar2021 at 11:13 (Batch/lot number: EN6207) and second dose administered in Arm right on 30Mar2021 at 10:45 AM (Batch/lot number: EP7533) both doses as a single dose for Covid-19 immunisation. Patient's medical history included, a traumatic brain injury on 18Jun1995 at age 11-17 years old treated (4 mo), and at the age of 37 now he has short term memory issues left side spasticity from brain injury and handicapped from an unspecified date and unknown if ongoing. Concomitant medications included ibuprofen, multiple vitamin 1day gummies, Cinnamomum spp. oil, citrus aurantium essential oil, commiphora myrrha oil, eucalyptus spp. essential oil, rosmarinus officinalis essential oil, syzygium aromaticum essential oil (DOTERRA ON GUARD), and Peppermint on guard for unknown indication. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as A6E37. After vaccination, on an unspecified date in 2021, patient experienced joint pain early morning and was hardly ever sick, was shocked at severity of sore throat in evening and actually bleeding. He went to doctor next morning and they though it could be Scarlet fever. After 2 days, it was reported that the symptom does not show the actual bleedings lower back of throat not shown also raw blisters punch like marks. The patient underwent lab test which included culture results as negative on an unspecified date and strep investigation test, results as negative on 02Apr2021 (did strep test looked like scarlet fever; Had no fever). The outcome of events was unknown.

Other Meds: IBUPROFEN; DOTERRA ON GUARD

Current Illness: Short-term memory impairment

ID: 1453703
Sex: F
Age:
State: FL

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Rash, Urticaria

Symptoms: Inflammation immediately after shot and four weeks later still lower half of body is inflamed. Dr. gave me a steroid injection in my back and have scheduled an MRI; Inflammation immediately after shot and four weeks later still lower half of body is inflamed. Dr. gave me a steroid injection in my back and have scheduled an MRI; This is a spontaneous report from a contactable consumer or other non health care professional (Patient, reported for self). A 63-years-old (non pregnant) female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number ER8735), via an unspecified route of administration, administered in Arm Left on 05Apr2021 17:00 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes mellitus, sleep apnoea syndrome, spinal stenosis (Narrowing of spine), hypersensitivity (Known allergies: yes). Other medications in two weeks was reported as, Yes. No other vaccine was received in four weeks. No COVID prior vaccination. On 06Apr2021 the patient experienced inflammation immediately after shot and four weeks later still lower half of body is inflamed. COVID tested post vaccination, on 17May2021 patient underwent lab tests which included sars-cov-2 Nasal Swab test, Covid test result: negative. Event resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result event includes Injection of steroid, it was reported that physician gave a steroid injection in her back and have scheduled an Magnetic resonance imaging. The outcome for both event was not recovered.

Other Meds:

Current Illness:

ID: 1453704
Sex: F
Age:
State: IL

Vax Date: 04/03/2021
Onset Date: 04/06/2021
Rec V Date: 07/07/2021
Hospital:

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Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: cellulitis; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 75-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8733, expiration date unspecified), intramuscularly, administered in Arm Left on 03Apr2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Patient medical history included type 2 diabetes mellitus (ongoing) Pertinent Details: 2018 Oct-Stomach gastric sleeve, sleep apnoea syndrome from 1999 and ongoing Pertinent Details: BI PAP Machine, spinal stenosis for 9 years (ongoing) Pertinent Details: Cortisone ingestions knees, brain and neck. The patient family history included cardiac failure congestive in 2002 to her mom, emphysema in 1988 to her Dad, which cause his death. The patient had x-ray of pelvis and hip on an unknown date in Nov2020 and results indicated lumber tailbone, fractured tailbone. The patient's concomitant medications were not reported. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6207, expiration date unspecified), intramuscularly, administered in Arm right on 13Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. On 06Apr2021, the patient experienced cellulitis. On 20May2021, the patient had her bone density checked and results are unknown at the time of report. The patient was treated with immediate care and received antibiotic shots for 7days. The outcome of the event cellulitis was reported as recovered on 21May2021.

Other Meds:

Current Illness: Sleep apnea (Pertinent Details: BI PAP Machine); Spinal stenosis (Onset date: 9 years ago Pertinent Details: Cortisone ingestions knees, brain and neck); Type 2 diabetes mellitus (Pertinent Details: 2018 Oct-Stomach gastric sleeve)

ID: 1453705
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/07/2021
Hospital:

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Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: still contracted the corona virus; still contracted the corona virus; This is a spontaneous report from a contactable consumer or other non hcp(patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received dose 1 of bnt162b2 on an unknown date for COVID-19 immunization. The patient experienced still contracted the corona virus on an unspecified date. Outcome of the events were unknown. Follow up(04Jun2021): This is a follow up spontaneous report from a consumer. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1453706
Sex: F
Age:
State: FL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 07/07/2021
Hospital:

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Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Course of the anaphylactic reaction: broke out in hives all over; Course of the anaphylactic reaction: broke out in hives all over; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK8982; Expiration date was not reported), intramuscular on the right arm on 01Feb2021 (10:00) as a 2nd dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK9231; Expiration date was not reported) on 08Jan2021 (10:00) as a single dose, intramuscular on the right arm for COVID-19 immunization. On 01Feb2021, after the second dose of vaccination, the patient had described the course of anaphylactic reaction as broke out in hives all over. The events were reported to be severe (assessed as medically significant). The patient had received treatment with adrenaline, corticosteroids and steroid creams for the events. The outcome of the events was recovered on an unspecified date in 2021. The reporter did not consider BNT162B2 to have a causal effect to the reported events (unrelated).; Sender's Comments: There is a reasonable possibility that the event "anaphylactic reaction as broke out in hives" was related to BNT162b2 based on known drug safety profile and close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1453707
Sex: F
Age:
State: MI

Vax Date: 04/11/2021
Onset Date: 06/01/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: itching on the hands; blister going in between the fingers; reaction had worsen; This is a spontaneous report from a contactable consumer or other non-health care professional. A 17-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, in right arm, on 11Apr2021 at 16:30 (at the age of 17 years), as single dose for COVID-19 immunization. The patient medical history included Strong Family History of Rheumatoid Arthritis, states her mother is crippled, immunodeficiency and borderline immunocompromised. Historical vaccine included cervical cancer vaccine. The patient didn't have any history of all previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines administered on Same Date of the Pfizer Suspect. The patient didn't receive any vaccines prior 4 weeks. The patient concomitant medications were not reported. The patient previously took cancer vaccines and experienced eczema, cancer vaccines and experienced pyrexia, lo loestrin fe for contraception and experienced heavy menstrual bleeding. She has not taken the second dose yet which is more than 21 days. On 1Jun2021, the patient had experienced Itching and blistering on her hands and between her fingers and it mostly started at the palm and she can't stop itching reported as worsened. Reporter wanted to know if anyone else had the same reaction. patient also started on birth control. She had prior reaction from cervical vaccine at 12 years of age, also had eczema at the top of feet and fever. Reporter wanted to know if her daughter can still take the second dose because her high school clinic has schedule for second doses on 24Jun2021. Reporter tried to ask if she could also take the second dose of the vaccine because she is "borderline immunocompromised", but she already had HCP appointments set for her and her daughter and decided shell ask the doctor as well. The events didn't lead to emergency room or physician office visit. No investigation assessment performed. Patient received treatment with Zyrtec, reporter states her daughter called from school and she forgot to take it today at school, it does help somewhat. UPC, Lot, Expiration Unknown. Caller states they tried an itching cream, but it was not the proper one, she thinks it did work but it had an extra ingredient for a feminine product. She wants to note her daughter started on Birth Control, Lo Lo Estrogen, Dosage unknown. Caller states it was strange because she had heavy periods and they are trying to find out if she has fibroids or endometriosis, and the doctor gave her a packet of birth control and when they tried to refill it 3 weeks ago, their insurance didn't cover it so it might be a combination of her stopping that. Caller states she thought maybe if someone else and reported it. Outcome of the events was reported as not recovered. Communication: Caller provided with Report Reference. The caller was provided with the phone number, hours of operation 8am-8pm EST Mon-Fri and 9am-3pm Sat-Sun

Other Meds:

Current Illness:

ID: 1453708
Sex: F
Age:
State: PA

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 07/07/2021
Hospital: Y

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Paralyzed 13 hours later; She reports her daughter has to use braces and a wheelchair and is unable to work; Left arm goes numb, cannot feel hot or cold; Shortness of breath; Always feels cold; Chest pain; Does not have full strength in her legs/both of her daughter's hands are weak, but the left hand is extremely weak; Heart issues; This is a spontaneous report received from a contactable consumer (patient's mother reported for her daughter). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 14Apr2021 between 11:00-11:30 (at the age of 33-year-old) as a single for COVID-19 immunization.The patient did not had any medical history (including any illness at time of vaccination). Concomitant medications were reported. There were no patient's family medical history relevant to adverse event. It was reported that, doctors have done two MRIs and a spinal tab and she was healthy and there was no doctor visits nothing before the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No previous immunization with the Pfizer vaccine considered as suspect. On 15Apr2021, the patient was paralyzed. It was reported that the patient received the Pfizer COVID-19 injection on 14Apr2021 between 11:00-11:30 and was paralyzed 13 hours later. She was taken to hospital. The mother stated her daughter did not have full strength in her legs, left arm goes numb, cannot feel hot or cold, has shortness of breath, always feels cold, and chest pain. She reported a cardiologist saw something on an EKG and that her daughter has also seen a neurologist and several other doctors.The mother said her daughter has been on the local news about her reaction.She reported her daughter has to use braces and a wheelchair and is unable to work. She stated there have been other people she was aware of with this same type of reaction, including a girl and a guy. Reporter stated she has several questions since her daughter has no feeling in one leg, no feeling in part of the other leg and one hand is very weak. Reporter stated so when this all happened the media reached out and they put a stop to that, but her daughter did do an interview to a local station and will possibly do an interview with a mainstream media.Reporter stated apparently there are several cases for this. Reporter asked for the ones that have experienced the paralyzed event where are they going, how are they doing because her daughter has a baby and was needing information on even what treatments to take. Reporter stated it has been reported and they received a letter saying the paralyzed was a side effect to the first initial shot. Reporter stated her concern is they need to get and want to get treatment so she can get back to walking and Pfizer should be able to provide this information. Reporter stated the paralyzed was not reported with Pfizer and also stated her daughter has no feeling at all-in-one leg, then the other leg she has feeling from hip to knee but no feeling knee to foot, both of her daughter's hands are weak, but the left hand is extremely weak. Adverse events resulted in visit to emergency room taken by ambulance to general hospital and paralyzed required visit to physician office. Reporter stated her daughter got to General Hospital and was there on Friday, Saturday, Sunday and on Monday she was transported to Clinic since it was more suit for her daughter.Reporter stated her daughter was taken to one hospital and taken to another Clinic on Monday and left Thursday where she was taken to acute rehab. The reporter stated her daughter has been in and out of the hospital and was still having issues 2 months after the Pfizer COVID-19 vaccine injection. Reporter stated the patient was showing signs of improvement but nowhere near how she was prior to vaccine. They told her it was a side effect from the shot. She was finally getting to feel back but now, was having heart issues. Treatment included medicine that was an injection for blood clots in the hospital, but she does not believe she was given any oral medication for her being paralyzed. Reporter confirmed that her daughter did not have a blood clot and the blood clot injection was for prevention. Reporter stated her daughter has not had the second dose.The patient was recovering from paralysis and outcome for the other events was reported as unknown. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1453709
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: She reports her daughter has to use braces and a wheelchair and is unable to work; patient received the Pfizer covid-19 injection on 14Apr2021 and was paralyzed 13 hours later; has to use braces and a wheelchair and is unable to work; her daughter has to use braces and a wheelchair and is unable to work; Does not have full strength in her legs; Left arm goes numb cannot feel hot or cold; Has shortness of breath; Always feels cold; Chest pain; This is a spontaneous report from a contactable consumer (patient's mother). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 14Apr2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the patient has to use braces and a wheelchair and is unable to work, reporter stated here have been other people she is aware of with this same type of reaction, including a girl in (withheld) and a guy in (withheld), patient received the Pfizer covid-19 injection on 14apr2021 and was paralyzed 13 hours later, does not have full strength in her legs, left arm goes numb cannot feel hot or cold, has shortness of breath, always feels cold, chest pain on Apr2021. Patient had been in and out of the hospital and is still having issues 2 months after the Pfizer covid-19 vaccine injection and had been on the local news about her reaction. It was reported that a cardiologist saw "something" on an EKG and patient has also seen a neurologist and several other doctors. The patient underwent lab tests and procedures which included electrocardiogram: unknown in 2021. Clinical outcome of the events was not recovered. Response: A review of the Prescribing Information (LAB-1457-9.0 Revised: 19May2021) for Pfizer-BioNTech covid-19 vaccine did not find information regarding leg paralysis. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your daughter's doctor/healthcare provider. Information about lot/batch no has been requested.

Other Meds:

Current Illness:

ID: 1453711
Sex: F
Age:
State: PA

Vax Date: 03/09/2021
Onset Date: 04/28/2021
Rec V Date: 07/07/2021
Hospital: Y

Vax Type:
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Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Cellulitis / Cellulitis in her leg; the right eye was sensitive to light; her eyes kept fluttering; It is still draining and is still a little red; It is still draining and is still a little red; right side of the face was swollen; both of her eyes were swollen; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 77-year-old patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266 and expiration date was not reported), via an unspecified route of administration in arm left on 09Mar2021 at 16:30 (at the age of 76 years) as a dose 2, single for COVID-19 immunisation. infliximab (REMICADE), via an unspecified route of administration from 27Apr2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. Patient's medical history included ongoing crohn's disease, She's had it for about 3 years, immune system disorder from an unknown date and unknown if ongoing, She has low immunity, skin cancer from an unknown date and unknown if ongoing, She had skin cancer. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265 and expiration date was not reported), via an unspecified route of administration in arm left on 17Feb2021 as a dose 1, single for COVID-19 immunisation and remicade for crohn's disease. Additional vaccines administered on same date of the Pfizer suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were and AEs following prior vaccinations were none. It was reported that, Patient who had both doses of the Pfizer COVID Vaccine. She had a birthday yesterday (date unspecified), so she was 77 years old when she experienced the events. She had her 2nd dose on 9Mar2021 and had a Remicade infusion on 27Apr2021. After her infusion, both of her eyes were swollen, the right eye was sensitive to light, her eyes kept fluttering while looking up or bending over, and the right side of the face was swollen. This was constantly happening but is now getting better but not completely over. She mentioned that she talked to several doctors and they think that Remicade, since it lowers the immune system and decreases white blood cell count and the vaccine increases the white blood count, it has interfered with the signals with her eyes. She was also hospitalized from 29May2021 to 2Jun2021 for cellulitis and was given some antibiotics and steroids which she thinks helped with her symptoms. She was asking if this has been reported and if this will happen again on 24Jun2021 for her next Remicade infusion. she was taking Remicade before giving her the vaccine. she had concern, would the vaccine affect the Remicade and cause these reactions. Upon follow up, It was reported that, patient had her second dose of the Covid Vaccine on 09Mar2021, and on 27Apr2021 she had a Remicade infusion. Both of her eyes were swollen, and the right side of her face was a little swollen. She wants to know if it could be an effect of the vaccine and if she will experience this again after her next infusion this June. she comes on the line. Her right eye was the worst. When she looked up it started to go closed. If she goes into a bright light it would go closed and bending over it would go closed. It would keep fluttering, and she would have to go sit down and close her eyes until it settled down. It interfered with her activities, and she didn't feel comfortable driving because she didn't know when it would hit her. Every time she talked to a doctor, they acted like she is crazy. It only seemed after the Remicade that this started happening, and now she was due for another Remicade infusion on 24Jun2021. She had some other health issues earlier this month and was put on antibiotics. The antibiotics seemed to help the eye it is not completely gone but better. She was wondering now if she should get the Remicade on 24Jun2021. She had skin cancer, and when they removed it, she got cellulitis in her leg. She was in the hospital for 3 days. She asked the doctor there and they brushed her off. The last day before she came home the nurse came in and wanted to know if she had her shot. She asked the nurse the same question about the vaccine and Remicade, and the nurse said now they ask people before they get the shot if they are on Remicade. The nurse didn't have anyone that said yes. It was seeming like there is some kind of problem with Remicade and the vaccine. That is why she was a little bit concerned about having it again. Event details Both eyes swollen: They were still swollen. It was reported that, Sometimes her right eye will still go closed. It has gotten better. Right side of face a little swollen: It lasted for at least a month. Cellulitis in her leg: That would have started on 21May2021. She went to the hospital on 29May2021 and came home on 02Jun2021. She doesn't know if it went away. She finished her medication on Wednesday, she took the last of the antibiotics they gave her to take at home. It is still draining and is still a little red. She doesn't think it is quite as red, but it is still draining. It is about the same. Along the way she went to Urgent Care. They put her on steroids that didn't help. A couple weeks after she got an infection and they had her on 3 or 4 different antibiotics. She didn't know if one helped, or it was just the Remicade wearing off. She was on 3 different antibiotics. One was Doxycycline and that didn't help. The other one they gave her to take home was Amox Clav 875, and it was 125mg. She took it 2 times a day for 6 days. Both of the antibiotics she took are in amber colored pharmacy vials. She doesn't remember the name of the steroid that she took. She had her first dose of the Covid vaccine on 17Feb2021 and second dose of the Covid vaccine on 09Mar2021. She has been on Remicade for many years, at least 3 or 4 years. Before that she was taking a pill. The Remicade is an infusion. They mix it up when she comes in. She did not know a dosage. She had gone to the eye doctor, and she did a bunch of bloodwork. The patient underwent lab tests and procedures which included blood test and computerised tomogram with unknown details. She doesn't know what bloodwork she did. She also had a CAT scan of her eyes in the hospital. The patient was hospitalized for cellulitis / cellulitis in her leg (cellulitis) from 29May2021 to 02Jun2021. She was in hospital for 3 days. Events did not require a visit to Emergency Room, but Physician Office visit is required. For her eyes she went to Urgent Care, and they said to make an appointment with an eye doctor. Family Medical History Relevant to the events were none. It was the Product Complaint, Product strength and count size dispensed: Amox Clav 185: 125mg strength. Outcome of the cellulitis / cellulitis in her leg was not recovered, both of her eyes were, the right eye was sensitive to light, her eyes kept fluttering, right side of the face was swollen were recovering. Outcome of it is still draining and is still a little and it is still draining and is still a little red were unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness: Crohn's (Onset Date: She's had it for about 3 years)

ID: 1453712
Sex: F
Age:
State: VA

Vax Date: 06/08/2021
Onset Date: 06/01/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Meningitis pain; she woke up and said her face felt funny; pressure on her chest; pressure behind her eyes; muscle pain; she had not slept,; fever; headache; the chills; sore throat; nauseous; Caller states she was assuming hives; inflammation stayed around awhile; body aches / pain through her head and back down her neck; trying to push her eyeballs out and it is really painful; she was slumpy; swelling from the digging and scratching; her hands began to swell yesterday; she was just not feeling right; couldn't walk by herself; lip swelling and numbness; lip swelling and numbness; itching on face, hands and feet / Caller states then her daughters hands and feet began to itch; This is a spontaneous report from a contactable consumer or other non health care professional. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EW0178; Expiration Date: 31Aug2021), dose 2 via an unspecified route of administration, administered in Arm Right on 08Jun2021 16:00 (age at vaccination: 12 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included, meningitis from an unknown date and unknown if ongoing at 7 years old. The patient's concomitant medications were not reported. The historical vaccine include COVID-19 Vaccine on 18May2021 for COVID-19 Immunization (1st dose Expiry Date of Covid 19 vaccine: 31Aug2021, lot EW0168 ,anatomical location: Right arm) and had she had itching on the hands. And other vaccine includes flu shots (she does the flu shot every year) for immunization. The patient experienced Meningitis pain on unspecified date, lip swelling and numbness, itching on face, hands and feet / caller states then her daughters hands and feet began to itch in Jun2021. She has pressure on her chest on 09Jun2021. She had pressure behind her eyes, muscle pain,she had not slept, fever, headache, the chills , sore throat, nauseous, caller states she was assuming hives, inflammation stayed around awhile , body aches / pain through her head and back down her neck, trying to push her eyeballs out and it is really painful , she was slumpy, swelling from the digging and scratching, her hands began to swell yesterday in Jun2021. she woke up and said her face felt funny on 09Jun202. she was just not feeling right and couldn't walk by herself on Jun2021, Caller relays her daughter will be (withheld) . HCP: Caller states she called the pediatrician office and 1 was by phone and she was seen by this provider yesterday and she encouraged her to reach out to us as well. Mom states she was aware of the possible symptoms to occur and her daughter came home Tuesday perfectly fine and went to bed and woke up with the typical symptoms, she had not slept, fever, headache, the chills, sore throat, nauseous and had all the symptoms pretty much. States she didn't have anything weird going on during the observation time the day of the vaccine. Caller relays her daughter didn't have anything weird after her 1st dose. Caller states she took a nap Wednesday about 24 hours after her 2nd dose and she woke up and her lips had begun to swell and she woke up and said her face felt funny and it was itchy. Caller states she was assuming hives. Caller states that there was nothing concerning as it wasn't in that initial 15minutes to 4 hour and that this occurs 24 hours after and that was a concern. Caller states then her daughters hands and feet began to itch and that was kind of along the same lines and said hives and she would itch itch itch and there was swelling from the digging and scratching. Caller states she has numbness in her lip with the swelling. Caller states the other symptoms that are bizarre is more yesterday and it started some on Wednesday she had a pressure in her chest and this was a child, her daughter was very strong, she got up yesterday and tried to do school and had a fever of 102 and Wednesday evening was so sick with symptoms and she still tried. Caller states the pressure in her chest is concerning and told them yesterday and she needed to be seen. States her daughter described it to the doctor that it felt like someone was sitting on her chest sort of pressure and on a scale of 1-10 she was a 7. Caller provides that not at any time did she experience trouble breathing and she never saw her lose or get weird coloring. Caller states she called her doctor Wednesday afternoon and talked to another doctor, that she called the help line after hours as they close 4:30 or 5pm. States she was told it was good news that she did not have trouble breathing but to have it at this point was weird and no one knows what to expect and everyone is different. States she was told to do Benadryl and continue with pain medication for fever and discomfort. Caller states her daughter was miserable the rest of the evening. Caller relays that the swelling subsided and the inflammation stayed around awhile and yesterday she woke up better with no nausea and the common symptoms are better and she still had the fever. Caller relays that at about 9:00 she began to have a problem where she said that behind her eyes she had significant pressure and that scared the caller what with the brain and swelling. Caller states her hands began to swell yesterday, like her lip and her fingers are itchy and swelling and it's constant itching and the pressure on her chest yesterday, that those 3 things freaked the caller out and she called the pediatrician and they said to have her checked out to make sure as nobody wanted to rush her to the ER as she was not struggling to breathe she was just not feeling right. Caller states the pediatrician did her research about heart inflammation and listened to her heart a couple of times and said her best observation for rubbing sounds was she did not hear any. Caller states when her daughter was younger she had meningitis and went through a whole lot with that and caller states she does not immediately rush to the hospital as that brings back emotions with that. Caller states the doctor said she didn't see any immediate distress and would do an EKG or they could wait and see, that she thought the pressure might be like body aches and her daughter had laid in bed all day the day before and had a time with it. Caller states she couldn't walk by herself and she was out of it. Caller states she could do the EKG or wait until today and they chose to wait. States that today she seems better and the only thing today is the continuing pressure behind her eyes that her daughter described as it felt like someone had 2 spoons and was trying to push her eyeballs out and it is really painful. Caller relays her daughter has been through meningitis pain and has pain through her head and back down her neck and the concern is swelling. Caller states it could be a weird reaction and the doctor thinks it is a weird headache she is having and is still doing ibuprofen. Caller relays that her chest is not nearly as heavy today and she has taken Benadryl again for itching and swelling. States the doctor says they don't know what did it because the risk was there and the benefit and don't want to get reactions. Caller states she had no problem with getting the shot, that weird things happen and the pediatrician is saying it can happen but doesn't know. States it is kind of scary. Caller states they checked her out and they checked her oxygen and blood pressure and that made the caller feel better. States that 9:30-10 last night after she got home she was slumpy and her head was hurting and she had chest pressure. Caller states with the hand swelling, that the caller herself went through reaction and hives and the doctor had asked if her daughter had anything new introduced and no nothing was and her daughter didn't seem concerned to share this but after her 1st dose her hands itched and she didn't pay it any mind. States she had no face swelling. Caller states she is wondering if those little hand itches after the 1st dose she didn't tell about till now was that a little bit of a sign that something else was there. States she didn't mention it after the 1st dose and was good to go.

Other Meds:

Current Illness:

ID: 1453713
Sex: F
Age:
State:

Vax Date: 06/10/2021
Onset Date: 06/11/2021
Rec V Date: 07/07/2021
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Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: fever; headache; felt like she even might cough a little due to the heartbeat increase; fast heart beating/ heartbeat increase in a short period of time; This is a spontaneous report from a contactable consumer (patient's father) via Medical Information Team. A 12-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 10Jun2021 as single for covid-19 immunisation. Previously received first dose of BNT162B2 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, her daughter is just 12 years old and she who received the second dose of the Pfizer-BioNTech COVID-19 Vaccine on 10Jun2021. Now she's suffering, there are some normal side-effects like fever, headache but she also experiencing like a heartbeat increase in a short period of time say two third of the time will be okay but it is one third of the time, she felt the heartbeat is going fast, faster than normal and then she felt like she even might cough a little due to the heartbeat increase. He mentioned that 24 hours after the shot (11Jun2021), his daughter has experienced a side effect listed in the pamphlet: the fast heart beating. So, he like to find out specifically, first of all if that is normal the heart beat thing, 2nd should we be concerned and worried and go to the hospital ER because of this. Pfizer Response to Reported Cases of Myocarditis in Recipients of COVID-19 Vaccine. Pfizer is aware of the Israeli observations of myocarditis that occurred predominantly in a population of young men who received the Pfizer-BioNTech COVID-19 vaccine. Adverse events are regularly and thoroughly reviewed and we have not observed a higher rate of myocarditis than what would be expected in the general population. A causal link to the vaccine has not been established. There is no evidence at this time to conclude that myocarditis is a risk associated with the use of Pfizer/BioNTech COVID-19 vaccine. [for non-HCPs]: we refer you to your healthcare provider to discuss this topic. Your healthcare provider knows your medical history, can discuss the risks and benefits of the vaccine, and can provide vaccination recommendations to you. If asked about how many cases of myocarditis have you seen after administration of the Pfizer/BioNTech vaccine? Pfizer is aware of the reports of myocarditis in recipients of the Pfizer-BioNTech COVID-19 vaccine. A causal link to the vaccine has not been established. Serious adverse events unrelated to but close in timing to vaccination will likely occur at a similar rate in vaccinated individuals as they would in the overall population. With a vast number of people vaccinated to date, the benefit risk profile of our vaccine remains positive. The outcome of events was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1453714
Sex: F
Age:
State: PA

Vax Date: 04/27/2021
Onset Date: 04/01/2021
Rec V Date: 07/07/2021
Hospital: Y

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Symptom List: Unevaluable event

Symptoms: Experiencing a heaviness in her chest; jaw pain; like she is freezing outside; she could barely walk with her walker; severe nausea; shaking from head to toe/having tremble; felt like burning up inside; Weakness; Has zero appetite; Anxiety.; This is a spontaneous report from a contactable consumer (daughter). This consumer reported for an 86-year-old female patient that: An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 27Apr2021 at 11:00 (at the age of 86 year) as single dose for covid-19 immunisation. Medical history included Chronic hives from an unknown date and unknown if ongoing, ongoing Unspecified reactions, ongoing Unspecified medication allergies and patient had a prior fall where she suffered a broken ankle. Concomitant medication(s) included dupilumab (DUPIXENT) taken for eczema from Sep2020 and ongoing and latanoprost (LATANOPROST) taken for glaucoma from an unspecified start date and ongoing. Patient historical vaccine includes shingles vaccine for immunization and within 48 hours, the patient broke out in severe eczema from head to toe and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533), via unspecified route of administration on Right arm for Covid-19 immunization and experienced no adverse event. She had Called on behalf of her mother who was 86 years old. Mother received the second dose of the Pfizer BioNTech Covid-19 vaccine last 27Apr2021, within 24 hours, mother experienced severe nausea with shaking from head to toe and felt like burning up inside. The weekend after the second dose, the mother experienced heaviness in the chest and jaw pain and was brought to the ER. Full cardiac work up was done, and results were fine. Doctors said this may be due to anxiety. Mother had CT abdomen, an endo scan, and blood works but they were all fine. Mother continues to weaken, having tremble and is nauseous. These symptoms would come and go. Mother was in the ER twice this past week and they could not find anything. Nausea got worse. It would come back strong around 3:30 in the morning. Caller wanted to know if these were reported with the Pfizer Covid-19 vaccine and if there was anything they could do further. Mother was taken to different doctors and tests were done but no findings. caller mentioned that the symptoms happened right after the shot. She reported that the patient has been seeing an infectious diseases doctor as during her lifetime, the patient has always had chronic hives. Caller reported that the patient has reactions to many things and is allergic to many medications. She reported that that weekend it got so severe, the patient was experiencing a heaviness in her chest and jaw pain. She reported that they thought the heaviness in the patient's chest and jaw pain might be cardiac, so the patient was taken to the emergency room. She reported that the patient stayed 2 nights in the hospital. Caller reported that the patient's heart was ruled out and her bloodwork came back ok. Caller reported that the hospital physicians thought that the heaviness and jaw pain could be anxiety and prescribed anxiety medication for the patient. She reported that the patient went to her primary care physician after leaving the hospital. Caller reported that the patient got worse and was experiencing nausea more and more. She reported that the patient's physician ordered an endoscopy and brain scan to rule out everything medically. Caller reported that the patient's physician informed her that her blood pressure was fine, her bloodwork was fine, and that all of her test results were normal. She reported that the patient just continues to weaken and trembles and burns up. Caller reported that the patient was so severely nauseous but never throws up. She reported that they are just at their wits end and do not know where to turn. Caller inquired if anyone else was calling with these side effects and if there was anything they can do. She reported that the patient went from being just fine, on no medications, to this. Caller reported that everyone keeps saying they do not know what was wrong with the patient. Caller reported that the patient's physician keeps saying that maybe it is anxiety, but the patient has been on the anxiety medications for 6 weeks and there are no signs of improvement. She reported that she does not want the patient to take the anxiety medications if they are not helping. The patient has been taking the generics for Lexapro and Xanax, escitalopram and alprazolam, for 6 weeks and has shown no improvement. Product strength and count size dispensed: Escitalopram 5 mg; dispensed in pharmacy bottle Alprazolam 0.25 mg; dispensed in pharmacy bottle Additional lot numbers: Caller unable to provide product lot numbers as they were dispensed in a pharmacy bottle. Caller reported that the Escitalopram was manufactured by Accord and the Alprazolam was manufactured by Sandoz. She reported that the patient was started on 5 mg of Lexapro, but the dose has been increased to 10 mg. Caller reported that the patient was taking two 5 mg tablets. Severe nausea: Caller reported that the patient's nausea has worsened. Caller reported that the patient initially would experience nausea for a couple of hours then it would ease. Caller reported that the last 10 days, the patient's nausea is almost all the time. Caller reported that the patient gets a couple good hours maybe before going to bed and that is it. Caller reported that the patient wakes up with severe nausea around 3:30 in the morning like clockwork. Shaking from head to toe: Caller reported that the patients shaking comes and goes. Caller reported that the patients shaking was definitely worse in the morning when she was the weakest or if she was getting a bad bout of it, like the nausea comes on stronger. Burning up inside: Caller reported that the patient feels like she is freezing outside when she was burning up inside. Heaviness in chest: Caller reported that the patient experiences heaviness in her chest when she gets episodes where the nausea and burning up inside, freezing outside come on. Caller reported that the patient does not always have the heaviness in her chest. Weakness: Caller reported that they took the patient to the emergency room a second time because she could barely walk with her walker. Jaw pain: Caller reported that the patients jaw pain comes and goes. Has zero appetite: Caller reported that they have to force the patient to eat. The patient underwent lab tests and procedures which included abdominal x-ray: normal on Apr2021, blood pressure measurement: fine on Apr2021, blood test: normal on 30Apr2021, cardiac function test: normal on 30Apr2021 results were fine computerised tomogram abdomen: all fine on Apr2021, endometriosis: all fine on Apr2021, endoscopy: normal on May2021 and scan brain: normal on May2021. Patient was visited to emergency room and physician's office for the events Jaw pain, heaviness in chest, nausea and weakness. Patient was hospitalized for the events experiencing a heaviness in her chest and jaw pain from 30Apr2021 to 02May2021. Therapeutic measures were taken as a result of the events with Escitalopram and Alprazolam. The outcome of the event's severe nausea, shaking from head to toe, felt like burning up inside, jaw pain, Weakness, has zero appetite, anxiety was not recovered and experiencing a heaviness in her chest, she could barely walk with her walker, like she is freezing outside and she could barely walk with her walker was unknown. Information on Lot/Batch number has been requested.

Other Meds: DUPIXENT; Latanoprost

Current Illness: Drug allergy (Verbatim: Unspecified medication allergies); Reaction nonspecific (Verbatim: Unspecified reactions)

ID: 1453715
Sex: F
Age:
State: CA

Vax Date: 05/03/2021
Onset Date: 05/01/2021
Rec V Date: 07/07/2021
Hospital: Y

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Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: she was admitted to hospital with a level 10 headache; The team were considering a diagnosis between a migraine and a neurologic issue; The team were considering a diagnosis between a migraine and a neurologic issue; This is a spontaneous report from a contactable consumer or other non-health care professional (patient's husband). Caller was calling on behalf of wife. A female patient of 50-year-old received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in arm left on 03May2021 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization at Pharmacy. Medical history included ongoing rheumatoid arthritis and patient had this condition for more than 10 years. She had an immune deficiency and was taking a biological to reduce the effects of RA. She was in full remission prior to the vaccination and the doctor recommended coming off biologicals. Concomitant medications included etanercept (ENBREL) taken for rheumatoid arthritis from 2021 and ongoing. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Expiry Date: 28Jul2021/Lot Number: not reported), via an unspecified route of administration, administered in arm left on 12APR2021 as dose 1, single for COVID-19 immunization and experienced mild to moderate headache, rheumatoid arthritis flares up, mild-chills, arm ache, bedridden on an unspecified date in Apr2021. These symptoms all lasted almost up until his wife got her second dose of the vaccine. After the first dose of vaccine, doctor recommended going back to biologics because of a RA flare up. Had been off this medication since Jan or Feb2021, was placed back on it after the first dose of the vaccine. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks of the suspect vaccine. No AE following prior vaccinations. No Family Medical History Provided Relevant to AE. After the second vaccination, on 03May202, the same evening after she received it, the patient developed a level 10 headache. The headache never stopped, and the caller took his wife to the Emergency Room. She was admitted to hospital with a level 10 headache, she saw neurologists, pain management, a whole team, trying to figure it out." The team were considering a diagnosis between a migraine and a neurologic issue on May2021. Patient was hospitalised for 5 days and 4 nights from 22May2021 to 27May2021 receiving care and she was discharged with her case unsolved, with the statement from the doctor's that they could not do anything else for her. All their discharge notes and statements indicate they can't do anything for her. The adverse events level 10 headache resulted in emergency room and physician office visit. His wife has been out of hospital for two weeks now. She was bedridden right now. Patient reported the migraine pain as, "a metal spike inside her skull." She has been this way for 2.5- 3 weeks. It has been relentless and was in a fully debilitated mode. The patient underwent lab tests and procedures which included blood test: unknown, computerised tomogram: unspecified, magnetic resonance imaging: unspecified on May2021. She has had head, neck, and spine CT/MRI scans. Headache was down to a level 7. Treatment included that she was on heavy narcotics and migraines medications. Doctor's determined that the common link was the Covid Vaccine and could be the Pfizer covid vaccine. The caller was asking for a doctor or team they can meet with to discuss her situation and asked did Pfizer have something to treat the person with, or something to reverse the vaccine. Outcome of event was recovered and unknown for Migraine and nervous disorder.

Other Meds: ENBREL

Current Illness: Rheumatoid arthritis (States his wife has had this condition for more than 10 years.)

ID: 1453716
Sex: M
Age:
State: MI

Vax Date: 04/16/2021
Onset Date: 04/01/2021
Rec V Date: 07/07/2021
Hospital: Y

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Symptom List: Injection site pain, Pain

Symptoms: Feeling hot and cold; Cramping; He lost weight in the hospital; He wasn't feeling well; He just had the feeling of being tired; blockage in the lower intestines.; Hard time going to the bathroom; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 64-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot number:ER8732) via an unspecified route of administration administered in left arm on 16-Apr-2021 at 10:30 (at age of 64-years-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient underwent lab test and procedures include cholesterol and result was unknown on unspecified and colonoscopy on 10May2021 result was unknown. It was reported that the patient received the first dose of the Pfizer covid vaccine and was in the hospital for blockage in the lower intestines on 17Apr2021. The patient wanted to know if that is associated with the Pfizer covid vaccine. He stated his nephew was a police dispatcher and got a call where someone else have reported similar issue what the patient has experienced. The patient did not know what vaccine that person had or age and gender of that person. The patient wanted to know about if Pfizer was going to get the FDA approval for the Covid vaccine. The patient reported that he had both doses and he was fine right now but when he had the first dose he was, he got it 16Apr2021 and he had some side effects the next day, on 17Apr2021 he was having cramping and he woke up and was feeling hot and cold and ended up in the hospital with a blockage in his intestine and he was wondering if that could have been anything that was related the vaccine. The patient has lost weight in the hospital, he thinks he was about 145 lbs now. It was reported that the patient was fine the whole day he got the vaccine, he ran errands and did things he needed to do, he went to bed and woke up and felt hot and cold and on 17Apr2021, he was having hard time going to the bathroom. He called his son and told him he wasn't feeling well on an unspecified date in Apr2021 and his son came over and called his other son who is a fireman and he told them to call the ambulance so they did and they took him to the hospital and they couldn't figure out, he was asking them and they had no answer, he just seen on the website and he has been wanting to call but he wasn't going to but he did so that they would have it documented. He confirms when the cramping and feeling of hot and cold and difficulty using the bathroom began it was after midnight and the date was 17Apr2021. When asked if the feeling of hot and cold is ongoing, he says he was in the hospital for 8 days. When asked if the feeling of hot and cold is ongoing or has it recovered, he says he just had the feeling of being tired on an unspecified date in Apr2021 and out of it even after the fact. He does not if it had to do with vaccine or if it was something, he had going on prior to that. The ER doctor told him it was possible that when he got the vaccine whatever could have been going on and put his system in overload. He confirms he was admitted to the hospital due to blockage in the intestine supposedly, the lower intestine. He says that is recovered, everything got taken care of, he had to schedule a colonoscopy after he got out of the hospital. He does not know why they couldn't have done it there while he was in the hospital. He was contemplating the second dose; it was scheduled on 07-May-2021 and he had his scheduled colonoscopy for 10-May-2021 and he didn't know what he should do. People were telling him do it or not to do it but his doctor told him to go ahead and get it so he followed what he said and he did get it. The hospitalization dates were from 17Apr2021 until 24Apr2021 was the day that he got out. He had blood work done for cholesterol in the hospital and he sees a cardiologist doctor for the cholesterol. They did blood work in the hospital every day, he has no idea what the results were. The events feeling hot and cold, cramping and hard time going to the bathroom after midnight and the middle of the night lead the patient to emergency room visit. He didn't know whether to call but it has been playing on his mind. He is sure they have given millions of doses and he did not know if it could be anything to do the vaccine. The outcome of events blockage in the lower intestines, feeling of hot and cold was recovered and outcome of other events was unknown. Follow-up attempts are needed: Further information has been requested.

Other Meds:

Current Illness:

ID: 1453717
Sex: F
Age:
State: FL

Vax Date: 06/05/2021
Onset Date: 06/05/2021
Rec V Date: 07/07/2021
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Symptom List: Injection site pain, Menorrhagia

Symptoms: Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head; This is a Spontaneous case report a contactable consumer(patient). A 17-years-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0196), via an unspecified route of administration on 05Jun2021 at 18:30 into left arm as a single dose for COVID-19 immunization (at the age of 17 years). The patient medical history and concomitant medications were not reported. The historical vaccine includes the patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration on 04May2021 at 19:00 pm into left arm as a single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.On 05Jun2021 at 20:30, patient had Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head. The patient underwent lab tests and procedures which included blood test, computerised tomogram, electroencephalogram, urine analysis was unknown on an unspecified date. The patient was visited to Emergency room/department or urgent care for the events. The patient had received Benadryl as a treatment for the adverse event. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1453718
Sex: M
Age:
State: OK

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 07/07/2021
Hospital: Y

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Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; he was diagnosed with peripheral neuropathy; Pressure, tingling, and numbness in his head and it spread to his arm and leg.; Migraines; Insomnia; Fatigue; This is a spontaneous report from a contactable other health care professional reported via Pfizer sponsored program . A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 13May2021 (Batch/Lot number was not reported) as dose 1, single (age at vaccination 31-year-old) for covid-19 immunisation. Medical history included none. There were no concomitant medications. No Family Medical History Relevant to AE. Prior to vaccination, the patient did not receive other medication within 4weeks. No AE reported following prior vaccination. On 13May2021, Patient started to experience fatigue and that was a normal side effect at approximately 10 am. The tingling and numbness she did not had exact time. While on 19May2021, patient started to have pressure, tingling, and numbness in his head, and it spread to his arm and leg. On unspecified date patient experienced Insomnia and migraines and he went to the doctor for tests to see what was wrong. Everything came back normal. The patient was hospitalized for two nights for the events pressure, tingling, and numbness in his head, and it spread to his arm and leg. Patient visited Emergency Room and Physician Office for the numbness, tingling and head pressure. Therapeutic measures were taken which included, patient has been given ibuprofen. That was what they typically give. It has been diagnosed as a migraine, for tingling given Gabapentin for he was diagnosed with peripheral neuropathy. For Numbness included Pretty much ibuprofen and gabapentin, it's all in one. Fatigue treatment included Gabapentin, they said gabapentin helps and makes sleepy and they increased it today and night because he was having insomnia as well. He was also taking magnesium and vitamin c. The patient underwent lab tests and procedures which included blood magnesium: low, blood test: normal, blood testosterone: low, thyroid function test: normal, vitamin c: low, vitamin d: low on an unknown date. Patient received his normal blood work. His thyroid and other normal labs. No investigation assessment was provided. The outcome for the event Pressure was ongoing it has been off and on recovering, Tingling, and numbness in his head and it spread to his arm and leg was not recovered while Fatigue was recovering, and rest of events outcome was unknown. His second was scheduled for 03Jun2021 and primary care assistant told him not to get the second shot, he only got one dose. Information on the lot/batch, further information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

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Current Illness:

ID: 1453719
Sex: M
Age:
State: CA

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 07/07/2021
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Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: rhythm of the beat of the heart changes; Giving me medications for the heart anti-inflammatories right now; Neurological problems; Heart has been abnormal with rapid beating; Some arm pain and then numbness; Some arm pain and then numbness; Burning in my body; This is a spontaneous report received from a contactable consumer. A 34-year-old male patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN0158), via intramuscular, administered in Arm Right on 07Apr2021 (at the age of 34-year-old) as dose 2, single for covid-19 immunisation. Medical history included tobacco user, I was also smoking a lot of marijuana prior. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208), via unspecified route of administration on 17Mar2021 (at the age of 34-year-old) as dose 1, single for covid-19 immunisation. On an unknown date in 2021, the patient experienced rhythm of the beat of the heart changes, his doctor gave him medications for the heart anti-inflammatories right now, had Neurological problems, heart has been abnormal with rapid beating, some arm pain and then numbness and burning in his body. Reporter stated that "he started getting heavy symptoms a month after receiving the vaccine and it started with his heart. Caller states he has seen a few people with the same side effects that he is experiencing. Caller states he has had heart problems and neurological problems that took place since his second dose of the vaccine on 07Apr2021. Caller states his heart has been abnormal with rapid beating. Caller states he also had some arm pain and then numbness. Caller states after the first dose he received on 17Mar2021 his heart was a little weird but then it went away. Caller states after the second dose and after the first two to three days he noticed his heartbeat was a little different. Caller states he never had issues with vaccines in the past and never had heart or neurological issues before". "I went to go see my doctor and they are giving me medications for the heart anti-inflammatories right now. Yeah, they are giving me aspirin right now and also another drug called Colchicine". "I was eating a lot of junk food and then I was also smoking a lot of marijuana prior but I stopped that like a month ago because I started getting a lot of heart problems a month ago which is almost like a month after the vaccine or a few weeks after. So I didn't get the heart problems like heavy heart problems till later like weeks later and that's just not heart problems there's also like neurological problems like in my brain different sensations and numbness in my body and stinging and burning in my body and also my heart you know It could mean like a rhythm of the beat of the heart changes and stuff like that I never had any issue like that so it must have been the side effect of the vaccine you know I know not a lot of people get it but some people do so I just thought to report it you". The patient underwent lab tests and procedures which included blood test: n/a, electrocardiogram: n/a on an unknown date in 2021. Therapeutic measures taken as a result of events included aspirin and colchicine. The outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1453720
Sex: M
Age:
State:

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 07/07/2021
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Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: he received an infusion at a hospital ' to purify' the blood; pain in back; pain in back then his ribs and then travelled to his chest; pain in back then his ribs and then travelled to his chest; virus in his system from the virus as a result of the pfizer covid vaccine.; he was in a lot of pain; This is a spontaneous report from a contactable consumer. This consumer (patient) reported himself that a 77-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), (at the age of 77-years-old) via an unspecified route of administration on 06Apr2021 as dose 2 single for COVID-19 immunisation. The patient historical vaccine included received first dose of bnt162b2(Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unspecified), via an unspecified route of administration on 16Mar2021 as dose 1 single informed that no reaction on previous exposure to drug. The patient's medical history includes liver transplant about 10years ago. Patient concomitant medications were not reported. On an unspecified date, 3 days after the second shot he developed pain in back then his ribs and then travelled to his chest. He has been to Emergency twice, seen 6 or 7 different doctors; doing testing, had a CAT scan and an echogram. He told this morning that the doctor suspects he has a ' virus in his system from the virus' as a result of the pfizer covid vaccine. Caller asking if we know anything about this and wanting treatment recommendations. Caller unable to clarify what the hcp means. States before he received the vaccine, he was healthy other than a liver transplant about 10 years ago. States he was in a lot of pain-prescribed morphine but did not want to take it. Also states he received an infusion at a hospital to purify' the blood. He felt better after the infusion then 2 hours later it came right back (unclear if caller referring to pain). He was told by his hcp that everything was normal, and they can't find anything wrong. He said he read on the news that people were reporting aches and pains from the pfizer covid vaccine, but he was surprised how long it took for pfizer to acknowledge it. The outcome of the adverse events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1453721
Sex: F
Age:
State: MO

Vax Date: 06/07/2021
Onset Date: 06/01/2021
Rec V Date: 07/07/2021
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Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Shingles; Fever; Slept for 18 hours; Was a little sick with both vaccines; Tired and exhausted; Entire arm hurt so much; Didn't feel well; she has just gained 100 pounds and was normally about 160 pounds.; it was flu-like symptoms; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0217, Expiration date: Unknown) via an unspecified route, administered in Left Arm on 07Jun2021 at 10:00 (46-year-old at vaccination) as a dose 2, single for COVID-19 immunization. The patient's medical history included ongoing thyroiditis, ongoing bipolar depression, ongoing anxiety, ongoing ulcer, ongoing hiatal hernia, ongoing jitteriness, ongoing hand shaking, ongoing nausea, ongoing back pain, ongoing vitamin d decreased and threw back out (back pain). The patient's family history relevant was reported as none. The patient's past medications included Flu shot which made patient sick for 24 hours, Benadryl which caused allergic reaction. The patient's concomitant medication(s) included ongoing levothyroxine 0.125 mg taken for thyroiditis probably from 2009 or 2010, ongoing levonorgestrel (MIRENA) taken for birth control and regulate her menstrual from 3 years ago, her first one was about 2010 or 20211, dextroamphetamine hydrochloride 100 mg daily, taken for bipolar depression from 2003 and ongoing, bupropion hydrochloride (WELLBUTRIN) 600 mg taken for bipolar disorder from 2003 and ongoing; ongoing pantoprazole 80 mg taken for ulcer, hiatal hernia probably from 2016, took 80mg for 7 or 8 months. Before that she took 40mg, ongoing clonazepam 1-3 mg per day taken for anxiety bipolar depression and sleep from about 20 years, ongoing Lamotrigine 400 mg taken for bipolar depression, switched to 400mg about 4 months ago. 300mg before that. Been on it for about 20 years, taken as off-label use drug, ongoing oxcarbazepine 600 mg taken for bipolar depression been on it for about 20 years. About 3 or 4 months ago, it dropped from 900mg to 600mg, propranolol 80 mg, 3 per day as needed taken for Jitteriness from about ago and ongoing, she said there had never been a period when she has been on it consistently, her hand was shaking, metoclopramide (MECLOPRAM) 10mg, 1 or 2 tablets taken for nausea from 2000 and ongoing; ongoing oxycodone 7.5mg -325mg , 1 every 6 hours taken for threw her back out (back pain), Oxycodone: Has Acetaminophen in it. It was first prescribed about 1 1/2 years ago, taken as needed for back every 6 hour, tizanidine 6 mg capsule once or twice per day, taken for back injury from about 25 years ongoing now, ongoing (MULTIVITAMINS [VITAMINS NOS]) took as healthy nutrients, colecalciferol (VITAMIN D3) 50mcg, 2000 IU taken for vitamin D low and tiredness from 7 or 8 year and ongoing folic acid taken to help her regulate menstrual cycle from 20 or 25 years and Benadryl or Tylenol taken for fever within 2 weeks of her covid vaccine shots. No additional vaccines administered on same date of the Pfizer suspect and was not on any other vaccine Prior Vaccinations (within 4 weeks). The patient was not related to any study or programme. The patient was a really healthy person, at least she was before COVID. She worked out. She used to weigh 160 pounds. She had a good BMI and weight before. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route, administered in upper Left Arm on 15May2021 at 15:00 or 15:30 (46-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was sick, tired and had fever after first dose of vaccination. The patient stated that she had no idea if this was really her vaccine or not. They said that if anything weird happened, she should report it because the data was being tracked. On 07Jun2021, she was a little sick with both vaccines, fever for 24 hours and slept for about 18 hours. Her fever broke. She slept and was tired for a day and then she was fine. She said that it was a little bit better. She was taking pain medicine less, maybe every 8 hours during the day. She was taking it every 6 hours at night. She stated that it hurt so much. The patient stated that it was the second part where it got weird. She got the second dose of the injection. People kept telling her they reacted within 12 hours. The patient said that she was down in 3 hours. She had fever and was exhausted. She said this was not shocking for her. Her body tended to do that. She ran a fever of 101. She got it on Monday. She tried to work on Monday. About 2 hours after her shot, her boss kicked her off of her computer and she was sleeping. She was running fever then. On Monday, Tuesday and Wednesday, she did not go to work. Her fever was 101 to 101 plus. Thursday she woke up and felt a little better. Her fever dropped to the higher 99's and lower 100's. It did not go higher than 100.2. The patient said that she took Tylenol and it went down for the most part. She was exhausted and didn't feel well. She said still was not feeling well. It was a different kind of not feeling well. After her shot, it was flu-like symptoms. It was different now that she was having pain. She dragged herself to her desk and worked Thursday and Friday. She functioned on Saturday. She slept during the weekend but she was functioning. Saturday her fever broke completely. On 12Jun2021 (Sunday) she woke up with what she thought was 3 bug bites on her arm. The patient stated that she flipped out. She thought it was 3 bug bites. Her entire arm hurt so much. The patient described it as it felt like a little person was under the skin poking her with needles. The patient stated that she sucked it up until Wednesday morning because she tended to do stuff like that. Then she started running a fever again. It started about 99.2 and jumped to 99.8. The bites were still there and she didn't feel well. She stated that her fever was still in the 99's. She normally ran low at 97.2 or 97.4. It was definitely better. It was down in the 99's. The patient stated that he doctor on 16Jun2021 took one look at what the patient thought was bug bites and she said she had shingles. She was put on antibiotic and pain medicine. On Wednesday afternoon she was exhausted and didn't feel well. She took a 2-hour nap. She was busy at work and forced herself to keep working. The patient reported that she was on day 3 of the antibiotic. It definitely still hurts if she doesn't take the pain medicine. She was still running a fever under 101 but over 100. The patient was still working because she doesn't have a choice. She stated that she has just gained 100 pounds and was normally about 160 pounds. Her body was not use to this, she doesn't know if that was flipping her body out or not, it was flipping her out though. The patient consulted her primary HCP to know if there was a possible connection with the shingles and vaccine. But HCP didn't really tell her about it. She was totally shocked. She thought she could only have shingles if she didn't have the chicken pox as a kid. wanted to know if shingles was an unusual or common side effect. She stated that bumps from the shingles started 12Jun2021 or 13Jun2021. She thought she had banged her arm on something when she was working on her apartment. She still had the bumps. They were getting slightly bigger, and she still had pain. They were a little redder around the edges. She stated that the little dude under the skin was still poking. She said the pain medicine was working. She barely had pain with the pain killers. She stated that she got the second dose 07Jun2021. She was supposed to get it on 06Jun2021, but she had to push it off a day. She did not have any tests for the shingles. She said that both the doctor and a nurse practitioner looked and diagnosed her with shingles. The patient received antibiotics and pain medication as treatment medication for Shingles. The patient had not visited emergency room. She visited physician office for 3 bus bites on her arm, shingles

Other Meds: LEVOTHYROXINE; MIRENA; DEXTROAMPHETAMINE HYDROCHLORIDE; WELLBUTRIN; PANTOPRAZOLE; CLONAZEPAM; LAMOTRIGINE; OXCARBAZEPINE; PROPRANOLOL; MECLOPRAM [METOCLOPRAMIDE]; OXYCODONE; TIZANIDINE; MULTIVITAMINS [VITAMINS NOS]; VITAMIN D3; FOLIC ACID

Current Illness: Anxiety (Verbatim: Anxiety); Back pain (Verbatim: Back pain); Bipolar depression (Verbatim: Bipolar Depression); Hiatal hernia (Verbatim: Hiatal Hernia); Jitteriness (Verbatim: Jitteriness); Nausea (Verbatim: Nausea); Shaking of hands (Verbatim: Hand shaking); Thyroiditis, unspecified (Verbatim: Thyroid); Ulcer (Verbatim: Ulcer); Vitamin D low (Verbatim: Vitamin D low)

ID: 1453722
Sex: F
Age:
State: OR

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 07/07/2021
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Symptom List: Nausea

Symptoms: two days post first vaccine onset of early, heavy bleeding.; Anatomical Location: Leg Left; This is a spontaneous report from a contactable consumer. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 08Apr2021 13:00 (age at vaccination 37 year) (Batch/Lot Number: EW0151) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included none. Concomitant medications included ibupropion taken for an unspecified indication, start and stop date were not reported. It was reported that adverse event Despite having little to no period with IUD, two days post first vaccine onset of early, heavy bleeding (medically significant) on 01May2021 08:00. Stopped after 7 days. Two days after second vaccine, extreme bleeding for 3 full weeks so heavy that my body expelled my IUD. Sought treatment from OBGYN. Had to take four progesterone pills a day for four days to get bleeding to stop and she still taking them 6 weeks after vaccine. Patient received treatment as Progesterone; scheduled uterine ablation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event Anatomical Location was Leg Left was unknown. Outcome of the other event was recovering.

Other Meds: BUPROPION

Current Illness:

ID: 1453723
Sex: F
Age:
State: AR

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 07/07/2021
Hospital: Y

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Symptom List: Injection site pain

Symptoms: Syncope and Fainting; Dizziness; blood pressure goes up; sick; Bradycardia; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking;; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking;; affecting her memory, she can't concentrate or focus, something is happening neurological with her thinking;; made a rash, the skin has a different texture where they injected the shot; Sore Arm; feels a heat rush like she is about to pass out; rash; feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps; This is a spontaneous report from a contactable reporter (LPN). This 50-year-old consumer reported for herself that: A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot number:EH9899) via an unspecified route of administration, administered in Arm right on 23-DEC-2020(at the age of 50-year-old) and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1284) via an unspecified route of administration, administered in Arm Left on 13Jan2021 at 09:00 as SINGLE for covid-19 immunisation. Medical history included blood pressure measurement. There were no concomitant medications. On 23Dec2020, the patient experienced dizziness, syncope and fainting, Bradycardia, blood pressure goes up, feels a heat rush like she was about to pass out, affecting her memory, she cannot concentrate or focus, something is happening neurological with her thinking, made a rash, the skin has a different texture where they injected the shot, can see and feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps, Sore Arm. but she took Aleve and it was gone in 2-3 days. On 24Feb2021 got very sick, dizzy, and lightheaded, and when she got there, her blood pressure was extremely high. The patient received treatment with Aleve, Hydralazine 10 mg, Amlodipine 25mg.The patient had Recovered from sore arm on 26Dec2020, not recovered from dizziness, syncope and fainting, feels a heat rush like she was about to pass out, affecting her memory, she cannot concentrate or focus, something is happening neurological with her thinking, made a rash, the skin has a different texture where they injected the shot, can see and feel the bump there; like how when a person gets burned and the skin feels different, lots of little bumps and Unknown for Bradycardia, blood pressure goes up.; Sender's Comments: Based on the strong temporal relation, the association between the events syncope, dizziness, blood pressure increased and illness and the vaccination cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1453724
Sex: F
Age:
State: NJ

Vax Date: 02/24/2021
Onset Date: 06/17/2021
Rec V Date: 07/07/2021
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Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Patient contracted COVID-19 on 17Jun21 and went for testing on 20Jun2021 which was positive.; Patient contracted COVID-19 on 17Jun21 and went for testing on 20Jun2021 which was positive.; This is a spontaneous report received from a contactable Other HCP (other health professional). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247) via intramuscular at single dose at age of 35-year-old in left arm for COVID-19 immunization, the first dose was on 03Feb2021 (Lot#: EL3247), the second dose of on 24Feb2021 11:15 AM (Lot#: EL3247). Medical history and concomitant medication received within 2 weeks of vaccination were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient contracted COVID-19 on 17Jun2021 and went for testing on 20Jun2021 which was positive. Covid test on 20Jun2021 was positive. The event resulted in doctor or other healthcare professional office/clinic visit. The events was assessed serious due to medically significant, not resulted in death, not life threatening, not caused/prolonged hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug BNT162B2.

Other Meds:

Current Illness:

ID: 1453725
Sex: F
Age:
State: TN

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 07/07/2021
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Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Rash on arm; Sore shoulder; Under arm hurts really bad; There is a lump where she received the vaccine and under her am/Knot in underarm and where they put injection; Neck was swollen; Lymph nodes were swollen; Had trouble breathing/couldn't hardly breathe; Flu-like symptoms; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0171) via an unspecified route of administration, administered on the left arm on 19Apr2021 13:00 as dose 2, single for COVID-19 immunization. The patient had no medical history and no family medical history relevant to AE. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 24Mar2021 for COVID-19 immunization with no reaction on previous exposure to drug (lot number/expiry date: ER8730/ Unknown, Anatomical Location: Left arm at 19:00). She reported sore shoulder, under arm hurts really bad. There was a lump where she received the vaccine and under her am. Her neck was swollen, lymph nodes were swollen, had trouble breathing, and had a rash but all those have resolved. "Anyone else reported this?" Patient said she received her second Pfizer vaccine on 19Apr2021, and she still has a really sore shoulder and her underarm hurts real bad. She asked her pharmacist about it, and they told her to call Pfizer. She reported shortly after having the second one, the lymph nodes in her neck swelled up and she had a rash on her arm that last about two weeks, but now just has a pain in her arm, almost felt like she has a knot in it and was hurting in her underarm as well. States she got both shots in the same arm. Patient stated that really sore shoulder and underarm hurts real bad started about one week after on 27Apr2021 10:00, and still persisting. Knot in underarm and where they put injection: stated when you press on it, it stings, and was still persisting. She clarified when she says underarm she means in the middle of her armpit. Rash on arm (where they put injection in), hard to breathe and Lymph nodes swelled in neck started about one week after on 27Apr2021, resolved. Caller does not provide date this resolved. She does not have any problem with her neck anymore just her arm and her underarm. Flu-like symptoms: she stated it occurred the day after, but that's normal, and only lasted a day. States it started around 10:00 the next day, 20Apr2021, as soon as she woke up. The other stuff started a week later about the same time of day, when she woke up. Investigations: she went to the doctor and they thought she may have had COVID and they tested her and it came back normal, she didn't have it. Stated she woke up that morning and couldn't hardly breathe, felt like she only had a tube or straw to breathe through. She confirmed that was a week after the dose. They did a flu test as well. Treatment: she took Advil for the fever, she took two of the 200 mg ibuprofen tablets, the day after. She took Benadryl Allergy for the arm rash and it cleared it up pretty quick. Took one 25 mg tablet. They put her on prednisone, and she took it and it made her heart race, so she didn't take it very long. She does not have the product available, she threw it away when it was bad, so she does not have Lot, NDC, Expiry date to provide. The event hard to breathe require a visit to the Physician Office. The facility where the vaccine was administered was in a Pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures on 27Apr2021 which included Flu test: negative and Covid test: normal. Outcome of the events neck was swollen, lymph nodes were swollen, difficulty breathing, flu-like symptoms recovered on an unspecified date in 2021 while not recovered for the other events.

Other Meds:

Current Illness:

ID: 1453726
Sex: F
Age:
State: TN

Vax Date: 06/20/2021
Onset Date: 06/20/2021
Rec V Date: 07/07/2021
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Symptom List: Tremor

Symptoms: They said it was an ovarian cyst rupture; Around 8 pm she started screaming in pain; feeling nauseous; feeling nauseous and dizzy; This is a spontaneous report from a contactable consumer (patient). A 15-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jun2021 12:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 2, SINGLE for covid-19 immunisation. Administered is Pharmacy or Drug Store. Medical history included asthma and no known allergies. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30May2021 11:00 at age of 15 years old (Batch/Lot Number: EW0196) as Dose 1, SINGLE for covid-19 immunisation. After her 1st covid shot on 30May2021 and then had her period on 02Jun2021. It was 4 days early and was the worse period she has experienced in 3 years. She was bleeding excessively and extreme cramps. It maybe a coincidence. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported; salbutamol (ALBUTEROL HFA) taken for an unspecified indication, start and stop date were not reported. After her 2nd covid shot on 20Jun2021 around 12 noon. Around 8 pm she started screaming in pain, hunched over, feeling nauseous and dizzy. Patient had clinic visit, ended up taking to ER where they gave her morphine for pain. They started IV, did bloodwork, ultrasound and ct scan with contrast all on 20Jun2021. They said it was an ovarian cyst rupture. Patient was only 15 years old and has had her period for 3 years and has never experienced anything like what she has in the last month. She is due for her next period on 29Jun21 and pray it's not as bad as last month after the shot. They do believe in science, but also think should study menstrual cycles with this shot. They pray this was just a fluke, but patient has never experienced pain or severe periods like this until shot. Treatment received for all events. The outcome of events was not recovered. Information on Lot/Batch number was available. Additional information has been requested

Other Meds: TYLENOL; ALBUTEROL HFA

Current Illness:

ID: 1453727
Sex: F
Age:
State: WA

Vax Date: 06/10/2021
Onset Date: 06/18/2021
Rec V Date: 07/07/2021
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Symptom List: Erythema, Pruritus

Symptoms: Early Miscarriage the week following the second vaccine- following 2 previous positive pregnancy tests; This is a spontaneous report from a contactable consumer (patient). A 31-years-old female pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right at age of 31 years on 10Jun2021 11:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included diagnosed with COVID-19 Prior to vaccination. The patient's concomitant medications were none, no any other vaccines within 4 weeks prior to the COVID vaccine; no any other medications the patient received within 2 weeks of vaccination. The patient previously took BNT162B2 dose 1 in left arm at age of 31 years on 21May2021 13:00. The patient experienced early miscarriage on 18Jun2021 17:00 the week following the second vaccine- following 2 previous positive pregnancy tests (Seriousness criteria reported as congenital anomaly/birth defect). Last menstrual date was 19May2021 and due to deliver on 22Feb2022. Since the vaccination, patient has not been tested for COVID-19. No treatment was received. The outcome of the event was recovered with sequelae in Jun2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1453728
Sex: M
Age:
State: VA

Vax Date: 06/10/2021
Onset Date: 06/10/2021
Rec V Date: 07/07/2021
Hospital:

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Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: Heart pain worse lying down and on exertion- stayed propped up; Can't think well; Brain fog; Chest pains and discomfort; Chest pains and discomfort/ felt like a elephant on chest; Reduced ability to ambulate due to chest pain; Tachycardia; Had fever (102 f); My arm was more swollen than the time before; The pain was more delayed than the time before/pain over hours spread across my upper back into my right arm and chest and back; Chest back pain worse with movement; Could not stand for two days due to pulse getting even higher standing.; Could not stand for two days due to pulse getting even higher standing.; Entire upper torso hurt.; Felt short of breath/ it hurt to breathe in; it hurt to breathe in; had to use urinals from bed because pulse; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Jun2021 15:30 (at age of 38 years old, Lot Number: EW0180) as a single dose for covid-19 immunization. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lorazepam, diazepam, paroxetine, bisoprolol. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 20May2021 12:15 PM (at age of 38 years old, Lot Number: EW0167) as a single dose for covid-19 immunization. The patient experienced brain fog and chest pains and discomfort, reduced ability to ambulate due to chest pain, tachycardia, had fever (102 f). After receiving the vaccine on 10Jun2021 22:00, the patient arm was more swollen than the time before and the pain was more delayed than the time before. This time the injection pain over hours spread across my upper back into he right arm and chest and back. He had tachycardia and had to increased beta blocker (bisoprolol). Could not stand for two days due to pulse getting even higher standing. Temp of 102. Entire upper torso hurt. Heart pain worse lying down and on exertion-stayed propped up. Chest back pain worse with movement. Felt short of breath. Thought had caught COVID while getting vaccine tested three times, was negative each time. Chest pain and tachycardia slowly improving, but brain fog has been impossible. Can't think well. Having moment of clarity now which was why writing now. It hurt to breathe in, felt like elephant on chest, had to use urinals from bed because pulse. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received included Increased bisoprolol dosage for tachycardia. Since the vaccination, the patient had been tested for COVID-19. Nasal Swab, Pixel by on 15Jun2021 was Negative. The outcome of the events " Chest pain and tachycardia" was recovering, for event " Can't think well, Brain fog" was not recovered. The outcome of other events was unknown.

Other Meds: LORAZEPAM; DIAZEPAM; PAROXETINE; BISOPROLOL

Current Illness:

ID: 1453729
Sex: M
Age:
State: MN

Vax Date: 03/01/2021
Onset Date: 03/19/2021
Rec V Date: 07/07/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for three patients. This is the first of three reports. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 01Mar2021 (at 71-year-old) as dose 2, single for COVID-19 immunization. Medical history included that he had the cholesterol of a twenty year old, the month prior to getting the second vaccine, he had a yearly work up of his heart and cholesterol and all that, they put a heart monitor on him to be sure everything was fine with that, and he had gotten a clean bill of health. He had never had any sort of medical situation or even surgeries until two years ago (2019), when he had a knee replacement, and he had a history of shingles, he got about fifteen years ago (2006) and they never really went away, so he's had on and off for the past fifteen years. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9267), via an unspecified route of administration, administered in left arm on 10Feb2021 (at 71-year-old) as dose 1, single for COVID-19 immunisation. The patient had two strokes on 19Mar2021 (reported as eighteen days after his second vaccine) and has been in the hospital ever since. He has developed anemia, he had muscle atrophy, and he was experiencing persistent fevers. He said that its like his blood was fighting/contradicting himself and they were pretty sure that it was from the vaccine. He already had 1 blood transfusions and his white blood cells were low and his ANC (absolute neutrophil count) was normal. Caller said nothing medically makes sense. She said it's like the vaccine changed the protein in the blood. The patient has had test after test after test, has had strokes in the medulla cerebellum, his hemoglobin won't stay above seven, he's had multiple blood transfusions, with signs of inflammation and infectious disease, but nothing in his body told them. No scans, blood tests, surgery, biopsies, ultrasound, he's literally had every test. Caller added patient was dying, and they didn't know why. He remained hospital from 23Mar2021 until he went home on 15Apr2021. While in rehab, patient started developing fever of unknown origin, that they can't figure out. On 25Apr2021, the patient went to the emergency room. He was home ten days and was declining that whole time, with fever up and down, lost cognition, really confused, which they thought was a result of stroke, but he was declining rapidly. He had fell a bunch, started losing muscle, muscle started atrophying at that point. When they took him in on the 25Apr2021, it's because his blood pressure dropped, another issue that started all of this, he could not maintain his blood pressure, if he sat up and moved, it would drop. And that day when he tried to stand and it dropped and he slid down. They took him to the emergency room and he had a potassium deficiency and they gave him potassium. He went home that day after the potassium. Then on 27Apr2021, he went back to hospital, into their emergency room, and spent a couple days in the ER, but was admitted into a room once available and stayed until 15May2021, when they transferred him from there. He remained here from 15May2021 to 21May2021. They were wanting to transfer him to another hospital. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1453730
Sex: U
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 07/07/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: stroke; hemoglobin won't stay above 7; anemia; muscle atrophy; persistent fevers; inflammation; infectious disease; white blood cells are low; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports which corresponds to the second person the reporter knew who experienced the same events as her father. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer was reporting for her father and mentioned that she personally knew two people who had the same situation in the blood as her father. It was reported that the patient experienced stroke, hemoglobin won't stay above 7, anemia, muscle atrophy, persistent fevers with signs of inflammation and infectious disease, and low white blood cells. The patient had been in the hospital for three months (90 days). Therapeutic measures were taken as a result of the events. The consumer mentioned that Pfizer has reached out to them and gave them some sort of medicine that helped regulate the blood. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021751102 same reporter and drug, similar events, different patients;US-PFIZER INC-2021748630 same reporter and drug, similar events, different patients

Other Meds:

Current Illness:

ID: 1453731
Sex: F
Age:
State: NY

Vax Date: 02/06/2021
Onset Date: 02/08/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Caller states she suffers from Bipolar disorder; Deep depression; This is a spontaneous report from a contactable consumer (patient). A 74-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 06Feb2021 18:00 (Lot Number: EN9581, Expiry Date: May2021) as single dose; dose 2 via an unspecified route of administration, administered in arm left on 27Feb2021 12:30 (Lot Number: EN6201, Expiry Date: Jun2021) as single dose, both dosage at the age of 74-year-old for covid-19 immunisation. Medical history included kidney stones, psoriasis, stenosis, compressed discs in her back, scoliosis back and neck, arthritis of hips, shoulders, knees and fingers , anxiety, ADHD (attention deficit hyperactivity disorder), hypothyroidism, manic period, depression. Family Medical History included patient thought her mother was depressed not after a vaccine just generally depressed and her brother was bipolar, an undiagnosed person. Concomitant medication(s) included clonazepam (KLONOPIN) taken for anxiety from an unspecified start date awhile ago and ongoing; methylphenidate hydrochloride (CONCERTA) taken for ADHD (attention deficit hyperactivity disorder) from an unspecified start date awhile ago and ongoing; methylphenidate hydrochloride (RITALIN) taken for ADHD from an unspecified start date awhile ago and ongoing (patient clarified the concomitant medications are not related to the bipolar specifically and it had also been determined that she had the thing when you are active all the time or when you are little you get this medication for being too active); levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date about 3-4 years ago and ongoing. No additional vaccines administered on same date of the Pfizer suspect. Patient previously received desvenlafaxine succinate (PRISTIQ) for depression; had been on aripiprazole (ABILIFY) 10mg and was reduced to 5mg about a year and a half ago because she had a manic period and reducing the mood stabilizer was one of the things the doctor did to try to stabilize her, she started taking Abilify awhile ago and she went up to the 10mg when she experienced depression. Patient stated she suffered from Bipolar disorder and what happened after the 1st injection was she experienced a descending depression that started probably the 2nd day after on 08Feb2021. Patient stated she then got her 2nd shot and went into a deep depression and continued in a downward sweep. Patient stated it just got worse after the 1st dose and went to a deep depression like bottom depression. Patient stated her psychiatrist shifted her medications and changed one of the medications and shifted a dosage of another, she took her off Pristiq 100mg every day that she had started years ago. Patient stopped taking that when she contacted her doctor and he switched her over by the 3rd day after the 1st dose of the vaccine to venlafaxine hcl (EFFEXOR), she was switched to Effexor 150mg once a day and she started the day after she stopped the Pristiq. As she kept getting worse he upped her Effexor to 225mg, she took a 150mg and a 75mg each day, after about a week and she kept getting worse. After her 1st vaccination he changed her Abilify which was a mood stabilizer from 5mg to 10mg once daily, she started taking that the same day, the 2nd day after the 1st vaccine. Patient stated she also took Oxybutin but she started that after she had the vaccine and was not relevant. Patient stated her provider was monitoring her carefully and she took awhile to get out of it, it was about 1 month to feel semi human and it has totally resolved now and that would have been about after 2 months. Regarding the onset of events, the patient guessed it started in the morning, she was not getting up in a very good mood. The events did not require a visit to Emergency Room while it could have, her therapist was pushing for that but her psychiatrist said no wait and see what happens, patient stated she was very deeply down and her deeply down can turn into suicide. The events resulted physician office visit. No relevant tests. Outcome of the events was unknown.

Other Meds: KLONOPIN; CONCERTA; RITALIN; SYNTHROID

Current Illness:

ID: 1453732
Sex: M
Age:
State: NJ

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: fever 104 degrees Fahrenheit; Chest pain; Shortness of breath; leg swelling; Dizzy; achy muscles; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; Caller received the first dose on 08 Apr 2021. He received the second dose on 24 Apr 2021.; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171 and Expiry date: Unknown) via an unspecified route of administration on 24Apr2021(at the age of 22-years-old) as Dose 2, Single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 08Apr2021(at the age of 22-years-old) as Dose 1, Single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any treatment and diagnosed with COVID 19 and has not been tested for COVID-19 since the vaccination. On 25Apr2021,the patient experienced fever 104 degrees Fahrenheit, chest pain, shortness of breath, achy muscles, leg swelling, dizzy. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date, electrocardiogram: unknown on an unspecified date, full blood count: unknown on an unspecified date, pyrexia: 104 Fahrenheit on 25Apr2021 104 degrees Fahrenheit ,sars-cov-2 test: unknown on an unspecified date, x-ray: unknown on an unspecified date. Therapeutic measures were taken as a result of fever 104 degrees Fahrenheit (pyrexia) and treatment included Tylenol immediately. She took him to the hospital, and he was given more Tylenol. He was discharged from the emergency room 6-10 hours later. His temperature did go down to 99 and then to normal range. The outcome of events fever 104 degrees Fahrenheit, pain, achy muscles, achy muscles, leg swelling, dizzy was recovered and outcome of shortness of breath recovering while the outcome of inappropriate schedule of vaccine administered and off label use was unknown. Follow-up needed. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1453733
Sex: F
Age:
State: LA

Vax Date: 03/13/2021
Onset Date: 04/01/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Prolonged neutropenia; This is a spontaneous report from a contactable Physician. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6204), via Intramuscular route of administration in the Left arm, on13Mar2021 at 06:00 AM, as single dose for COVID-19 Immunisation (age at vaccination:63-year-old). Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9210), via Intramuscular route of administration in the Left arm, on 10Feb2021 at 07:00 AM, as single dose for COVID-19 Immunisation. On 01Apr2021 at 12:00AM, the patient experienced prolonged neutropenia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Neutropenia and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1453734
Sex: F
Age:
State: NY

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 07/07/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: she got her first vaccine dose and "1 week later I caught covid".; This is a spontaneous report from a contactable consumer reported for herself. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number & Expiry date not reported) via an unspecified route of administration on Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient is asking for guidance on getting her second vaccine dose after having covid. Reported that back in March she got her first vaccine dose and "1 week later I caught covid". Caller reports that she was treated in the hospital with Remdesivir. Upon follow up (22Jun2021) patient stated in march she had COVID and then she was treated for which rest of year in hospital and was told wait to 90 days to get the 2nd shot. This past Sunday the 90 days were up and when she went to schedule the second shot and she was told "I have to start the series over". Caller reports that she spoke with her doctor who told her he had not heard of that and that he understood that you wait 90 days and then get the second shot. Patient enquired indeed do I need to now take two more dose of the vaccine even though I have one over 90 days ago. The Outcome of event was unknown. Follow-up(22Jun2021)This is a spontaneous report from a contactable consumer. This Female consumer (patient) reported for herself that: new information was obtained regarding treatment of Covid-19 Follow-up attempts are needed; information about lot/batch number can be obtained

Other Meds:

Current Illness:

ID: 1453735
Sex: M
Age:
State: FL

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Inflammation arm/face/ left hand; Hand pain more intense; Vertigo; This is a spontaneous report from a Non-contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9263) via an intramuscular route of administration in upper right arm on 02Feb2021 at 13:30 as 1st dose, single for covid-19 immunization. Patient medical history included Diabetes from 1993 and its ongoing, Cancer from Jul2017 to Nov2018 and done Chemo, lumpectomy, Radiation, Inflammation in both wrists hands (7 incisions in left hand) on 30May2020, both knees completely replaced (8Oct + 18Nov). Both knees, however right knee collapsed & it had to be redone same day time. Family history included High blood pressure, diabetes, inflammation (back and knees) and stroke. Patients concomitant medications included hydrocodone bitartrate, paracetamol (HYDROCODONE/ACETAMINOPHEN) from 2019 and its ongoing for pain and diclofenac sodium from 2020 and its ongoing for inflammation, take 3 meds for blood pressure, cancer med, diabetes med, HBP med, depression med and cholesterol med. The patient previously took second dose of shingles vaccine on 11Jan2021 for immunization. On 03Feb2021, patient experienced vertigo, vertigo remained on and off, inflammation of arm, face and left hand. Hand pain was more intense. Patient took second dose BNT162b2 on 24Feb2021 (Lot No: EN6200) and experienced fatigue. The patient underwent lab tests and procedures which included Blood pressure measurement: 137/70 mmhg on Dec2020 and HbA1C (Glycosylated haemoglobin): 6.9 on Nov2020. Serious criteria for event Inflammation arm/face/ left hand was reported and hand pain more intense as important medical event and for vertigo it was persistent /significant disability/incapacity. The events did not require any treatment. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: HYDROCODONE/ACETAMINOPHEN; DICLOFENAC SODIUM

Current Illness: Diabetes

ID: 1453736
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: little bit of bleeding, like menses, vaginal bleeding; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient's husband). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a little bit of bleeding, like menses, vaginal bleeding. Patient had bleeding the following night, after the first dose. The outcome of the event was unknown. Additional information has been requested and will be provided as it becomes available.

Other Meds:

Current Illness:

ID: 1453737
Sex: F
Age:
State: VA

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: swelling in her ankle and foot before the second vaccine; She had feet swelling before she has taken the first dose of the vaccine but it had worsen after getting the Pfizer COVID-19 vaccine.; her feet to swell/She had feet swelling before she has taken the first dose of the vaccine; tumor markers to increase/ jumped about 400 points; inflammation in the body; This is a spontaneous report from a contactable consumer. A 66-years-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided) via intramuscular route administered on 26Jan2021 as Dose 1, Single for COVID-19 immunization. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not provided) via intramuscular route administered on 16Feb2021 as Dose 2, Single for COVID-19 immunization. The patient's medical history included Metastatic stage 4 breast cancer. The patient's concomitant medications were not reported. Right now, reporter's wife has a spike in her tumor marker. They have laboratory tests every month. There has been no progression of cancer but the tumor marker was doubled. This happened 6 weeks after getting the vaccine. Their oncologist is also perplexed by this matter and they think it might be possibly from the vaccine. Not long after, she was having other issues from the medications she was on. It caused her feet to swell. Reporter wanted to know if there were any reported cases of swelling causing the tumor markers to increase. Her tumor markers had been positive for a long time. The tumor marker after the last shot went down 01Mar2021. The next one that was 4 weeks later almost doubled. That was on 30Mar2021. Also stated that his wife had also been taken off of some medications and it was very possible that it was the medications that allowed the spike to occur and was wondering if the swelling sort of reaction would continue to show up in the monthly lab work. The patient experienced swelling in her ankle and foot before the second vaccine/ it was going on for several months, she had feet swelling before she has taken the first dose/her feet to swell of the vaccine (reporter attributed this as an AE of another cancer drug his wife is taking) but it had worsen after getting the Pfizer COVID-19 vaccine, her feet to swell, tumor markers to increase/ jumped about 400 points, and inflammation in the body on an unspecified date. The patient underwent laboratory tests and procedures which included tumor marker was went down on 01mar2021 and almost doubled on 30mar2021. The outcome of the evets was unknown. Information regarding the Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1453738
Sex: F
Age:
State: IN

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: diagnosed with autoimmune hepatitis type 1; 10.87 igG index/ spike protein igg 10.87; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 16Mar2021 (at the age of 68-year-old) as dose 2, single for COVID-19 immunisation at community hospital (to get protection from covid). Medical history included auto immune hepatitis type one, had fat in her liver, her liver was enlarged from an unknown date and unknown if ongoing. Concomitant medications included azathioprine taken for autoimmune hepatitis from 30Apr2021 to an unspecified stop date. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration on 19Feb2021 (at the age of 68-year-old) as dose 1, single for COVID-19 immunisation at community hospital and no reaction on previous exposure to vaccine. Investigation assessment was provided. It was reported that the patient's doctor called her on an unknown date in Jan2021 to get her liver levels test. The patient was diabetic and gets her liver levels tested four times a year. On an unknown date In Jan2021, her numbers were high, but not that high. She did not have any tumors or anything. She got an ultrasound done that showed she had fat in her liver, and her liver was enlarged. Last week, the patient went for an antibody test. Her test results said spike protein igg 10.87. She got a scan/fibroscan also, saw a hepatologist/ internist doctor at the hospital who ran some tests and did a liver biopsy. The pathologist told her that she had auto immune hepatitis type one. That was the bad news about the auto immune disease. But the good news was that there was an immune suppressor medication that was very successful, that she was taking. She was at stage one. The medication was supposed to make it better, or it may cure her completely. She must be on it for 2 or 3 years and will find out later. She read that the vaccine may not be effective to people with auto immune diseases. She called her immunologist, and he said she can get this test. She got a blood test last Friday, and her results came back on "Friday" evening. The patient would like to know what information Pfizer has on immunosuppressed patients who take the covid vaccine. She was asking what does the 10.7 mean. The reporter did not specify any seriousness for events. The patient underwent lab tests and procedures which included Antibody test, spike protein igg: 10.87 (unknown units), liver biopsy: auto immune hepatitis type one, blood test with unknown results on an unknown date. The patient received the treatment for all events. The outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.

Other Meds: AZATHIOPRINE

Current Illness:

ID: 1453739
Sex: F
Age:
State: NY

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: got infected with covid-19; got infected with covid-19; fractured a bone; got hurt; This is a spontaneous report from a contactable other healthcare professional (hcp). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date not reported), via an unspecified route of administration in Feb2021 as dose 1, single covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got hurt and had fractured a bone around 3 weeks when she was due for 2nd dose (2021). So, patient waited to recover but got infected with covid-19 (2021). She was better now but asked what steps to take next regarding the dose if she should get the 2nd dose or not. She has an appointment this Saturday (date unspecified) so she would appreciate any guidance as soon as it is available. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Drug causality for suspect drug in the onset of the reported events cannot be excluded, in acontext of LOE, for event Covid, other reported events unrelated.

Other Meds:

Current Illness:

ID: 1453740
Sex: M
Age:
State: UT

Vax Date: 05/28/2021
Onset Date: 06/07/2021
Rec V Date: 07/07/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Hearing loss; This is a spontaneous report from a contactable consumer (patient). A 31-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0187; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 28May2021 at 16:30 as single dose for COVID-19 immunization at Pharmacy or Drug Store. The patients medical history and concomitant medications were not reported. Patient did not have covid prior vaccination. Patient did not receive any other vaccine in four weeks prior to the COVID vaccine nor any other medications received within 2 weeks of vaccination. On 07Jun2021 at 07:00 the patient experienced hearing loss. No treatment was received for adverse event (AE). Patient had not tested for COVID-19 post the vaccination. The outcome of event was not recovered. Information on the lot/ batch number has been requested.

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Current Illness:

ID: 1453741
Sex: M
Age:
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Vax Date: 03/03/2021
Onset Date:
Rec V Date: 07/07/2021
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Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report received from a contactable Pharmacist. This Pharmacist reported for a male patient via medical information team. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 03Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the reporter was a pharmacist and stated he had patient who received his first dose of the Pfizer COVID-19 on 03March2021 and when it was time to get his second dose, he tested positive for COIVD-19 and was advised to wait 3 months before getting his second dose. The reporter would like to know how to proceed and can the patient receive the second dose of the vaccine. The events were reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date in 2021. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1453742
Sex: F
Age:
State: MA

Vax Date: 02/04/2021
Onset Date: 02/01/2021
Rec V Date: 07/07/2021
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Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Flare of her RA/ rheumatoid arthritis really got bad and painful in joints; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) via an unspecified route of administration in left arm on 04Feb2021 at 12:30 as dose 1 single (at the age of 77-year-old) and also received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6200) via an unspecified route of administration in left arm on 25Feb2021 at 14:00 as dose 2 single (at the age of 77-year-old) for COVID-19 immunization. Medical history included illness at time of vaccination, rheumatoid arthritis, blood pressure, cholesterol, occasional spastic bowel, blood type: Rh-Negative. No investigation assessment was reported. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history relevant to adverse event were reported as none. Concomitant medications included methotrexate 2.5 mg, weekly (2.5 mg tablets orally. Takes 9 tablets by mouth once a week) for Rheumatoid arthritis from 23 years, atorvastatin 40 mg, daily for Cholesterol (had been taking 10-15 years), atenolol 25 mg, daily for Blood pressure (Had been taking 10-15 years), hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ) daily (37.5/25 mg) for fluid retention and blood pressure (Had been taking 10-15 years). The patient experienced flare of rheumatoid arthritis, it really got bad and pain in joints lasted about 5 weeks before she contacted the rheumatologist, started around 17Feb2021 or 18Feb2021 and had subsided. She had flares on occasions and when agent asked her about documenting the experience, she added that there was no way to be proven whether it was due to the shot or that she came off her medication. Patient stated it subsided within a couple days of going on the prednisone, some time in Apr2021. Patient stated it took about six weeks to get back. Patient stated she had both vaccine shots from Pfizer back in Feb2021 and a couple weeks ago, she heard on the news, and some friends have told her about it since, and she did check it out online, that a study was done at the same time, on the effectiveness of the Pfizer vaccine on patients who had been on methotrexate. Patient stated the findings were that those patients, in four control groups, were 62% covered on the vaccine versus the 95%. Patient added that means some were above 62%, and some were below. Patient stated she was curious because she's been on methotrexate for 23 years, she did stop it the week before and after each shot. Patient asked was there any way of finding out her own personal protection. Patient stated she did call her doctor about antibody testing, and the doctor told her she was not sure what it would show her, since she's not under a controlled situation, with exact dates that she stopped taking and retook it, also she had a flare at that time, about two weeks after the shot, where her rheumatoid arthritis really got bad and painful in joints. Patient stated it took about six weeks to get back. Patient stated she would have the flares on occasions anyway. Patient clarified this was not why she called and adds that when she mentioned it to her rheumatologist, she was told insurance would not cover it because she was not classified under any research program. Patient stated she did not go to the doctor, she suffered with it until her primary said call your doctor, call you rheumatologist for the pain. Did not go to the doctor, only called because it was covid time and everything was either via phone or video. Stated her rheumatologist has known her long enough to feel safe diagnosing. Not required to visit Emergency Room and Physician Office. Patient again stated she was not sure the event reported was from the vaccine. Patient reported an AE/PC for Methotrexate reports she's been on methotrexate for 23 years, she did stop it the week before and after each shot. Patient stated she would have the flares on occasions anyway. Relevant tests were reported as none. Product strength and count size dispensed: 2.5 mg tablets. Treatment medication included Prednisone: 5 mg tablets, started with four tablets once a day for two days, then three tablets for two days, then two tablets once a day for two days, then one tablet once a day for two days. Took a total of eight days. The outcome of the event was recovered in Apr2021. Information on the lot/batch was available, Additional information has been requested.

Other Meds: METHOTREXATE; ATORVASTATIN; ATENOLOL; TRIAMTERENE & HCTZ

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am