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: 1332709
Sex: M
Age:
State: VT

Vax Date: 04/01/2021
Onset Date: 05/04/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: redness in the back of the patient's throat and blisters or ulcers; Redness in the back of the patient's throat; He can talk a little bit better, but it's still sore; Throat lesions; He developed this ulcer on his tongue and throat; He developed this ulcer on his tongue and throat; Difficulty swallowing; Ear feels plugged; This is a spontaneous report from contactable consumer (patient). A 67-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on Apr2021 at 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced throat lesions on an unspecified date in 2021 which got worse over the weekend. He was able to speak to his healthcare professional (HCP) and recommended the second dose. He was prescribed amoxicillin for throat lesions and mentioned that he was on the way to the appointment for second dose. He asked if he could receive the second dose. The patient had his first vaccine about 1 month ago (Apr2021) and is due to get second dose today (05May2021) in about 30 minutes. The last few days (2021), he developed ulcer on his tongue and throat, difficulty swallowing, and his ear felt plugged. He went to the doctor on 04May2021 and the doctor said he saw redness in the back of the patient's throat and blisters or ulcers and put him on an antibiotic. As the patient has been reading up more, he saw that was one of the symptoms being reported after the vaccine. He was wondering if he should or shouldn't get the second dose as scheduled today relative to these events. It did seem like today he could talk a little bit better, but it's still sore (2021). The outcome of the event throat lesion and throat ulcer was not recovered and unknown for all other events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1332710
Sex: F
Age:
State: WI

Vax Date: 05/04/2021
Onset Date: 05/05/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: started her period/has not had a period in over a year/had been bleeding very bad on period/ hasn't had her period in over a year but she has been bleeding a lot down there; Fever/ Running a High Fever; This is a spontaneous report from a contactable consumer (patient's son). A 50-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 04May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's son called to report that his mother received the second dose on an unspecified date and on 05May2021 she experienced a fever and has started her period. The reporter stated that the patient has not had a period in over a year. The patient had been bleeding very bad on period and she kept getting all that and she has been running a high fever. She hasn't had her period in over a year but she has been bleeding a lot down there. The reporter was wondering if he should take her to the hospital or if this was just normal. The patient did not receive treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1332711
Sex: M
Age:
State: NV

Vax Date: 04/21/2021
Onset Date: 05/03/2021
Rec V Date: 05/20/2021
Hospital: Y

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: Congestive heart failure, in AFIB; Congestive heart failure, in AFIB; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 21Apr2021 (at the age of 59-years-old) as 1 st dose, single for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. The reported Events were congestive heart failure, in AFib on 03May2021, hospitalization not prolonged. The events resulted to emergency room/department or urgent care. Received unspecified treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1332712
Sex: F
Age:
State: CA

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 05/20/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.

Other Meds:

Current Illness:

ID: 1332713
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital: Y

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: thromboembolic stroke; This is a spontaneous report from a contactable pharmacist. A 69-year-old female patient 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 1st dose, single for COVID-19 immunization. Medical history included hemophilia A. Concomitant medication included factor VII for hemophilia A. The patient with hemophilia A, usually gives herself activated factor VII before vaccines. So, she did, and a couple minutes later, she received the first dose of the Pfizer COVID vaccine. 48 minutes after, she suffered a thromboembolic stroke and was now hospitalized. The pharmacist was told by the patient as well as a biologist with Pfizer who has severe hemophilia that they read somewhere (unidentified source) that the Pfizer vaccine was contraindicated in people with bleeding disorders. The pharmacist would like to know, on behalf of a patient, whether the Pfizer COVID vaccine is contraindicated in persons with bleeding disorders such as hemophilia A. The outcome of the event was unknown. Information on the lot/ batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event thromboembolic stroke cannot be totally 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: FACTOR VII

Current Illness:

ID: 1332714
Sex: F
Age:
State: PA

Vax Date: 04/24/2021
Onset Date: 05/02/2021
Rec V Date: 05/20/2021
Hospital: Y

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: She was diagnosed with appendicitis; This is a spontaneous report received from a contactable consumer (parent; patient's mother). A 19-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 at 11:00 (at the age of 19 years old) (Lot Number: ER8736, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medication reported as none. One week after the vaccine dose, the patient went to the ED with pain and vomiting on 02May2021. She was diagnosed with appendicitis after running some tests on 02May2021 and had her appendix has been removed on the same day she was admitted. The reporter asked if there was any further information about more patients getting appendicitis after the Pfizer vaccine and if the patient should get the second shot. One of her daughter's friends knew someone else who got the shot and got appendicitis, so the reporter wanted to know if it was a common side effect or coincidence. The reporter has no identifying information about her daughter's friend who knew someone that got the shot and had appendicitis. No additional vaccines administered on same date of the Pfizer suspect. They knew from the blood test something was wrong, the patient's WBC results were too high on 02May2021. The regular range was between 4.31-10.16 but the result was 22.03 units per microliter, she was not sure what the units mean. The patient's urine test results (unknown results) were not explained to the reporter and the CAT scan confirmed positive for appendicitis on 02May2021. No prior vaccinations within 4 weeks. The patient was recuperating from it with no more complications. The events require emergency room visit. The patient was recovering from the events. The events were assessed as serious (hospitalization from 02May2021 to 03May2021) Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1332715
Sex: F
Age:
State: MD

Vax Date: 04/25/2021
Onset Date: 04/25/2021
Rec V Date: 05/20/2021
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: entire intestines hurt her; back pain/sharp pain in the lower back; Back pain felt like nerve inflammation like sciatica; Back pain felt like nerve inflammation like sciatica; sore pain in the spine area/pain can change from day to day; it can be on both sides of spine, or tailbone; right side neck pain (felt like a pulled muscle); sharp shoulder blade pain/shooting pain in the hips when she walks; right ear, it felt swollen; hearing was muted- approximately 20% hearing loss, could not hear clear sounds/partial hearing loss/ dulled, similar to wearing a thick hat/transferred to her other ear; Feeling like a pressure on her ear; little pinkish rash/pinkish marbled rash; felt woozy; felt a little drunk or funny; felt a little drunk or funny; She currently has these symptoms, limited movement; difficulty walking, can't walk fast; felt like body could not hold her weight anymore; She can't bend over without pain and is unable to get things on the bottom of the refrigerator or pots in the kitchen; jerking muscle in the left thigh and right thigh; felt a heaviness on her face, felt like a heavy mask on it even when the mask was removed; Pain is a stabbing pain very painful and then the stabbing pains come and go and feels like a pulling pain, like a nerve pain; numbness in buttocks and central part of buttocks like tingling pins and pricks; numbness in buttocks and central part of buttocks like tingling pins and pricks/tingling sensation in both hands and both feet; pain in buttocks; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 25Apr2021 at 16:15 (at the age of 35 years old) (Lot Number: EW0176, unknown expiration) as 1st dose, single for COVID-19 immunization. Medical history included ongoing penicilline allergy since at the age of 17 years old (manifested by breathing issues, tightness in neck, all swollen up) and currently the patient does not have a thyroid. Concomitant medications included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL), both ongoing as the patient does not have a thyroid. The patient previously took codeine and experienced allergy (at the age of 17 years old). A few minutes after receiving the vaccine on 25Apr2021, the patient experienced right side neck pain (felt like a pulled muscle) and sharp shoulder blade pain. She got the vaccine in her right arm but had no arm pain. Then in her right ear, it felt swollen and her hearing was muted- approximately 20% hearing loss, could not hear clear sounds. Feeling like a pressure on her ear with partial hearing loss. It was dulled, similar to wearing a thick hat. Then it transferred to her other ear. Her face was feeling swollen, but it was not swollen, and she had a little pinkish rash but just under her mask. She didn't have any breathing problems. She asked the (name) staff member if these symptoms were normal. Patient was sitting in the waiting area of (name) pharmacy after administered the COVID-19 vaccine; all of these symptoms started happening around 3-4 minutes after receiving the vaccine. She would say within first 15 minutes after the COVID-19 vaccine was administered, it affected her other ear, where both ears had the muted hearing sensation which lasted about 2 hours. These side effects lasted about 1-2 hours and resolved on their own, no ointments were used. About 15 minutes after receiving the vaccine, she started having back pain, felt woozy, and felt a little drunk or funny. About 45 minutes later, she had sharp pain in the lower back, shooting pain in the hips when she walks. She currently has these symptoms, limited movement, difficulty walking, can't walk fast. After that, she was in bed all day and could barely make it to the bathroom. She previously was very healthy and regularly took long walks. Her back and hips feel sore. Back pain felt like nerve inflammation like sciatica where she got sharp pain in her lower back that felt like immediate inflammation. She got to the point where she was not able to sit straight, felt like body could not hold her weight anymore. She can't bend over without pain and is unable to get things on the bottom of the refrigerator or pots in the kitchen. She is unable to wash her hands together, she felt like her back can't support her weight. She had to wash one hand at a time. She is unable to get out of bed regularly, she has to roll out of bed. It has been 9 days from the vaccine and is still having shooting pains in her hips and jerking muscle in the left thigh and right thigh and it felt like nerves pulling string in the right leg which lasted only like 30-45 seconds. Before she went to the (name) pharmacy for the COVID-19 vaccine, she had never had any sorts of back issues, no strain, no health problems in that area. She told her husband she was going to have to lay on the ground or go home, so they left. She can't walk more than 10-15 minutes. She left the pharmacy, and when she got in the car about 20 minutes after she had gotten the vaccine, she felt a heaviness on her face, felt like a heavy mask on it even when the mask was removed. She felt initially that her face was swollen, like it was pressed, but there was no visual swelling that she could see in the mirror. When she took her mask off the triangular area where the mask had covered she could see a little more of a rash, like pinkish marbled rash but it would go away in about 45 minutes to 1 hour, started to slowly fade away. She felt that if it was a rash it would be all over her face; but this area was only where the face mask had been. She had no injury that could have caused that. The pain the next day was so bad, she was not able to sit or stand. She was barely rolling out of bed, had to hold on to furniture and walls to make it to bathroom. She is still not able to fully bend down. She has limit in movement. She still has pain, it did improve since the first day; but she still gets like a sore pain in the spine area, lower spine like a shooting pain from hips to connection where her legs meet bone which is still there. The pain can change from day to day; it can be on both sides of spine, or tailbone, hips, joints from where her legs attach to the hip area. Pain is a stabbing pain very painful and then the stabbing pains come and go and feels like a pulling pain, like a nerve pain but there is constant soreness in that area; on top of that still has the stabbing pain; this has been going on for the last 9 days did not have a break from this. She has tried massaging the area, tried Bengay on her back, tried ketoprofen (Ketonal), tried Capsaicin patches, Voltaren for the pain but none of those have helped the pain. Pain is a deep pain. The only thing that has helped it is like hot or thermal water bottle that you fill up with hot water which helps mute the pain to where it is manageable and helps her fall asleep at night. She still feels pain at time of call feels like a spinal injury. She experienced for 3 days; she would say on day number 3 (in 2021), the pain moved from the lower back to the half of buttocks on both sides and started getting numbness in buttocks and central part of buttocks like tingling pins and pricks feeling for maybe a day or 2 then it resolved. She still has pain in buttocks and hips and the pain can move to lower back and will hurt in lower back. Then on 04May2021, symptoms like entire intestines hurt her, she wasn't eating, it started at night when she was going to bed; so she is thinking maybe the pain is radiating to other parts of body to like her lower abdominal area; she used the hot water rubber bottle to relax muscles. She does not have the tingling sensation in her buttocks any longer; but does have tingling sensation in both hands and both feet that she sometimes feels, it is ongoing most of the time and is pretty severe. She feels pain getting up and down, still having pain; She is glad she can walk, because before walking was not very possible for her. She also tried a little bit of a back massage where she lay on

Other Meds: SYNTHROID; CYTOMEL

Current Illness: Penicillin allergy (since at the age of 17 years old; manifested by breathing issues, tightness in neck, all swollen up.); Thyroidectomy

ID: 1332716
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: tested positive for Covid after the first dose of the Pfizer Covid 19 Vaccine; tested positive for Covid after the first dose of the Pfizer Covid 19 Vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid after the first dose of the Pfizer Covid 19 Vaccine. The patient received remdesivir as treatment. The reporter asked if the patient can still receive the second dose of the vaccine. The outcome of the adverse events was unknown. Information about the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, COVID-19 and the suspect vaccine BNT162B2.

Other Meds:

Current Illness:

ID: 1332717
Sex: F
Age:
State: TX

Vax Date: 03/29/2021
Onset Date: 04/07/2021
Rec V Date: 05/20/2021
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've had 3 separate issues of cold symptoms in the past month/she has had a cold; I had flu like symptoms with the headache, body aches; low grade fever; not feeling well; This time, it's like sinus issues; nose stuffy and runny; super tired; nose stuffy and runny; in my chest, I was wheezing; pneumonia; coughing/dry cough; I had flu like symptoms with the headache, body aches; I had flu like symptoms with the headache, body aches; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 29Mar2021 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included , autoimmune disorder, blood cholesterol increased from 30Dec2020, crohn's disease from Oct2014, hysterectomy from 2016. The patient previously received BNT162B2 on 08 Mar2021 for COVID-19 immunization (Lot EN6205, Expiration is unknown. Injected intramuscularly on left arm. Concomitant medications included vedolizumab (ENTYVIO) taken for crohn's disease from Aug2020 to an unspecified stop date; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol increased from 30Dec2020 to an unspecified stop date; testosterone (TESTOSTERONE) taken for an unspecified indication from 12Apr2021 to an unspecified stop date. Ever since she took it, she has had a cold. She has been to Urgent care 3 times, and has had COVID test and they were negative. Flu test was also negative. Her symptoms have been kind of different each time, but it seems like cold symptoms. She clarified to say that all occurred after second dose and she meant that each occurrence of side effects, her symptoms were a little different. She would like to know if this is related to the vaccine or is it just a cold. There was no prescriber. She had No effects after first vaccine. The following day after my second dose, I had flu like symptoms with the headache, body aches; that cleared up in 2 days on 07Apr2021. Within the first week after second dose, it was like the flu. She had body aches from head to toe, coughing on 19Apr2021, fever, and felt blah overall. That went away. Then the second week ,she thought she had pneumonia on 21Apr2021 and had wheezing in her chest on 21Apr2021, dry cough, low grade fever, over all body aches, same thing as first. Now this week it feels like sinus problems, such as headache on 07Apr2021, sinus, no body aches, On 02May2021, This time, it's like sinus issues, nose stuffy and runny, super tired. She thought it was allergies at first. Feeling blah overall improved after they gave her medication. They gave her a Z-Pak, wish she later said was Azithromycin. They gave her the same thing both times.Azithromycin tablets 250 mg. two tablets first day and one tablet rest of time for 4 days. It helped her get better. It is in a pharmacy vial with no lot or expiration. Second medication was Benzonatate 200 mg one capsule by mouth three times daily for cough. It is also in a pharmacy vial with no lot or expiration. She has been taking over the counter stuff. She has the same ones they gave her before and she did not take those this time because her symptoms were different. This time she took over the counter because she thought it was allergies. She took Benadryl, Nyquil, TheraFlu, Alka-Seltzer cold and cough drops. She bought all over the counter and did not feel they are working. Benadryl 24 capsules, Lot 1805148, Expiration Mar2022, Dose 25mg, Count size 24, Sealed and intact. She would not be willing to send a sample. Nyquil Lot 0315171912, Expiration Dec2022, 30 ml every 6 hour, count size in bottle is 12fl ounces. Sealed and intact. She would not be willing to send a sample.Thera-Flu Lot 6N8S Expiration Jun 2021, Dose is 1 packet every 4 hours, She did not take it like that though. Count size is 6. Sealed and intact. She would not be willing to send a sample. Alka Seltzer cold and flu, Lot NAA85RD, Expiration May2021, dose is 2 tablets every 4 hours and count size is 16. Sealed and intact. She would not be willing to send a sample. Ricola cough drops, Batch 2000049350, Expiration Jun2023. Sealed and intact. She would not be willing to send a sample. The patient underwent lab tests and procedures which included covid-19: negative on negative, influenza: negative on negative. Therapeutic measures were taken as a result of the events. The outcome of the event pneumonia, headache, general body pain, low grade fever, in my chest, I was wheezing was recovering, the outcome of the event coughing/dry cough, This time, it's like sinus issues, nose stuffy and runny, super tired, nose stuffy and runny was not recovered, while unknown for the other events.

Other Meds: ENTYVIO; LIPITOR [ATORVASTATIN]; TESTOSTERONE

Current Illness:

ID: 1332718
Sex: M
Age:
State: CA

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: difficulty breathing; face was flushed; heart rate went up; Wheezing; This is a spontaneous report from a contactable consumer. A 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 57 years, on 26Apr2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis, allergies, hay fever, allergies to grasses, cheese and weeds; all from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for autoimmune thyroiditis, start and stop date were not reported and an unspecified Antihistamine. The patient stated that 45 minutes later (26Apr2021) he stated that his face was flushed, his heart was beating fast, he was wheezing and had difficulty breathing but, not severe. He states that these conditions were not serious enough to seek medical attention and reports that they were gone by the end of the next day. The patient reported 5 hours after shot at his symptoms were at about 50 percent of what they were, By the next morning, they were down to about 10 percent and by the end of the day, on 27Apr2021, they were gone. The patient would like to know if this will keep him from getting his second dose of the vaccine. The patient underwent lab tests and procedures which included heart rate: increase on 26Apr2021. The outcome of the events was recovered on 27Apr2021.

Other Meds: LEVOTHYROXIN

Current Illness:

ID: 1332719
Sex: F
Age:
State: OH

Vax Date: 01/27/2021
Onset Date: 01/29/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bell's palsy; Eye twitching; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Jan2021 13:00 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure and acid reflux. Other than those, patient was "pretty healthy." Patient was not diagnosed with COVID prior vaccination. Concomitant medications included irbesartan, pantoprazole, meloxicam, and biotin. Patient reported that she had Bell's palsy when she was in college. When she was teaching years later, she noticed that every year when she got the flu shot, her eye would twitch for about 8 or more weeks after the shot. She finally connected the fact that it was happening every year after the shot so she saw a neurologist. She was told that an egg derivative was used in the flu shot, which was connected to Epstein bar disease, which was connected to Bell's palsy. She was told to stop getting the flu shot so she quit getting the flu shot and never had another occurrence until after getting the COVID Pfizer shot. On 29Jan2021, the patient experienced bell's palsy and eye twitching. The twitch appeared a few days after getting the shot, but seemed mild enough, but as of late it has become quite an annoyance. The only thing she can attribute it to was the COVID vaccine. She was a little leery of getting a booster if necessary. No treatment was received. Outcome of the events was not recovered. Patient was not tested for COVID post vaccination. Information about lot/batch number has been requested.

Other Meds: IRBESARTAN; PANTOPRAZOLE; MELOXICAM; BIOTIN

Current Illness:

ID: 1332720
Sex: F
Age:
State: FL

Vax Date: 03/29/2021
Onset Date: 03/29/2021
Rec V Date: 05/20/2021
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Symptom List: Rash, Urticaria

Symptoms: Super tired; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8730), via an unspecified route of administration, administered in Arm Left on 29Mar2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing outbreaks on lip (oral herpes) began having outbreaks on her lip when she was 39. The patient had a family history of Fib (atrial fibrillation) from an unknown date reported that her mother has a fib but it's not genetic. Concomitant medication included valaciclovir hydrochloride taken for oral herpes from an unspecified start date and ongoing. On 29Mar2021, the patient experienced sore arm for 2 days and on 30Mar2021 experienced super tired. The reporter considered the events as medically significant. The patient underwent lab tests and procedures which included covid-19 screening: negative and X-ray: normal both on Apr2021. The outcome of the event sore arm was recovered on 31Mar2021 while for the event super tired was recovered on 30Mar2021.

Other Meds: VALACYCLOVIR HCL

Current Illness: Oral herpes (she began having outbreaks on her lip when she was 39)

ID: 1332721
Sex: F
Age:
State: TX

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 05/20/2021
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Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: mouth and tongue started feeling like she ate or drank something way too hot felt burning; mouth and tongue started feeling like she ate or drank something way too hot felt burning; tongue was swollen; tongue was swollen and really red; tongue was swollen and really red making it difficult to speak; can't taste plus eating was difficult; can't taste plus eating was difficult; This is a spontaneous report from a contactable healthcare professional (patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Apr2021 at 16:30 (Lot Number: EW0167) as 1st dose, single for covid-19 immunization, administered at the hospital. Medical history included rheumatoid arthritis. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient previously took Xarelto and experienced allergies: adverse reaction to Xarelto. On 01May2021 at 17:00, patient's mouth and tongue started feeling like she ate or drank something way too hot felt burning, have it another day or two and getting worse; her tongue was swollen and really red making it difficult to speak the swelling and redness was nearly an inch and can't taste plus eating was difficult because it feels like she burnt her mouth and very uncomfortable. The patient didn't have any of these symptoms before the vaccine and initially not worried as both of her daughters are nurses and has heard of it but nothing to this extreme. The patient was advised to contact her doctor on 07May2021 or if worse, urgent care. The events resulted in doctor or other healthcare professional office/clinic visit. Outcome of the events was not recovered.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported events 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: 1332722
Sex: F
Age:
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Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: Tested positive for Covid virus after first Covid vaccine; Tested positive for Covid virus after first Covid vaccine; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient's son). This consumer reported similar events for his parents. This is the 2nd of two reports. A female patient of an unspecified age received bnt162b2 (Pfizer Covid 19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid virus in 2021 after first Covid vaccine. Outcome of the events was unknown. The patient underwent lab tests and procedures which included COVID-19: positive in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021504750 same reporter, product and events, different patient

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Current Illness:

ID: 1332723
Sex: M
Age:
State: MI

Vax Date: 03/03/2021
Onset Date: 03/01/2021
Rec V Date: 05/20/2021
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Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Bronchitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202; Expiration date was not reported) on the right arm, on 03Mar2021 (19:10) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included pacemaker, high blood pressure, and was diabetic; all were ongoing. Concomitant medication included metformin. In Mar2021, after the first dose of vaccination, the patient had bronchitis. The patient's bronchitis got real bad, and he fought it for three to four weeks. The physician had given him some pills to be taken one every day, and a stronger steroid that had knocked the bronchitis out of the patient. The event, bronchitis, was assessed as serious (medically significant). The event had resulted into a physician office visit. The patient had a chest x-ray on an unspecified date in 2021 (results were not provided). The outcome of the event was recovered on 20Apr2021. The patient was scheduled to receive the second dose of vaccination on 24Mar2021 or 26Mar2021 ("or something like that"). The physician advised the patient to get the second dose until he was better from the bronchitis. No follow-up attempts are needed. No further information is expected.

Other Meds: METFORMIN

Current Illness: Blood pressure high; Diabetic; Pacemaker syndrome

ID: 1332724
Sex: M
Age:
State: TX

Vax Date: 04/14/2021
Onset Date: 04/04/2021
Rec V Date: 05/20/2021
Hospital: Y

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

Symptoms: Seizure; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 17Mar2021 (Batch/Lot Number: EN6206) as 1ST DOSE, SINGLE and then on 14Apr2021 (Batch/Lot Number: ER8733) as 2ND DOSE, SINGLE; both dose administered via an unspecified route in the right arm for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included pain and inflammation and has a little problem hearing. The patient had no other medical history and no family medical history. Concomitant medication included ongoing etodolac taken for pain and inflammation. The patient was in good health and everything. He got the first shot on 17Mar2021, and 17 days later, he had a seizure on 04Apr2021. He has never had seizures in his whole life. He had the second vaccine on 14Apr2021 and had a second seizure 17 days later on 01May2021. Patient had both seizure in the afternoon. The patient further reported that he was taking a medicine that was supposed to keep him from having another seizure. It was Lev, and he can't read the rest. It looks like pmr, then acetam. He started taking that when he had the first seizure. The patient also mentioned that they did a brain magnetic resonance imaging (MRI) and bloodwork. He doesn't remember the exact date. The patient was taken to the emergency room by an ambulance. He was hospitalized both times. He doesn't remember how long he was in the hospital the first time. The second time he was there for 5 to 6 hours. They cut him loose pretty quick. The patient was first hospitalized from 04Apr2021 to an unknown date and then hospitalized again on 01May2021 for seizure. Therapeutic measures were taken as a result of seizure. The outcome of the event was unknown.

Other Meds: ETODOLAC

Current Illness:

ID: 1332725
Sex: F
Age:
State: CA

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 05/20/2021
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Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: racing heart; dizziness; disorientation; blurred vision; forearm muscle pain/lower leg muscle pain; fatigue; loss of strength and coordination in fingers and arms/ residual arm & leg weakness; loss of coordination.; right lower lip became numb; difficulty with concentration; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient (non-pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in the right arm on 26Apr2021 at 02:30 AM as single dose for COVID-19 immunisation. Medical history included lumbar disc degeneration, spinal surgeries x2, stem cell injection (lumbar disc) a little over a year ago, allergies to shellfish. Concomitant medications reported as none. No other vaccine in four weeks. None other medications in two weeks. No Covid prior vaccination. No Covid tested post vaccination. On 26Apr2021 at 14:30 PM, (reported as after approx 15 min), racing heart, dizziness, disorientation, blurred vision (inability to focus), forearm muscle pain, fatigue affecting ability to perform my job, loss of strength and coordination in fingers and arms, right lower lip became numb, lower leg muscle pain and loss of coordination. Symptoms that continued to persist after 10 days were right lower lip numbness, difficulty with concentration and fatigue that was affecting my ability to perform my job, and some residual arm & leg weakness and coordination. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Unknown if treatment received for events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect vaccine BNT162B2 cannot be excluded. 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:

Current Illness:

ID: 1332726
Sex: F
Age:
State: CA

Vax Date: 04/10/2021
Onset Date: 04/12/2021
Rec V Date: 05/20/2021
Hospital: Y

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Symptom List: Ear pain, Hypoaesthesia

Symptoms: Mild heart attack,Raised triponin levels; Mild heart attack,Raised triponin levels; This is a spontaneous report from a contactable consumer (patient). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: Er8729), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (36-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history included that prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient was not pregnant at time of vaccination. Concomitant medications were not reported. The patient experienced mild heart attack, raised triponin levels on 12Apr2021 with outcome of recovering. The patient underwent lab tests and procedures which included Nasal Swab: negative on 12Apr2021. The adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse event was Medication, Angiogram, ultrasound, bloodwork, cats. Therapeutic measures were taken as a result of events.

Other Meds:

Current Illness:

ID: 1332727
Sex: F
Age:
State: NC

Vax Date: 03/10/2021
Onset Date: 03/01/2021
Rec V Date: 05/20/2021
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Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: This is a spontaneous report received from a contactable nurse (patient) via a Pfizer-sponsored program. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206), via an unspecified route of administration in the right arm, on 10Mar2021, as 1st dose, single, for COVID-19 immunisation. Medical history included ongoing fibromyalgia (diagnosed in 1996), ongoing allergies from 1981, ongoing food allergies and chemical allergies, ongoing allergy to alcohol, ongoing hypothyroidism from 2012, ongoing pre-diabetic from 2012, Lyme disease for 11 years before being correctly diagnosed and treated, concussion in Sep2019, and post concussion syndrome in Sep2019. The patient previously took nalbuphine hydrochloride (NUBAIN) in 1981 and experienced anaphylaxis; and paracetamol (TYLENOL) and was very sensitive, had rash and high blood pressure. Within the first 15 to 20 minutes following the administration of the first dose of the Covid-19 vaccine, on 10Mar2021, the patient's face and ears got very red, flushed, and itchy. The patient reported that she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction. She reported that she has had glycol before and has never reacted quite like that. The flushing, redness, and itchiness of her face and ears subsided within an hour and were gone by 4 hours. Her allergist instructed her to take 2 Zyrtec before getting the second dose of the Covid-19 vaccine. After her face and ears became flushed, red, and itchy, she ended up having a really bad headache that continued until the next day. Her headache was severe for about 12 hours and continued for a total of a day and a half. She stated that her headache was more like a migraine during the 12 hours when it was severe. It felt like a migraine, but worse. On 10Mar2021, the patient reported that she experienced flu-like symptoms like being nauseous, had dizziness, achiness all over, and was not feeling well, her post-concussion syndrome was triggered and had more headaches, dizziness, nausea. She reported that things have been going awry in her body since she had the COVID-19 vaccine. She reported that the increase in headaches seemed to have improved, but the nausea and dizziness have in some ways improved and then some days it feels like "here we go again" when it hits. About a week after she received the first dose of the Covid-19 vaccine, in Mar2021, the patient noticed a change in her urination. It wasn't severe or anything at that point, she just felt like she was not able to release the urine (urine retention). She thought to increase her intake to see if it would help her urinate and it didn't seem to help much. She received a prescription on 26Mar2021, and during that week, she noticed that she was having more issues with some burning during urination and was developing pelvic pain and pressure. The patient stated that the scent and color of her urine looked fine. She reported that the frequency started to increase with not much urine coming out. When she finished her antibiotics about 7 days later, the urine retention had really improved and went away at the end of March. In the morning of 26Mar2021, when the patient woke up, she had blood in her urine and clots. The clots were about the size of a pea and a couple were about the size of a dime. The blood and blood clots in her urine were what made her go to the doctor. She reported she has never had blood in her urine that she remembers. She was put on Macrobid for 5 days. She reported that Macrobid wasn't relieving enough of her symptoms and her provider ended up adding a couple more days. The patient reported feeling more worn out in Mar2021, since she received the first dose of the COVID-19 vaccine. This did not improve and some days it was worse. The patient did not have the energy level and stamina that she used to (Mar2021). She reported that whether it's combined with the retriggering of her post-concussion syndrome, it is significant for her life. She was also not eating well and had lost some weight (Mar2021). She reported that her appetite is improving but it is still not normal for her. She mentioned it was harder for her to want to eat something because of feeling nauseated. The patient assessed the events "face and ears became very flushed, red, and itchy", headache, "headache was more like a migraine/felt like a migraine, but worse", "post concussion syndrome was retriggered", "blood in her urine and clots", "not eating well and had lost some weight" and "feeling more worn out" as serious (medically significant). The patient recovered from "face and ears became very flushed, red, and itchy" and "she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction" on 10Mar2021; headache, "headache was more like a migraine/felt like a migraine, but worse", "she was not able to release the urine (urine retention)", "blood in her urine and clots", "flu like symptoms", dizziness, "achiness all over", "pelvic pain and pressure", and "some burning during urination" in Mar2021; and was recovering from "not eating well and had lost some weight". The outcome of the remaining events was unknown. The patient assessed the causality of events headache, flu like symptoms, nausea, "face and ears became very flushed, red, and itchy", dizziness, "post concussion syndrome was retriggered", and "not eating well and had lost some weight" as related to BNT162B2.; Sender's Comments: Based on the information in the case report and a plausible temporal association, A possible causal relationship between urinary retention, hemorrhage urinary tract 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: Allergy; Allergy to chemicals; Fibromyalgia (diagnosed in 1996); Food allergy; Hypothyroidism; Pre-diabetic

ID: 1332728
Sex: F
Age:
State: CA

Vax Date: 04/16/2021
Onset Date: 04/17/2021
Rec V Date: 05/20/2021
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Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: stroke like symptoms; similar to migraines; mini-strokes; Passing Out; Blind spots in her vision; Nausea; Believes it effected her memory; stroke like symptoms; similar to migraines; mini-strokes; This is a spontaneous report received from a contactable consumer. A 59-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0153; Expiration Date: 31Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 59 years). Medical history included ongoing strokes, ongoing third and fourth Nerve Palsy. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for blood thinner; metoprolol for Stroke, Heart regulation; lovastatin taken for Stroke, Heart regulation. The patient states that she went to the Emergency Room on 17Apr2021 and then went again on either 18Apr2021 or 19Apr2021. The patient states she does not know if she was admitted or not. States that she thinks she just was in the emergency room the time that she was there. Says that after the Covid Vaccine she was having stroke like symptoms; similar to migraines; mini-strokes. She was passing out, had nausea, blind spots in her vision, and she believes it effected her memory. The events occurred on 17Apr2021. Also, she said on her first emergency room visit they did a CT Scan and on her second emergency room visit they did a MRI and both was not reported. States they told her there was no issues. The patient underwent lab tests and procedures which included CT Scan: and MRI: not reported on Apr2021. Outcome of the event vision impairment was not recovered while outcome of the event nausea was recovered on Apr2021. Outcome of the event memory impairment was recovering while outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: PRADAXA; METOPROLOL; LOVASTATIN

Current Illness: IIIrd nerve palsy; IVth nerve palsy; Stroke

ID: 1332729
Sex: M
Age:
State: GA

Vax Date: 04/08/2021
Onset Date:
Rec V Date: 05/20/2021
Hospital: Y

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Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Shortness of breath; Unable to pass stool; Extreme water retention; Excessive mucus drainage; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved; This is a spontaneous report from contactable consumer (patient) reported for himself. A 54-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 14:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization, at the age of vaccination of 54 years old. Medical history included sleep apnoea syndrome, irritable bowel syndrome, high blood pressure, congestive heart failure, diabetes. Patient known allergies included Sulfa drugs and Lisinopril. Concomitant medications included metformin; hydrochlorothiazide, omeprazole, Blood the (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient experienced shortness of breath after 2 min walk, unable to pass stool, extreme water retention, excessive mucus drainage, swollen legs, feet ,thighs and stomach that remains after 4 visits to ER not resolved, all on an unspecified date with outcome of not recovered. The patient was hospitalized for events for 4 days. The patient underwent lab tests which included computerised tomogram Cat scan): unknown result magnetic resonance imaging (MRI): unknown result, x-ray: unknown result, all on unknown date. No other vaccine in four weeks. The events resulted in: Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Treatment received for events. No Covid prior vaccination. No Covid tested post vaccination. Information about the Lot/batch number has been requested.

Other Meds: METFORMIN; HYDROCHLOROTHIAZIDE; OMEPRAZOLE

Current Illness:

ID: 1332730
Sex: F
Age:
State: NC

Vax Date: 03/31/2021
Onset Date: 03/01/2021
Rec V Date: 05/20/2021
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Symptom List: Unevaluable event

Symptoms: severe arm pain; Nausea; Dizziness; klebsiella pneumoniae, 50,000 to 100,000 cfu; Headache; Urine retention; blood and blood clots in her urine; blood and blood clots in her urine; tore or messed up a ligament in her hand; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable nurse (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number not reported), via an unspecified route of administration, administered in arm right on 31Mar2021 (at the age of 62-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included fibromyalgia from 1996 and ongoing, allergies from 1981 and ongoing, hypothyroidism and is pre-diabetic from 2012 and ongoing, Lyme disease from an unknown date and unknown if ongoing, concussion from Sep2019 to an unknown date, post-concussion syndrome from Sep2019 and ongoing , seasonal, food and chemical allergies from an unknown date and unknown if ongoing and had wisdom teeth extracted on an unknown date. The patient's concomitant medications were not reported. The patient previously took nalbuphine hydrochloride (NUBAIN) and experienced anaphylaxis. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: EN6206), administered in right arm on 10Mar2021 for COVID-19 immunisation and experienced Face and ears became very flushed, red, and itchy, Headache, headache was more like a migraine/felt like a migraine, but worse, Post concussion syndrome was retriggered, not eating well and had lost some weight, feeling more worn out, she is allergic to alcohol and thought maybe it was the glycol in the COVID-19 vaccine that caused the reaction, flu like symptoms, achiness all over, pelvic pain and pressure, some burning during urination, did not have the energy level and stamina that she used to, blood in her urine and clots, she was not able to release the urine (urine retention), Nausea and Dizziness. About a week after receiving the second dose of the Covid-19 vaccine on 31Mar2021, she noticed the feeling again of retaining the urine. She was not swollen or anything and immediately went with increased fluids. The urine retention was not as severe at that point. It really showed up and intensified quickly with groin pain, pelvic pain, abdominal pain, and some back pain. She woke up the next morning after being doubled over in pain the night before and there was so much blood in her urine that she couldn't see any urine. Her urine was the darkest burgundy and the color of the darkest wine. She did not have anything in her urine the night before when she was doubled over in pain. She was increasing fluids and even drinking Propel for the electrolytes to make sure she was not making things worse. She woke up around 5 AM and felt so sick to her stomach. She had nausea the night before, but she was really nauseated the morning that she discovered blood in her urine. She woke up with severe nausea last Friday, 30Apr2021. Her doctor performed a urine culture. The urine culture returned positive for Klebsiella Pneumoniae with 50,000 to 100,000 CFU/mL on 30Apr2021. She does not have the urine culture results from her first doctor visit. Her friend is an RN that is administering the Covid-19 vaccine, was talking to company representatives and told the caller that she needed to call company to make a report and see if anyone else has experienced the same adverse events. Urinary retention came back in Apr2021 following her second dose of the Covid-19 vaccine on 31Mar2021. She can really go to the bathroom, but she is still feeling the abdominal and pelvic pressure as well as some burning and pain. Her symptoms are improving but not enough. It feels like she always has a full bladder still. She tore or messed up a ligament in her hand and she has been going to occupational therapy. She can't seem to be able to handle a pain level like she used to. It seems like pain is triggering her feelings of nausea and dizziness. Her body is not doing things well right now. The day before, of, and after getting the Covid-19 vaccine, someone suggested taking electrolytes before the second dose of the Covid-19 vaccine, so she drank Powerade. She was expecting the symptoms following the second dose of the Covid-19 vaccine to be a lot worse and they were a walk in the park in comparison. She had a mild headache the first day, 31Mar2021. She woke up in the morning of 01Apr2021 and her headache was gone. Following the second dose of the Covid-19 vaccine, she had severe arm pain. It felt like she was walking around with someone constantly punching her. She was moving her arm all around trying to get it to stop hurting. She saw blood and blood clots in her urine for over 24 hours. The blood and clots were lessening over the 24-hour time period. She probably saw in a 2-hour period at least 60 clots about the size of a quarter to a half dollar. The pain was excruciating. She was taking Phenazopyridine but is still feeling a sense of urgency, burning, and sometimes pain during urination. Her doctor did give her a prescription for phenazopyridine, but it was cheaper for her to buy over the counter and take the same dosage. She has been taking generic Macrobid, Nitrofurantoin Mono, 100 mg twice daily. It was dispensed in a pharmacy bottle. She is seeing a urogynecologist tomorrow, 06May2021. The patient underwent lab tests and procedures which included culture urine: unknown cfu on 26Mar2021 and culture urine: klebsiella pneumoniae, 50,000 to 100,000 cfu on 30Apr2021. The outcome of the event Headache was recovered on 01Apr2021 while of the rest was unknown. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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: Allergy; Fibromyalgia; Hypothyroidism; Post concussion syndrome; Pre-diabetic

ID: 1332731
Sex: F
Age:
State:

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: breasfeeding mom; breasfeeding mom; Pain at injeciton site; Back pain; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer sponsored program. This consumer reported for information for both mother and baby. This is the maternal report. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical hisrtory and concomitant medications were not reported. Reporter stated they were concerned of lack of effect. She received the 2nd dose of the covid vaccine 2 days ago (May2021), she had pain at the injection site, back pain, and she was a breasfeeding mom on May2021. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021506631 baby case

Other Meds:

Current Illness:

ID: 1332732
Sex: M
Age:
State: WA

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 05/20/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Stroke; Left ventricular thrombus in his heart; This is a spontaneous report from a contactable physician. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Lot Number: EW0153) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included coronary artery disease (several years ago) and had a bypass (several years ago; not ongoing). The patient's concomitant medications were not reported. It was reported that the patient had a stroke on 17Apr2021 after he formed a left ventricular thrombus in his heart in Apr2021. The patient was hospitalized for the events from 17Apr2021 to 23Apr2021 and was treated with Coumadin. The outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely for BNT162B2 vaccine since there is no plausible mechanism implicating the subject drug to the events. The reported events may be regarded as natural progression of patient's pre-existing conditions. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 1332733
Sex: M
Age:
State: NY

Vax Date: 04/20/2021
Onset Date: 04/27/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: first dose on 20Apr2021 and had positive COVID-19 test on 27Apr2021; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A male patient of unspecified age received BNT162VB2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first dose on 20Apr2021 and had positive COVID-19 test on 27Apr2021. The patient will be off quarantine on 07May2021. The patient was scheduled to receive his second dose on 11May2021. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1332735
Sex: M
Age:
State: KS

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Allergic reaction; still have massively swollen lymph nodes on the left side of my neck and left shoulder; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 22Apr2021 14:15 (Batch/Lot Number: EW0151) at single dose for COVID-19 immunization. Medical history included known allergies shellfish and tree nuts and he might be allergic to iodine, asthma, high blood pressure, acid reflux. Concomitant medications included finasteride (PROPECIA), cetirizine hydrochloride (ZYRTEC R), metoprolol, lisinopril, pantoprazole sodium sesquihydrate (PANTOPROL), all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 31Mar2021 14:00 (Batch/Lot Number: EI28733) at single dose for COVID-19 immunization. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Allergic reaction within 5 minutes (also reported as 22Apr2021 14:30) of the dose. Rushed to ER and given an IV of steroids, antihistamines, and another drug he can't remember. The patient on week #2 and still had massively swollen lymph nodes on the left side of his neck and left shoulder. Dr. prescribed additional steroids (second regimen since the reaction) and antibiotics. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included An IV of Antihistamines, steroids, etc. Facility where the most recent COVID-19 vaccine was administered was Hospital. The outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: PROPECIA; ZYRTEC R; METOPROLOL; LISINOPRIL; PANTOPROL

Current Illness:

ID: 1332736
Sex: F
Age:
State: TX

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Swelling of feet, legs, hands, arms and face; Swelling of feet, legs, hands, arms and face; itching in face and neck; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in Arm Left on 06Apr2021 17:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old. Medical history included severe back issues and "I have had 6 back surgeries", allergy to all Nsaids. The patient previously received bnt162b2, dose 1 administered in Arm Left on 16Mar2021 08:30 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation at the age of 53-year-old. Concomitant medications included hydrocodone, cefixime (FLEXERIL [CEFIXIME]), buprenorphine hydrochloride (BELBUCA), atorvastatin, clarithromycin, omeprazole, tinidazole (OTC-HP) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling of feet, legs, hands, arms and face, itching in face and neck on 07Apr2021 02:00 with outcome of recovered in 2021. Therapeutic measures taken to all events included Benadryl and prescribed EpiPen. The events were assessed as medically significant. The events resulted in Emergency room/department or urgent care visit. It was reported as: Swelling of feet, legs, hands, arms and face as well as itching in face and neck after about 8 hours of receiving 2nd dose. 1st dose was unremarkable. The lot/batch number has been requested.

Other Meds: HYDROCODONE; FLEXERIL [CEFIXIME]; BELBUCA; ATORVASTATIN; OTC-HP

Current Illness:

ID: 1332737
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: tested positive for the Covid virus after the first vaccine; tested positive for the Covid virus after the first vaccine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was hospitalized, when she tested positive for the Covid virus after the first vaccine on an unspecified date. She stated she would have been getting her second dose on 05May2021. She was not in the hospital anymore at the time of report, but still can't go outside. Outcome of the events was unknown. Information on Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021507654 similar report from same reporter

Other Meds:

Current Illness:

ID: 1332738
Sex: F
Age:
State: SC

Vax Date: 01/18/2021
Onset Date: 02/01/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: testing positive for covid-19; testing positive for covid-19; feels like she has a lot of weight on her chest; sinus issues; This is a spontaneous report from a contactable consumer (patient's husband). A 71-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jan2021 at the age of 71-years-old (Batch/Lot Number: EL3246; Expiration Date: Apr2021) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included breast cancer from an unknown date, ongoing thyroid disorder, ongoing lung issues, gets bronchitis easy. Concomitant medications included patient took thyroid medication and blood thinners. There were no Prior Vaccinations (within 4 weeks). The patient had first dose of Covid vaccine then had covid, she was wanting to know if she was eligible to take 2nd dose within 90 days period or if she needed to start over. Caller clarified his wife received her first Covid 19 vaccine on 18Jan2021 and before she got her second Covid 19 vaccine he and his wife tested positive for the Covid 19 virus. The caller's wife was worse than he was. His wife was not admitted to the hospital, she went to the hospital at the advice of her lung doctor to receive an infusion and was only at the hospital for 3 hours getting the infusion. At that point his wife was told she had to wait 90 days to receive her second Covid 19 vaccine. If she had no symptoms of the Covid 19 virus she would be able to get her second vaccine. Her 90 day time frame was up yesterday, 05May2021 and she received her second Covid 19 vaccine yesterday 05May2021. Caller reported the CDC and his wife's lung doctor and her primary care doctor all had different answers when it came to deciding when his wife could receive her second Covid 19 vaccine. Her doctors have said she still had the Covid 19 virus and she's been treated with steroids and inhalers and she's had chest x-rays. She had been to her primary care doctor once and her lung doctor twice. The patient felt like she had a lot of weight on her chest on 01Feb2021 and she was coughing constantly on 01Feb2021. His wife's doctor's were supposed to get together and converse through emails and the doctor's finally decided it was ok for his wife to receive her second Covid 19 vaccine. Now her doctor's are trying to decide if his wife needs a third Covid 19 vaccine because there is some confusion if having to wait more than 42 days between Covid 19 vaccines will require a third vaccine. The caller reported his wife came down with the Covid 19 virus on 01Feb2021. His wife started having symptoms on 01Feb2021. She had a cough, headache, sinus issues and tiredness all on 01Feb2021. His wife's symptoms were worse than his own symptoms. When he was getting over his symptoms, hers were getting worse. Her coughing was really bad. She had weakness on 01Feb2021. His wife was tested for the Covid 19 virus on 03Feb2021 with the swab in her nose and she received her positive results on the morning on 04Feb2021. His wife called her lung doctor's office and talked to the nurse practitioner there. The nurse practitioner took his wife's information and spoke with the lung doctor. The lung doctor advised the caller's wife to either come into the hospital for an infusion or come to the hospital for admission. The caller's wife went into the hospital and received a plasma infusion and that took about 3 hours. That was at Hospital on 06Feb2021 at around 12:00PM. The caller reports his wife takes thyroid medication and blood thinners. Nothing relevant, that he knows of, as it pertains to the Covid 19 virus. He would say she doesn't take any medications that would either help or hurt the Covid 19 virus. He also reports she's had breast cancer, lung issues and gets bronchitis easy. He reported with the Covid 19 virus she had been sick constantly. She's had two rounds of steroids and some inhalers. She was still having weakness, coughing, and breathing issues on 01Feb2021. But her primary care doctor and her lung doctor said there was no problem with her receiving her second Covid 19 vaccine so she got her second dose yesterday, 05May2021 at around 4:00PM. He reported both he and his wife were tested for the Covid 19 virus at a mini-hospital. This facility can do all kinds of tests. This facility can do anything except admissions to the hospital. The adverse events required a visit to Physician Office. The outcome of the events testing positive for covid-19, coughing, tiredness, weakness, breathing issues was not resolved and of the other events was unknown.

Other Meds:

Current Illness: Lung disease; Thyroid disorder

ID: 1332739
Sex: F
Age:
State:

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: I thought I was having heart attack.; At midnight I woke up with severe chest pains.; Nausea; It was severe gas & cramping.; It was severe gas & cramping.; This is a spontaneous report from a non-contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Mar2021 19:30 (Batch/Lot Number: 1621146-00) (at the age of 68 years old) as 1st dose, single for COVID-19 immunization. The patient had no other medical history and concomitant medications were not reported. The patient previously took polyethylene glycol and had known allergies to the medication. No other vaccine in four weeks. The shot given was at 19:30. At midnight (16Mar2021 12:00 AM), the patient woke up with severe chest pains. She thought she was having heart attack. It was severe gas (Gas in chest) and cramping. The patient had this almost daily for 2 weeks. She had nausea for one week. The patient reported that she never experienced this in her life and still happens at least once a week. There has been no change in her diet before or after the vaccination. Events usually will be relieved within 2 hours after taking GasX. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1332740
Sex: M
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/09/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: testing positive for amphetamine; This is a spontaneous report from a contactable consumer reported for himself. A 27-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 16:50 at the age of 27-years-old (Batch/Lot Number: ER8733) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included stomach pain from an unknown date and colons (as reported). The patient's concomitant medications were not reported. The patient reported that he tested positive for amphetamine after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine. He wanted to know if there were reported cases of testing positive for amphetamine after getting vaccinated for COVID 19. He mentioned that he never used any prohibited drugs. He stated he got his first vaccine on 08Apr2021 and like he took around the mid-day then the second day suddenly he went to a sample, a urine sample and somehow it showed there was he tested positive in case, he didn't use drugs and he did not do drugs and anything that it showed he tested positive, he had a word with doctors they said it might be a positive reaction or something but you got to call Pfizer and just tell them about that. He got the vaccine at mid-day like it was around his appointment was 16:50 and he got it that on 08Apr2021 and he did the drug test on 09Apr2021 when he woke up on the next day. The outcome of the event was unknown. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1332741
Sex: M
Age:
State: MN

Vax Date: 04/30/2021
Onset Date: 05/02/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: temporary facial paralysis; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 30Apr2021 14:00 (Batch/Lot number was not reported) (at the age of 41 years old) as unknown (dose number), single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. On 02May2021, the patient experienced temporary facial paralysis. There was no treatment for the event. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the event was recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1332742
Sex: M
Age:
State: NY

Vax Date: 03/20/2021
Onset Date: 03/30/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: diagnosed with cutaneous T-Cell lymphoma; A pimple- like mushroom lump; This is a spontaneous report from a contactable consumer. A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Mar2021 (Batch/Lot Number: EN6208) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included high blood pressure. On 30Mar2021 (reported as 10 days after the last vaccine), the patient had a pimple-like mushroom lump. On 01Apr2021, the patient was diagnosed with cutaneous t-cell lymphoma. The patient underwent lab tests and procedures which included biopsy: unknown result on 22Apr2021. The patient received an unspecified treatment for the events. The outcome of the events was not recovered. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested post vaccination.

Other Meds:

Current Illness:

ID: 1332743
Sex: M
Age:
State: NC

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Fainted; Dizziness; Sweaty palms; Heart rate dropped; Weird burning sensation in the back of his neck with tension; Weird burning sensation in the back of his neck with tension; Disorientated; Lost his color; Weird sensation in throat; Headache; Had pressure in his ears; Gassy; This is a spontaneous report from a contactable consumer (mother of the patient). A 17-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731; Expiration date was not reported) on 15Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). The patient had no relevant medical history and concomitant medications. On 15Apr2021, after the first dose of vaccination, the patient had fainted; dizziness; sweaty palms; heart rate has dropped; had weird burning sensation at the back of the neck with tension; was disorientated; and had lost his color. In Apr2021, the patient had weird sensation in the throat; headache; had pressure in his ears; and was gassy. The outcome of the events was unknown for 'lost his color'; was not recovered for 'headache'; and was recovered on an unspecified date in 2021 for all the other events. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1332744
Sex: F
Age:
State: CA

Vax Date: 04/18/2021
Onset Date: 05/05/2021
Rec V Date: 05/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: kidney inflammation; Fever up to 104.7 degrees; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0162), via an unspecified route of administration, administered in the left arm, on 18Apr2021, as 2nd dose, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), on an unspecified date, for COVID-19 immunisation. It was reported that the patient had fever up to 104.7 degrees and kidney inflammation when she went to the hospital (pending clarification) in the morning of 05May2021. The events resulted to physician's office visit. The patient was prescribed with unspecified treatment for the events. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1332745
Sex: F
Age:
State: IL

Vax Date: 01/04/2021
Onset Date: 01/18/2021
Rec V Date: 05/20/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: The patient received her 1st Pfizer vaccine on 1/4/21. She then tested positive for COVID-19 on 1/18/21; The patient received her 1st Pfizer vaccine on 1/4/21. She then tested positive for COVID-19 on 1/18/21; This is a Spontaneous report from Pfizer sponsored program from a contactable pharmacist. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Jan2021 at the age of 40-years-old (Batch/Lot Number: EL0142) as 1ST DOSE,SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021. The patient was hospitalized for the event. She then received a "plasma transfusion" on 28Jan2021. She was now returning for her 2nd vaccine dose today 06May2021. The reporter asked if this was ok since it had been 90 days and if her first dose need to be repeated. The outcome of the events was resolved on an unspecified date in 2021. The reporter considered Pfizer Covid-19 Vaccine with event tested positive for Covid-19 after first dose was unrelated. Follow-up attempts are needed. Further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship. Case will be re-assessed upon the additional information provided.

Other Meds:

Current Illness:

ID: 1332746
Sex: M
Age:
State:

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 05/20/2021
Hospital:

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: he's had high blood sugar readings for no reason; This is a spontaneous report received from contactable consumer, the wife of the patient. A 49-year-old adult male received the first dose of BNT162b2 (solution for injection; batch/lot and expiry information not provided) as a single dose via an unspecified route on 22Apr2021 (at 49-years-old) for COVID-19 immunization. Relevant medical history included diabetes. There were no concomitant medications reported. The consumer reported that ever since her husband got his first dose of the COVID-19 vaccine on 22Apr2021, he has had high blood sugar reading for no reason. The consumer explained that the patient has only had a black coffee today and his blood sugar is greater than 200 (no unit reported). The consumer reported that his blood sugars have event been as high as 400 (no unit provided). The outcome of the event had high blood sugar reading for no reason was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness:

ID: 1332747
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: She stated that a few seconds after receiving the first dose of the vaccine, the patient blacked out; chills; This is a spontaneous report from a Pfizer sponsored program, via a contactable pharmacist. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She stated that a few seconds after receiving the first dose of the vaccine, the patient blacked out and when they went home, she experienced chills. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event loss of consciousness and the suspect drug BNT162B2. 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: 1332748
Sex: F
Age:
State: NY

Vax Date: 04/30/2021
Onset Date: 05/01/2021
Rec V Date: 05/20/2021
Hospital: Y

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Allergies:

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

Symptoms: Enlarged liver; Pain in liver; This is spontaneous report received from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 30Apr2021 at age of 18-year-old at single dose, unknown dose number for COVID-19 immunization. Medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at time of vaccination and events onset. It was unknown if there was other vaccine in four weeks. It was unknown if patient had COVID-19 prior to vaccination. And it was unknown if COVID-19 was tested post vaccination. Patient experienced enlarged liver and pain in liver, both on 01May2021 with outcome of unknown. Events were serious as hospitalization. It was unknown if patient received treatment for the events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1332749
Sex: M
Age:
State: OR

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 05/20/2021
Hospital: Y

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Allergies:

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

Symptoms: Rash on arms, hands, legs, feet, and a little bit on chest.; The worst part was that his groin swelled up to about the size of a Cantaloupe.; lost about 60-70 pounds in water weight.; fisrt dose on 20Jan2021/second dose on 06Feb2021; fisrt dose on 20Jan2021/second dose on 06Feb2021; This is a spontaneous report from a contactable consumer(patient). A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 06Feb2021 15:00 (Lot Number: EL9261) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, High Blood Pressure, Obese. Concomitant medication included 17 medcations (unspecifed). The patient previously took first dose of bnt162b2 (lot number: EL3249) on 20Jan2021 at age of 61 years old, administered in Left arm, for covid-19 immunisation. The patient previously took lithium. The patient reported rash on arms, hands, legs, feet, and a little bit on chest. The worst part was that his groin swelled up to about the size of a Cantaloupe. He was catheterized in the hospital and over a period of about two weeks he lost about 60-70 pounds in water weight. The adverse events occurred on 07Feb2021. The adverse event resulted in emergency room/department or urgent care. Catheterization and Furosemide were received as treatment for the adverse events. The outcome of events was recovered with sequelae. Follow attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1332750
Sex: F
Age:
State: AZ

Vax Date: 05/03/2021
Onset Date: 05/01/2021
Rec V Date: 05/20/2021
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Symptom List: Pain in extremity

Symptoms: fist dose on 19Apr2021, second dose on 03May2021; fist dose on 19Apr2021, second dose on 03May2021; Irregular pulse; a cardiac patient; This is spontaneous report from contactable consumer. This 54 year-old female consumer (patient) reported that: report about covid_vaccine: Yes reporting type: AE reporter type: Patient if other vaccine in four weeks No other medication in two weeks Methylphenidate Hydrochloride adverse event start date 26Apr2021 if patient recovered: Not recovered other medical history: asthma fibromyalgia Drug(s) Information: Proprietary medicinal product name: Pfizer Batch/lot number: EW0161 Date of start of drug: 19-Apr-2021 Anatomical Location: Arm Left Dose Number: 2 Proprietary medicinal product name: Pfizer Batch/lot number: ER8730 Date of start of drug: 03-May-2021 Anatomical Location: Arm Left Dose Number: 1 Start Date/Time: [Pfizer] 19-APR-2021 06:00 PM Start Date/Time: [Pfizer] 3-MAY-2021 12:00 PM Facility where the most recent COVID-19 vaccine was administered:Doctor's office/urgent care Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No List of any other medications the patient received within 2 weeks of vaccination:Methylphenidate Hydrochloride Reported Event: Irregular pulse started about a week after the second vaccine, went to emergency room on Monday, 5/6 because symptoms were getting worse. Am now a cardiac patient. Did the adverse event result in any of the following?: Doctor or other healthcare professional office/clinic visit Did the adverse event result in any of the following?: Emergency room/department or urgent care What treatment received for the adverse event? cardiac monitoring Prior to vaccination, was the patient diagnosed with COVID-19?:No Since the vaccination, has the patient been tested for COVID-19?:No Device Date : 06May2021 Information on Lot/Batch number was available. Additional information has been requested This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 12:00 (Batch/Lot Number: EW0161) as SINGLE DOSE for covid-19 immunisation . Medical history included asthma fibromyalgia from an unknown date and unknown if ongoing. Concomitant medication(s) included methylphenidate hydrochloride (METHYLPHENIDATE HYDROCHLORIDE BRECKENRIDGE) taken for an unspecified indication, start and stop date were not reported. The patient experienced irregular pulse started about a week after the second vaccine, went to emergency room on monday, 5/6 because symptoms were getting worse. am now a cardiac patient. (heart rate irregular) (medically significant) on 26Apr2021 with outcome of not recovered , irregular pulse started about a week after the second vaccine, went to emergency room on monday, 5/6 because symptoms were getting worse. am now a cardiac patient. (cardiac disorder) (medically significant) on 26Apr2021 with outcome of not recovered , fist dose on 19apr2021, second dose on 3may2021 (inappropriate schedule of product administration) (non-serious) on an unspecified date with outcome of unknown. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of irregular pulse started about a week after the second vaccine, went to emergency room on monday, 5/6 because symptoms were getting worse. am now a cardiac patient. (heart rate irregular), irregular pulse started about a week after the second vaccine, went to emergency room on monday, 5/6 because symptoms were getting worse. am now a cardiac patient. (cardiac disorder).

Other Meds: METHYLPHENIDATE HYDROCHLORIDE

Current Illness:

ID: 1332751
Sex: M
Age:
State: WA

Vax Date: 04/03/2021
Onset Date: 04/04/2021
Rec V Date: 05/20/2021
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Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: AS sensorineural hearing loss; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 15:00 (Lot Number: EN8737) as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included bupropion hydrochloride (BUPROPION HCL XL) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 (Lot number: EN6208) on 13Mar2021 15:30, administered in Left arm for covid-19 immunisation. The patient experienced Sudden AS sensorineural hearing loss likely causing tinnitus possibly related to Covid vaccination response on 04Apr2021 08:00. Event seriousness criteria was disability. The patient presented with hearing loss for 1 month, onset after COVID vaccine which was on 03Apr2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included two separate transtympanic steroid injections, and prednisone medication (60mg then taper). Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: BUPROPION HCL XL

Current Illness:

ID: 1332752
Sex: M
Age:
State: NJ

Vax Date: 03/29/2021
Onset Date: 05/04/2021
Rec V Date: 05/20/2021
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Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: My sugar level used to be between 100 to 129 before the shot. after taking covid 19 vaccine when i got my blood test it came around 266.; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration administered in left arm on 29Mar2021 13:30 (Batch/Lot Number: EP7534) (age at vaccination: 48 years old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had previously received the first dose of BNT162b2 on 10Mar2021 07:30 (Batch/Lot Number: EN6206) for COVID-19 immunisation. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported. The patient's sugar level used to be between 100 to 129 before the shot. After taking the COVID-19 vaccine, he got blood test it came around 266, on 04May2021 07:45. No treatment was received for the event. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was unknown.

Other Meds: SYMBICORT

Current Illness:

ID: 1332753
Sex: M
Age:
State:

Vax Date: 04/19/2021
Onset Date: 04/20/2021
Rec V Date: 05/20/2021
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Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: fever; headache; lot of general malaise; yellow coloration in my eyes; skin rash; This is a Spontaneous report from a contactable consumer. A male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19Apr2021 at 16:28 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On 20Apr201, the patient presented fever, headache and a lot of general malaise, currently presenting yellow coloration in eyes and skin rash. 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: 1332754
Sex: M
Age:
State: NC

Vax Date: 04/24/2021
Onset Date: 04/25/2021
Rec V Date: 05/20/2021
Hospital: Y

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Symptom List: Vomiting

Symptoms: felt unwell; took his oxygen level and it was at 80%; he had swelling; difficulty breathing; tachycardia; allergic reaction; tested Covid-19 positive; blood clots; he got very sick; This is a spontaneous report from a contactable consumer(patient's daughter). A 71-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) at the age of 71-year-old as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was fine and nothing happened until after the vaccine. The patient took the 1st dose on 24Apr2021 and the next day he got very sick, they thought it was just a reaction from the vaccine, then he was swelling said he was not feeling well. The day after the vaccine, the patient was rushed to the emergency room and confined to the ICU. He felt unwell and it got worse and worse, we took his oxygen level and it was at 80%, he had swelling, difficulty breathing and tachycardia. The reporter thought it was an allergic reaction but this morning the patient tested positive for covid, he didn't go out the only time he went out was to get the vaccine. The reporter asked If he didn't know he had covid and got the vaccine, will he get more sick. In the report they found blood clots and the doctors thought it was from the vaccine. He was diagnosed with blood clots and difficulty breathing and he tested Covid-19 positive. Events seriousness criteria reported as hospitalization. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1332755
Sex: F
Age:
State: PA

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 05/20/2021
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Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Passed out; Vasovagal reaction; Dizzy; Skin was sweaty; Pale; This is a spontaneous report from contactable Pharmacist. A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 06May2021 10:15 am (Lot Number: EW0171) at the age of 17-year-old as single dose for covid-19 immunisation. Medical history reported as none. No known allergies. The patient was not pregnant. The patient's concomitant medications were not reported. Vaccine was given, patient was sitting with her mother. Approximately 10 minutes after vaccine, she slumped to the side and passed out. When the reporter got to her she was just waking up. She still felt dizzy, skin was sweaty and pale. Paramedics arrived within 5-10 minutes to evaluate. They said they had seen this vasovagal reaction with the covid vaccine. Patient left on gurney with the paramedics. Adverse events start date was 06May2021. Events resulted in Emergency room/department or urgent care. The outcome of the events was unknown. The patient had no covid prior vaccination, no Covid tested post vaccination.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Loss of consciousness. 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: 1332756
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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Allergies:

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

Symptoms: She is curious because she was just diagnosed with an immune disease; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at 61-year-old) at second dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at first dose, single for COVID-19 immunisation. The patient was curious because she was just diagnosed with an immune disease recently. She asked if side effects can start 4 weeks after receiving the second dose of the vaccine. The outcome of the event was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1332757
Sex: F
Age:
State: CA

Vax Date: 05/05/2021
Onset Date: 05/06/2021
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: anal bleeding/when she pooped and there was blood/it was only on her rectum; blood in her stool; anal bleeding/when she pooped and there was blood/it was only on her rectum; she peed and the water was red like she was on her period/ went to pee and there was blood; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 05May2021 10:00 at single dose for COVID-19 immunisation at the age of 50-year old. Medical history reporter as none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) in the Arm Left on 05Apr2021 at the age of 50-year old for COVID-19 immunization. The patient was not received additional other vaccines on same day of the BNT162B2 vaccination. The caller received her second dose of the vaccine yesterday 05May2021 at 10:00 am. Stated caller woke up today 06May2021 at 05:00 a.m. and noticed she was bleeding. Stated she first noticed it when she pooped and there was blood, she didn't specify if the blood was in the water or in the stool. A few minutes later, she peed and the water was red like she was on her period. Caller said anal bleeding but didn't specify more. Caller clarified, at 5:00 a.m. in the morning, when she went to the bathroom and evacuated she realized there was blood in her stool and a moment ago she went to pee and there was blood, like she was on her period. Caller stated when she peed she didn't have any blood coming out of her vagina, it was from her rectum because when she was cleaning the vagina, there was no blood, it was only on her rectum. Treatment: None. Caller stated this had never happened to her before, and the only thing that was different was the vaccine. Stated she thought it was due to that because she hasn't ingested anything. Stated she wanted to make an appointment with her doctor but he doesn't open until 1:00 p.m. The events were not resulted in Emergency Room or Physician Office visit. Family Medical History Relevant to adverse events reported as none. Relevant Tests reported as none. Event onset date reported as 06May2021 05:00. No treatment received for the events. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1332758
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: Caller mentioned that patient was 6 months pregnant, and had a "transverse myelitis" attack after the vaccine; Caller mentioned that Patient is 6 months pregnant, and had a "transverse myelitis" attack after the vaccine; This is a spontaneous report received from a contactable consumer (patient's caregiver). A 37-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller mentioned she was asking on behalf of a patient advocacy organization for a young pregnant woman (Patient). Caller mentioned that patient was 6 months pregnant, and had a "transverse myelitis" attack after the vaccine. Caller disconnected remotely before being able to offer Safety transfer, ask for other questions, offer survey, and closing. Outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1332759
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/20/2021
Hospital:

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

Allergies:

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

Symptoms: bladder infection; when she took her first dose she was tired afterwards but now she is tired before she even begins with the shot; already has other aches and pains; This is a spontaneous report from a contactable consumer (patient). A 101-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation at an unknown age. The patient medical history and concomitant medications were not reported. The patient had bladder infection, and when she took her first dose she was tired afterwards but now she is tired before she even begins with the shot, and already has other aches and pains. The outcome of the events was unknown. Clinical course: Caller is a 101-year old, Female and her first dose of the PFIZER-BIONTECH COVID-19 VACCINE. Following her first dose, she developed a bladder infection and was on sulfa antibiotic (did not provide the specific drug name) until Saturday. Caller was set to have her second dose tomorrow and she read that side effects following the second dose may be more intense the first one and would like to know if it is okay for her to get the second dose of the vaccine considering the side effect she experienced and the drug she just took. Also, caller was not able to provide prescribing physician's information as she explicitly mentioned that she was healthy and did not frequently go to the doctor, not when it was needed or on semi-annual check-up (every 6 months). She mentioned she may consult with her physician on 15May2021. Caller sounded like she must have forgotten her physician's name. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. Refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Referred to HCP in regards her concern to proceed with her second dose. Caller said that she had a question. She had her first COVID vaccine and she had a bladder infection last week and she didn't know if it is completely gone. She took an antibiotic (sulfa antibiotic) which she ended last Saturday and she was so tired and she was due to take her second shot tomorrow. Is it okay for her to take it or not. Last time, when she took her first dose she was tired afterwards but now she is tired before she even begins with the shot. She didn't know if she was tired from the bladder infection or what. She didn't want to cause anymore problems, she already has other aches and pains. Caller asked to speak to medical information now so she could know if she can take the 2nd dose or not. Caller was informed that MI was unable to tell her to take or not take the second dose but they may have resources to provide to assist her in making this decision. Caller declined to complete the report at this time, unable to obtain further details. Information on the lot/ batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am