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
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1508881
Sex: F
Age:
State:

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: horrible headache all the way down to her body; horrible headache all the way down to her body; Pulsatile tinnitus; it is going like tingling when touch her leg; it's like little like arm go to sleep it tingles but now starting to twitch giving her twitching you know for no reason; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an dose 1 via an unspecified route of administration on 13Apr2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took gabapentin. On Apr2021,After Three days of vaccination, the patient experienced horrible headache all the way down to her body, pulsatile tinnitus that you can hear heart beat in your ear and it started with that it went all of her into her face area and then down on left side it went down in her left arm and then her right left leg ,it is going like tingling when touch her leg, it's like little like arm go to sleep it tingles but now starting to twitch giving her twitching you know for no reason. The outcome of events was unknown. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1508882
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Her father is scared either way; Her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient's daughter). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported; Expiration Date: Aug2021), dose 1 via an unspecified route of administration on 28Jun2021 (at 68-years-old) as dose 1, single for covid-19 immunisation. The patient medical history included had multiple health conditions and concomitant medications were not reported. Reporter calling about her parents having been shot with Pfizer-BioNTech COVID-19 Vaccine that was beyond the total time of use. Caller stated that her parents got their 1st dose of vaccine on 28Jun2021, however, they were informed on 02Jul2021 that the vaccines were expired (start date 28Jun2021). According to them, the vials was supposed to expired in Aug2021, but the vial has been stored in the fridge for 38 days and you're not supposed to use it after 31 days. The vaccine shot that was in the refrigerator for 38 days was still given to reporter's parents. The patient (her father) was the very concern and had multiple health conditions and was afraid of allergic reactions. The patient wanted to make sure that if he doesn't get revaccinated, he was still protected. The patient was scared either way on unspecified date. Reporter wanted to know if they should be revaccinated or to resume the vaccination series as scheduled or was it safe to use the 38 days; and let's say they want to get revaccinated and decided to go for the full MODERNA series instead of Pfizer because they fear getting Pfizer again since they already got one shot, what was the data Pfizer have on people getting one shot of something and change to a different COVID Vaccine. Information on lot /batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021865048 same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1508883
Sex: F
Age:
State: WI

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: feel lightheaded; tired; couldn't relax; a slight fever; she feels hot after getting the vaccine; I was sweating a little more than normal on my forehead; my joint pain was more than normal; I had something already bothering my left foot on my toe; Headache; This is a spontaneous report received from a contactable consumer who reported for herself. This report is also reported from a Pfizer sponsored. A 69-year-old female patient received her first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) via an unspecified route of administration at 0.3 mg as a single dose on 18Jun2021 (lot number EW0179, expiration date Aug2021), for COVID-19 immunization. The patient had food allergies and weather issues like when the seasons change like pollen. Concomitant medications were not reported. At the day of vaccination (18Jun2021), the patient was tired and couldn't relax. And then she might have had a slight fever too and she felt hot, but it was hot that day too. She was sweating a little more than normal on her forehead. And her joint pain was more than normal. She had something already bothering her left foot on her toe. It seemed liked everyday for a while. She did something to her toe about 2 months now. When she standed or walked too long she felt lightheaded, but she had had that before. She might have felt a little lightheaded before she left the hospital too. She was there for 15 or 20 minutes before she left but she had someone with her. Also it was not too much of a headache, she did have some days where she felt light headed or dizzy, like when she first got up. The patient didn't want to get the Johnson and Johnson vaccine because of the things with the veins and legs and she had a lot of veins in her legs, she was hoping that Pfizer's vaccine did not affect the veins. The outcome of the events was unknown. The patient's second dose was scheduled on 09Jul2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508884
Sex: F
Age:
State: SC

Vax Date: 03/10/2021
Onset Date: 03/28/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Her mother had a couple falls within a couple days; Her mother had 2 ankle fractures from one of the falls; This is a spontaneous report from a contactable consumer or other non-hcp. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6204; Expiration Date: Jun2021) via an unspecified route of administration (age at vaccination 71-year) in Right Arm on 10Mar2021 as dose 1, single for COVID-19 immunization. Medical history included crohn's disease from 1980 to an unknown date; pulmonary fibrosis (diagnosed 2 years ago), fibromyalgia (for at least a decade), arthritis, stress fracture, ankle fracture, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No prior Vaccinations (within 4 weeks) was reported. As patient's daughter reported, her mother had a couple falls within a couple days on 28Mar2021; her mother had 2 ankle fractures from one of the falls in 2021. The caller said her mother had a fall, and her mother had not gotten her second COVID-19 Vaccine dose. The caller asked if her mother should start over with getting the COVID-19 Vaccine, or could her mother get the second COVID-19 Vaccine dose. Person stated she gave the caller the number for Pfizer Medical Information. Reviewed and confirmed the transferring agent's report details with the caller. Reported she didn't believe that her mother's fall was related to her mother's first COVID-19 Vaccine dose. She said there was too much time that had gone by between when her mother received her first COVID-19 Vaccine dose and her mother's fall. Stated her mother said she believed she received her first COVID-19 Vaccine in her right arm because she was left-handed but was not positive. Reported her mother had past stress fractures and did not realize she had 2 ankle fractures. She said she called EMS the following day of her mother's fall, and her mother didn't have surgery on her foot right away because she had too much swelling. She clarified her mother had surgery on her one foot at a later date. Reported her mother was in a residential care facility for 2 months and had to cancel her second COVID-19 Vaccine. She said her mother was unable to get another COVID-19 Vaccine appointment during that time, and the residential care facility her mother was in used a different COVID-19 Vaccine. Her mother not getting her second COVID-19 Vaccine was strictly a timing issue because she was unable to schedule a Pfizer COVID-19 Vaccine while at the residential care facility. The adverse event ankle fracture leads to visit Emergency Room/Physician Office. Her mother had surgery one her foot, and her mother was in a skilled nursing rehab center for 2 months. No further details provided. Her mother was still in recovery with Physical Therapy and Occupation Therapy being done at home. Therapeutic measures were taken as a result of the adverse events. The clinical outcome of the events was recovering. Follow-up attempts are needed. Further information is expected.

Other Meds:

Current Illness:

ID: 1508885
Sex: F
Age:
State: MS

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: intense gastric/stomach pain; pain still persisted; intense abdominal cramping, which was around, either right below the stomach, or right around that large intestine; Sore left arm; discomfort for two days that went up into her chest a little bit, but the predominant gastro location; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was EW01a8 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 01Jul2021 at 21:50 (at the age of 35-year-old) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included small heart, and pains on the left side of her chest prior to vaccination. She stated that she did not know if it was a condition, she just found out recently she has a small heart, but she was a pretty petite girl, and did not know if that was normal for her. Family history included she had an immunocompromised parent who received the Pfizer BioNtech Covid-19 Vaccine and her dad had a heart attack after Moderna vaccination. She stated she didn't really want to comment too much because she did think he had pre-existing conditions, they did not have a great relationship so she really could not give a lot of information on him, she couldn't even tell his favorite color. The patient's concomitant medications were not reported. The patient previously took Panmist and experienced reaction to Panmist. She stated that Panmist sent her central nervous system out of whack, and added, compared the ingredients and it was said that nothing was in the Pfizer vaccination that was in Panmist. She stated that it occurred around the age of 12 years, and form or how medication was taken was unknown. On 01Jul2021, the patient experienced intense gastric/stomach pain, pain still persisted, intense abdominal cramping, which was around, either right below the stomach, or right around that large intestine, sore left arm, discomfort for two days that went up into her chest a little bit, but the predominant gastro location. Clinical course: The patient stated that she received the first dose of the Pfizer BioNTech covid-19 Vaccine on 01Jul2021 and experienced intense gastric pain for about 20 minutes and subsided. The pain still persisted for about 2 days. She also experienced abdominal cramping for about 2-3 days. The patient stated that she got her first shot 01Jul2021, which was really exciting, but about twenty minutes after she got her shot, she started having really intense gastro pains, and it did not come out either end, it was not vomiting or diarrhea, it was just pain. She added that lasted a few minutes, then for about two days, it wasn't acid reflux, but it was that whole kind of feeling for two days. She did not have a history of acid reflux, she was 35, pretty good so far, on a lot of boxes, she wa pretty healthy. Her question really was regarding that pre-covid checklist, on page six of the pre-vaccination checklist, it said if you have any gastrointestinal reactions, that you shouldn't get the second shot. She asked, was that true. She stated, if this sounds familiar at all, she did not know if it would give her peace of mind that it's not necessarily uncommon, because she hadn't really heard anyone having this that she knew. She got the shot from pharmacy around 21:40 or 21:50, she tried to go at a minimal time, she cared for a immunocompromised individual, so she needed the most minimal traffic as possible. She clarified the symptoms occurred before 22:30. There was a real discomfort for two days around that same area, that almost went up into her chest a little bit, but the predominant gastro location. She confirmed after forty-eight hours, it did completely resolve. She had the sore arm, which was fine, she's just more concerned about that gastro cramping, and why it said not to get the second shot, she just wants to know, she did not want to screw up. It was her left arm, and it occurred later that same night, but she immediately started wrapping it with cold rags and exercising it, and she did not experience a big issue with that, due to the proactive measures she was taking to try to heal the muscle. She stated by the full second day, she was doing well compared to a lot of people, and she confirmed the sore arm had resolved by 03Jul2021. Caller confirms the gastro pain was fully resolved by Sunday, 04Jul2021, it was all relieved, it was all ok, she was on alert. She confirmed the time of vaccination as 21:50. She was pretty healthy overall and was not on any medications and still was not, she didn't even take ibuprofen or anything like that for her arm, she just wrapped it and exercised it. She stated that she had been having pains on the left side of her chest prior to vaccination, but she thought it's stress induced, because her x-ray looked okay. She thought it's just from the isolation and extreme measures. Investigations: she stated no, but added, the weekend prior to her getting the shot, she ended up in urgent care for her mom, and caller got looked at for her chest, and they referred her to a cardiologist, but her tests were scheduled for this week, so Tuesday of this week, 06Jul2021, she had blood work and they did an x-ray. She clarified this was for the previous chest pain that she had prior to getting vaccinated and not for the symptoms reported after the vaccine. She confirmed it was a chest x-ray, and states everything looked fine. She added, there was a number she needed to ask the doctor about, that was low, but she didn't understand it. She stated she did not know what lab was low, she would have to pull it up. She stated she would hate for this to be correlated with the vaccination, when there was no science to it whether it was related to that experience or not. The outcome of the event sore left arm was resolved on 03Jul2021 and other events were resolved on 04Jul2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508886
Sex: M
Age:
State: CA

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Nausea; fatigue; decreased appetite; This is a spontaneous report from a contactable physician. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose intramuscularly, administered in Arm Right on 05Apr2021 (Lot Number: EW0150, expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation. Medical history included neoplasm left kidney from 2007 to an unknown date. The patient's concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route on 15Mar2021 (Lot Number and expiration date not provided) at age of 44 years old as a single dose for covid-19 immunisation and experienced Nausea. The patient experienced nausea, fatigue, decreased appetite, all in 2021. Nausea, fatigue and decreased appetite which has persisted after his second Pfizer COVID-19 vaccine 05Apr2021. The outcome of the events was not recovered. The report was reported as non-serious. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for events.

Other Meds:

Current Illness:

ID: 1508887
Sex: U
Age:
State: TX

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: pain in the injection site; fever of 37.7 ?C; pain in his neck; This is a spontaneous report from contactable consumer. This consumer reported for his children (patient). A 12-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 08Jul2021 (at the age of vaccination 12-year-old) as dose number unknown, single for covid-19 immunization.The patient's medical history and concomitant medications were not reported. It was reported that yesterday reporter and children (patient) both were vaccinated with the Pfizer Covid-19 vaccine around noon. On 08Jul2021 at night, one of the children had pain in his neck, the other malaise and reporter gave them paracetamol. On 09Jul2021(Today), they have a fever of 37.7 degree C and pain in the injection site. The patient underwent lab tests which included body temperature: 37.7 centigrade on 09Jul2021.The outcome of all events was unknown. Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021875528 same reporter/ drug, different AE/patient

Other Meds:

Current Illness:

ID: 1508888
Sex: F
Age:
State: FL

Vax Date: 07/08/2021
Onset Date: 07/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: bloating; abdominal pain; Cramping; stomach bloated, like it was filled gas, with severe pain; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA6780), via an unspecified route of administration in the left arm on 08Jul2021 (at the age of 61-year-old) as dose 2, single for COVID-19 immunisation. Medical history included acid reflux from an unknown date and unknown if ongoing, sjogren's syndrome from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (started about 4-5 years ago) taken for acid reflux disease from an unspecified start date and ongoing; cevimeline (about 4-5 years) taken for sjogren's syndrome from an unspecified start date and ongoing; cyanocobalamin (B-12) (started this in the last month and for to be healthy) taken for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in the left arm on an unknown date as dose 1, single for COVID-19 immunisation. It was reported that the she got the second Pfizer COVID vaccine shot yesterday, 08Jul2021, and not sure if this is a side effect or not, states she pretty active yesterday, but after lunch about 3-4 hours after the vaccine her stomach got very bloated, like it was filled with gas, had severe pain and cramping, abdominal pain, stated that subsidized with heating pad that evening but bloating and abdominal pain was coming back "today", bloating and abdominal pain was tender to the touch, has improved some. Caller was wondering if these are side effects that has been reported with the Pfizer COVID-19 vaccine. The patient was received treatment for the events. The outcome of the events was resolving. Follow-up attempts are needed. Additional information has been requested.

Other Meds: PANTOPRAZOLE; CEVIMELINE; B-12

Current Illness:

ID: 1508889
Sex: F
Age:
State:

Vax Date: 07/07/2021
Onset Date: 07/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Today, 09JUL2201, wakes up and there is a little allergy, like little pimples around.; Today, 09JUL2201, wakes up and there is a little allergy, like little pimples around.; The day after receiving the vaccine, had a little ball in the area where the vaccine was given; a rash/itching in the area of the vaccine injection; a rash/itching in the area of the vaccine injection; This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported for a 66-year-old female (patient) reported that: A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 07Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The caller was a consumer who called regarding her mother, the caller's mother received the first dose Pfizer COVID 19 vaccine two days ago, 07Jul2021 at the "PRIVACY" Hospital. The callers mother has a reaction to the first dose Pfizer COVID 19 vaccine and the caller wants to make sure it was okay and part of the reaction to the Pfizer COVID 19 vaccine. On 08Jul2021, the day after receiving the first dose Pfizer COVID 19 vaccine, the callers mother got a little ball in the area where the patient received the first dose Pfizer COVID 19 vaccine and a rash/itching in the area of the vaccine injection. The caller states her English was kind of bad. The patient put ice and lotion on, like when "you" are working out. The patient's little ball in the area was getting better. "Today", 09Jul2021 the patient wakes up with a little irritation a little allergy little pimple around. The caller has never seen this reaction. The caller's husband said maybe the caller should call Pfizer. The caller stated her mother does not have a doctor and came to visit the caller, no doctor or anything. The caller would like to know if these reactions are part of the Pfizer COVID 19 vaccine, this irritation the patient was having. The outcome of "vaccination site mass" was reported as resolving and rest of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1508890
Sex: F
Age:
State: TX

Vax Date: 07/08/2021
Onset Date: 07/09/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: fever/orally temperature was 100.8 degrees Fahrenheit; severe body aches; chills/heater on 80 degrees because she had the chills so bad; pains like joint inflammation; pains like joint inflammation; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration high on left shoulder on 08Jul2021 08:45 AM (Lot number: EW0150, NDC number: Unknown, Expiry Date: Unknown) (at the age of 52-year-old) as single dose for Covid-19 immunisation. The patient took the Pfizer Covid vaccine because as she could not leave the house without being vaccinated, she got a new job. When probing for indication of the Covid 19 vaccine she reported she started a new job. She was laid off on 15Jul2021 due to the Covid 19 virus and this job literally fell in her lap. She talked to her new employer on Wednesday, and he hired her on Thursday and she thought she could not leave the house without being vaccinated. She had been quarantining at home. The patient's medical history included mononucleosis from 07Jul2021, Covid-19 from May2021, hypertension and attention deficit hyperactivity disorder (ADHD). Concomitant medications included ongoing amfetamine aspartate/amfetamine sulfate/dexamfetamine saccharate/dexamfetamine sulfate (ADDERALL XR) and ongoing hydrochlorothiazide/lisinopril (LISINOPRIL HCTZ, 12.5 mg/20 mg). When probing medical history and concomitant medications she reported she had not taken her Adderall in a week or so because she ran out. Her last refill was 05May2021 and she did not want to take her prescription medications while she had Covid and she did not want to have to go anywhere while quarantining. On 09Jul2021, the patient experienced severe body aches, pains like joint inflammation, fever, temperature today orally is 100.8 degrees Fahrenheit, chills, had her heater on 80 degrees because she had the chills so bad, she was still out of breath, could not go up and down the stairs because she was so winded. She was calling about the Pfizer Covid vaccine. She had her first dose yesterday on 08Jul2021. The patient stated that she was seen by her doctor on 07Jul2021, and now had been diagnosed with Mononucleosis. Caller reported her symptoms as being fever and body aches. She was feeling the same way as felt when had Covid back in May2021 since she received the Pfizer Covid vaccine, she was infectious to her family and children, did not need to isolate. The Pfizer-BioNTech COVID-19 Vaccine did not contain SARS-CoV-2 (the virus that causes COVID-19) and could not give COVID-19. Spoke from DOC-0063577 that the side effects that experiencing were consistent with what had been reported. Reporter seriousness for the events was unspecified. She had gone to her doctor on Wednesday, 07Jul2021 because she was not feeling well. She had the Covid 19 virus in May2021 and is still experiencing extreme fatigue and extreme, severe body aches. Her doctor did some bloodwork on Wednesday, 07Jul2021 and tested her for mononucleosis. Today 09Jul2021, she received the results of her mononucleosis test and she is positive for mononucleosis. Yesterday, 08Jul2021 she received her first Covid 19 vaccine and she was told to expect side effects because she had the Covid 19 virus in May2021 and that had been in the past 60 days. Today she was having severe body aches and pains like joint inflammation and a fever. She was told she might have a fever and now that she had a fever, wanted to know whether she was at risk of infecting anyone else (contagious). She was concerned because she was supposed to babysit her granddaughter in weekend. To clarify she went to her doctor on Wednesday 07Jul2021 because she was still having symptoms from the Covid 19 virus she had in May2021. She had not to go to the doctor or emergency room regarding symptoms since receiving her first dose of the Covid 19 virus on 08Jul2021. She provided the following information historically from her encounter in May2021 with the Covid 19 virus. She read that some people were still having Covid 19 symptoms even after testing negative for the Covid 19 virus. The body aches she had been having were incredibly painful. She was tested for the Covid 19 virus in May2021 on a Friday but her test was negative. She could not remember the exact dates but had the prescription bottle of a medication she received during that time dated 07May2021. She was told to quarantine with her husband because they were together a lot. The same day that she tested negative for the Covid 19 virus her husband tested positive. She was tested again for the Covid 19 virus on that Monday and tested negative. But on that same Monday she developed some coughing and the next day on Tuesday she had a fever. Later that week she still had the fever and then she experienced fatigue and on Thursday and Friday she had body aches that were so incredibly painful that she could not even get out of bed to use the restroom. At that point she found it interesting that she was in so much pain. Her doctor prescribed her Acetaminophen-Cod3 300 mg on 07May2021. When she started taking that medication her fever started breaking. Her fever had reached 102 degrees Fahrenheit. The body aches and the joint pain during that time was incredible unbearable. Her fever was breaking, and she was sweating and just had a low grade fever. She reported her temperature today orally is 100.8 degrees Fahrenheit. She was still out of breath since having the Covid 19 virus. Before she had the Covid 19 virus she was extremely active with jogging, bike riding, and gardening. Now she could not go up and down the stairs because she was so winded. When probing for information regarding her symptoms after receiving the Covid 19 vaccine she reported she was back to having the severe body aches, fever and chills. When she went to get her medications, she had her heater on 80 degrees because she had the chills so bad. No PQC present. Follow-up attempts are needed. Further information is requested.

Other Meds: ADDERALL; LISINOPRIL HCTZ

Current Illness:

ID: 1508891
Sex: M
Age:
State: TX

Vax Date: 06/25/2021
Onset Date: 06/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: pain spreading through his body, arm, should, elbow, it gets worse when he uses more force like when lifting.; minimum pain at inject site of Left arm; had fever blisters all over on my lower lip; I tried moving the couch and both arms went numb gave out on me; felt like I had internal fever until they showed up; as severe muscle and joint pain; as severe muscle and joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 25Jun2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. No medical history and concomitant medications were not reported. It was reported that side effects started the same day as vaccine stated it was normal at injection site went on for 2 to 3 days minimum pain at inject site of Left arm. By the 4th day till today it has gotten worse, pain spreading through his body, arm, should, elbow, it got worse when he used more force like when lifting. 2 or 3 days ago (as reported), he started experiencing internal fever, although no temperature had fever blisters all over on his lower lip. they are still there and started 3 days ago, when his joint pain got worse, felt like had internal fever until they showed up. Right now, few hours ago, tried moving the couch and both arms went numb gave out on him. It was also reported that he did not want to go to the emergency room (ER) until he spoke. He wanted to know if this was a severe reaction. The patient explained that he was experiencing severe muscle and joint pain. The outcome of the events was not resolved. Follow-up attempts are possible. Information on lot/batch number can be obtained.

Other Meds:

Current Illness:

ID: 1508892
Sex: F
Age:
State: GA

Vax Date: 06/18/2021
Onset Date: 06/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Got infection in left arm 1 week after injection; Hit too touch painful and had to get VQ scan to see if u had a blood clot; This is a spontaneous report from non-contactable consumer (patient). A 29-year-old female (not pregnant) patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Jun2021 15:30 (Batch/Lot number was not reported) at the age of 29 years as single dose for covid-19 immunisation. Medical history included Factor 5 linden and known allergies: Ceclor product, sulfur, cat scan dye. The patient had no concomitant medications. The patient previously took cefaclor (CECLOR) and sulfur and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient got infection in left arm 1 week after injection. Hit too touch painful and had to get VQ scan to see if patient had a blood clot. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient had to go on antibiotics. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1508893
Sex: F
Age:
State: TX

Vax Date: 06/23/2021
Onset Date: 06/23/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Fevers over 100; chest pain; hard time breathing.; Sore Joints; This is a spontaneous report from a contactable consumer. A non-pregnant 14-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for inejction), dose 1 via an unspecified route of administration, administered in left arm on 23Jun2021 13:00 (Batch/Lot Number: EW0217) as dose 1, single (at the age of 14 years old) for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. The patient experienced fevers over 100, chest pain, hard time breathing and sore joints on 23Jun2021. The patient received TYLENOL. Prior to vaccination, the patient was not diagnosed with COVID-19 and not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1508894
Sex: F
Age:
State: CA

Vax Date: 07/07/2021
Onset Date: 07/08/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: a temperature of 101.7; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; I had a pale/ blue appearance to my skin and shivering; the injection site was very swollen almost all the way around my arm; wispy breathing; This is a spontaneous report from a contactable consumer. A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 07Jul2021 13:30 (Batch/Lot Number: FA6780) as dose 1, single (at the age of 43 years old) for COVID-19 immunisation. Medical history included ADHD and anxiety and known allergies: only to penicillin. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]), quetiapine fumarate (SEROQUEL), buspirone hydrochloride (BUSPAR) and guanfacine all taken for an unspecified indication, start and stop date were not reported. The patient stated, "the second day (08Jul2021) I had a pale/ blue appearance to my skin and shivering and had to take a hot shower to warm up. Third day, the injection site was very swollen almost all the way around my arm and I have pictures and a temperature of 101.7, and wispy breathing. I had to call the nurse advise line for what to do and the nurse said to treat at home". Prior to vaccination, was the patient was not diagnosed with COVID-and not been tested for COVID-19. The patient received no treatment for the events. The outcome of the events was not recovered.

Other Meds: VITAMIN D [COLECALCIFEROL]; SEROQUEL; BUSPAR; GUANFACINE

Current Illness:

ID: 1508895
Sex: F
Age:
State: TN

Vax Date: 03/01/2021
Onset Date: 03/26/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report received from a contactable consumer or other non hcp. A 50-years-old female patient received bnt162b2 (COMIRNATY,Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on Mar2021 as DOSE 1, SINGLE for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced later that evening she had shortness of breath (dyspnoea) , after one hour, she had severe dizziness, slept for one hour and when patient woke up she had abdominal cramps that lasted about an hour (abdominal pain) on 26Mar2021.The outcome of the events was recovered.The patient didn't received any other vaccine within 4 weeks after covid vaccine. The patient was not admitted to hospital as the case was not serious.

Other Meds:

Current Illness:

ID: 1508896
Sex: U
Age:
State: LA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: they gave it to me 'in my leg'; This is a spontaneous report from a contactable consumer reported for self. This 76-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Leg on 18Feb2021 at age of 76-year-old as DOSE 1, SINGLE (Lot # EL9265) for covid-19 immunisation. Medical history included Rheumatoid arthritis, Osteoarthritis, Hypertension, breast cancer issues, knee replacement. Concomitant drugs included hydroxychloroquine sulfate (PLAQUENIL S), Gabapentin, Levothyroxine for thyroid problem, and diazepam (VALIUM) at 5 mg. No vaccination prior to the COVID 19 Vaccine. The patient got the first shot in January, they gave it to the patient 'in my leg' because of breast cancer issues. They got permission to give it to in my 'leg', two weeks 'of debate they wanted to give it in my legs'. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: PLAQUENIL S; GABAPENTIN; LEVOTHYROXINE; VALIUM

Current Illness:

ID: 1508897
Sex: F
Age:
State:

Vax Date: 07/10/2021
Onset Date: 07/10/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

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

Symptoms: I haven't had my periods from almost 10 years; all of the sudden I started vaginal bleeding; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 10Jul2021 09:15 as dose number unknown single for COVID-19 immunization. Patient stated, she just wanted to know that the whole sheet of information that she was given to from the pharmacy that she got the shot today this morning 10Jul2021 at 9:15 and she came home she had not had her periods from almost 10 years and all of the sudden she started vaginal bleeding. Patient stated, the name of the product was the Pfizer shot which she got this morning, the COVID, (confirmed as Pfizer Covid 19 vaccine). The outcome of the event was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1508898
Sex: M
Age:
State: MO

Vax Date: 07/09/2021
Onset Date: 07/10/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Seizure; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 42-years-old, via an unspecified route of administration, administered in upper arm right on 09Jul2021 14:15 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Patient's weight: 83.91 kg and Height: 174 cm. Medical history included ongoing visually disabled, scarred kidneys, one side of body shorter than other half and epilepsy. Concomitant medication included levetiracetam (KEPPRA) taken for epilepsy from an unspecified start date and ongoing. The patient experienced seizure on 10Jul2021 16:30 which did not require emergency room of physician's office visit. Someone in the background of the call could be heard sounded like stating patient gets a seizure when he gets sick. He just rested at home and took care of himself at home. He just treated the seizure like he would any other time and rested. He commented his seizure was due to visual disability. The patient had no previous immunization and no other vaccines administered within 4 weeks. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds: KEPPRA

Current Illness: Glomerulosclerosis; Hemihypertrophy; Visual impairment

ID: 1508899
Sex: M
Age:
State: FL

Vax Date: 06/07/2021
Onset Date: 06/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: His heart is beating too fast/a rapid heartbeat; Chills; Fever; He has been feeling like very very different; He feels like his muscles is not, he feels like he is not himself; He cannot sleep with his heart like that; This is a spontaneous report received from a contactable consumer (Patient mother). A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0181) via an unspecified route of administration in left arm on 07Jun2021 (at the age of 21-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were No. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0174), via an unspecified route of administration on 07May2021 as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccine prior to COVID-19 vaccine. The patient mother reported that the patient got his second shot like almost month and half ago but since then from an unspecified date, he has been feeling like very, very different like his heart is beating too fast and he feels like his muscles is not, he feels like he was not himself, and a week later he started with symptoms of chills, fever and a rapid heartbeat, like he can't control it. Patient mother took him to the hospital, but they found nothing, he was hospitalized for a few days from an unspecified date, but they found nothing. He was healthy before, so patient mother knew that this was related to the vaccine. Patient mother stated that he can't sleep with his heart like that, and she was very worried and was just calling to know what she can do or what's happened with him or she don't know because she already took him to the hospital, they kept him to the hospital till 8 and they couldn't find nothing, so she was like worried, and it was desperate already. The reporter seriousness was assessed as serious (hospitalization). The patient underwent lab tests that included a lot of checkup of the health, and everything says normal range on an unspecified date. When asked about treatment, the patient mother replied as, "No they didn't give nothing". The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508900
Sex: U
Age:
State: PA

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

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

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

Symptoms: Physician did not give it to the patient/Unknown if the patient missed the dose; had a failure of one of the syringes, the glass broke in the middle; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date (Lot number DW2998, Expiry Date: Feb2023) as DOSE NUMBER UNKNOWN, SINGLE for immunisation. The patient medical history and concomitant medications were not reported. Physician administered to the patients a Pfizer product called TRUMENBA one dose pre-filled syringes and the physician had a failure of one of the syringes the glass broke in the middle and physician want to report it and get the dose replaced and also report the problem because it was obviously unusable but also it seemed to physician kind of dangerous that it broke like this. Physician did not give it to the patient. It broke before it got to the patient. Thank goodness broke in physician's hand as the physician was getting it ready. Unknown if the patient missed the dose. Physician stated the other thing was the product was unusable. The physician would like it to be reimbursed for the value of that. Physician was suggested not to discard the product as the report would be forwarded for review by Quality Department and if it was determined that the sample was needed for further evaluation a pre-paid mailer might be sent to you within 3 to 10 business days. There might be a delay due to ongoing COVID19 situation. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1508901
Sex: M
Age:
State: OH

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Aches and pains on ours hands and our legs and sometime we cannot even close our fist; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the 1st case of 2 split cases. A elderly male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for COVID-19 immunisation. On an unknown date, patient stated,I had the Pfizer, my 2nd shot I had it at the end of March this year and my wife had it at the same time and we have had aches and pains on ours hands and our legs and sometime we cannot even close our fist and I was just wondering if anybody else called and have this complaint at all. Consumer stated, I am going in for surgery, back surgery and that is why I wanted this information. (Further clarification unknown) No treatment was received. The outcome for event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021874165 as same reporter/drug/event, different patient.

Other Meds:

Current Illness:

ID: 1508902
Sex: F
Age:
State: OK

Vax Date: 05/03/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: fatigue; I felt some chills; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 25-years-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 03May2021 (at the age of 25-years-old) (Batch/Lot Number: Er8731) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included polycystic ovaries, depression, insulin resistance, asthma, allergies. The patient's concomitant medications were not reported. It was reported that the patient felt some chills and fatigue for the first 24 hours after first vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1508903
Sex: F
Age:
State: TX

Vax Date: 07/05/2021
Onset Date: 07/08/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe.; menstrual cramping; chest pain; heart palpitations, like pounding and felt like her chest was going to burst; Shortness of breath; chest real tight; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 05Jul2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing asthma. Patient has probably had it for about 6 years. It came on as an adult. She doesn't even take an inhaler regularly. It is not extreme or anything like that. Concomitant medication(s) included hydrocodone (HYDROCODONE) taken for back pain. No prior vaccination with in four weeks. No illness at time of vaccination and family medical history was None. Caller stated regarding the Pfizer Covid vaccine. She got vaccinated on Monday, which would have been 5Jul2021. Starting yesterday, she started to have chest pain, shortness of breath and felt like her chest was really tight. It was basically like she was having heart palpitations, like pounding and, felt like her chest was going to burst. Her heart was pounding really fast. It lasted for maybe about 30 minutes to an hour. It was constant for that long and then, it went away. She still felt it but was not as strong. She ended up going to sleep. She woke up this morning and felt it again, it was getting strong again. It was reported that, The patient experienced chest pain, heart palpitations, like pounding and felt like her chest was going to burst, shortness of breath, chest real tight on 08Jul2021, when the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe, menstrual cramping on an unspecified date. It subsided, then she went to bed. Today, she is feeling it again. She was up for about an hour or so, then it started with the pounding heart again. When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe. Is still experiencing all of the symptoms. It feels like it is getting worse, then it subsides a little, then comes back. Like, her heart goes back to normal for a little bit then, just hits, like back and forth. The only thing she took yesterday was, Pamprin for menstrual cramping. She does know that it has caffeine in it. However, she takes it every month during the cycle, and this has never happened before. The outcome of all events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: HYDROCODONE

Current Illness: Asthma (Verbatim: Asthma)

ID: 1508904
Sex: F
Age:
State:

Vax Date: 06/08/2021
Onset Date: 06/09/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: dizzy; migraine; fatigued; This is a spontaneous report from a Non-contactable consumer (patient). A 21-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Jun2021 15:00 (21-years-old at the time of vaccination), as dose 1, single for covid-19 immunisation. Medical history included migraine from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that, on 09Jun2021 (24 hours after 1st dose), felt very dizzy and fatigued. Had to leave work and go home early due to feelings that I might pass out. Thankfully, I did not pass out. Patient had a migraine for the rest of the day, was fine 36 hours after dose. Patient did not take any treatment for the event. The clinical outcome of the events was recovered on 10Jun2021. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508905
Sex: F
Age:
State: OH

Vax Date: 04/18/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Severe pain in her left leg; the pain is becoming increasingly difficult; Severe pain in her left leg; the pain is becoming increasingly difficult; This is a spontaneous report from a contactable consumer (patient's husband). This is the second report out of two split reports. A 79-year-old female patient received bnt162b2 (formulation: solution for injection; COVID-19 Vaccine manufacturer: Unspecified; NDC number, UPC number, expiry date and Lot number: Unknown), dose 2 via an unspecified route of administration, administered in left arm (at the age of 79 years) on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included heart issues from an unknown date and unknown if ongoing and too many dimensions (not clarified) she had heart issues, mainly heart issues. The patient's concomitant medications were not reported. The patient historical vaccine included BNT162B2 dose 1 (lot number: ER8732) on 28Mar2021 for Covid-19 immunization at the age of 79 years. The patient's husband reported that his wife had the same shots, at different times of Pfizer and we were just beginning to explore what the issue was. She had severe pain in her left leg. After her second shot on an unknown date in Apr2021. Patient had been dealing with her primary care doctor. She had doppler on her leg because she had the similar pain in her left leg and it's not been resolved yet. This was an ongoing thing. So, she had now taken a doppler and the pain is becoming increasingly difficult, and she is in the process of evaluating what this is and gone down the emergency room the next day. The patient underwent lab test which included Doppler scan with unknown result in 2021. The outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1508906
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Eyes won't stop twitching spastically all day from the moment of waking until sleeping. Eyes twitch at least 1000 times a day. Right eye twitches more than left.; Cognitive disconnect after first and second doses for a week; Brain fog; emotional disassociation.; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age (adult) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW 0177) dose 1 via an unspecified route of administration, administered in arm right on an unspecified date (at the age of 21-year-old) as dose 1, single and dose 2 via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot Number: EW 0172; at the age of 21-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications (other medications within 2 weeks of vaccination) included docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3); ascorbic acid (VITAMIN C); vitamin D3; curcuma longa (TURMERIC); all concomitant medications taken for an unspecified indication, start and stop date were not reported. Patient received the most recent dose of vaccination at pharmacy or drug store facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date, the patient's eyes would not stop twitching spastically all day from the moment of waking until sleeping. Eyes twitch at least 1000 times a day. Right eye twitched more than left. Cognitive disconnect after first and second doses for a week. Brain fog and emotional disassociation. The events immediately followed both vaccines but the eye twitching started more profusely after the second dose. No hospitalization prolongation was reported. No treatment received for events. The outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHEROL]; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; TURMERIC [CURCUMA LONGA]

Current Illness:

ID: 1508907
Sex: F
Age:
State:

Vax Date: 03/12/2021
Onset Date: 06/15/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: I am experiencing significant hair shedding (tellogen effluvium). The hair loss started approximately 3 months after the first vaccination.; This is a spontaneous report from a non-contactable consumer (patient). A 52-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 12Mar2021 15:00 (at the age of 52-years-old) as dose 1, single and second dose (Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 12Mar2021 15:00 (at the age of 52-years-old) as dose 2, single for covid-19 immunisation in hospital. The patient medical history included lupus, endometriosis, fibroid tumors, hypersensitivity. Concomitant medications were not reported. The patient had allergies to medications, food, or other products. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested for covid-19 since the vaccination. On 15Jun2021, it was reported that, she was experiencing significant hair shedding (tellogen effluvium). I have had no change in medication, diet, etc. The hair loss started approximately 3 months after the first vaccination. Ethnicity information was available. Treatment was not received for the adverse event. Device Date was 12Jul2021. The reporter assessed the events as non-serious. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1508908
Sex: F
Age:
State: NY

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: itchy; redness; rash; Hives; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) from Pfizer sponsored program. A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 72-years), on 28May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date in 2021, the patient experienced itchy, redness, rash, hives. She received her vaccination of Pfizer covid 19 first dose on 28May2021 and the second 18Jun2021. After receiving both doses she started getting itchy and redness and would like to report. Caller stated she also had a rash and hives. She wanted to know what she could buy to put on it. The clinical outcome for the events was reported as unknown. Reporter details: Alternative Telephone & Email Address: Caller declined to provide at this time. She wanted to go to the pharmacy to see what she can put on for the terrible itch.

Other Meds:

Current Illness:

ID: 1508909
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: She has been having aches and pain; This is a spontaneous report from a Program. A specialty pharmacy (other HCP) reported for patient that, A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. Patient stated that is not as effective since receiving covid vaccines, she has been having aches and pain on unspecified date. She has been to hospital emergency room, urgent care and md office (dates not provided), nothing has been determined as to source/cause of pains and aches, patient was told it's not rheumatoid arthritis, had seen md 3 weeks ago, will see md again a couple of weeks. The outcome of the event was unknown. Information about batch/Lot number has been requested

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1508910
Sex: F
Age:
State: AZ

Vax Date: 05/27/2021
Onset Date: 06/02/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; Very horrible reaction burned me from inside out; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; I broke out in gradual hives on extremities especially hands blistered and shed new skin, (still healing after a month)arms, legs, hives then rash worsening at night and better upon wakening; This is a spontaneous report from a contactable consumer (patient). This 54-year-old non-pregnant female patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0176) via an unspecified route of administration on 27May2021 at 13:00 in right arm (at 54-year-old) as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medications included estradiol, estriol (Biestrogen), testosterone cypionate and progesterone all were taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0162) via an unspecified route of administration on 28Apr021 at 15:00 in right arm (at 54-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient had no known drug allergies (NKDA). It was mentioned that patient received no other vaccine in four weeks, did not have covid prior vaccination and was not tested for covid post vaccination. Six-days later, on 02Jun2021 at 12:00 hours patient broke out in gradual hives on extremities especially hands blistered and shed new skin (still healing after a month) arms, legs, hives then, rash worsening at night and was better upon wakening. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with MEDROL pack and improved but returned as soon as tapered off med, she had very horrible reaction that burned her from inside out (onset: 02Jun2021 12:00 hours). The patient was recovering from all the events. No follow-up attempts were possible. No further information was expected.

Other Meds: BIESTROGEN; TESTOSTERONE CIPIONATE; PROGESTERONE

Current Illness:

ID: 1508911
Sex: F
Age:
State: IL

Vax Date: 03/03/2021
Onset Date: 04/02/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Shoulder pain after shot; This is a spontaneous report from a contactable consumer(patient).A 52-years-old non-pregnant adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection,Batch/Lot Number: EJ1685)via intramuscular route of administration, administered in Arm Left on 03Mar2021 at 09:00 (at the age of 52-years-old)as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. There were no any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19.On 02Apr2021 at 08:00,the patient experienced Shoulder pain.The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14May2021 for a Nasal Swab.The outcome of event was recovering. Follow-up(13Jul2021): New information received in response to the mail trait sent regarding the confirmation of query. The response included: Clinical information Follow-up attempts are needed. Further information is requested

Other Meds:

Current Illness:

ID: 1508912
Sex: F
Age:
State: MD

Vax Date: 06/13/2021
Onset Date: 06/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: "an electric shock down her left arm"; she's been having heart palpitations; it is scary; This is a spontaneous report from a contactable consumer (patient). This 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 13Jun2021 as single dose for Covid-19 immunisation. The patient's medical history and medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 Immunization. The patient experienced ?An electric shock down her left arm, she's been having heart palpitations on, it is scary on Jun2021. There was no Investigation Assessment. There were no Prior vaccinations within 4 weeks. Reporter asked, "Okay, can I ask you a question. Okay, well done, I am looking for a cardiologist to see me because that palpitation I don't like it. It happens when I was reading my book and when I was washing tv and its scary. So, I need to speak to somebody. So, please." Consumer was informed about the Pfizer medical information department. The outcome for all the events was unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1508913
Sex: F
Age:
State: OH

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Pain worsened; swelling of feet, legs, hands, arms and lips and is still ongoing; This is a spontaneous report from a contactable consumer 78-year-old female consumer (patient) reported for herself that: A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jul2021 10:00 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included cardiac failure congestive from 2004 and ongoing. The patient's Concomitant medications were not reported. The patient experienced Swelling of feet, legs, hands, arms and lips and is still ongoing on 09Jul2021, Pain worsened on an unspecified date. There was no Investigation Assessment. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect administration date of the suspect vaccine. AE(s) did not require a visit to Emergency Room and Physician Office Doctor came to her home. There was no Prior Vaccinations within 4 weeks. There was no AE(s) following prior vaccinations. Communication: Reference number provided. Caller initially said her first dose was on Thursday, then clarified it was on 07JUL 2021 when looking at vaccine card. Provided with phone number and hours of operation prior. The outcome of event was not recovered.

Other Meds:

Current Illness: Congestive heart failure

ID: 1508914
Sex: F
Age:
State: TX

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Slept all day; very tired; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 08:00 as dose 1, single, and via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Lot Number: EP6955) as dose 2, single for Covid-19 immunisation (Vaccinated at 77years of age). Medical history and concomitant medications were not reported. No family medical history relevant to adverse events reported. The patient slept all day, very tired on 09Mar2021. Patient reported that she received her first dose on a Sunday(07Mar2021) and was tired on Tuesday(09Mar2021) and just slept all day and by the 3rd day(10Mar2021) she was up and fine. The patient said that the tiredness was with her first dose. She stated that the tiredness was just for 1 day. Her vaccines were received 2 weeks apart and thought they were in May. Patient clarified that they were actually 3 weeks apart and she received them in Mar2021. NDC number of Pfizer Covid-19 Vaccine was Unknown. AE(s) did not required a visit to Emergency Room or Physician Office. There was no Prior Vaccinations within 4 weeks. There was no AE(s) following prior vaccinations. No relevant tests. The outcome of events were resolved on 10Mar2021. Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508915
Sex: F
Age:
State: OH

Vax Date: 02/17/2021
Onset Date: 02/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: tremors; thought it was sugar dropping and had been tested; voice changes; heart palpitations; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9266, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Feb2021 (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history included heart surgery/triple bypass surgery (The patient had open heart surgery at age 70, 2 years prior to getting the COVID vaccines, she was 70 and it was a triple bypass surgery and she has not had any problems until she got the vaccines). The patient did not have family medical history relevant to the adverse event. The patient's concomitant medications were not reported. The patient previously took a flu shot that last fall and a month before the COVID vaccine had a pneumonia shot. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines the same day of either COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was Pharmacy/Drug Store. The vaccine was not administered at Military Facility. The patient did have a reaction with the vaccine and still had side effects from the Pfizer shot. On an unspecified date in 2021, after the first dose, the patient experienced tremors, voice changes and heart palpitations. She stated that after the first shot she started with the tremors and voice changes, now she knows what it was like when people stutter. The heart palpitations happened the first two days of getting the first shot. The tremors were still with her and sometimes were better than other times. She thought it was her sugar dropping and had been tested and it had nothing to do with it. She saw a heart specialist because she was very concerned whether something had happened. The heart surgeon/specialist did do some tests and he didn't see anything that would have indicated any trauma to her heart. The adverse events required a visit to Physician Office. The adverse events did not require a visit to the Emergency Room. The patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6202, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 10Mar2021 (age at vaccination was 73 years) as dose 2, single for COVID-19 immunization. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected. Follow-up (16Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508916
Sex: F
Age:
State: PA

Vax Date: 06/18/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

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

Symptoms: She mentioned that she had no issues with her 1st dose other than a sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 18Jun2021 (at the age of 35 years old) (Batch/Lot Number: EW0167) as single dose for COVID-19 immunisation. Medical history included migraine, anaphylactic reaction due to selfish, 3 months postpartum. Concomitant medications included vitamin d3; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). On an unspecified date the patient experienced sore arm. She mentioned that she had no issues with her 1st dose other than a sore arm but had problems with her 2nd dose. The patient was asked if her side effects from the vaccine would affect her baby as she was breast feeding. The outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Other Meds: VITAMIN D3; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1508917
Sex: M
Age:
State: NV

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Caller received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs / numbness in his feet / numbness in his knees; when he pinches his skin in his left leg and some parts of his body, he doesn't feel the pinch; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0196, Expiration Date was not reported), via an unspecified route of administration on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (Lot number: EW0196) received on an unspecified date (at the age of 78-years-old) for COVID-19 immunization. Patient states that, the person at the pharmacy told him to mention that he was calling in regards to the Pfizer BioNTech COVID vaccine EUA although his card after both doses has EW0196. Patient received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs, feet, and knees. Patient states when pinching his left leg and other parts of his body he doesn't feel the pinch. Patient would like to know if this is a common side effect, if there have been any other reports of this side effect, if this side effect will go away in a couple weeks on its own without having to go get medication for it. No information in PI regarding numbness in legs, feet, and knees being reported as a side effect, when pinching the left leg and other parts of the body not feeling the pinch. Patient confirms he received the Pfizer Covid 19 Vaccine. Additonal information is expected.

Other Meds:

Current Illness:

ID: 1508918
Sex: F
Age:
State: MI

Vax Date: 07/08/2021
Onset Date: 07/11/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Has swelling of the arm where the second dose vaccine was administered; Further down in the fold of arm at elbow joint is redness and swelling; Further down in the fold of arm at elbow joint is redness and swelling; Further down in the fold of arm at elbow joint is redness and swelling was reported as worsened/11Jul2021 and is worsening; This is a spontaneous report from a contactable consumer. A female 74-year-old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EW0173), dose 2 via an unspecified route of administration, administered in Arm Left on 08Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EW0172) on 17Jun2021 via an unspecified route of administration, administered in Arm Left for covid-19 immunisation. On 11Jul2021 the consumer calling for her sister. The caller sister received the second dose Pfizer BIONTECH Vaccine on 08Jul2021. The caller was calling to report her sister side effects that the patient was showing today and see what the caller can do. The caller wanted to know how to treat the side effects the patient was having Reporter details: The caller did not wish to provide an email address. The patient had swelling of the arm that the second dose Pfizer BIONTECH Vaccine was administered in. Further down in the fold of arm, at elbow joint, was redness and swelling was reported as worsened. Has swelling of the arm that the second dose Vaccine was administered in: The caller states apparently this began yesterday, 11Jul2021 and was worsening. Further down in the fold of arm, at elbow joint, was redness and swelling this began yesterday, 11Jul2021 and was persisting. The caller does not wish to provide HCP name, address, telephone number or email. The caller states she was calling the primary care physician when she hangs up with the DSU Agent. When asked to complete an additional questionnaire the caller replies no, no not really. The caller states she really wanted recommendations on treating the patient redness and swelling. The caller appreciates the DSU Agent telling the caller to consult the doctor for treatment and documenting the side effects. The outcome of the event further down in the fold of arm, at elbow joint, was redness and swelling was reported as worsened was unknown and not resolved for other events.

Other Meds:

Current Illness:

ID: 1508919
Sex: F
Age:
State: FL

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Cough; Pain in her body; She couldn't close her hand; Diarrhea; Vomit; She had a fever for 3 days; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration on 07Apr2021 in left arm as dose 1 single (at the age of 53-year-old) for COVID-19 immunization. Medical history included Covid-19, issue with immunology. Concomitant medications were not reported. Confirmed the immunology condition was prior to vaccine. Patient clarified she had Covid twice prior to vaccine, had symptoms for 5 months, off and on, reason she went to immunology doctor, studied why she had Covid so many times. Patient stated that after first dose of the vaccine she had a fever for 3 days, cough, pain in her body, states she had no pain in her arm, states she couldn't close her hand, she had diarrhea and vomit for 3-4 days, exact dates unknown, states this lasted a few days. Patient was scheduled to receive the second dose on 28Apr2021, stated she was unable to take it due to immunology problem, wanted to know if it is it okay to get 2nd dose even though it has been 90 days since taking first dose. Patient had been advised by HCP to receive the second dose >90 days from first dose of Pfizer Covid-19 vaccine Patient was asking if that is okay to receive the second dose within that time frame. Patient was asking if she can restart the vaccination series. Stated she does have antibodies for Covid, stated her doctor told her she had great antibodies right now. The outcome of the events was recovered on an unspecified date.

Other Meds:

Current Illness:

ID: 1508920
Sex: M
Age:
State:

Vax Date: 02/03/2021
Onset Date: 02/04/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Crohn's aggravated; Chills; Aching joints; This is a solicited report based on the information received by Pfizer from Manufacturer (Mfr. control no.: 21K-163-3936556-00). A contactable 82-year-old male consumer (patient) and a non-contactable consumer (Patient's wife): A 82-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via intramuscular route of administration on 03Feb2021 as dose 2, single for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from 2020 (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg, 1 in 2 wk) for crohn's disease.The patient previously received first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) vial intramuscular route of administration on 13Jan2021 as dose 1, single for COVID-19 immunization.The patient medical history include hypersensitivity, Crohn's disease, Anxiety, pain, Supplementation therapy. Patient's wife stated that the patient was allergic to two medications to improve his bone density but could not recall the specific medication, bone density abnormal, Abstains from alcohol, Sesame Seeds and Oil allergy manifested by red face and throat swelling and Sulfa Drugs Allergy. The patient was non-tobacco user.Concomitant medication included ciprofloxacin (CIPROFLOXACIN) for crohn's disease, azathioprine (AZATHIOPRINE) for crohn's disease, lisinopril (LISINOPRIL) for crohn's disease, balsalazide (BALSALAZIDE) for crohn's disease, venlafaxine (VENLAFAXINE) for anxiety, oxycodone (OXYCODONE) for pain, betacarotene;calcium carbonate;cyanocobalamin;folic acid;nicotinic acid;pyridoxine hydrochloride;riboflavin;sodium ascorbate;thiamine hydrochloride;tocopheryl acetate taken for supplementation therapy, hyoscyamine for crohn's disease and valsartan taken for an unspecified indication. On 04Feb2021, the patient experienced Chills, Aching joints and Crohn's aggravated.On an unknown date, the patient underwent lab tests which included computerized tomogram: unknown results. The action taken in response to the event(s), for adalimumab was unknown. On 07Feb2021, the patient recovered from chills and Aching joints and had not yet recovered from Crohn's aggravated. Causality as per reporter for event chills and aching joints as probable and for Crohn's aggravated not reportable No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in narrative, a possible contributory role of the suspect vaccine BNT162B2 or Comirnaty in triggering the reported events of Crohn's aggravated ,chills and arthralgia 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: CIPROFLOXACIN; AZATHIOPRINE; LISINOPRIL; BALSALAZIDE; VENLAFAXINE; OXYCODONE; BETACAROTENE;CALCIUM CARBONATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIB; HYOSCYAMINE; VALSARTAN

Current Illness:

ID: 1508921
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Sick since getting first dose; I came down with flu symptoms in the middle of the night.; Body aches; headache; throat swollen and scratchy. Voice.; throat swollen and scratchy. Voice.; My head is pumped up.; Sore throat; Throat swollen scratchy and hardly talk.; This is a spontaneous report received from a contactable consumer (patient). A 55-Year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 03Jul2021 as dose 1 single (at the age of 55-Year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that she was sick since getting first dose on 03Jul2021. On an unspecified date in 2021, She came down with flu symptoms in the middle of the night. Body aches, headache around Thursday mild throat swollen and scratchy Voice. Her head was pumped up. Taking Mucinex D, Aleve, Alternating Tylenol, and Night Quil. Barely Blood Boogers. Symptomatic when the medication wears out. Sore throat started third day. All of this triggered by that vaccine. Throat swollen scratchy and hardly talk. Got worse over the days. Patient was asking so you have the sore throat as a reported. Patient indicates she does not have a HCP. Patient previously gal went day by day. The outcome of the events was unknown. Information about batch/lot number has been requested

Other Meds:

Current Illness:

ID: 1508922
Sex: M
Age:
State: PA

Vax Date: 06/23/2021
Onset Date: 06/25/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Tingle/needle feeling in hands, feet, legs; Itchy scalp; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: EW0162) via unspecified route in the left arm on 23Jun2021 at 16:30 (at the age of 50-years) as dose 1, single for COVID-19 immunization.Medical history was none. There were no known allergies. Patient received balance of nature within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 25Jun2021at 07:00, patient experienced tingle/needle feeling in hands, feet, legs, itchy scalp, patient would be making a doctor appointment. The patient did not receive any treatment for events. The patient had not yet recovered from the events. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508923
Sex: F
Age:
State:

Vax Date: 06/18/2021
Onset Date: 07/06/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: rash; onset of rash on 06Jul2021 that has worsened; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737), dose 1 via an unspecified route of administration, administered in Arm Right on 18Jun2021 (around 13:30-14:00, around 15:00) (at the age of 67-years-old) as single dose for covid-19 immunisation. The patient's medical history included ongoing arthritis, ongoing prior to any doses of Pfizer-BioNTech Covid-19 Vaccine, ongoing diabetes, ongoing cholesterol, bronchitis, sinus infection, rash, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities and obesity (start date was unknown, and unknown if ongoing). She thinks they said she has Bronchitis, but it's not really bad; she has an inhaler, but she never has to use it. She thinks she has had maybe a sinus infection or something like that. She has history of having had a rash that comes up on her hand and sometimes on legs but went to dermatologist gave her some cream that cleared it up. The patient had no family medical history relevant to adverse event. The patient's concomitant medications included simvastatin taken for cholesterol started years ago, enalapril taken for diabetes mellitus started years ago. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations (within 4 weeks) or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. The patient previously took flu shot, she just always gets the flu shot every year and never had any reaction with those. The patient took vaccine to help prevent the Covid, where she wouldn't be so sick if she got it. The patient received the first dose of the Pfizer Covid 19 vaccine on 18Jun2021. On 06Jul2021, Tuesday, developed a rash. She asked could it be related to the first dose. She initially reported having had no reaction to the first dose of the Pfizer-BioNTech Covid-19 Vaccine shot but later reported having onset of rash on 06Jul2021 that has worsened. She asked for further information on side effects, rash, and if she should go to her doctor about this. The rash started out small on 06Jul2021, now rash has worsened and keeps spreading. She does not know what the rash was, but it was irritating, going all across her back and all up under her breast. She does not know if rash was from the first dose of Pfizer-BioNTech Covid-19 Vaccine and just didn't show up until later. The adverse event not required emergency room and physician office visit. No relevant tests were done. Last Friday (09Jul2021), the patient received the second dose (of bnt162b2). The patient has been administered both doses of the Pfizer-BioNTech Covid-19 Vaccine. The outcome of the event was not recovered. Follow up information has been requested.

Other Meds: SIMVASTATIN; ENALAPRIL

Current Illness: Arthritis (Ongoing prior to any doses of Pfizer-BioNTech Covid-19 Vaccine); Cholesterol; Diabetes

ID: 1508924
Sex: F
Age:
State: SC

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: numbness; tingling in her arm which radiated to her hand.; The injection was maybe 3 inches down from her left shoulder. She is not sure if given in the muscle.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0196) via an unspecified route of administration (age at vaccination 45-year) in Left Arm on 21Jun2021 around 17:00-17:30 or 17:15 as dose 1, single for COVID-19 immunization.Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, diabetes, obesity, upper respiratory tract infection from Nov2019.The patient's concomitant medications were not reported.The patient previously took omega XL and fish oil (6-7 years ago).There was no prior Vaccinations within 4 weeks.On 27Jun2021 the patient experienced numbness and tingling in her arm which radiated to her hand. It was reported that the injection was maybe 3 inches down from her left shoulder. she was not sure if given in the muscle. The reporter was at the pharmacy seeking guidance whether she should receive the second of the Pfizer COVID-19 vaccine or not. She got first shot on 21Jun2021 and on 27Jun2021, her arm and hand in the side it was given became numb and tingly. It was not as bad as it was. Her hand was still tingly. She came to get second shot and pharmacist said she needs to find out if it was ok to receive second dose. The reporter mentioned she doesn't have an HCP and can't afford to go the emergency room because she does not have insurance. She was a CNA. She does not have a primary care provider. She called where she got the shot last Friday past. The pharmacist said they probably hit a nerve or something. Her whole left arm in the beginning was numb for 3-4 days and then just her hand. If she touches fingers together with thumb, she can still feel tingly sensation, but it was not as bad. It felt like when you lay on your hand like when falling asleep. It was not as aggravating as it was. The injection was maybe 3 inches down from her left shoulder. She was not sure if given in the muscle. She thinks she had COVID in Nov2019, and at the time they did not know if it was COVID and called it an upper respiratory infection. On 06Jun2021, she thought she got the new strand and after she got well, she went ahead and got the vaccine because she did not want to get it again. She does not take other medication unless it may be an Advil or Ibuprofen and was not taking any when she got the vaccine. Therapeutic measures were taken as a result of the adverse events. The patient was recovering from numbness and tingling in her arm which radiated to her hand, while the outcome of another event was unknown.

Other Meds:

Current Illness:

ID: 1508925
Sex: F
Age:
State: PA

Vax Date: 03/23/2021
Onset Date: 04/16/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Random headaches on daily basis; my cycle is back in full swing day after my second dose; Bottom number of BP rising; Swelling in feet and legs.; Lightheartedness; I really feel that something is just not right; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EV0164, patient was 51-year-old and not pregnant at the time of vaccination) via an unspecified route of administration, administered in arm left on 23Mar2021 as dose 2, single for COVID-19 immunization. Medical history included ADHD, bipolar, depression, anxiety, colon cancer, migraines, bananas tree nuts, premenopausal. Concomitant medications included amlodipine besilate (5mg); ascorbic acid, ferrous fumarate (VITRON C) both was taken within 2 weeks of vaccination. The patient previously took dilantin [phenytoin] and experienced Allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot umber: EN6208) via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. Patient does not receive other vaccine in four weeks. Reported that never had an issue with bottom number before only top. No COVID prior vaccination. Patient was not tested COVID post vaccination. On 16Apr2021 at 12:00, the patient experienced random headaches on daily basis, my cycle is back in full swing day after my second dose, bottom number of bp rising, swelling in feet and legs, lightheartedness, I really feel that something is just not right. The patient underwent lab tests and procedures which included blood pressure measurement resulted as bp rising on 16Apr2021 as bottom number of BP rising. Patient received treatment for events and increased BP medication. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: AMLODIPINE BESILATE; VITRON C

Current Illness:

ID: 1508926
Sex: F
Age:
State: CT

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Headache; Right arm funny bone nerve pain that would go all the way up and down arm; nerve pain; UTI; she is still dizzy and having bad effects for the UTI; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/NDC number: Unknown; Expiry date: Unknown) via an unspecified route of administration in left arm on an unknown date in 2021 14:00 (at 80-year-old) on left arm as single dose for COVID-19 immunization. The patient's medical history thyroid issues was over 30 years ago, penicillin allergy (since 1964) that gave her hives so bad. loaded with hives and was a pimply mess, ongoing doxycycline allergy that gave her severe diarrhea, sulfonamide allergy, iodine allergy, fever and could not breathe/extreme difficulty breathing. The past drug event included tetracycline, arithromycin, Levaquin, ceftin, Zithromax that caused drug allergy (ongoing). Concomitant medications included levothyroxine (Other products: Yes) taken for thyroid disorder (had it for 30 years or more and had been taking for the same then). The patient previously took doxycycline and experienced diarrhoea, tetracycline and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, levaquin and experienced drug hypersensitivity. It was mentioned that no investigation assessment was done. She came home on an airplane on 03Jan2019, the year COVID started. When she got back, she told her doctor she thought she had gotten Covid, so they tested her, but she was negative. She thought she had it and volunteered for antibodies. She did not get over it until mid Jan2019. They told her she was over it for too long though if she had it. It was mentioned that history of all previous immunization with the Pfizer vaccine, prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration were reported as none. Received call from consumer regarding the Pfizer COVID vaccine. She has ongoing symptoms that started after she received the vaccine. She only got the first dose. On an unknown date in 2021, she started having headaches that she never knows when they are going to come on and they are continual. She did not have them before she got the vaccine. She did not remember the start date and said it was right away after the first dose that she received about a month and a half ago. It started right away. She was not getting the second one because the headaches would not go away. They become more continuous and more often. She was hesitant to get the vaccine because she was allergic to just about all antibiotics. She does not have names, lot or expirations for any. She later provided that Penicillin gave her hives so bad. She was loaded with hives and was a pimply mess. She also said that Doxycycline gave her severe diarrhea. She then found her list and also provided allergies to the following: Tetracycline, Arithromycin, Sulfa, Levaquin, Ceftin, Zithromax, and no contrast Iodine. She does not remember the exact reaction. It is either severe hives or severe diarrhea. She does not have the lot or expiration for any of them. No further details provided. She had another issues immediately after the shot. She had funny bone pain in the right arm but she got the shot in the left arm. This pain was described as a nerve pain that would go all the way up and down her right arm. It would come at night after the shot but then it went away. She does not have it right now. Right now she was trying to get rid of a UTI. It was recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she was still dizzy and had bad effects for the UTI. She took the medication and had to refill it. Medication was Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It was in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. She finished them and has none left. Her friends were upset because she would not get second shot and certainly not a third because of these headaches. She felt she may take a chance at getting something worse than these headaches. She does not feel she should get them or anymore. The patient did not require emergency room and physician office visit. She had been to her doctor since and she mentioned the headaches, and all they say was to take Advil. Outcome of the events headache, urinary tract infection and dizzy was not recovered, whereas other events were recovered on an unspecified date in 2021. Description of Product Complaint: Description of complaint: Right now she is trying to get rid of a UTI. It is recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she is still dizzy and having bad effects for the UTI. She took the medication and had to refill it. Medication is Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It is in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. It was mentioned that product strength and count size dispensed: 100mg, 14 count. Information on lot/batch number had been requested.

Other Meds: LEVOTHYROXINE

Current Illness: Iodine allergy (either severe hives or severe diarrhea Stop Date: ongoing.); Penicillin allergy (Penicillin gave her hives so bad. loaded with hives and was a pimply mess.); Sulfonamide allergy (either severe hives or severe diarrhea Stop Date: ongoing.)

ID: 1508927
Sex: F
Age:
State:

Vax Date: 04/10/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Patient mentioned she was in a lot of pain and swelling; Patient mentioned she was in a lot of pain and swelling; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen (manufacturer control number: US-AMGEN-USASL2021093868). This case was split from master case 2021755177 for a 61 years old female patient taking BNT162B2 and experienced pain and swelling. This non-serious solicited report (USASL2021093868) was reported to Amgen on 16Jun2021 by a consumer from a commercial program (PSP00086). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Apr2021 (age at vaccination was 61 years) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Apr2021 (age at vaccination was 61 years) dose 2, single for COVID-19 immunization. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No co-suspect medications were reported. The patient's concomitant medications included diclofenac (topical), calcium, Vitamin D (ergocalciferol), start and stop date unknown, taken for unspecified indication. Concomitant medications included diclofenac, calcium and ergocalciferol (VITAMIN D [ERGOCALCIFEROL]) all taken for an unspecified indication. The patient began etanercept (Enbrel) with Reusable Autoinjector 50 milligram, qwk (lot number: 1104398, expiry date: 31Jan2023) on 02Jun2021 and (lot number: 1121827, expiry date: 30Apr2023), taken for rheumatoid arthritis. The patient experienced ran down leg/then was a few drops on floor, had stomach ache, indigestion, low grade fever while receiving Enbrel, Reusable Autoinjector. On an unknown date in Jun2021, the patient stated that she had a stomach ache after taking Enbrel, had indigestion the day she takes the injection and the day after and for two days she had a low grade fever of 98.8 and 99. The patient stated that her rheumatologist was aware. On 16Jun2021, the patient took her Enbrel injection. The patient stated when she gave her third injection today, the Enbrel ran down leg and then was a few drops on floor not a puddle. She did not remember the status button flashing green the green bars in the progress bar. The patient stated that the AT (AutoTouch) did not alarm or have a red light. She did not feel the needle stick. She thought it was uneven. No treatment information was received. The outcome of the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia were reported as unknown. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the events abdominal pain upper, dyspepsia and pyrexia. The causal relationship between the events accidental exposure to product, abdominal pain upper, dyspepsia, pyrexia and Enbrel, Reusable Autoinjector was not provided by the consumer. Additional information was received on 01Jul2021 reported to Amgen by a consumer from a commercial program (PSP00046b) and involved a patient who stated part of the injection didn't go in, it went onto the floor, stress, flare in her knees/lot of pain, lot of swelling, while receiving Enbrel with Reusable Autoinjector. The patient stated she had five injections of Enbrel with Enbrel AutoTouch and Enbrel Mini Cartridge for treatment of rheumatoid arthritis. She had been instructed to use once a week. On an unknown date in 2021, the patient then further clarifies that she may have more like four and half injections due to she was under a lot of stress, she does not think the injection was level or even. Patient had a death in the family and her daughter had fallen and she was distracted. She did answer a bunch of questions when she stated this and she did contact her doctor and was instructed to take another dose and she just did not. Patient had been able to administer successful injections later, she had no problems with the injector. Patient stated it was a bad day, part of the injection didn't go in, it went onto the floor. The patient then mentioned that she just wants to walk. Patient was having a flare in her knees and that was why she was given the Medrol dosepak (methylprednisolone). Patient also had some diclofenac topical which she would try first. Patient stated she would like to walk and bend her knees. She had a lot of swelling. Patient had a lot of swelling and her doctor said a lot of people that didn't have underlying conditions had pain and swelling. Patient mentioned she was in a lot of pain and swelling. Patient received the Pfizer COVID-19 vaccines. The outcome of the event stress, arthralgia, joint swelling, was reported as unknown. Action taken with Enbrel, Reusable Autoinjector was reported as unknown for the events stress, arthralgia, and joint swelling. The causal relationship between the events stress, arthralgia, joint swelling, and Enbrel, Reusable Autoinjector was not provided by the consumer. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: ENBREL; DICLOFENAC; CALCIUM; VITAMIN D [ERGOCALCIFEROL]

Current Illness: Rheumatoid arthritis

ID: 1508928
Sex: F
Age:
State: PA

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1508929
Sex: F
Age:
State: FL

Vax Date: 05/28/2021
Onset Date: 05/29/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient second dose received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0164, Expiry date: not reported), via an unspecified route of administration on 28May2021(age at vaccination: 43-year-old) as dose 2, single for covid-19 immunization. Medical history was none. The patient had no known allergies. The patient's concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (Lot number EW0171), on 07May2021 for covid-19 immunization. The patient was not diagnosed with covid prior to vaccination and was not tested for covid-19 post vaccination. The patient did not receive any other vaccine within four weeks and did not receive any other medications in two weeks after the vaccination. On 29May2021 (following day after vaccine), the patient had chills and fever which subsided on 30May2021. And around 3 weeks later on 14Jun2021, the patient had noticed an oval rash on her chest with some discoloration, resembled ring worm. A few weeks after that her body developed little rashes on chest, trunk and legs. So she went to the dermatologist on Friday 09Jul2021 and was diagnosed with Pityriasis Roses. She was asked if she recently had a fever or was sick, she didn't remember that she had recently received the covid 19 vaccine and had a fever after until she got home. The patient did not receive any treatment for the events. The patient visited doctor or other healthcare professional office/clinic visit due to adverse events. The events were non-serious. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1508930
Sex: F
Age:
State: DE

Vax Date: 04/26/2021
Onset Date: 04/01/2021
Rec V Date: 07/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: She has bumps all over her head; feel weak; felt heart beating; felt really tired; check her blood pressure and it went down to 95; her cholesterol was kind of high; her head feels like it is swelling and bleeding; her head feels like it is swelling and bleeding; Hives; itching all over her body; Skin feels tight; sometimes she would get up in the middle of the night due to the itching; Rash; This is a spontaneous report from a contactable consumer (patient herself). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 26Apr2021 11:45 (age at vaccination: 72 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included ongoing asthma. Concomitant medication(s) included fluticasone propionate (+) salmeterol xinafoate (ADVAIR) taken 250mg inhaler twice a day for asthma. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot: EP7533 Exp: 31Jul2021) administered in left arm, dose 1 for covid-19 immunisation. On 26Apr2021, the patient's head feels like it is swelling and bleeding especially when she scratches, hives, itching all over her body; On an unknown date in 2021, the patient had rashes, On an unknown date in April2021, the patient's skin feels tight, sometimes she would get up in the middle of the night due to the itching, scratching; On an unknown date, the patient had bumps all over her head, but she cannot really see them because of hair; On an unknown date in June2021, the patient's cholesterol was kind of high. The patient did not require a visit to emergency room but required a physician's office visit. The event of hives and rash were reported to be worsened. She reported that it was like from head to toe and her head feels like it was swelling and bleeding. All around her body she has rash, itching, hives, and now it goes down to her thighs, front and back of legs. She has seen her allergy doctor who tried to treat her with steroids first. The reporter stared that she has seen the allergy doctor and skin doctor and it's like no one can help her. The hives started right away from the moment she got the shot. She got bumps that goes all the way around the location of where she got the shot. At first, they were on her left arm and now they're around her back, left arm, shoulder. It's gone to her right arm. It's on both shoulders, shoulder blades. She has itching and it goes all the way down her back. The hives are now around her belly. She stated she is scratching right now. She was scratching so bad sometimes she was bleeding. The itching started right away. The last couple of days she could not stand it. At first, she saw withheld, the allergy doctor and was informed it was a Covid vaccine reaction she was having. She was prescribed Prednisone two different times, 40mg a day for seven days after that 10mg a day, but it did not work. After this did not work, she went back to the doctor who gave another Prednisone dose, it was a low dose 5mg, two tablets a day by mouth for seven days and one a day for 14 days. She was given Clobetasol- 5mg ointment, Ivermectin- 12 tablets, told to take one day 6 tablets, wait for week and take another 6 tablets in one day. Second time took the last six tablets and started to feel weak. Sometimes she felt heart beating and it stopped. About 2 hours later she felt really tired. She went to check her blood pressure and it went down to 95 and that time. She was also given a cream to put all over body from head to toes for the rash, Triamcinolone 1% cream 464gm (Expiration date: April2023). This did not work. withheld said since all the other medication did not help, he will have to do a biopsy now and will have to try and cut where she has the rash and take some blood or something to be sent. The doctor will call with the results to determine what to do from there. The patient did not have any prior vaccinations in 4 weeks. The patient underwent lab tests and procedures which included: on an unknown date in June2021, blood cholesterol was high, blood glucose was normal, blood pressure measurement: 95 mmhg, blood test was normal, thyroid function test was normal. Doctor wanted her to go in for lab work. She had an annual check-up Jun2021 and had blood work done. Her thyroid, blood sugar, and cholesterol were checked. She stated everything was normal except her cholesterol was kind of high. The outcome of haemorrhage, skin tightness, swelling, mass, sleep disorder, scratch, blood cholesterol increased was unknown and urticaria, rash, pruritus was not recovered. Information about lot/batch number has been requested.

Other Meds: ADVAIR

Current Illness: Asthma (Verbatim: Asthma Have because have late husband smoked)

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm