VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1673419
Sex: F
Age:
State: CA

Vax Date: 07/26/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Beats; Result Unstructured Data: Test Result:140,138; Comments: her beats per minute has went up

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Its 140, 138, beats per minute. It is persisting, her beats per minute has went up; Heart irregularities/ sky rocketing pulse rates and irregularity; Chest pain; Chest discomfort; Just uncomfortable/uneasy feeling; This is a spontaneous report from a contactable consumer. This contactable consumer (patients husband) reported for a 58-year-old female patient (reporters wife) that, A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 26Jul2021 (at the age of 58-years-old) as single dose for COVID-19 immunization. Medical history included as none. There were no concomitant medications. It was reported that the patient received second dose of COVID vaccine (Lot number- FD8448). In Aug2021 the patient experienced its 140, 138, beats per minute. it is persisting, her beats per minute has went up (medically significant), In 2021 heart irregularities/ sky rocketing pulse rates and irregularity (intermittent and random morning and night), chest pain, chest discomfort, just uncomfortable/uneasy feeling in 2021. Caller was calling because his wife received the covid vaccine. She received her first dose on 26Jul2021 and her second dose on 16Aug2021. After the first dose she experienced an adverse event. She had heart irregularities, chest pain and chest discomfort. She went to her primary care provider and had a physical. She followed up with her physical based on her pulse. She was having skyrocketing pulse rates and irregularity. They are referring her to a cardiologist to fit her for a heart monitor device. It's been really erratic she can pull up her information from her heart rate. The event heart irregularities was started the first of august week after the dose. In the middle of the night, she was not in pain just uncomfortable and she looked at her watch and its 140, 138, beats per minute. It was persisting, her beats per minute have went up and it's an uneasy feeling. For the treatment it was reported not yet she was waiting for the appointment to be fitted for a heart monitoring device. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. The AE require a visit to physician Office. No Prior Vaccinations within 4 weeks. AE did not occur following prior vaccinations. Patient underwent lab test and procedure which included Heart rate 140,138 her beats per minute has went up 2021.The outcome of the event its 140, 138, beats per minute. it was persisting, her beats per minute has went up, Heart irregularities/ sky rocketing pulse rates and irregularity was reported as not recovered and the outcome of the events Chest pain, Chest discomfort and Just uncomfortable/uneasy feeling was reported as unknown. No follow-up attempts are possible, no further information expected.

Other Meds:

Current Illness:

ID: 1673420
Sex: M
Age:
State: NY

Vax Date: 08/12/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital: Y

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

Lab Data: Test Date: 20210811; Test Name: echo; Result Unstructured Data: Test Result:Normal; Test Date: 20210811; Test Name: EKG; Result Unstructured Data: Test Result:Normal; Comments: EKG was ok; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Test Result:elevated; Test Date: 202108; Test Name: Troponin; Result Unstructured Data: Test Result:0; Comments: troponin came down to zero.; Test Date: 20210819; Test Name: Troponin; Result Unstructured Data: Test Result:elevated

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: the troponin levels were elevated; headache and his chest felt off; headache and his chest felt off; diagnosed with myocarditis; Dizziness; he was not feeling well 6 hours after receiving the vaccine; he couldn't sleep; he also had a rash too; States the patient can't do sports or anything; EKG was elevated/once that that resolved the EKG was ok; This is a spontaneous report from a contactable consumer. A male patient of 15-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was FA7484), first dose on left arm via an unspecified route of administration on 12-AUG-2021 11:15 at unknown DOSE 1, SINGLE for COVID-19 immunization. No medical history reported. No concomitant medications reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. He was diagnosed a week later with the myocarditis but he was not feeling well 6 hours after receiving the vaccine and it took him seeing so many HCPs and he was just observed and said it was a reaction to the vaccine except that they did Troponin levels at the hospital and the troponin levels were elevated and he was rushed to the Hospital. He states the Troponin levels were done a week after the vaccine was administered and the levels of the troponin were 47 or 46 and thinks it was 46 or 45 and then it dropped down after another couple of hours later down to 37 and in 24 hours the troponin came down to zero. He States the Troponin level was drawn on 19Aug2021 around 2:00 or something and in another hospital two days prior to that he was not feeling well and mostly was going into the hospital due to headache and his chest felt off and they did the troponin levels there per protocol after the Pfizer vaccine and the troponin levels were normal at that time on Tuesday and on Thursday the troponin level was elevated. He States the patient's headache and dizziness began right after the vaccine about 6 hours later and he couldn't sleep and she took him to doctors and ENTs. He States the scary part was that he did not have massive chest pain.States the headache resolved about two days ago and the dizziness he still is a little dizzy at times. He States she took him to the cardiologist the day before the vaccine on 11Aug2021 to make sure and they did the echo and EKG because she herself is so neurotic and cleared the patient to get it and the echo and EKG were all normal. He saw the cardiologist prior to the vaccine to make sure he was fine and had no underlying conditions and took him to the pediatrician two times and the ENT and went to another hospital and said he also had a rash too and that was a reaction to the Pfizer covid vaccine and then he got just so much worse so they went to White Plains by ambulance to the (#) because of his Troponin levels. States the rash began and happened after the vaccine 3 days later and is off and on; states the EKG was elevated when the troponin levels were elevated and once that that resolved the EKG was ok and they did the echo after and it was ok and he has to go back for another echo on Monday but there is still pressure in his chest and that is ongoing and maybe a tiny bit better; states the chest pressure has not stopped and began probably around 3-4 days after the vaccine. The outcome for Events for myocarditis, troponin , Malaise, sleep disorder, rash, Loss of personal independence was unknown and for events headache, dizziness, chest discomfort was not recovered. Additional Context: Caller states she was speaking to someone before, states her son got myocarditis because of this Pfizer Covid vaccine, states this is already reported, no reference number provided, caller developed myocarditis after his first dose of the Pfizer Covid vaccine, caller wants to know what do we know about myocarditis and this vaccine as well as if we can guarantee that her son will be okay after getting this vaccine that everyone is pushing. Caller states she provided the Lot number of the vaccine her son received on her previous report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673421
Sex: F
Age:
State: NC

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 09/04/2021
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: Test Name: body temperature; Result Unstructured Data: Test Result:99.0 Fahrenheit; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:99.8 Fahrenheit; Test Date: 202006; Test Name: CT of lungs; Result Unstructured Data: Test Result:Unknown; Comments: had bilateral midlobe pulmonary nodules; Test Date: 20210822; Test Name: Covid-19; Test Result: Positive

Allergies:

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

Symptoms: second dose: has the delta variant; second dose: has the delta variant; second dose: allergies; pulmonary nodules in her lungs; lymph nodes swelling; asthma; second dose- lymphadenopathy on both sides; second dose: fever; second dose: coughing; second dose: stated that she became flushed; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0171 and Expiry date was not reported), via intramuscular route of administration administered in Arm Left on 22Apr2021 (at the age of 46-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypersensitivity from 13Jul2021 and ongoing Verbatim: allergies, asthma from 13Jul2021 and ongoing Verbatim: Asthma, stress from 2010 and ongoing Verbatim: PTSD. Concomitant medication includes: other medications for other conditions (unspecified date). No further details provided. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EP69SS and Expiry date was not reported), via intramuscular route of administration on 27Mar2021 (at the age of 46-years-old) in Arm Left as dose 1, single for COVID-19 immunization and experienced Blistering of fingers bilaterally, Palm of hands were burning and Swelling of the fingers bilaterally. Patient who has a history of asthma that received the Pfizer BioNTech Covid 19 vaccine in April. Stated that she had a reaction with each injection. Stated that with the second one she had lymphadenopathy on both sides. Stated that she was on steroids and antibiotics. Stated that one side was still swollen. Stated that she has pulmonary nodules in her lungs. Stated that she has the delta variant. Wanted to know if she needed the booster vaccine. Stated that since she had reaction to first two doses will the booster vaccine benefit her. Wanted to know once over delta variant and well enough for booster should she attempt since she had two adverse reactions to two doses. Stated that on Jun 2020 had CT of lungs had bilateral midlobe pulmonary nodules. Stated that she has them bilaterally upper and lower lobes and still to her middle lobes prior to the vaccine. Stated that whenever her immune system kicks in that the blistering of fingers and swelling and palms of hands burning flare up. Stated that in seven hours after the vaccine that her lymph nodes swelling. Stated that the left side was still swollen. Stated she was treated with prednisone and antibiotics. Stated two days ago she became flushed and had a low grade temperature of 99.8. Stated that she noticed increased coughing which she attributed to allergies and asthma because she was allergic to things in her backyard. Stated that the coughing was worst and the fever increased yesterday so she got the home test and the test came back positive. Stated that she went to the emergency room yesterday for them to do blood work and swabbing and the variant came back as delta. Stated that she just got those results this morning. Stated that the cough was productive. Stated that her fever is 99.0 axillary digitally. Treatment information was given as none for the symptoms of the hands. Stated that she takes Advil dual for fever. Stated that if she misses a dose then the fever spikes. She had the second dose on 22Apr2021 where she experienced lymphadenopathy. And now she has the Delta variant. She wanted to know if she should take the booster or third shot. She had already asked the pharmacy and CDC but they did not give her a clear recommendation. She also mentioned that she was currently being pre-screened for cancer and if she will test positive for cancer she might be eligible for the booster shot. The patient underwent lab tests and procedures which included body temperature: 99.0 fahrenheit on, body temperature: 99.8 fahrenheit on 2021 , computerised tomogram: unknown on Jun2020 had bilateral midlobe pulmonary nodules , sars-cov-2 test: positive on 22Aug2021. The outcome of the event second dose- lymphadenopathy on both sides was recovering and rest all events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Allergy (Verbatim: allergies); Asthma (Verbatim: Asthma); Stress (Verbatim: PTSD)

Date Died:

ID: 1673422
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Died after taking the vaccine; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were Not Provided. The reporter said his cousin died after taking the Covid vaccine and reported as serious due to death. The caller mentioned about that our website or recorded line doesn't say FDA approval and she told him that will be updated by the end of the day and they are aware of that. Reporter then started to say is the president lying and the agent ended the call at that time. Investigation Assessment was Not Provided. It was not reported if Autopsy Done. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died after taking the vaccine

Other Meds:

Current Illness:

ID: 1673423
Sex: F
Age:
State: IA

Vax Date: 02/19/2021
Onset Date: 02/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: tested for arthritis; Result Unstructured Data: Test Result:did not have that

Allergies:

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

Symptoms: had the worst pain and it was all over her body; has had random pains in her calves and in her arms and fingers; her hands and abdomen and her head hurt; her hands and abdomen and her head hurt; she is getting the pain with random leg cramps and feet cramps and charley horses.; shakes; she was cold inside; having like lower back pains with this; has sciatica; her balance is off; never had a temperature with this and never ran a temperature with these side effects; This is a spontaneous report from a contactable Nurse. A contactable Nurse reported different events for 2 patients. This is 1 of 3 reports. A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 19Feb2021 18:00 (at the age of 70-years-old) as dose 1, single for covid-19 immunisation. The patient's medical history included stenosis, patient stated she had the carotid artery taken care of about two years ago and her neurologist knew in the hospital and she had been complaining about bending her neck and her neck was stiff and they did a CT scan at that time and found out she has severe stenosis and it just about killed her and she has stenosis in her lower back, passed out (two years ago she was at her daughter's house and passed out on the floor), blocked carotid artery (she had 85 percent blocked carotid artery that was maybe three years ago). There were no concomitant medications and no other products. The patient had first shot of the Pfizer COVID vaccine on 19Feb2021 and went home and that day and felt just fine and by the next morning on 20Feb2021, when she woke up she had the worst pain that you would not believe and it was all over her body and her hands and abdomen and her head hurt; states she clenched her hands so hard that it hurt her little finger and that did not make this too good and it went on for weeks. States since then she has had random pains in her calves and in her arms and fingers and has been tested for arthritis and did not have that. States she has been in pretty good health and has never had a reaction to the flu shot or anything and was still miserable and her balance was off and never had a temperature with this and never ran a temperature with these side effects and the symptoms were still with her and she went to her family doctor and was trying to switch doctors because the doctor was no help to her or her husband. States she went to the health care professional (HCP) and they said to take a Tylenol before the next dose of the Pfizer COVID Vaccine, and she has four kids and was an OBGYN labor nurse and would rather go through labor than have this kind of pain; states her question was what does she do and how can she possibly have the 2nd dose of the Pfizer COVID vaccine if the first time she had this so bad and after the 2nd dose people can have it. States she went to the hospital outpatient clinic; states somebody called her yesterday or the day before and went through a report, but it was from Innovation and the guy was very vague. Caller states she went to see her HCP after the vaccine and the HCP said this was no big deal and it upset her. States her pain began the very next morning and she had the Pfizer Covid vaccine at 6:00 pm and woke up the next morning 12 hours later at 6:00 am and had unbelievable pain and thought she can't believe she was having this; states the pain was ongoing and she was going to say maybe a little better and has it barely at times and not always and gets random pains then it goes all over her body and was strange; states she has shooting pain down her finger maybe a minute and then it would stop and she would maybe have shooting pain in her forearm and that will go on for a minute and then feels like stabbing and hurts so bad; states it just does all over and gets in her legs and now she was getting the pain with random leg cramps and feet cramps and charley horses. States she feels this was very serious of a problem and was asked seriousness criteria and states it was very serious; this report filed as medically significant. States she should have gone to the hospital and it went on an on for weeks and was unbearable and did stay home and the whole thing really got her, and she had no temperature and also had not like chills but shakes and like she was cold inside. States she called a covid hotline and reported this. States she has not started any new medications at the time of the reported event or within two weeks prior and was hardly sleeping at night and having like lower back pains with this and gets thigh pains and has sciatica; states also two years ago she was at her daughter's house and passed out on the floor and was pretty active and found out at that time that she had 85 percent blocked carotid artery and that was maybe three years ago. States her grandson had long QT syndrome and the day he was born his heart tissue was dying and he was age 17 and they thought he had the flu and took him to the HCP and gave him Theraflu and got him home and in bed and he was so sick and took a bath and made him soup and his mom heard him yelling from the bedroom and when they got there he was gone, and she was in the emergency room looking down at him. She stated her weight because of Covid. She told the nurse she spoke to before about her experience and gave her information and she said she would be transferring her over. Caller says that she had an adverse reaction to the Pfizer shot, clarified to Pfizer COVID-19 vaccine, and she had her first shot only. She says she never had a reaction to a shot before, and she was a nurse before she retired so the agent was gauging how she felt seriousness was since she was still having reaction. She says her question was what to do since she had not her second shot and her family doctor and other doctors and the health department didn't answer this question and she was still having same problems. She says nobody in withheld could tell her what she should do for the reaction or for her second dose. She had her first shot done 19Feb2021 and she was supposed to go back 13Mar2021, but she didn't go back. She says that she has a handwritten vaccine card, which doesn't provide the NDC/EXP for the dose she got. The events required visit to physician office. Seriousness criteria-Other medically important condition. The outcome of the events she is getting the pain with random leg cramps and feet cramps and charley horses, her balance is off, never had a temperature with this and never ran a temperature with these side effects was not recovered. The outcome of the events shakes, she was cold inside, having like lower back pains with this, has sciatica was unknown and the outcome of other events was recovering. Reaction assessed: had the worst pain and it was all over her body and her hands and abdomen and her head hurt. Drug result: Related. Reaction assessed: has had random pains in her calves and in her arms and fingers, Source of assessment: Primary Reporter, Drug result: Related. Conclusion from product quality complaints group of previously completed investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6200 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.

Other Meds:

Current Illness:

ID: 1673424
Sex: F
Age:
State: PA

Vax Date: 03/24/2021
Onset Date: 08/26/2021
Rec V Date: 09/04/2021
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: Test Date: 20210826; Test Name: Covid test Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: Vaccination Failure; Nasal Swab: Positive; This is a spontaneous report received from a contactable consumer(patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Lot Number: EL3247) at age of 34-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (Lot Number: EP6955) at age of 34-year-old, both as single dose for covid-19 immunisation. Medical history included Penicillin hypersensitivity. No covid prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced vaccination failure on 26Aug2021. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 26Aug2021. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673425
Sex: M
Age:
State: VA

Vax Date: 08/16/2021
Onset Date: 08/18/2021
Rec V Date: 09/04/2021
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: I had Cornea transplant in my eye in my left and right eye and it affected my left cornea transplant. So, now I have 70% vision in my left eye. I do not have full vision in my left eye; I had Cornea transplant in my eye in my left and right eye and it affected my left cornea transplant. So, now I have 70% vision in my left eye. I do not have full vision in my left eye; I received the swelling of the face, left side, tremendously and it is numb; I received the swelling of the face, left side, tremendously and it is numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE ) via an unspecified route of administration on the left arm on 16Aug2021 at 01:00 (Lot Number: RA1987; Expiration Date: Unknown) at the age of 54-year-old as single dose for COVID-19 immunization. Medical history included depression, arthritis and gout. Investigation assessment was none. Prior vaccination, the patient haven't had the vaccination in 25 years. Concomitant medications included naproxen taken for arthritis and ongoing and mirtazapine. On 18Aug2021 at 01:00, 48 hours after the shot, the patient experienced swelling of the face, left side, tremendously and it is numb. On 20Aug2021, the patient had cornea transplant in eye in left and right eye and it affected left cornea transplant. So, now, the patient had 70% vision in left eye. The patient didn't had full vision in left eye. So, the patient was seeing an eye specialist regarding this matter and trying to get vision back. The patient couldn't wear eye glasses any longer because he gone to get new prescription and everything to correct he cornea. The patient stated "all this because of this Pfizer injection". The patient also stated the anatomical site was left arm and that's why he was affected on the left side of face and he didn't think of that and it's possible. The patient stated the due date of the second dose of BNT162B2 was 01Sep2021. NO treatment was received for vision loss, numbness in face and facial swelling and the patient stated he was going to see the doctor on Monday. The patient have had read the Pfizer paper work. He wanted to known how he get the compensation for his illness. And he stated that he have seen the program, the Pfizer has compensation for his injury. The outcome of vision loss and corneal disorder was unknown. The outcome of other events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: Naproxen; Mirtazapine

Current Illness:

ID: 1673426
Sex: F
Age:
State: OH

Vax Date: 04/07/2021
Onset Date: 08/24/2021
Rec V Date: 09/04/2021
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: She was barely four months vaccinated when we got Covid; She was barely four months vaccinated when we got Covid; This is a spontaneous report from a contactable consumer. A 39 years old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 07Apr2021 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) at age of 38 years old as DOSE 1, SINGLE for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was barely four months vaccinated when got covid on 24Aug2021. The outcome of events was unknown.

Other Meds:

Current Illness:

ID: 1673427
Sex: F
Age:
State: MO

Vax Date: 02/16/2021
Onset Date: 08/12/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test; On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test; This is a spontaneous report from a contactable consumer (patient). A 55 year old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 16Feb2021 08:00 (at the age of 54 years old) (Lot number was not reported) as dose 2, single; the first dose intramuscular, administered in Arm Left on 26Jan2021 08:00 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to amoxicillin. There were no concomitant medications. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test. The event resulted in a Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. Since the vaccination, the patient has been tested for COVID-19. The outcome of the event was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673428
Sex: F
Age:
State: MS

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

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

Lab Data: Test Name: Colonoscopy; Result Unstructured Data: Test Result:Unknown result; Comments: colonoscopy done and took two days to take the bowel prep

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Rash on both of her legs; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received second dose of bnt162b2(PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Aug2021(at the age of 69-years-old) as a single dose for COVID-19 immunisation. The patient had received first dose of bnt162b2(PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included Chronic Pain Syndrome, Allergic to Yellow Jactkets, Constipation, diarrhoea, colonoscopy (all from an unknown date and unknown if ongoing). The patient's concomitant medications were not reported. On 20Aug2021, the patient experienced rash on both of her legs. Patient took Zyrtec, Pepcid and Prednisone as a treatment medications. It was reported that later that day started having complaints of a rash on both of her legs, on the front of her thighs and below that is still there and looks like a measles rash per Caller. Caller spoke with her HCP who prescribed her Zyrtec, Pepcid, and Prednisone per Caller (did not specify dosage but states that she takes 2 each of the Zyrtec and Pepcid).Caller has a medical history of Chronic Pain Syndrome, Allergic to Yellow Jactkets, and Constipation due to medications and states that last year she was taking a powder medication (did not specify name) and stool softener then started having complaints of diarrhea.Caller also stated that she had a colonoscopy done and took two days to take the bowel prep.she is suspicious that she is allergic to PEG. Starkville and her phone number is # and she actually just hung up so, I just go ahead if you don't mind I mean finish getting you this stuff and I will try to give her a call back if that's okay with you and so she is a 69 Year old (Further not clarified hence not captured in tab) female(Not clarified hence not captured in tab) and on last Friday on 20Aug2021, she got the second dose of Pfizer COVID 19 vaccine and later that day she developed a rash on both lower extremity, so it's on front of her thighs and her legs and she describe this is looking like a measles rash. Her doctor prescribed her Zyrtec, Pepcid and Prednisone (Intent Treatment).Listen I cannot understand the words you are saying, I am sure you can understand me I am from #, I have a southern accent but I can not understand you, I mean I think you asked what my name was and this is going to be a long conversation, if I can't understand you so I don't know if we make somebody else, I mean I don't mean to be rude. I just can't understand you. I am really disgust with Pfizer and I am mad right now and I just don't want to talk about it, so I do my own research and you know so bad but thanks anyway. Further probing could not be done as consumer abruptly hung up the call. Hence, limited relevant information available over the call. The patient underwent lab tests and procedures which included colonoscopy: unknown result on an unspecified date colonoscopy done and took two days to take the bowel prep. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673429
Sex: M
Age:
State:

Vax Date: 02/24/2021
Onset Date: 08/20/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210820; Test Name: Covid Test; Test Result: Positive

Allergies:

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

Symptoms: Patient tested positive following full COVID-19 vaccination.; Patient tested positive following full COVID-19 vaccination.; This is a spontaneous report from a non-contactable other health care professional. A 43-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN5318) dose 2 via an unspecified route of administration 24Feb2021 (at the age of 42-years-old) as dose 2, single and bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN5318) dose 1 via an unspecified route of administration 05Feb2021 (at the age of 42-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive following full COVID-19 vaccination on 20Aug2021. 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 and since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Covid Test was positive on 20Aug2021. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.

Other Meds:

Current Illness:

ID: 1673430
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 08/19/2021
Rec V Date: 09/04/2021
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: So my friends husband that received the Pfizer vaccination in April has developed Covid/he has developed Covid over a week ago. He is pretty sick; So my friends husband that received the Pfizer vaccination in April has developed Covid/he has developed Covid over a week ago. He is pretty sick; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sales representative. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on Apr2021, at dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the full vaccination (as reported) at the end of Apr2021 and developed Covid over a week ago from the time of report (19Aug2021). Also reported that he was very sick. The outcome of the event was unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673431
Sex: M
Age:
State:

Vax Date: 07/27/2021
Onset Date:
Rec V Date: 09/04/2021
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: dizziness/lightheaded; brain fog; kind of head pressure not being there; This is a spontaneous report from a non-contactable consumer (Patient). A 57-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 27Jul2021 (age at vaccination 57 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 2021 the patient experienced dizziness/lightheaded, brain fog, kind of head pressure not being there. Patient reported that symptoms have improved some not completely and asking if the second Pfizer Covid 19 Vaccine will cause "worst vertigo?" also asking if the vaccine will cause Central Nervous System issues, if any have been reported? The outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673432
Sex: F
Age:
State: TX

Vax Date: 01/08/2021
Onset Date: 08/14/2021
Rec V Date: 09/04/2021
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: Test Date: 20210814; Test Name: COVID-19 PCR test; Test Result: Positive

Allergies:

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

Symptoms: COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a Pfizer Sponsored Program Covax US Support. A contactable consumer (patient) reported that a 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) (age at the time of vaccination was 68-year-old), on 08Jan2021 15:00 (Lot Number: EL3248) as dose 2, single and on 18Dec2020 15:00 (Lot Number: EK5730) as dose 1, single, both via an unspecified route of administration, administered in Arm for covid-19 immunization. Medical history included and concomitant medications were reported as none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine: None. It was reported that the patient COVID-19 PCR test was positive on 14Aug2021 and was treated with Regeneron antibody treatment via Subcutaneous injections. One injection in back of each arm, two injections in abdomen. All injections administered at one time. She was told that if she needs to get a 3rd/booster dose she would need to wait 90 days after the Regeneron treatment before doing so. She asked do we have information on this. It was unknown whether culture performed. There were predisposing factors (eg. immunosuppression, contact with other infected persons). Then patient went to an urgent care (Physician Office) for follow-up to see if she was progressing as expected). The outcome of event COVID-19 was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673433
Sex: F
Age:
State:

Vax Date: 06/30/2021
Onset Date: 06/30/2021
Rec V Date: 09/04/2021
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: Certain joints on Right hands/right middle finger got stuck in straight position, point finger had the most damage; Certain joints on Right hands/right middle finger got stuck in straight position, point finger had the most damage; Second toe on right foot started hurting; Took first Covid-19 vaccine and had Anaphylactic reaction; This is a Solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4051900-00) received from a contactable consumer (patient). Solicited report by a consumer of a 50 year old female with events of took first covid-19 vaccine/had anaphylaxis and non-serious certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting. On 30Jun2021, the patient experienced took first covid-19 vaccine/had anaphylaxis. Pfizer covid-19 vaccine (tozinameran) was also considered suspect. On the morning she had certain joints on right hand, right middle finger got stuck in a straight position and point finger had the most damage, second toe on right foot was starts hurting. Took first covid -19 vaccine had anaphylaxis within 5 minutes after take first shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 30Jun2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of took first covid-19 vaccine/had anaphylaxis, certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting was not provided. opinion is that there is no reasonable possibility that the events of took first covid-19 vaccine/had anaphylaxis, certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting are related to Humira(adalimumab). Check all appropriate to Adverse reaction: Other Medically important condition. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment The lot number for bnt162b2 was not provided and will be requested during follow up; Sender's Comments: For events Joint range motion decreased, Limb injury, Pain in extremity the company causality was assessed as Unrelated as there was no strong relation to make it Related. But where as for event Anaphylactic reaction which has a strong temporal association with suspect BNT162B2 company causality was assessed as Related.

Other Meds: HUMIRA

Current Illness:

ID: 1673435
Sex: M
Age:
State: MS

Vax Date: 04/26/2021
Onset Date: 08/27/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210827; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp. A 20-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration on 26Apr2021 (age at vaccination: 20-year-old, Batch/Lot Number: EW0170) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration on 05Apr2021 (age at vaccination: 20-year-old, Batch/Lot Number: ER8729) as single dose for COVID-19 immunisation. On 27Aug2021, the patient experienced tested positive for COVID. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 27Aug2021. No treatment was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor or other healthcare professional office/clinic visit required for events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673436
Sex: M
Age:
State: IL

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

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: Developed Diabetes type II; Dose 1 on 20May2021 09:00 AM/dose 2 on 20May2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 59-year-old administered in arm left on 20May2021 (Batch/Lot number was not reported) at single dose, dose 1 via an unspecified route of administration at age of 59-year-old administered in arm left on 20May2021 09:00 AM (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history was reported as none. There was no covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medications were reported as none. There was no other vaccine in four weeks and no other medications in two weeks. The patient developed diabetes type II on 05Jul2021. The patient was hospitalized for 5 days. Adverse event resulted in Emergency room/department or urgent care, hospitalization and life-threatening illness. The patient received treatment included insulin and oral meds. The outcome of event was not recovered. The lot number for the [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673437
Sex: F
Age:
State: KY

Vax Date: 08/25/2021
Onset Date: 08/25/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210819; Test Name: Covid rapid at work; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: shot throat started closing up; couldn't breathe; Fever day one day two 1.5 days into shot throat started closing up couldn't breathe. Went to er everything checked out except I was in anaphylaxis from a allergy.; Fever; This is a spontaneous report from a contactable nurse (patient). This non-pregnancy 35-year-old female patient received bnt162b2 (Brand=Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 25Aug2021 10:00 (Batch/Lot Number: Fa7485) as dose 1, single for covid-19 immunisation. Medical history included chronic pain depression. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: paracetamol. Known allergies: No true allergies just adverse side effects like clarithromycin (MACROBID) vomiting trazadone weird dreams varenicline tartrate (CHANTIX) we. The patient experienced anaphylaxis and fever on 25Aug2021 13:00, shot throat started closing up couldn't breathe on 26Aug2021. Fever day one day two 1.5 days into shot throat started closing up couldn't breathe. Went to ER everything checked out except she was in anaphylaxis from an allergy. No new meds or foods eaten. No new allergens introduced except vaccine. Never had a true allergic reaction in my life only side effects from certain meds like vomiting with clarithromycin for instance. Her throat still felt like it was trying to close up about once a day and she had to take more benedryl. The adverse event result in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received for the adverse event included Iv steroids famotidine and benedryl. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Covid rapid at work on 19Aug2021: Negative (Nasal Swab). The outcome of event shot throat started closing up was not recovered. The outcome of other event was unknown.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug. 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 RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: TYLENOL

Current Illness:

ID: 1673438
Sex: M
Age:
State: GA

Vax Date: 03/24/2021
Onset Date: 08/12/2021
Rec V Date: 09/04/2021
Hospital: Y

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

Lab Data: Test Date: 20210806; Test Name: COVID test; Result Unstructured Data: Test Result:Unknown resultes; Comments: nasal swab

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: blood clog on left leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: Ep8732, also reported as Em9809), at the age of 66 years old, in right arm on 24Mar2021 at 09:30 at single dose for COVID-19 immunisation. The patient's medical history was not reported. Known allergies was N/A. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications were received in two weeks was N/A. On 12Aug2021 at 20:15, the patient had a blood clog on left leg. Clog removed on 16Aug2021. Event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for one day. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (nasal swab): unknown results on 06Aug2021. Therapeutic measures were taken as a result of event and included treatment with surgery. The outcome of event was unknown.

Other Meds:

Current Illness:

ID: 1673439
Sex: F
Age:
State:

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/04/2021
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: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Medical history included ongoing anticoagulant therapy from an unknown date. Concomitant medication included ongoing apixaban (ELIQUIS) and Metoprolol; both taken for blood thinner start and stop date was not provided. On 26Aug2021 after receiving the first dose of Pfizer Covid 19 Vaccine, the patient had chills, felt tired and had a little arm pain. On 26Aug2021, the patient took Ibuprofen, as a treatment. Patient scheduled for the second dose of Pfizer Covid 19 Vaccine on 16Sep2021 but was unable to make it since she was scheduled for a surgery on that day. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds: ELIQUIS; METOPROLOL

Current Illness: Anticoagulant therapy

ID: 1673440
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Pain at the injection site.; sore arm; arm felt feverish; This is a spontaneous report from a Pfizer sponsored program via a consumer reported for a patient (reporter's daughter in law). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in 2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's 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: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location an unspecified date in 2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and experienced flu symptoms for a week after the first vaccine, her arm felt feverish and sore arm on the injection arm. She felt like she had the flu for 5-7 days. Her doses were either in Apr2021 and May2021 or May2021 and Jun2021. It was the end of Apr2021 or the middle of May2021 and the second one was probably in Jun2021. On an unspecified date in 2021, the patient experienced pain at the injection site, sore arm and her arm felt feverish. She didn't want to report it because she felt like it was normal. The reporter and her daughter in law had the same side effects. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119253 same reporter/SD/AE,different patient

Other Meds:

Current Illness:

ID: 1673441
Sex: F
Age:
State: MI

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 202102; Test Name: Xrays; Result Unstructured Data: Test Result:still awaiting results

Allergies:

Symptom List: Unevaluable event

Symptoms: life threatening blood clots/blood clots to brain and clots in neck; life threatening blood clots/blood clots to brain and clots in neck; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Lot number was not reported) at the age of 38-year-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. It is reported the caller reports he has a couple of family members who had the Covid vaccine back in Feb2021. They suspect they are experiencing a side effect of the life-threatening blood clots on Feb2021. They have never had issues until they had the vaccine. He found out that the day after the vaccine, his sister-in-law, blood clots, life threatening blood clots to brain and clots in neck started, but it hasn't been confirmed but the doctors say there is a high suspicion and likelihood there is blood clotting. She just got the x-ray from emergency room 2 days ago and went back yesterday and they are still waiting for the results. Caller unsure if patient had both shots. Know she got a Pfizer Covid shot and the day after the blood clots started. Event caused patient visit physician office and emergency room. The patient underwent lab tests and procedures which included x-ray: still awaiting results on Feb2021.

Other Meds:

Current Illness:

ID: 1673442
Sex: M
Age:
State:

Vax Date: 05/16/2021
Onset Date: 08/16/2021
Rec V Date: 09/04/2021
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: Test Date: 20210817; Test Name: COVID test/Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: I tested positive for a breakthrough infection of COVID-19; I tested positive for a breakthrough infection of COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185), via an unspecified route of administration on arm right on 16May2021(age at vaccination: 28 Years) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0171), via an unspecified route of administration on arm right on 25Apr2021 as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications were not reported. On 16Aug2021, the patient tested positive for a breakthrough infection of COVID-19. The event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has tested for COVID-19. Treatment received was reported as no. The lab test included SARS-CoV-2 test(Nasal Swab): positive on 17Aug2021.The outcome of event was resolving. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1673444
Sex: M
Age:
State:

Vax Date: 03/11/2021
Onset Date: 07/21/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210721; Test Name: COVID test type post vaccination= Nasal Swab; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Breakthrough COVID-19 case; Breakthrough COVID-19 case; This is a spontaneous report received from a non-contactable consumer (patient). This 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 at the age of 73-year-old (lot unknown) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history and allergies was Unknown. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. The patient experienced Breakthrough COVID-19 on 21Jul2021 and reported as Non-serious. It was unknown if treatment received for AE. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab covid test on 21Jul2021 with Positive result. The outcome of the event was Recovered in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1673445
Sex: F
Age:
State:

Vax Date: 03/05/2021
Onset Date: 08/27/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210827; Test Name: COVID-19 Nasal Swab; Test Result: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Confirmed breakthrough COVID-19 infection; Confirmed breakthrough COVID-19 infection; This is a spontaneous report from a contactable consumer. This consumer reported that a Non-pregnant 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at the age of 43-year-old (Lot unknown) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not repoted. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was Confirmed breakthrough COVID-19 infection on 27Aug2021. No Hospitalization Prolonged associated. Event reported as non-Serious. It was unknown if Treatment received. Since the vaccination, the patient has been tested Positive for COVID-19 Nasal Swab on 27Aug2021. The outcome of the event was Recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 1673446
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: COVID 19; Test Result: Positive

Allergies:

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

Symptoms: They both later tested positive for COVID at around the same time; They both later tested positive for COVID at around the same time; This is a spontaneous report from same non-contactable consumer for 2 patient about same events. This is 2 of 2. This consumer reported that a male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (Lot unknown) as a single dose for COVID-19 immunization. It was unknown If Covid prior vaccination. Medical history and concomitant medications were not reported. This report is about two patients, both of whom received the vaccine. They both later tested positive for COVID at around the same time. Their illness was not severe and was mostly coughing, sneezing, etc. Event was reported as serious. There is Covid tested post vaccination with the result of Positive. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116677 Same reporter/drug/event for different patients.

Other Meds:

Current Illness:

ID: 1673447
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Stroke; Can't walk; This is a spontaneous report from a contactable consumer. A 4-decade-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization.The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date, the patient experienced Stroke and was unable to walk. The reporter stated she was told, from the group of employees, that they know a woman, who was in her 30's and healthy, that had a stroke, and can't walk after the Pfizer vaccine. Reporter stated she was at a pharmacy and was told by the pharmacist that the BioNTech vaccine was the one that was not FDA approved, and the vaccine that was approved, was not in stock. Reporter stated she was told that some employees are sick with Covid right now, after having the Pfizer vaccine. Reporter stated that her personal surgeon, told her, not to get the Pfizer vaccine, and to wait for other vaccines, such as Novovax. Reporter stated her surgeon is not recommending the Pfizer vaccine to his employees. Reporter stated telling their employees that Pfizer is only 35% effective, not 95% effective. Reporter stated the employees were told that only the vaccinated employees got Covid, not the unvaccinated employees. Reporter does not provide any specific details. Reporter stated her surgeon was not recommending the Pfizer vaccine to his employees. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673448
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: She has swollen not swollen, Painful arm first; This is a spontaneous report from a contactable consumer (patient's mother). A 13-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date (age at the time of vaccination 13-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced She has swollen not swollen, Painful arm first. No treatment was received. No prior vaccine within four weeks. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673449
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: really painful and hemorrhagic menstrual cycles; really painful and hemorrhagic menstrual cycles/hemorrhagic cycle and cramps and pain. excruciating painful, hemorrhagic cramps and pain; Painful arm first and second dose; This is a spontaneous report from a contactable consumer (mother) reported for patient(daughter). A 13-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history of the patient was reported as no. The concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2(solution for injection) on an unspecified date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The reporter stated her daughter got vaccinated with the Pfizer vaccine and had adverse event. She had swollen not swollen, Painful arm first and second dose and she got a really, really painful and hemorrhagic menstrual cycles, she usually doesn't have menstrual cramps for anything like that but she was up in the middle overnight one hour in excruciating pain. Cramps and pain which was not the usual course, so reporter thought for the safety report it was really important hemorrhagic cycle and cramps and pain. On a scale of 0 to 10 on the 'EVA' she had 9, so it was excruciating painful which was again it was very, it was not at all that usual mode of operating. Therapeutic measures were not taken as a result of events. The outcome of the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673450
Sex: U
Age:
State: HI

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

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: Heart attack; This is a spontaneous report received from a contactable consumer or other non-health care professional via Medical Information Team. This consumer reported for a patient (cousin). A patient of unspecified age and gender received bnt162b2 (COVID-19 VACCINE ? MANUFACTURER UNKNOWN, Formulation: Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart attack on an unspecified date. The event assessed as serious (hospitalization, medically significant). Caller stated she was concerned about various information she was finding around the FDA approval of the Comirnaty Vaccine. Caller stated her employer was planning on mandating vaccination against Covid-19, but she was concerned because she had two cousins that had heart attacks and another who had a severe allergic reaction with paralysis from the neck down to an unspecified Covid-19 Vaccine. They were hospitalized. The outcome of the event was reported as unknown. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673451
Sex: U
Age:
State: HI

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

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: paralysis from the neck down; a severe allergic reaction; This is a spontaneous report contactable consumer or other non health care professional. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, patient experienced severe allergic reaction with paralysis from the neck down. Events resulted in hospitalization on an unspecified date. Reporter concerned about various information she was finding around the FDA approval of the Comirnaty Vaccine and states her employer was planning on mandating vaccination against COVID-19, but she was concerned because she had two cousins that had heart attacks and another (patient), who had a severe allergic reaction with paralysis from the neck down to an unspecified COVID-19 Vaccine, They were hospitalized. The outcome of all the events was unknown. Information about lot/batch number not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1673452
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Brain filled with blood clots; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. On an unknown date, the patient's brain filled with blood clots. The caller states that she was at a pharmacy with a group of employees and was told by the pharmacist that the BioNTech vaccine was the one that was not FDA approved, and the vaccine that was approved, was not in stock, so she wants to asks, was the approved vaccine on the market yet or not. She clarifies she was calling about the Pfizer BioNtech Covid vaccine and also stated that they also told her that another employee, male, his brain was filled with blood clots, and there were two of them, and they both got the Pfizer vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673453
Sex: M
Age:
State: TN

Vax Date: 03/19/2021
Onset Date: 06/23/2021
Rec V Date: 09/04/2021
Hospital: Y

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

Lab Data: Test Date: 20210626; Test Name: Nasal Swab; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Bilateral pulmonary embolism; Deep Vein Thrombosis in lower left leg; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 19Mar2021 09:30 (Lot Number: EN6204) at the age of 68 years old as DOSE 2, SINGLE for covid-19 immunisation. The patient received the first dose of BNT162B2 on 26Feb2021 at 10:00 AM Lot number EN6200 at Right arm at the age of 68 years old for Covid-19 Immunisation. Medical history included ongoing hypertension from an unknown date. No known Allergies. Concomitant medications included propranolol (PROPRANOLOL); calcium (CALCIUM); krill oil (KRILL OIL) and unspecified multivitamin all taken for an unspecified indication, start and stop date were not reported. The patient experienced bilateral pulmonary embolism and deep vein thrombosis in lower left leg on 23Jun2021 12:00 with outcome of recovering. The events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 4 days, Life threatening illness (immediate risk of death from the event)]. The patient received tPA and Heparin therapy as treatment. The patient underwent lab tests and procedures which included Nasal Swab: negative on 26Jun2021 Nasal Swab.

Other Meds: PROPRANOLOL; CALCIUM; KRILL OIL

Current Illness: Hypertension

Date Died:

ID: 1673454
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: passed away; This is a spontaneous report from a Pfizer-sponsored program via Regulatory Authority Support received from a non-contactable consumer. The consumer reported same events for two patients (two friends). This is one of the two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient took both doses and passed away on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101123407 Same reporter/suspect product/event, different patients; Reported Cause(s) of Death: took both doses and passed away

Other Meds:

Current Illness:

ID: 1673455
Sex: F
Age:
State: NJ

Vax Date: 04/17/2021
Onset Date: 04/18/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20201223; Test Name: Food Allergy test; Test Result: Negative ; Comments: I never had any allergies from peanuts and sesame. Also these came (-) on Food Allergy test done on 23Dec2020 at ENT and Allergy facilities

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine; getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine; getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine; This is a spontaneous report from a contactable consumer (patient). This female consumer reported that a 41 years old female (no pregnant) patient received BNT162B2 (lot number=EL3302), at the age of 41-year-old, on 17Apr2021 vaccine location in Left arm at single dose for covid-19 immunization. Medical history was Gastrooesophageal reflux disease (GERD), Arthritis. Known allergies to Peanut, Soya, Sesame. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks included Omeprazole, Desloratadine. Adverse event on 18Apr2021 was getting allergy attacks and severe breathing difficulties from peanuts, sesame, charcoal, coaltar which didn't happen earlier before taking Pfizer vaccine. I never had any allergies from peanuts and sesame. Also these came (-) on Food Allergy test done on 23Dec2020 at ENT and Allergy facilities. Event resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment was Nebulization, Prednisone, Breo. Outcome of the event was Not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: DESLORATADINE; OMEPRAZOLE

Current Illness: Food allergy; Peanut allergy

ID: 1673456
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Test Name: COVID; Result Unstructured Data: Test Result:positive

Allergies:

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

Symptoms: Came up positive for COVID; Came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; I took the booster shot...I started feeling like woozy like on Tuesday and Wednesday and then I thought I had allergy and all and I went to get tested last night and I came up positive for COVID; Woozy; I thought I had allergy and all; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, batch/lot number and expiry date were unknown), dose 3 via an unspecified route of administration on an unspecified date in 2021 (Lot Number: EW0175) as dose 3, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient historical vaccine includes bnt162b2 dose 1, single in Jan2021 and dose 2, single on 22Jan2021; both doses for covid-19 immunization. Patient got both the Pfizer shots back in January, the last one in January was 22Jan2021. Last week, they had the booster shot and patient took the booster shot on an unknown date in 2021, it was of Pfizer EW0175 patient thinks, it was the booster. The side effect was that, patient was surprised, took that last Saturday and started feeling like woozy like on Tuesday and Wednesday and then thought had allergy and all and patient went to get tested last night and came up positive for COVID on an unknown date in 2021. This was the Pfizer booster that the patient got which was administered last week, last Saturday. The patient underwent lab test which included Covid (sars-cov-2 test) was positive on an unknown date. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1673457
Sex: M
Age:
State: NJ

Vax Date: 03/01/2021
Onset Date: 08/25/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210825; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: Fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1.; Fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the second dose and first dose of BNT162B2, second dose via an unspecified route of administration in Mar2021, first dose via intramuscular on the left arm on 09Mar2021 at 10:00 AM (Lot Number: EL3247), both at the age of 60-year-old as single dose for COVID-19 immunization. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. known allergies was none. Concomitant medication was not reported. On 25Aug2021 at 02:15 PM, the patient fully vaccinated in Mar2021 and contracted COVID-19 in Aug2021. Acquired two PCR to rule out a false positive from PCR test #1. COVID test (PCR, Nasal Swab) post vaccination on 25Aug2021 and result was positive. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673458
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: she got her first covid vaccine dose and then got covid; she got her first covid vaccine dose and then got covid; This is a spontaneous report from a contactable consumer (patient). This 41-year-old female patient received the first dose of bnt162b2 (COMIRNATY) on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Reporter was asking how long she has to wait after having covid to receive her second vaccine dose. She got her first covid vaccine dose and then got covid causing her to miss her second dose. Now asking how long she would have to wait to get her second dose after having Covid. The outcome of the event was unknown. Information about lot/batch number requested.

Other Meds:

Current Illness:

ID: 1673459
Sex: U
Age:
State: GA

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 09/04/2021
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: Pericarditis; This is a spontaneous report from a contactable consumer (patient) via Pfizer RXPathways. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jan2021 (Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient stated that over the past 4-5 weeks from the time of reporting, the patient has been having chest pain with breathing and movement. The patient thought of having some heart issues, so the patient went to PCP (primary care physician), then sent the patient to ER (emergency room), then referred to cardiologist. The cardiologist scheduled the patient for an Echo and Stress Test. Then on 24Aug2021, the pain was worse, so the patient went back to cardiologist. The patient was sent back to ER again and finally the ER diagnosed the patient with pericarditis. The patient had no past cardiac issues or heart related conditions. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

Date Died: 05/18/2021

ID: 1673460
Sex: F
Age:
State: TX

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 09/04/2021
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: Renal Failure; This is a spontaneous report from a contactable consumer. A 94-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Batch/Lot number was not reported) (at the age of 94-year-old, not pregnant) as single dose for COVID-19 immunisation. Medical history: none, she was just old. Concomitant medications included temazepam; ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER); ascorbic acid, betacarotene, copper, tocofersolan, zinc (OCUVITE). The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 on 23Feb2021 at 12:00 PM in left arm at the age of 94-year-old for COVID-19 immunization and experienced Renal Failure. No covid prior vaccination. No other vaccine in four weeks. No covid tested post vaccination. No known allergies. The patient experienced periodic uncontrollable shaking renal failure. AE resulted in: Doctor or other healthcare professional office/clinic visit. No treatment. The patient died on 18May2021. An autopsy was not performed. The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101102004 same reporter, patient, product, event, different doses and potential; Reported Cause(s) of Death: Renal Failure

Other Meds: Temazepam; Centrum Silver [Ascorbic Acid; Calcium; Minerals Nos; Retinol; Tocopheryl Acetate; Vitamin B NOS; Vitamins; Ocuvite [Ascorbic Acid; Beta carotene; Copper; Tocofersolan (TPGS); Zinc]

Current Illness:

ID: 1673461
Sex: F
Age:
State: FL

Vax Date: 04/24/2021
Onset Date: 04/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: COVID-19 virus test (nasal swab); Test Result: Negative

Allergies:

Symptom List: Pain in extremity

Symptoms: Congestive heart failure; This is a spontaneous report received from a contactable consumer (patient). A 31-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left on 24Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. The patient has not been diagnosed with COVID-19 prior to vaccination. Patient was not pregnant and was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccine within 4 weeks prior to the COVID-19 vaccine. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) on 04Apr2021 in left arm for covid-19 immunisation. The patient experienced congestive heart failure (disability, life threatening) on Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative on 14Aug2021. Therapeutic measures were taken as a result of the event and included unspecified medication (treatment ongoing). The lot number for bnt162b2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1673462
Sex: F
Age:
State: PA

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 09/04/2021
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: mettallic taste in mouth; mettalic/burning smell; Rash; This is a spontaneous report from a contactable consumer (patient). This 42-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0150) intramuscular on 01Apr2021 at 07:30 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history, family history, and concomitant medications were none. The patient did not receive any prior vaccinations (as reported). On 02Apr2021 at 08:00 the patient experienced rash. The event was reported as non-serious. On unknown dates the patient experienced metallic taste in mouth and metallic/burning smell. The events were reported as serious (persistent/significant disability/incapacity). The patient had a constant burning smell/taste. Sweet foods were okay, but any other foods such as meat and vegetarian tasted like metal and were gross. This change in smell ability could be a serious issue if she would be unable to do her job as a scientist in a chemical lab since she could not determine chemical potency. The patient did not receive any treatment for the events. The outcome of rash was recovered on 30Apr2021. The outcomes of metallic taste and smell were not recovered. It was also reported that the patient received dose 2 of BNT162B2. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100943663 same patient, different dose/events

Other Meds:

Current Illness:

ID: 1673463
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: Covid-19; Test Result: Positive

Allergies:

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

Symptoms: Received a Positive covid-19 diagnosis after first shot and before the second shot.; Received a Positive covid-19 diagnosis after first shot and before the second shot.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received a positive COVID-19 diagnosis after first shot and before the second shot. Event took place after use of product. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Date Died:

ID: 1673464
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: who got the vaccine and died three days later; This is a spontaneous report from a non-contactable other hcp. The reporter reported for herself and another patient. This was for another patient. A patient of unspecified age and gender received bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine and died three days later on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: who got the vaccine and died three days later

Other Meds:

Current Illness:

ID: 1673471
Sex: M
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 09/04/2021
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: Rheumatoid arthritis flare up; Heartburn; Pain in hand; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4052045-00 from a contactable 59-year-old male consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 04Mar2021 (Batch/Lot number was not reported), dose 2 on 04Apr2021 (Batch/Lot number was not reported), both at age of 58-year-old intramuscular as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Lot Number: 1142175) and ongoing, at Citrate Free for Moderate to severe rheumatoid arthritis, methotrexate sodium (METHOTREXATE SODIUM), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced gallbladder removal (medically significant) on 30Jul2021, heartburn, rheumatoid arthritis flare up, adverse drug reaction, pain in hand on unknown date. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was dose not changed, for methotrexate sodium was permanently withdrawn on an unspecified date. the outcome of gallbladder removal was recovered in 2021, Rheumatoid arthritis flare up, Adverse drug reaction (as reported) was not recovered , for other event was unknown. Clinical course: Solicited report by a consumer of a 59-year-old male with events of gallbladder removal and non-serious heartburn, rheumatoid arthritis flare up, had reaction to methotrexate and occasional pain in hands with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced heartburn, rheumatoid arthritis flare up, had reaction to methotrexate and occasional pain in hands. On 30Jul2021 the patient experienced gallbladder removal. On an unknown date, gallbladder removal resolved. Methotrexate was also considered suspect. Patient had reaction to methotrexate which caused heartburn and had to stop the drug. It was unknown if he was enrolled in a covid-19 vaccine trial. On 04Mar2021, he received first dose covid-19 vaccine manufactured by Pfizer. On 04Apr2021, he received second dose covid-19 vaccine manufactured by Pfizer. Causality for Humira (Adalimumab): The reporters causality for the event(s) of gallbladder removal, heartburn and had reaction to methotrexate with Humira (Adalimumab) was no reasonable possibility. The reporters causality for the event(s) of rheumatoid arthritis flare up with Humira (Adalimumab) was a reasonable possibility. The reporters causality for the event(s) of occasional pain in hands was not provided. RA opinion is that there is no reasonable possibility that the events of gallbladder removal, heartburn, rheumatoid arthritis flare up, had reaction to methotrexate and occasional pain in hands are related to Humira (Adalimumab). The reporter's assessment of the causal relationship of the events with the suspect products bnt162b2 and methotrexate sodium was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and known drug profile, a possible causal relationship cannot be excluded between the suspect vaccine product bnt162b2 and the reported event rheumatoid arthritis flare up. The other events are not considered likely related to the suspect product bnt162b2. Based on available information and possible temporal association, a possible causal relationship cannot be excluded between the suspect vaccine product methotrexate sodium and the reported events heartburn and pain in hand. The event rheumatoid arthritis flare up is not considered related to the suspect product methotrexate sodium based on negative dechallenge result that the event not recovered after methotrexate sodium withdrawn. This case will be reassessed once additional information is available.

Other Meds: Humira; Methotrexate Sodium

Current Illness:

ID: 1673472
Sex: F
Age:
State: NJ

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 09/04/2021
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: Arrhythmia; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 56-year-old female patient received the first dose of BNT162B2 (Lot number EN6206) via an unspecified route of administration in the left arm on 09Mar2021 at 11:00 (at 56-years-old) as a single dose for COVID-19 immunisation. Medical history included arrhythmia well controlled by medications, chronic vertigo from ear injury well controlled by medications, ear injury, walnut allergy, and pineapple allergy, all from unknown dates and unknown if ongoing. Concomitant medications included diltiazem (CARDIZEM), rosuvastatin calcium (CRESTOR), pizotifen malate (SANDOMIGRAN), lysine, curcuma longa (TUMERIC), ascorbic acid (VITAMIN C), all from unknown dates for unknown indications. The patient previously received moxifloxacin hydrochloride (AVELOX) for an unknown indication and experienced allergy. Prior to vaccination the patient was not diagnosed with COVID-19 and had not received any other vaccines in 4 weeks. The patient reported experiencing arrhythmia 2 minutes after the first dose, which had been well controlled with medications for over 10 years. The event resulted in a doctor's office and emergency room visit. The patient was treated with steroid pills and injection. The clinical outcome of the event was not recovered. Since vaccination the patient was not tested for COVID-19.

Other Meds: CARDIZEM [DILTIAZEM]; CRESTOR; SANDOMIGRAN; LYSINE; TURMERIC [CURCUMA LONGA]; VITAMIN C [ASCORBIC ACID]

Current Illness:

Date Died:

ID: 1673473
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: died; This is a spontaneous report from a contactable consumer. This consumer reported for an adult male patient. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunization. Reason for no lot number of Pfizer COVID-19 Vaccine: complainant hung up abruptly/transfer incomplete. The patient medical and concomitant medication history were reported. Other products, patient history and investigation assessment not provided. The patient experienced died on an unspecified date. It was not reported if an autopsy was performed. Caller was asking why Pfizer not reporting the side effects to VAERS? Caller states that the data on VAERS has stopped counting the fatalities from the Pfizer COVID-19 vaccine and the death count exceeds 12,000. Caller states that the Pfizer COVID-19 vaccine has metals and was asking how was it being passed through the FDA and Pfizer? Normally with other shots, they take years to get approved. FDA only allows, if people die, they did not put it on the market. Caller states that the data on VAERS has stopped counting the fatalities from the Pfizer COVID-19 vaccine and the death count exceeds 12,000. Caller asked if we had COVID, we had the antibodies, why do we have to get the shot. The lot number was not provided. Information on lot number has been requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101134188 same reporter/drug/event, different patient.; Reported Cause(s) of Death: unknown cause of death

Other Meds:

Current Illness:

Date Died:

ID: 1673475
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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 have lost 3 friends in Spain; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not reported) via an unspecified routed of administration on unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend in Spain. The cause of death was unknown. It was unknown whether an autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100059 same reporter/drug/event, different patient; Reported Cause(s) of Death: I have lost 3 friends in Spain

Other Meds:

Current Illness:

ID: 1673476
Sex: M
Age:
State: CA

Vax Date: 12/06/2020
Onset Date:
Rec V Date: 09/04/2021
Hospital: Y

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: still having problems with his face it burnt his face.; it scarred his face really bad around his eye; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) dose 1 via an unspecified route of administration on 06Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE for immunisation. The patient's medical history and concomitant medications was not reported. The patient was still having problems with his face it burnt his face, it scarred his face really bad around his eye. He got the shot at withheld pharmacy. Patient had to go to the hospital and doctor. He needs to speak to someone about compensation in regards to his face and eyes, terrible scarring. He does not have the exact name of the pneumonia shot or the flu shot and cannot provide any details. States the pharmacy has that information and he can get it. Its been bothering him for a while. He has been to the eye doctor and had to get new glasses and it left a terrible scar on his face. Therapeutic measures were taken as a result of events. The outcome of events was unknown. The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673477
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; They have 7 or 8 people positive for covid at this time; all of them have received the vaccine and 6 people out of 7 or 8 that are infected have the Pfizer BioNTech Covid19 vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the sixth of six reports. A patient of an unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP8573), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the nurse reported that they had 7 to 8 patients positive of COVID-19 and out of which 6 were given Pfizer vaccine and they got infected. The patient tested positive for COVID-19 on an unknown date in 2021. The events were assessed as medically significant. The outcome of the events was reported as unknown. Investigation Results for Lot Number: EP8573: Conclusion of Previously Completed Investigation : The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot ER8734 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8734, fill lot EP8686, and the formulated drug product lot EP8573. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Follow-up (19Aug2021): New information updated. This is a follow-up spontaneous report received from a Complaint Group. This report included Lot number: EP8573 was updated. No follow-up attempts are possible. No further information is expected. Follow-up (01Sep2021): This is a follow-up report to notify that the case 202101065553 and case 202101138804 are duplicates. All subsequent follow-up information will be reported under Manufacturer report number 202101138804.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Covid 19, Drug ineffective and the suspect drug BNT162B2.,Linked Report(s) : US-PFIZER INC-202101058200 Different patient, same drug/event.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am