VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1692083
Sex: F
Age:
State: FL

Vax Date: 03/22/2021
Onset Date: 03/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp (Patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced horrible reaction where her throat closed up, unable to swallow on Mar2021. The consumer said that she was vaccinated in on 22Mar2021 and had an immediate and horrible reaction where her throat closed up and was unable to swallow. She also said that she was almost hospitalized. 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: 1692084
Sex: F
Age:
State: TX

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Possible flare of psoriatic arthritis; Possible serum sickness; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Aug2021 16:45 (Lot Number: Fc3181) at age of 42-year-old as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, known allergies sulfa. No Covid prior vaccination. Concomitant medications included sertraline hydrochloride (SERTRALINE); pantoprazole; famotidine. No other vaccine in four weeks. The patient experienced Possible serum sickness, Severe myalgias, joint swelling, Possible flare of psoriatic arthritis on 17Aug2021 21:00. Adverse events resulted in [Doctor or other healthcare professional office/clinic visit]. Patient received NSAISA as treatment. Covid was not tested post vaccination. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: SERTRALINE [SERTRALINE HYDROCHLORIDE]; PANTOPRAZOLE; FAMOTIDINE

Current Illness:

ID: 1692085
Sex: U
Age:
State:

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Itching; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported, NDC and UPC number was unknown), via an unspecified route of administration on 23Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching on 23Aug2021.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: 1692086
Sex: F
Age:
State: IL

Vax Date: 04/26/2021
Onset Date: 05/05/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 202106; Test Name: Nasal Swab; Test Result: Negative ; Test Name: transvaginal ultrasounds; Result Unstructured Data: Test Result:found with fluid and polyps on ovaries

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: polyps on ovaries; Prolonged period; polyps; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: EWO165), dose 2 via an unspecified route of administration, administered in Arm Right on 26Apr2021 at 10:30 (at the age of 32-years-old) as DOSE 2, SINGLE for covid-19 immunization. Medical history included allergies from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing and chronic back spasms from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot Number: ER8729), dose 1, via an unspecified route of administration in Arm Right on 07Apr2021 at 12:15 as DOSE 1, SINGLE for COVID-19 immunization with no reported adverse effects. The patient did not receive any other vaccines within four weeks prior to the vaccination. No other medications were received within 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05May2021, the patient experienced polyps on ovaries and prolonged period that lasted for 5.5 weeks and didn't stop until she was put on a hormone (unspecified). She had several transvaginal ultrasounds found with fluid and polyps on ovaries. She was also informed that, she would not be able to get pregnant with out help from a specialist. The patient underwent lab tests and procedures which included sars-cov-2 test (Jun2021): negative (rapid test, nasal swab) and ultrasound scan vagina (Unknown date): found with fluid and polyps on ovaries. The adverse events resulted in a Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Clinical outcome of the events was resolved with sequelae (reported as lasting effects). Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692087
Sex: F
Age:
State: OH

Vax Date: 03/18/2021
Onset Date: 03/25/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: bloodwork; Result Unstructured Data: Test Result:normal; Test Name: chest x-rays; Result Unstructured Data: Test Result:normal; Test Name: Chest CT; Result Unstructured Data: Test Result:normal; Test Name: echocardiogram with bubbles; Result Unstructured Data: Test Result:normal; Test Name: heart monitor; Result Unstructured Data: Test Result:"fine"; Test Name: Heart rate; Result Unstructured Data: Test Result:135; Test Name: Heart rate; Result Unstructured Data: Test Result:Really bad

Allergies:

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

Symptoms: her heart rate would be 135/ racing heart; racing heart that lasted 2 months; really bad shortness of breath; This is a spontaneous report from a contactable consumer reporting for herself. A 38-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 at 13:30 (Batch/Lot number was not reported) as a single dose (at the age of 38 years old) for COVID-19 immunization. There was no medical history or concomitant medications. There was no relevant family medical history. There was no additional vaccines administered on the same date as the Pfizer vaccine and no prior vaccines administered within 4 weeks. There were no adverse events following prior vaccinations. The patient reported she received the Pfizer Covid-19/Comirnaty vaccine on 18Mar2021. 7 days later (on 25Mar2021) she developed "really bad shortness of breath" and a racing heart that lasted 2 months. The onset time of the events was morning, around 10:00-11:00a.m. Patient reported they were on the way to (City), and it started happening. Sometimes she would wake up and her heart rate would be 135, and she was sleeping and she would get shortness of breath, "it was really scary." Tests showed that everything was fine. They did an echocardiogram with "bubbles," Chest CT with dye, bloodwork, chest x-rays, and they were all normal. She also wore a heart monitor for 2 days. During the time when her heart rate was really bad, she was on a beta blocker for a couple of months to slow her heart rate, but she was able to stop taking that. Treatment included PROZAC, which reporter stated was the only way she could keep it under control. She states she feels much better, but she would still say that it was ongoing but improved because she was still on the PROZAC for it. The events required a visit to the emergency room and physician's office. She did not get the second dose of the vaccine because of this adverse event. The patient was recovering from the events. She wanted to know if she were to go proceed with the second dose now, would she need to re-start the series or only take one dose. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692088
Sex: M
Age:
State: WI

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I felt very sick for the first 24 hours and it went away.; I experienced the worst herpes outbreak of my life.; I experienced the worst herpes outbreak of my life. Lasted 3+ weeks and was very painful.; It left painful scar tissue and I struggle with intimacy now; 1st dose on 16Mar2021 and 2nd dose on 30Mar2021; This is a spontaneous report from a contactable consumer. A 28-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 30Mar2021 at 13:00 (at the age of 28-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included drug hypersensitivity (Known allergies: had some poor reactions to some antibiotics) from an unknown date and unknown if ongoing. Asthma and gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. No concomitant medication was reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported) as dose 1, single administered in right arm on 16Mar2021 at 13:00 for COVID-19 immunization. No COVID prior vaccination. No other vaccine in four weeks. No other medications in two weeks. Facility type vaccine reported as other. On 02Apr2021 at 13:00, the patient felt very sick for the first 24 hours and it went away. Shortly after, patient experienced the worst herpes outbreak of life. Lasted 3+ weeks and was very painful. Patient was recovered but it was very scary. It left painful scar tissue and struggle with intimacy now. Had not reported because patient was so embarrassed. Was urged by a friend to report. Adverse event resulted in: Disability or permanent damage. If patient recovered: Recovered with lasting effects. No treatment received for the adverse event. No COVID tested post vaccination. The outcome of the event inappropriate schedule of vaccine administered was unknown while other events were recovered on 2021. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1692089
Sex: U
Age:
State: NC

Vax Date: 08/07/2021
Onset Date:
Rec V Date: 09/11/2021
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: Stomach cramps; Diarrhea; My stomach is so sore and I cannot stand it, it is like the nervous stomach; My stomach is so sore and I cannot stand it; Some anxiety with the taste, it is kind of like something stuck in my throat and still going on; it is kind of like something stuck in my throat; it's like something in your throat; anxiety; arm got sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. About 3 or 4 days after vaccine, took on the 07Aug2021 and was due to take the next one on the 28th. On an unspecified date, the patient experienced stomach cramps, diarrhea, my stomach is so sore and i cannot stand it, it is like the nervous stomach, my stomach is so sore and i cannot stand it, some anxiety with the taste, it is kind of like something stuck in my throat and still going on, it is kind of like something stuck in my throat, it's like something in your throat, anxiety and arm got sore. The outcome of the event taste abnormality was unknown and rest events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692090
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: Pulse rate; Result Unstructured Data: Test Result:116; Test Name: Pulse rate; Result Unstructured Data: Test Result:99-100; Comments: pulse has stayed between 99-100 for the past hour.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: felt like I was going to pass out; chest still hurts and feels tight; chest still hurts and feels tight; pulse and it was 116; couldn't breathe; dizzy; couldn't stand up; had a very worrisome response; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported, Expiration date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt like I was going to pass out, chest still hurts and feels tight, pulse and it was 116, couldn't breathe, dizzy, couldn't stand up, had a very worrisome response. Patient also stated I just had my first vaccine dose and had a very worrisome response. I'm trying to determine what this means going forward with the second dose and whether I should receive the second dose or not. About 15 minutes after receiving my first dose I my chest started hurting and felt as if I couldn't breathe. It got worse to where I couldn't stand up. My husband checked my pulse and it was 116. A few minutes after while still sitting I got very dizzy and felt like I was going to pass out. My husband checked again and it read "low" and continued for a couple of minutes. It then went away and I felt okay. My chest still hurts and feels tight. I have some shortness of breath but not like before. My pulse has stayed between 99-100 for the past hour. Lab test included pulse rate: 116 and 99-100. The outcome of events was unknown. Follow-up(25Aug2021): No new follow-up information received from a contactable consumer (patient). Follow-up(25Aug2021): This follow-up processed as non-significant. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1692091
Sex: M
Age:
State: RI

Vax Date: 08/21/2021
Onset Date: 08/23/2021
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data: Test Date: 20210823; Test Name: CAT scan; Result Unstructured Data: Test Result:inflamed pancreas; Comments: inflamed pancreas

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Abdominal pain resulting in hospital visit. CAT scan showed inflamed pancreas; Abdominal pain resulting in hospital visit. CAT scan showed inflamed pancreas; This is a spontaneous report from a contactable consumer (reported for himself). A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 21Aug2021 at 11:00 (at the age of 43-years-old) as dose number unknown, single for COVID-19 immunisation at Workplace clinic. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included omeprazole (OMEPRAZOLE), high blood pressure med and advanced, taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received benadryl and experienced drug hypersensitivity, wellbutrin and experienced drug hypersensitivity. On 23Aug2021 at 07:00, the patient experienced abdominal pain resulting in hospital visit. cat scan showed inflamed pancreas. The event assessed as serious (hospitalization). The reporter stated the events result in Emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included computerised tomogram: inflamed pancreas on 23Aug2021 (inflamed pancreas). Therapeutic measures were taken as a result of events included treatment with CAT scan, morphine, pancreatic diet. The outcome of the events was resolving. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1692092
Sex: M
Age:
State: FL

Vax Date: 08/21/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
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: Blood test; Result Unstructured Data: Test Result:didn't have COVID; Test Name: IVGG; Test Result: Negative ; Comments: And up until 3 weeks ago he was negative for IVGG; Test Name: Platelets; Result Unstructured Data: Test Result:168; Comments: His level was 168, which was before the COVID vaccine and which is a low normal; Test Name: Platelets; Result Unstructured Data: Test Result:163; Comments: the other lab said it was 163.; Test Name: Platelets; Result Unstructured Data: Test Result:140 to 143; Comments: checked his platelets after he had COVID and everything was fine, it was 140 to 143 which is not that bad but it did drop a little.; Test Date: 20210824; Test Name: Platelets; Result Unstructured Data: Test Result:123; Comments: his platelets dropped 40 points to 123 thousand; Test Name: blood test and a PCR; Test Result: Negative

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: His platelets dropped 40 points to 123 thousand; This is a spontaneous report from contactable nurse. This nurse (patient's mother) reported for her 22-year-old son (patient). A 22-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 21Aug2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient age at vaccination was 22-year-old. Medical history included when he was little, like 11-years-old, he had issues with an allergic reaction, it was hives, and his platelets dropped but he had never had any problems with that. He had played contact sports, like hockey, and was fine. He had the disease, COVID, 10 months ago (Oct2020) and it was just like a bad cold, the worst part for him was that he lost his taste and his smell for 3 weeks. She obviously checked his platelets after he had COVID and everything was fine, it was 140 to 143 which was not that bad but it did drop a little. The patient's concomitant medications were not reported. Due to patient had history of COVID-19, reporter's husband who was a physician monitored patient's antibodies because obviously the antibodies were better than the vaccine. And up until 3 weeks ago he was negative for IVGG. They made the choice to get the Pfizer COVID vaccine. The hematologist said to check her son's platelets before and after he had the COVID vaccine, like 48 hours to 72 hours afterwards because it may drop between that time period. They tested with two different labs. Patient's level was 168, which was before the COVID vaccine and which was a low normal and the other lab said it was 163. Reporter was fine with that since it was normal. So patient got the COVID vaccine. Also, before her son was tested for COVID with a blood test and a PCR to make sure that he didn't have COVID. They did his blood work yesterday (24Aug2021) and his platelets dropped 40 points to 123 thousand. 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: 1692093
Sex: M
Age:
State: IL

Vax Date: 03/01/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
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: 2021; Test Name: Fever of 102; Result Unstructured Data: Test Result:102; Test Date: 20210824; Test Name: Covid; Test Result: Positive

Allergies:

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

Symptoms: This is a spontaneous report from a contactable nurse (patient's wife) from a Pfizer Sponsored Program Regulatory Authority. A 66-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, and second dose via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. A 61-year-old registered nurse and her 66-year-old husband (patient) said they received both doses of the Pfizer-BioNTech Covid-19 Vaccine in March 2021. Yesterday, 5 months after their 2nd dose, they both tested positive for Covid. Patient was "pretty darn ill" and has a fever of 102. The outcome of event was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided the lack of efficacy of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed if there is any new information available.

Other Meds:

Current Illness:

ID: 1692094
Sex: F
Age:
State: GA

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210822; Test Name: Blood pressure; Result Unstructured Data: Test Result:High; Test Date: 202108; Test Name: Antigen test; Result Unstructured Data: Test Result:Have Covid 19 antibodies; Test Date: 201912; Test Name: COVID test; Result Unstructured Data: Test Result:Covid with double pneumonia

Allergies:

Symptom List: Rash, Urticaria

Symptoms: it was evenly coming down her head down to her chin, then next her neck swelled up like a box even with her jaw./ eyebrow puffed up as well; it was evenly coming down her head down to her chin, then next her neck swelled up like a box even with her jaw.; the whole right eye lid had fallen over her eye, puffed up and her eyebrow puffed up as well/ swelling of her left eyelid; the whole right eye lid had fallen over her eye; Her right eyelid was hanging over her right eye.; forehead became inflamed; Swelling of her left eyelid which was drooping also over her left eye,; blood pressure shot up real high; Dysentery; in bed with all the Covid symptoms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FL3181), via an unspecified route of administration, administered in Arm Left on 12Aug2021 11:00 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing Congestive heart failure, fibromyalgia from 2015 and ongoing (Doctor has her going through some testing feels like she has degenerative disc disease lumbar, and some other things wants to determine exactly what problems are as she is very sensitive to touch shoulders, arms, hips, things like that. Small range of motion turning her head. Used to be multitasker), Covid with double pneumonia from Dec2019 to an unknown date (Hospitalization in Dec2019 for this event), blood pressure abnormal from an unknown date and unknown if ongoing, cardiac death in Aug2020 (Her younger brother passed away suddenly last august from heart attack), Wall in her heart is thick (cardiac valve thickening) from Nov2020 to an unknown date, fatigued from an unknown date and unknown if ongoing, Does not have energy (asthenia) from an unknown date and unknown if ongoing, Degenerative disc disease lumbar from an unknown date and unknown if ongoing, allodynia (very sensitive to touch shoulders, arms, hips) from an unknown date and unknown if ongoing, Small range of motion turning her head from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril 2.5mg tablet once daily taken for blood pressure abnormal from Nov2020 to 22Aug2021; carvedilol 20 mg 2x/day taken for blood pressure abnormal from Nov2020 and ongoing. The patient reported that she expected some soreness in arm but for the next 3 days after the 12Aug2021 she was in bed with all the Covid symptoms again, only this time she also had dysentery. On 22Aug2021 she experienced effects: felt like she had an eyelash at first in the corner of eye. Within minutes after that she pulled the sun visor down to look in the mirror while her husband was driving; and the whole right eye lid had fallen over her eye, puffed up and her eyebrow puffed up as well. Her right eyelid was hanging over her right eye. Then her forehead became inflamed and squishy to the touch-she could not feel bone, but it felt squishy like a sponge. Then within minutes she had onset of swelling of her left eyelid, which was drooping also over her left eye, but not as bad as the right eye. Then suddenly she felt it traveling down her temples on both sides into the jaw, like TMJ area; it was evenly coming down her head down to her chin, then next her neck swelled up like a box even with her jaw. Her husband immediately pulled over into withheld; she was kept under observation and for treatment in the Emergency Room, but not admitted to the hospital. While in the Emergency Room they started her on IV fluids; they were suspicious that it might have been caused by her blood pressure medication: Lisinopril; but she told them she had been on Lisinopril since Nov2020 and never had a problem with that. Her blood pressure shot up real high as if she did not even take her Lisinopril that morning. She was on IVs for 6 hours trying to get her blood pressure reduced. Then they gave her a prescription for an Epipen and told her she could not drive home-that she had to go to a hotel and rest. She has talked to a pharmacist locally and she and the pharmacist are doubtful it was the Lisinopril, they don't believe it was the Lisinopril, they believe the events were caused by the Covid 19 Pfizer Shot. She did talk to her Cardiologist who changed her Lisinopril to an unknown new product she thinks starts with Al but doesn't have product with her to provide further information on it. The patient underwent lab tests and procedures which included blood pressure measurement: high on 22Aug2021, sars-cov-2 test: have covid 19 antibodies in Aug2021, sars-cov-2 test: covid with double pneumonia in Dec2019. Outcome of events dysentery and suspected covid-19 was unknown and for rest of the events it was recovering (the swelling has gone down; she still has a little bit of a dropping over the right eye but basically her face looks back to normal compared to what it was; it looked like an elephant and was frightening). No follow-up attempts are needed. No further information is expected.

Other Meds: LISINOPRIL; CARVEDILOL

Current Illness: Congestive heart failure (Verbatim: Congestive heart failure); Fibromyalgia (Verbatim: Fibromyalgia)

ID: 1692095
Sex: F
Age:
State: CO

Vax Date: 08/18/2021
Onset Date: 08/19/2021
Rec V Date: 09/11/2021
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: Shortness of breath; abdominal pain; fatigue; slight headache; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: FC3180; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 18Aug2021 16:00 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history and concomitant medications included none. The patient previously took SULFONAMIDE and experienced known allergies (reported as known allergies: Sulfer). No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced shortness of breath, abdominal pain, fatigue, slight headache on 19Aug2021 15:00. Therapeutic measures were taken as a result of the reported events. The events were reported as not serious and seriousness criteria included none. AE resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment with IV, oxygen, dicyclomine, ketorolac, ondansetron. Clinical outcome of events was recovering at the time of this report.

Other Meds:

Current Illness:

ID: 1692096
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: right arm he has two fingers that have been numb for 3 weeks; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration, administered in Left arm on an unspecified date as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Investigation Assessment was not provided. The Reporter was calling about the Pfizer covid vaccine. The patient had the vaccine on his left arm but his right arm, he has two fingers that have been numb for 3 weeks on an unspecified date. The second dose was supposed to be this Friday. The reporter asked, what should he do? Should he get the second dose? His doctor said to call Pfizer? The outcome of 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: 1692097
Sex: F
Age:
State: SC

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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: Passed out; bad memory; Pneumonia; almost died; fall and hit the floor 3 times; This is spontaneous report from contactable consumer (patient) reported for herself. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 20Apr2021 as dose 1, single for COVID-19 immunization (Age at vaccination 61 years). The patient medical history was not reported. Concomitant medication(s) included varenicline tartrate (CHANTIX) taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19 since the vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. It was reported that the agent gave the patient information on how to get Chantix through the Patient assistance program. During the call the patient states she would really like to use Chantix. She is on nebulizer and oxygen and has been smoking for 40 something years. She also has a bad memory. The caller confirms the details provided by the transferring agent but states she has never consumed the product Chantix. She has 2 or 3 friends that have tried Chantix and it worked for them. She didn't know she could get help with Chantix until one of her son's told her. Her son is 27 years old and it a paraplegic. One of her son's aids told her she could get help getting Chantix. The caller states her bad memory started after she got the first dose of the Covid 19 vaccine. It put her in the hospital for 12 days the day after she got the Covid 19 vaccine on an unspecified date. When probing for the caller's healthcare provider's information the caller states her doctor told her that her hospitalization didn't have anything to do with the Covid 19 vaccine. She received her first Covid 19 vaccine on 20Apr2021. When probing for NDC/Lot/Expiry she states her daughter threw the card away. She doesn't even know if the Covid 19 vaccine was a Pfizer product. She had the dose at withheld. She reports she was in the hospital with pneumonia, but she's been smoking for 40 something years and she's had pneumonia at least 15 to 20 times in her life. She has never had to go to the hospital before with pneumonia. She has never passed out before and she didn't remember her family for 9 days after getting the Covid 19 vaccine. She woke up on the 9th day in the hospital and remembered who her family was. She states on 21Apr2021 her son's friend happened to be at her home and he had to pick her up off the floor 3 times and she doesn't remember any of it. Her son heard her fall and hit the floor 3 times. She doesn't remember anything until the 9th day. She was withheld for 12 days. She states that her sister asked to get in her wallet to look for the white card while she was in the hospital and the card says Covid 19 on it. The caller didn't tell anyone she was getting the Covid 19 vaccine. When probing for testing done at the hospital the caller states she doesn't remember. Her son was so upset because he thought the caller was going to stay that way. She almost died, that's what she was told, that she almost died when she was in the hospital on an unspecified date. The caller asks when Chantix will be available. She admits she lied in the beginning of the call and she has tried Chantix before. She states a friend gave her a week's worth of Chantix about 10 years ago. The amount of Chantix wasn't enough to get her past the nonsmoking stage. She does not have any product information like the NDC/Lot/Expiry because it was 10 years ago. She states the Chantix is a good product and she's seen it work on her friends. She can't even smoke in her friend's cars anymore. She needs to stop smoking or it's going to kill her. Outcome of all events was Unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: CHANTIX

Current Illness:

ID: 1692098
Sex: M
Age:
State: TN

Vax Date: 08/04/2021
Onset Date: 08/18/2021
Rec V Date: 09/11/2021
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: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown; Comments: Blood work

Allergies:

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

Symptoms: Seizure; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in left arm on 04Aug2021 at 17:19 (at the age of 38-year-old) as a single for COVID-19 immunisation. Medical history included sleep apnoea syndrome from an unknown date and unknown if ongoing: Sleep apnea, seizure from an unknown date and unknown if ongoing: Hay fever, seasonal allergy from an unknown date and unknown if ongoing: Seasonal allergy, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. No investigation assessment was reported. No relevant family medical history to adverse event was reported. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for seasonal allergy, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; fish oil taken for an unspecified indication, start and stop date were not reported; zinc taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for obsessive compulsive disorder (OCD), start and stop date were not reported (taking for probably about 2 years); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR) taken for attention deficit hyperactivity disorder, start and stop date were not reported, Multivitamin taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191), first dose via an unspecified route of administration, administered in left arm on 22Jun2021 (at the age of 38-year-old) as a single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. No relevant tests were performed. Report was not related to a study or programme. No adverse event following prior vaccinations. On 18Aug2021 at 02:00, the patient experienced seizure. Adverse events required a not visit to emergency room and visit to physician office, he did go to the neurologist office and saw the Nurse Practitioner, He is who ordered the lab tests and the EKG. When he goes back, he was not very impressed with him. When he goes back, he wants to see the neurologist in that practice. It was reported that caller states he was calling regarding the Pfizer Covid-19 vaccination. He got the second vaccine earlier this month, he thinks 04Aug2021. He got both of the vaccines at a local, both of the Pfizer vaccines. The reason he was calling is that 2 weeks after he got the vaccine, pretty much to the day of getting the vaccine, he had a seizure. He has had seizures before but, he has not had one in 3 years. It was going on pretty good and did not have any problems with seizures until then. It was right, 2 weeks after the second dose he had the seizure. Right now, he was trying to get in with the neurologist. He saw his nurse practitioner the other day and he was trying to see the actual neurologist. It was kind of hard to get in with the neurologist. They usually have 6 months to a year waiting period. Caller provided the name of the neurologist but stated that he was unsure of the spelling. He was still trying to talk to him. The other day, he talked to the nurse practitioner and he was not trying to mean but he does not think he knew a lot about certain things. He was talking to him about some seizure laws and the caller looked at it and stated that some of it was just wrong. He thinks he was trying to get in with the actual doctor. He knows it was really hard to get in really fast. It was early in the morning Wednesday, last week, 18Aug2021. It was like Tuesday night into Wednesday morning, clarifies it was at like at 02:00 in the morning Wednesday. It was pretty bad. His wife has a video of it. His wife took a video of it. That was the thing that got him. He had taken his medicine and was wearing his continuous positive airway pressure (CPAP) machine. He had never had one when he had done everything. He usually never had one. His wife had been there for all of them and said that he has not had one in 3 years. And before that, it was a couple of years before that. This one was the worst of all, his wife thought, that he ever had. he never had one before when he was actually wearing his CPAP mask. He was waking medicine the way he was supposed to. He cannot remember having one when he was doing everything he was supposed to be doing. His wife said it lasted longer. She said his seizure lasted a little over 10 minutes. It was usually between 5 and 7 minutes. She was worried that it went a little past 10 minutes. She called 911 and they sent an Emergency medical technician (EMT) out. He does not even remember half of the stuff that happened. When he woke up, he remembered the EMT above him. He was very incoherent. His wife said he ended up on her side of the bed. She said that he got up and was wobbling around to her side of the bed. He does not remember any of that. He did not go to the hospital. When the EMT came, they asked some questions and waited until he got lucid. They had asked him who the president was, and he said (PRIVACY). They told him to think a little harder. It took him a little while, then eventually he came back around. They stayed until he kind of got lucid again. He had asked them where his wallet was, and he had no idea where it was. Simple things, he could not remember. Eventually, he came back, and they were like ok. He was then in the right state of mind. After that happened, they said they could take him to the hospital emergency room, but the emergency room was backed up with COVID and if they were to take him to the hospital, he would get exposed to COVID. The Emergency Room (ER) was full so, he said he would wait until he had an appointment with the neurologist. They did not think he was in any danger at that point. He does take generic of Keppra, 2,000 milligram (mg) extended release. He takes it at night before bed. He had been taking it for probably 2 and a half years. They switched him to that about 2 and a half years ago from regular Keppra. They said the extended release might help his sleeping habits. They said Keppra can make you maybe drowsy, so they said taking it at night would be better. So, they switched it to extended release. Provided the name of the generic medicine, Levetiracetam ER. They only make it in 500 mg tablets, so he has to take four 500 mg tablets to equal 2000 mg total. It was an anti-convulsion medicine. He does have sleep apnea. They suspected he stopped breathing at night because of sleep apnea, which may cause him to have seizures. He was wearing his CPAP when it happened. They even pulled it up when he did go to sleep. The Nurse Practitioner pulled it up, his CPAP. It has smart chip in it and monitors while he is asleep. They pulled it up and he did not really have any stoppage of breathing or any major incidences that might have caused him to have a seizure or would have stopped breathing. He knows it sounds silly now, but he has a medical history with seizures in the past. He thought that he did not want to get sick or get COVID or have something like that. He thought that if he were to get COVID, and could not breathe, he might have seizures. That was the whole reason for getting it was to avoid getting seizures. Then, he turns around and got the seizure. All of this he was thinking of trying to do all this to help with COVID. He thought, especially around the shot, he would build up his immunity too. Has hay fever and seasonal allergies but nothing too bad. He knows one of the worst things about having seizures was that he cannot drive for 6 months. He was a little bit bummed out because he thought he was doing something good w

Other Meds: ALLEGRA; D3; FISH OIL; ZINC; LEXAPRO; ADDERALL XR

Current Illness:

ID: 1692099
Sex: F
Age:
State: AZ

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:The results were all normal.; Comments: Brain activity was normal; Test Name: MRI; Result Unstructured Data: Test Result:The results were all normal.; Comments: Brain activity was normal; Test Name: MRI; Result Unstructured Data: Test Result:The results were all normal.; Comments: Brain activity was normal

Allergies:

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

Symptoms: Itchy; became extremely hot; could not get comfortable; Headache more like a migraine; Headache more like a migraine; could not sleep all night; Felt like she could not breathe; Had really bad fatigue; Really blurry vision; Increased symptoms of vertigo and had balance issues; Increased symptoms of vertigo and had balance issues; Sweaty and then chilly; Sweaty and then chilly; soreness in shoulder area and neck area; soreness in shoulder area and neck area; felt like a heavy brick was on top of her head; Sjogren's; This is a spontaneous report. A contactable consumer (patient mother) reported for a 49-year-old female patient (reporters daughter). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Apr2021 at 12:00 (at the age of 49-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Reason for no lot number: of Pfizer COVID vaccine: Complainant does not have the product with them at the time of call. Medical history included, obesity (Patient was trying to work on it and is not doing so well. Obesity started after high school) from an unknown date and unknown if ongoing. Vertigo (Patient did confirm that she had vertigo prior to getting the vaccine) from an unknown date and unknown if ongoing. Thyroid disorder (Patient did take medication for thyroid) from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported) as dose 1, single on an unspecified date for COVID-19 immunization. Other products, patient history and investigation assessment: no. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available). Previous doses was unknown. Additional vaccines administered on same date of the pfizer suspect: none. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. Adverse events following prior vaccinations: None. Patient never had any kind of reactions. Family medical history relevant to adverse events: none. Relevant tests: none or unknown. Vaccination facility type clinic. Caller wanted to speak with someone in medical research. We may be entrusted to know how the vaccine has affected patient (her daughter). Patient had both doses of the Pfizer COVID vaccine. Did not say what the side effects were. On 28Apr2021, the patient experienced, within 15 minutes after receiving 2nd vaccine, event the nurse kept patient for a longer time because patient was having a reaction. Patient became itchy, extremely hot, could not get comfortable at 12:00, and had a headache. That night, patient could not sleep all night when patient went to bed. Patient felt like could not breathe unknown time. Patient had really bad fatigue felt that way all the rest of the afternoon. Unknown time of start also, started really blurry vision. Patient could not even see with prescription glasses on. Patient felt like a very heavy brick was laying on top of head unknown time it started. It felt like patient had a migraine. Patient was very sweaty and then chilly unknown time. Also, doctor noticed it increased symptoms of the vertigo also had balance issues started that evening. Patient had vertigo and something that starts with an S. Patient later remembered it was called Sjogren's. Patient had soreness in shoulder area and neck area and this was already there and was part of Sjogren's. Patient had to report out of work the next day because of all of these Symptoms. Headaches were more like a migraine and improved at times at 12:00, but comes back periodically. Patient was treated for the vertigo and balance issues and did not know the outcome. She did confirm that patient had Vertigo prior to getting the vaccine. Patient does take medication for thyroid and for Sjogren's and Vertigo. Did not know the names, doses, or any other information about them. Ophthalmologist recommended she see a neurologist because of blurry vision. He said he did not think baby cataracts were an issue but recommended patient see Neurologist. They were there before the vaccine. Went to Neurologist and he did 3 special MRI's and did not know what they were. The results were all normal. Brain activity was normal. He did prescribe a medication for the vertigo, but patient did not have any information on the medication name, dose, lot or expiration. She felt it might be useful and wanted Pfizer to be aware, because obviously this and COVID was so new and we did not know a lot about it yet. List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebro-spinal fluid culture, pleural fluid culture, urine culture, diagnostic imaging, (e.g., chest X-ray, MRI). The patient underwent lab tests and procedures which included magnetic resonance imaging: the results were all normal (Brain activity was normal). Magnetic resonance imaging: the results were all normal. (Brain activity was normal). Magnetic resonance imaging: the results were all normal (Brain activity was normal). Caller just wanted to let us know her neurologist and ENT doctor both agree second vaccine very well may have a negative reaction to some of her other medical issues. If the patient was hospitalized, how many days was the hospital stay reported as none. Adverse events require a visit to not to emergency room, but visited to physician office. Neurologist was giving medication to help sleep and it was helping. Going off of symptoms until got results from 3 specific MRI's that did. He did give medication because he did not have anything to go on other than symptoms. She did say it kind of helps patient sleep. She did not know the name of the medication and had no lot or expiration. He just renewed the prescription around 18Aug2021. The outcome of the event vision blurred was not recovered and pruritus, feeling hot, vertigo and balance disorder were unknown while other events were recovering. The lot number was not provided. Information on lot number has been requested during follow up.

Other Meds:

Current Illness:

ID: 1692100
Sex: M
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: ill; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date, after taking both doses of the Pfizer COVID 19 vaccine, patient became ill; went to the doctor and was in the hospital. Patient was seeking compensation. 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: 1692101
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: COVID 19 test; Test Result: Positive ; Comments: She states that she and a few of her coworkers all tested positive after they had already had the first dose of the Pfizer COVID 19 vaccination; Test Name: COVID 19 test; Test Result: Negative ; Comments: She and one other coworker have both tested negative now

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: positive COVID 19 test after first dose of vaccination; positive COVID 19 test after first dose of vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced positive covid 19 test after first dose of vaccination. It was reported that, patient stated that patient and a few of her coworkers all tested positive after they already had the first dose of the Pfizer COVID 19 vaccination. Patient and one other coworker have both tested negative now. Patient would like to know if she needs to start the series over again or if she can receive her second dose of the vaccine today. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (She states that she and a few of her coworkers all tested positive after they had already had the first dose of the Pfizer COVID 19 vaccination) on unspecified date and sars-cov-2 test: negative (She and one other coworker have both tested negative now) on unspecified date. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692102
Sex: F
Age:
State: IL

Vax Date: 06/10/2021
Onset Date: 07/31/2021
Rec V Date: 09/11/2021
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: She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding; vaginal bleeding was out of control/causing excessive bleeding; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer (Patient) reported. A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in arm right on 10Jun2021 09:00 (at the age of 43-year-old) as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After the vaccination, the patient did not have a menstrual cycle the rest of the month or most of July. Then on Sat. 31Jul2021 7:00 AM patient started bleeding bright red blood vaginally and Sunday 01Aug2021 she was rushed to the Emergency Room because the vaginal bleeding was out of control. she went to her Doctor on 04Aug2021 and was tested for everything. Nothing came back abnormal. She stated it was most likely due to the COVID shot messing up my menstrual cycle and causing excessive bleeding. The patient was not diagnosed with covid prior vaccination and patient didn't test for covid post vaccination. No allergies reported. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1692103
Sex: F
Age:
State: MI

Vax Date: 07/16/2020
Onset Date: 05/01/2021
Rec V Date: 09/11/2021
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: sick; Miss 3-4; missed a dose/missed 3-4 doses of Gocovri; pneumonia; general malaise; super fatigued; sleeping a lot; Didn't gain back her general energy; Might have been her allergies; Nausea; she was congested; rib pain; fear of throwing up; she had lost 40 pounds; This is a solicited report based on the information received by Pfizer from another Manufacturer. A contactable consumer (patient) reported that a 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) (at the age of 74-year-old) as DOSE 2, SINGLE for covid-19 immunisation; and amantadine hydrochloride (GOCOVRI, capsule), oral from 16Jul2020 (Batch/Lot number was not reported) and ongoing at 137 mg, once daily at night for dyskinesia. Medical history included ongoing dyskinesia, parkinson's disease, diarrhoea, respiratory disorder (other respiratory disorders), mixed incontinence, non-hodgkin's lymphoma from an unknown date to 1995 (Got rid of it by 1995), daydreaming, multiple allergies, chemotherapy, Penicillin allergy, Sulfonamide derivatives/antibiotics allergy, disease of the upper respiratory tract, allergies, and absent mindedness. Concomitant medications included cyanocobalamin (B12); carbidopa, levodopa; carbidopa; tolterodine l-tartrate (DETROL); bismuth subsalicylate (PEPTO-BISMOL); probiotics; paracetamol (TYLENOL); oxycodone; rotigotine (NEUPRO) from 2021 to Jul2021; and CBD-KINGS WITH LIDOCAINE (LIDOCAINE; MENTHOL; METHYL SALICYLATE; CAMPHOR; CAPSICUM). The patient previously took macrolides and ketolide, both as drug therapy and experienced drug hypersensitivity. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunization. On unspecified date in 2021, the patient experienced pneumonia, general malaise, super fatigued, sleeping a lot, didn't gain back her general energy, might have been her allergies, nausea, she was congested, rib pain, fear of throwing up, and she had lost 40 pounds. On 20Jul2021, the patient experienced sick; and miss 3-4; missed a dose in May2021. It was further reported that on an unspecified (presumably in 2021), after starting Gocovri, the patient missed 3-4 doses of Gocovri due to being sick. On an unspecified date in Jul2021, being sick was resolved. As of 30Jul2021, treatment with Gocovri was ongoing. On 06Aug2021, it was learned that additional medical history included allergies, absent mindedness, and non-Hodgkin's lymphoma for which she went through chemotherapy and completely got rid of it by 1995. Carbidopa/levodopa ER was removed from concomitant products as the patient had never taken it. Additional concomitant products included oxycodone and Neupro (rogitogine; tried "recently" and stopped 1.5 weeks ago, relative to 06Aug2021). The starting date and dose of Gocovri were confirmed. On an unspecified date, the patient received a first dose of COVID vaccine (Pfizer) at an unreported dose, route and frequency, for an unreported indication. On an unspecified date in Apr2021, the patient received her second dose of COVID vaccine (Pfizer). Subsequently, presumably in Apr2021, the patient missed a dose of Gocovri because she experienced general malaise and was super fatigued and sleeping a lot after her second COVID vaccine. On an unspecified date in 2021, the general malaise, fatigue and sleeping a lot improved, but she did not gain back her general energy she used to have. On an unspecified date in May2021, the patient missed a dose of Gocovri due to absent mindedness/forgetting. On or around 20Jul2021, the patient became sick. She thought she was coming down with pneumonia. She experienced nausea, she was congested and had rib pain and fatigue, and just wanted to sleep. She thought it might have been her allergies as that was her normal reaction to allergies. She missed a few doses of Gocovri for fear of throwing up. On an unspecified date in Jul2021 or Aug2021, she went to the doctor and it was determined that she did not have pneumonia. No specific diagnosis was given, but she was prescribed an unspecified antibiotic. When they weighed the patient at the doctor's office, she found out she had lost 40 pounds. She didn't know when the weight loss began, but she had always been around 150 pounds and she was 111 pounds at the doctor's office. The patient felt the weight loss was unusual for her because she has a good appetite. She was placed on a high protein diet and added carbohydrates. On an unspecified date, the patient also saw a neurologist and they talked but no treatment or diagnosis was provided. On an unspecified date, after taking the antibiotic, the symptoms of nausea, congestion, rib pain, fatigue, and wanting to sleep, which may have been her allergies, resolved. As of 06Aug2021, treatment with Gocovri was ongoing. They were still working on figuring out what was causing the weight loss, but the patient had gained "a couple of pounds" and was up to around 112 pounds. The action taken in response to the events for amantadine hydrochloride was dose not changed. Therapeutic measures were taken as a result of super fatigued, sleeping a lot, nausea, she was congested, and rib pain. On unspecified date in 2021, the patient recovered from general malaise, super fatigued, sleeping a lot, nausea, she was congested, and rib pain; recovered from sick on unspecified date in Jul2021; was recovering from she had lost 40 pounds; had not yet recovered from didn't gain back her general energy while outcome of the other events was unknown. 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: B12; CARBIDOPA/LEVODOPA; CARBIDOPA; DETROL; PEPTO-BISMOL; PROBIOTICS; TYLENOL; OXYCODONE; NEUPRO

Current Illness: Dyskinesia

ID: 1692104
Sex: F
Age:
State:

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 09/11/2021
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: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Comments: Caller states her family member has had multiple cat scans, x-rays, blood work; Test Date: 2021; Test Name: Cat scans; Result Unstructured Data: Test Result:Unknown results; Comments: Caller states her family member has had multiple cat scans, x-rays, blood work; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Comments: Caller states she is now having a repeat MRI; Test Date: 2021; Test Name: X-rays; Result Unstructured Data: Test Result:Unknown results; Comments: Caller states her family member has had multiple cat scans, x-rays, blood work

Allergies:

Symptom List: Unevaluable event

Symptoms: stabbing pain in her hip; feeling foggy/fight or flight feeling; Blood pressure went up; Had tingling in her head; Palpitations; Leg weakness; Head pressure; Internal vibrations; She couldn't drink a cup of coffee and never experienced this before; she can't stand for long periods, has nerve sensitivity feet to waist; Sharp pain at top of head stabbing pain; Numb spots and tingling in her head; This is a spontaneous report from a contactable consumer or other non health care professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 20Feb2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and experienced brain fog. Reporter states she is following up on a phone call a family made regarding adverse reactions to the vaccine. Reporter states the family member is still experiencing the symptoms is there anything Pfizer can do. Reporter states her family member received 2 doses of the Pfizer vaccine; her second dose was 20Feb2021 and after the first dose she had some brain fog but was tentatively ok. Reporter states that after the second dose she had the same thing; feeling foggy like an out of body experience and then felt fine. Reporter states that a couple of weeks went by and her family member developed stabbing pain in her hip and she went to ER, but it only lasted one day. Reporter states that day after day after that her blood pressure went up, had tingling in her head, palpitations, leg weakness, head pressure, internal vibrations, and a fight or flight feeling and she couldn't drink a cup of coffee and never experienced this before. Reporter states we thought it was anxiety, but then as the weeks and months go by all of her symptoms are repeated in thousands of other people. Reporter states she has seen groups of people saying how they feel and everything she says has been written by other people. Reporter states her family member has had multiple cat scans, x-rays, blood work, and thought she might have MS. Reporter states she is now having a repeat MRI because they think she has inflammation of her spinal cord. Reporter states this is all from 20Feb and now she cant stand for long periods, has nerve sensitivity feet to waist, sharp pain at top of head stabbing pain, numb spots and tingling in her head. Reporter states it is torture and nobody is acknowledging it so there is no treatment. Reporter states she has called other places trying to help her and there is nowhere to go. Reporter states she believes her sister did already report her symptoms. Reporter also states her family members side effects are being ignored and we are continuing to give out the vaccine. The patient underwent lab tests and procedures which included blood work (blood test): unknown results (Caller states her family member has had multiple cat scans, x-rays, blood work) on an unspecified date of 2021, Cat scans (computerised tomogram): unknown results on an unspecified date of 2021, MRI (magnetic resonance imaging): unknown results (Caller states she is now having a repeat MRI) on an unspecified date of 2021, x-ray: unknown results on an unspecified date of 2021. The outcome of the event stabbing pain in her hip was recovered on an unspecified date of 2021 and outcome was unknown for other events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1692105
Sex: F
Age:
State: AZ

Vax Date: 03/29/2021
Onset Date: 03/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had a rash; Hives; Iching from Mid waiste to top of head; High Blood pressure; Ponding Heart; Rasing Heart; Vision was effected; Anxious felt like I was in a cloud; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; My tonge lips and throat started to tingle and swell; This is a spontaneous report from a contactable other healthcare professional (Patient). A 53-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), first dose via an unspecified route of administration, administered in left arm on 29Mar2021 at 10:45 (at the age of 53-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/(privacy) administration facility. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing, menopause from an unknown date and unknown if ongoing, food allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took propofol and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient also administered with Other Vaccine (lot number=EW0161) on 29Mar2021 in Left arm as dose 2 single. On an unspecified date in Mar2021 at 10:45, had a rash, Hives, Itching from Mid waist to top of head. High blood pressure, Ponding Heart, Raising Heart. Vision was affected, Anxious felt like I was in a cloud. Her tongue lips and throat started to tingle and swell. Told many providers trying to figure out what was going on. Adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability, or permanent damage.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug bnt162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1692106
Sex: M
Age:
State: TN

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Within 12 hours after the first dose: Upon retiring to bed, I experienced the sudden onset of very unpleasant ice cold feet and knees, which could not be remedied with blankets. This lasted all night; Within 12 hours after the first dose: Upon retiring to bed, I experienced the sudden onset of very unpleasant ice cold feet and knees, which could not be remedied with blankets. This lasted all night; Within 12 hours after the first dose: Upon retiring to bed, I experienced the sudden onset of very unpleasant ice cold feet and knees, which could not be remedied with blankets. This lasted all night; This is a spontaneous report from a contactable physician. A 69-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:45 (at the age of 69 years old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder) from an unknown date and unknown if ongoing , autism spectrum disorder from an unknown date and unknown if ongoing , food allergy from an unknown date and unknown if ongoing Known allergies: Cashews. Concomitant medication(s) included Ritalin (Methylphenidate Hydrochloride) taken for an unspecified indication, start and stop date were not reported; Elavil (Allopurinol) taken for an unspecified indication, start and stop date were not reported; Aspirin (E.C.) ( Acetylsalicylic Acid) taken for an unspecified indication, start and stop date were not reported. It was reported that If other vaccine in four weeks was No. If COVID prior vaccination was No. If COVID tested post vaccination was No. The patient experienced within 12 hours after the first dose: upon retiring to bed, i experienced the sudden onset of very unpleasant ice cold feet and knees, which could not be remedied with blankets. this lasted all night on 22Apr2021 23:45 and reoccurred only at bedtime for days.The same pattern appearred again about 6 weeks later, along with pulse and blood pressure irregularities. Ae resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage, Congenital anomaly or birth defect. About 2 months after the last vaccine dose, a first-occurrence thyroglossal duct cyst (a 'birth defect' which appears in early life, almost never in the elderly) arose on the left side between the hyoid bone and the thyroid cartilage.Therapeutic measure were as no as a result of all event. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between the events Peripheral coldness, Heart rate irregular , Blood pressure abnormal and suspect drug BNT162B2 cannot be excluded" The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: RITALIN; ELAVIL [ALLOPURINOL]; ASPIRIN (E.C.)

Current Illness:

ID: 1692107
Sex: F
Age:
State: TN

Vax Date: 08/21/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: Body Temperature; Result Unstructured Data: Test Result:97.5 Fahrenheit; Comments: she is usually 97.5 , running 99.5; Test Date: 202108; Test Name: Body Temperature; Result Unstructured Data: Test Result:99.5 Fahrenheit; Comments: she is usually 97.5 , running 99.5; Test Date: 20210826; Test Name: covid-19 virus test; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Bad cough; Chest still hurts; Heart beating fast and kind of hurt; Only got a couple hours of sleep; Heart beating fast and kind of hurt; Stuffy; Low temp; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 30-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart beating fast and kind of hurt leading to angina pectoris, stuffy leading to nasal congestion, low temp leading to body temperature decreased, bad cough, chest still hurts leading to chest pain, heart beating fast and kind of hurt leading to heart rate increased and she only got a couple hours of sleep leading to insomnia on Aug2021. The patient underwent lab tests and procedures which included body temperature at 97.5 Fahrenheit, she is usually 97.5 but running 99.5 , sars-cov-2 test: negative on 26Aug2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692108
Sex: M
Age:
State: NJ

Vax Date: 04/05/2021
Onset Date: 08/07/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HV 2 flare up ( previously undiagnosed) in August; This is a spontaneous report from a contactable consumer or other non hcp (male patient). A 60-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Arm Left on 05Apr2021 11:00 as 2nddose, single for COVID-19 immunisation (Age at vaccination was 60 years). Historical vaccine was a 60-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021 as 1st dose, single for COVID-19 immunisation. Medical history included (High blood pressure) hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included amlodipine besilate (AMLODIPINE BESILATE) taken for an unspecified indication, start and stop date were not reported; prazosin (PRAZOSIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced hv 2 flare up (previously undiagnosed) in august on 07Aug2021.Patient must visit the physician office. Outcome of the event was recovered with sequelae. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds: AMLODIPINE BESILATE; PRAZOSIN; LOSARTAN; PRAVASTATIN.

Current Illness:

ID: 1692110
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: Bell's palsy for 3-5 weeks; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: Unknown), dose 1 via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Post-vaccination, patient experienced Bell's palsy for 3-5 weeks. The clinical outcome of the event was unknown. Information about batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 1692111
Sex: F
Age:
State: NH

Vax Date: 08/09/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210817; Test Name: eye exam; Result Unstructured Data: Test Result:two tares and a Detached Retina left eye

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Detached Retina left eye; experiencing dark floaters; This is a spontaneous serious report from a contactable consumer (patient herself). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jul2021 (Batch/Lot Number: EW0180) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration, administered in Arm Left on 09Aug2021, at noon (Batch/Lot Number: GN0191) as DOSE 2, SINGLE, (age at vaccination was 51 years old) for covid-19 immunisation. Medical history included broken thumb from 07Aug2021 to an unknown date. The patient's concomitant medications included allergy shot, current frequency every 3 weeks for allergy (last dose was on 29Jul2021, has received on and off for the last decade). Patient reported receiving second dose of Pfizer covid vaccine 09Aug2021 and a couple of days after (unspecified date in Aug2021) she started experiencing dark floaters. She developed a detached retina of the left eye with 2 tears. She had an eye exam on 17Aug2021 and was referred to a specialist. She had surgery that same day due to having the detached retina with 2 tears. The events required a visit to Physician Office. She had no AE(s) following prior vaccination (first dose). Patient stated she has not had any trauma to her eye at all prior to this. She would like to report this experience. Unable to provide outcome of event for dark floaters. She is still is unable to see out of her left eye. Patient adds that she read where others have reported this and ocular issues. Details are unknown to her. One was a science article. She forgot where she read the other one. They were different articles but with the same issues. She is unsure if this has been reported. The patient underwent lab tests and procedures which included eye exam (ophthalmological examination): two tears and a detached retina left eye on 17Aug2021. Treatment for the events was eyesurgery performed on 17Aug2021. The outcome of detached retina left eye was recovered/resolved with Sequel on 17Aug2021 and outcome for experiencing dark floaters in eye was unknown.

Other Meds:

Current Illness:

ID: 1692112
Sex: M
Age:
State: TN

Vax Date: 05/13/2021
Onset Date:
Rec V Date: 09/11/2021
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: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:irregular; Comments: same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities; Test Date: 2021; Test Name: Pulse rate; Result Unstructured Data: Test Result:irregular; Comments: same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities

Allergies:

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

Symptoms: 2 months after the last vaccine a FIRSTOCCURRENCE THYROGLOSSAL DUCT CYST; Within 12 hours after the first dose: Upon retiring to bed, I experienced the sudden onset of very unpleasant ice cold feet and knees, which could not be remedied with blankets. This lasted all night; same pattern appearred again about 6 weeks later, along with pulse and blood pressure irregularities; same pattern appearred again about 6 weeks later, along with pulse and blood pressure irregularities; This is a spontaneous report from a contactable physician reported about himself (patient). A 69-year-old male patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: 59267-1000-01), via an unspecified route of administration, administered in left arm as dose 2, single on 13May2021 12:45 (at the age of 69-year-old) for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), autism spectrum disorder, asperger's syndrome and known allergies: Cashews. Concomitant medications included methylphenidate hydrochloride (RITALINE), allopurinol (ELAVIL [ALLOPURINOL]) and acetylsalicylic acid (ASPIRIN) all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included patient previously took first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration, administered in left arm as dose 1, single on 22Apr2021 12:45 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications ritalin, elavil, aspirin and multivitamin. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Lab tests and procedures which included blood pressure measurement: same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities and heart rate: same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities both on unspecified date in 2021. On unspecified date in 2021, the patient experienced sudden onset of very unpleasant ice-cold feet and knees, which could not be remedied with blankets and lasted all night and reoccurred only at bedtime for days, same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities and thyroglossal duct cyst. Within 12 hours after the first dose: Upon retiring to bed, patient experienced the sudden onset of very unpleasant ice-cold feet and knees, which could not be remedied with blankets and lasted all night and reoccurred only at bedtime for days. The same pattern appeared again about 6 weeks later, along with pulse and blood pressure irregularities. About 2 months after the last vaccine dose, a first occurrence thyroglossal duct cyst (a 'birth defect' which appears in early life, almost never in the elderly) arose on the left side between the hyoid bone and the thyroid cartilage. Adverse events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage and Congenital anomaly or birth defect. No treatment was received for adverse events. At the time of this report, outcome of the events was not recovered, except thyroglossal duct cyst was unknown .; Sender's Comments: Based on current information available, the event cold feet, pulse irregular, blood pressure abnormal were considered related and thyroglossal duct cyst represented intercurrent condition in this patient with advanced age and with congenital anamoly. unrelated to Bnt162b2. More information is needed to better assess the case. 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: RITALINE; ELAVIL [ALLOPURINOL]; ASPIRIN

Current Illness:

ID: 1692113
Sex: M
Age:
State:

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: Heart Rate; Result Unstructured Data: Test Result:170 for 2 hrs

Allergies:

Symptom List: Nausea

Symptoms: Heart Rate 170 for 2 hrs; vaccine is administered outside the range19 - 42 days after the first dose; Insomnia; Fever; Sweets; Chills; Headache; This is a spontaneous report from a non-contactable consumer (Patient). A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 22Apr2021 10:15 (at the age of 31-year-old) as single dose for covid-19 immunisation. The patient medical history was reported as none. Concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. The historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 25Feb2021 10:15 as single dose for covid-19 immunisation. On 22Apr2021 23:00, the patient experienced heart rate 170 for 2 hrs, vaccine is administered outside the range19 - 42 days after the first dose, insomnia, fever, sweets, chills and headache. The patient underwent lab tests and procedures which included heart rate: 170 for 2 hrs. No treatment was received to treat this adverse event. The events insomnia, heart Rate 170 for 2 hrs, fever, sweets, chills, headache were recovered on an unspecified date in 2021 and outcome of vaccine is administered outside the range19 - 42 days after the first dose was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1692114
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 03/28/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210813; Test Name: COVID; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Injection site pain

Symptoms: tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-year-old (non-pregnant) female 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, administered in arm left, administration time was 11:00 am on an unspecified date at dose 1, single for covid-19 immunisation. Medical history included covid-19 (if covid prior vaccination: Yes) and Known allergies: penicillin, Ceftin. Concomitant medications were not reported. Patient did not receive other vaccine in four weeks and other medications in two weeks. On 28Mar2021 the patient experienced tingling in hands and feet, which progressively got worse, to burning all over body within one week. 4 months later, still burning. Diagnosed with small fiber neuropathy. Otherwise, healthy with no underlying conditions. Events led to doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included (Nasal Swab) sars-cov-2 test: negative on 13Aug2021 (If COVID tested post vaccination: Yes). Patient received treatment with Gabapentin, minocycline for the adverse events. Outcome of the events was not resolved. This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1692115
Sex: F
Age:
State: NC

Vax Date: 03/05/2021
Onset Date: 03/12/2021
Rec V Date: 09/11/2021
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: 20210506; Test Name: SARS-CoV2 Antibodies Nucleocapsid; Test Result: Negative ; Comments: Blood test

Allergies:

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

Symptoms: Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; One week after second Pfizer vaccine (@12Mar2021), I suffered sudden onset short-term memory loss.; Diagnosis: autoimmune encephalitis or post vaccine induced inflammation.; This is spontaneous report from a contactable other health care professional (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route at left arm on 05Mar2021 at 12:00 pm (lot number: EN6205) (age at vaccination 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported and concomitant medication were none. The patient had no known allergies. The patient received historical vaccine first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at left arm on 12Feb2021 at 12:00 pm (lot number: EN6201) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. After one week of second Pfizer vaccine, the patient suffered from sudden onset short-term memory loss, diagnosis: autoimmune encephalitis or post vaccine induced inflammation on 12Mar2021 at 04:00 pm. The events resulted for doctor or other healthcare professional office/clinic visit. The patient received prednisone as treatment for the events. The patient laboratory investigation included SARS-CoV2 Antibodies Nucleocapsid was negative on 06May2021. The outcome of the events was recovering. Follow-up attempts completed. No further information expected.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event autoimmune encephalitis cannot be completely excluded.The case will be reassessed if 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.

Other Meds:

Current Illness:

ID: 1692116
Sex: F
Age:
State:

Vax Date: 08/24/2021
Onset Date: 08/25/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 20210825; Test Name: Fever; Result Unstructured Data: Test Result:99.4

Allergies:

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

Symptoms: loss of appetite; Fever of 99.4,; body aches; headache with sharp stings in back of head; This is a spontaneous report from a non-contactable consumer. This 15-year-old female consumer reported that: A 15-year-old female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number ew0165) via an unspecified route of administration in right arm on 24Aug2021 03:30PM (at the age of 15-year-old) for COVID-19 immunisation. The patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, Lot number ew0179) via an unspecified route of administration in right arm on 03Aug2021 (at the age of 60-year-old) for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient did not have COVID prior vaccination and was not tested post vaccination. On 25Aug2021 the patient had fever of 99.4, body aches, headache with sharp stings in back of head and loss of appetite. The patient was treated with pain relief pills. Events resolved on an unspecified date. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692117
Sex: F
Age:
State: MA

Vax Date: 08/03/2021
Onset Date: 08/13/2021
Rec V Date: 09/11/2021
Hospital: Y

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: I have been post menapausel for 20 years and 8 days after receiving this I started to have spotting and light bleeding I have never had this in 20 years, I have had to go through many painful procedur; This is a spontaneous report from a contactable other hcp and nurse (patient). A 65-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, #lot: EW0187) via an unspecified route of administration, administered in left arm on 03Aug2021 16:45 (at the age of 65-years-old) as single dose for covid-19 immunization. The patient's medical history included HTN Seizures from an unknown date and unknown if ongoing. The patient previously took percocet and experienced vomiting. The patient's concomitant medications were not reported. On 13Aug2021 04:00, the patient has been post menapausel for 20 years and 8 days after receiving this she started to have spotting and light bleeding she never had this in 20 years, she have had to go through many painful procedure. The patient was hospitalized for 1 day and therapeutic measures were taken as a result of the adverse event. Treatment reported that uterine bx and scheduled d&c. The outcome of the event was recovered on unspecified date.; Sender's Comments: Based on temporal association and known safety profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the reported event cannot be completely excluded.The case will be reassessed if 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.

Other Meds:

Current Illness:

ID: 1692118
Sex: F
Age:
State: KS

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 09/11/2021
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 Name: Antibody test; Result Unstructured Data: Test Result:No antibodies; Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:143/78; Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:142/80; Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:131/78; Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:127/78; Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/70; Test Name: Pulse/Heart rate; Result Unstructured Data: Test Result:Normal; Comments: Fine; Test Name: sats/O2; Result Unstructured Data: Test Result:Normal %; Comments: Fine; Test Name: Vitals; Result Unstructured Data: Test Result:Unknown result

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: numbness/numbness in arms and legs, like ice in her veins; tingling/tingling in arm and legs and feet; a cold sensation in her arms and feet; blood pressure was high/Blood pressure increased; her throat became itchy; lightheaded/dizzy; hot flash with her head; felt crappy; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received BNT162B2, via an unspecified route of administration, administered in Arm Right on 24Aug2021 10:00 (Lot Number: EW0177; Expiration Date: 14Sep2021), at the age of 35-years-old, as dose 1, single for COVID-19 immunization. Medical history included ongoing High cholesterol and COVID-19 from Oct2020 to an unknown date. Concomitant medications included atorvastatin taken for High cholesterol from Mar2021 and ongoing. The patient previously had Flu shot (her last shot was in Sept or Oct2020) for immunization. The patient experienced numbness/numbness in arms and legs, like ice in her veins, tingling/tingling in arm and legs and feet, a cold sensation in her arms and feet, blood pressure was high/blood pressure increased, her throat became itchy and lightheaded/dizzy on 24Aug2021 10:10; and hot flash with her head and felt crappy on 24Aug2021. The events ('numbness/numbness in arms and legs, like ice in her veins', 'tingling/tingling in arm and legs and feet', 'a cold sensation in her arms and feet' and 'hot flash with her head') were assessed as serious- medically significant. The events ('blood pressure was high/blood pressure increased' and 'her throat became itchy') were assessed as serious- disability. The event ('lightheaded/dizzy') was assessed as serious- disability, medically significant. The event ('felt crappy') was assessed as serious- non-serious. The clinical course was reported as follows: She is a registered nurse, but is calling as the patient. She is 35 years old. She received first dose of Pfizer COVID19 vaccine on 24Aug2021. She had a reaction and spoke to her healthcare practitioner. She experienced numbness, tingling, numbness and tingling in arms and legs and feet, states it felt like there was ice in her veins, cold sensation in her arms and in her feet, her throat became itchy, and her blood pressure was high/went up after they measured it. All of this occurred 10 minutes after receiving the injection. She confirmed details provided by transfer agent and wanted to add that within 10 minutes she got lightheaded and dizzy as well. Blood Pressure was High: it was 143/78 and then another time it was 142/80. It started to go down and then it was 131/78 thirty minutes after the vaccine. She had got a hot flash with her head and that is why they took the last blood pressure reading. The hot flash was only in her head and her head got really hot. Throat was Itchy: she has been taking antihistamines and the itchy throat has gone away. This morning without medication her throat was itchy. It felt like it wanted to come back. She was able to drink water and it felt better. The antihistamines were generic Zyrtec 10mg (lot number: PY920025, expiry: Apr2022) and generic Claritin 10mg (lot number is LVE24488 or 1VE24488. Expiry: Jan2021). She clarified that the itchy throat did go away with the medications. This morning she had not taken either one and she felt it a little bit and then the sensation went away after a few hours. Tingling: she has never had that happen before. It was bizarre. The throat being itchy worried her the most. She would say it was disabling because she didn't know what would happen. She didn't know if it would get worse or better. She saw her nurse practitioner for an appointment at 11:15 that morning. The vaccine was given at 10AM. Blood pressure was high: she would say disabling because if it went over a certain amount it could have caused a stroke. Outcome of Events: It all has resolved. Later in the day she didn't feel quite right. She kind of assumed it was normal because she had COVID before. She thought it was a reaction. She had antibody test before the vaccine and it showed no antibodies. She clarified that she had COVID in Oct 2020. She clarified for the events numbness, tingling, cold sensation in her arms and in her feet, blood pressure was high, dizzy, and lightheaded the stop date would have been 25Aug2021. Tuesday she woke up better, but felt crappy. Investigations: they tested her blood pressure and vitals. Her blood pressure was 127/78. Her pulse was fine and her sats were fine. The nurse practitioner did a physical assessment and felt caller's throat and looked in her throat. It wasn't growing, so she said unfortunately there was nothing she could do to undo the vaccine. She wants to know if she should get the second dose, and if she should she report to VAERS. States her blood pressure went up to 142/80 which she says is high for her. States she was treated with Benadryl, states she did not take any antihistamines today and she feels fine. She states her blood pressure returned to normal, her symptoms all resolved that same day but the itchy throat lingered, states it is improving today. States she has never had a reaction to anything before. States that during the event her O2 was 100%, her heart rate was normal and her blood pressure came down to 120/70 after about 30 minutes. Caller states she has had Covid before so she anticipated an immune response but had an antibody test and did not show any antibodies which is why she went ahead and felt more comfortable getting the vaccine. The patient underwent lab tests and procedures which included antibody test: no antibodies on an unknown date; blood pressure: 143/78, 142/80, 131/78, 127/78 and 120/70 all on 24Aug2021; Pulse/Heart rate: normal (Fine) on an unknown date, sats/O2: normal (Fine) % on an unknown date; and Vitals: unknown result on an unknown date. Therapeutic measures were taken as a result of tingling/tingling in arm and legs and feet , a cold sensation in her arms and feet, blood pressure was high/blood pressure increased, her throat became itchy, lightheaded/dizzy and hot flash with her head. The outcome of the event 'felt crappy' was unknown; event 'her throat became itch' was recovering; events 'a cold sensation in her arms and feet' and 'hot flash with her head' was recovered in Aug2021 and outcome of the other events was recovered on 25Aug2021. Relatedness of drug to reactions/events: Reaction assessed: Numbness, Tingling, cold sensation in her arms and in her feet, throat became itchy, blood pressure was high, Dizzy and lightheaded; Source of assessment: Primary Source Reporter, Drug result: Related.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: ATORVASTATIN

Current Illness: High cholesterol

ID: 1692119
Sex: F
Age:
State: CA

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 09/11/2021
Hospital: Y

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: blood pressure; Result Unstructured Data: Test Result:very very low; Test Name: full blood worked on; Result Unstructured Data: Test Result:unknown result

Allergies:

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

Symptoms: She was diagnosed with the POPS syndrome, Postal tachycardia syndrome.; This is a spontaneous report from a contactable consumer (patient's husband). A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0172) via an unspecified route of administration, administered in Arm Left on 29Apr2021 at age of 27-year-old at single dose for COVID-19 immunisation. Medical history included birth control. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) taken for contraception. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: "EW0158.") on 08Apr2021 at age of 27-year-old at left arm for COVID-19 Immunisation. The reporter reported the adverse effect from the Pfizer vaccine do to with the patient so, she was usually vaccinated. She had a first dose on 08Apr2021 and second on 29Apr2021 so, after her second dose between 29 within 1-2 minutes of getting the vaccine on 29Apr2021, she lost her vision, had severe headache, dizziness and that subsided and about 30 minutes after that, it came back and didn't go away. Quite a few day they had to go to emergency room, she was admitted by the night. Some of them were shorten since then, she had been in emergency room four times, undergoing medical treatments with medical doctors, cardiologists, neurologist and medical doctors, then they saw to specialist and she diagnosed with POPS syndrome by the result of the Pfizer vaccine. The reporter stated the doctor believed for the vaccine so just wanted to report that. When probed treatment for adverse events: Reporter stated, nitially, When taken her in emergency room and admitted, she was given migraine cocktail through IV, she had severe migraine since she got her vaccine, that was cleared about 50%, then she was diagnosed with the POPS syndrome, postal tachycardia syndrome (as reported), that was medical person, diagnosed with professional at doctor office which result from the Pfizer vaccine, since then she was diagnosed with undergone treatments to health people, Involves. She was having IV therapy. She was taking puncture black supplement (not further clarify) magnesium Albertine, she was having soft pills for blood pressure which was very very low. She took some pain killer for headache, that has not gone away since that day. She took NAD, injections. She also a therapist to her Cardiovascular health and exercise. Reporter stated, "Well help her some medical dose." Lab test information included she had full blood worked on, She was actually like tested everything(not further clarified). The outcome of the event(s) was recovering. Follow-up (30Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds: NUVARING

Current Illness:

ID: 1692120
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The site where shot is the red and swollen and tender; The site where shot is the red and swollen and tender; The site where shot is the red and swollen and tender; had the COVID vaccine her third COVID shot; had the COVID vaccine her third COVID shot; This is a spontaneous report from a contactable consumer (reported for wife). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose 3, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) on an unspecified date as single dose for COVID-19 immunization. It was reported that, the wife of reporter "had the COVID vaccine her third COVID shot" (yesterday) and "the site where shot is the red and swollen and tender" on an unspecified date. It was reported that, the patient took the third shot, she took the booster. The reporter was asking if anything could be put on her arm to help with the swelling, and the redness and the tenderness. Reporter was informed about the role of Pfizer Drug Safety. Further probing could not be done as the reporter hung up the call abruptly. Hence limited information available over the call. The outcome of the events was unknown. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds:

Current Illness:

ID: 1692121
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: tingling feet; Experiencing sore arm; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported; Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced tingling feet and experiencing sore arm. The patient reported she has no doctor or no insurance as also their ER is full with unvaccinated people. Told (withheld) that a nurse or Pharmacist could also call Pfizer regarding this concern. She did not want to provide any further information. She just wanted to know if the events were normal and if they have any report on sore arm and tingling feet. She denied providing her birth date, address and email. Reporter seriousness for the events were unspecified. Outcome of the events were unknown. Follow-up (26Aug2021): This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable female consumer (patient) reported for herself included clinical information. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].

Other Meds:

Current Illness:

ID: 1692122
Sex: M
Age:
State: OH

Vax Date: 08/25/2021
Onset Date: 08/26/2021
Rec V Date: 09/11/2021
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: The day after the shot I went to a cardio exercise class and fainted after 1/2 hr.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 73-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 25Aug2021 (at the age of 73-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not take other vaccine in four weeks and did not took other medications in two weeks. The patient not had covid prior vaccination and not tested for covid post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on an unknown date (at the age of 73-year-old) (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. On 26Aug2021 10:00AM, the day after the shot the patient went to a cardio exercise class and fainted after 1/2 hr. The patient not received any treatment for the event. The clinical outcome of the event was recovered on 26Aug2021. No follow-up attempts are possible; information about lot/batch numbe cannot be obtained.

Other Meds:

Current Illness:

ID: 1692123
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital: Y

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: Pneumonia; Dementia; This is a spontaneous report from a non-contactable consumer reporting for patient (Reporter's aunt). An elderly female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included dementia and Coagulation disorder from an unknown date. Concomitant medications included warfarin sodium (COUMADIN SODIUM) taken as blood thinner, start and stop date were not reported; warfarin sodium (WARFARIN SODIUM) taken as blood thinner, start and stop date were not reported. The reporter stated that her elderly aunt was not told about the blood thinners. She stated that her aunt was on coumadin and warfarin and had dementia. The reporter stated her aunt got both of the Pfizer covid 19 vaccines and developed pneumonia in the hospital and complete dementia after on an unspecified date. The reporter asked, is bleeding disorder/been on blood thinners a contraindication. The reporter stated that there have been 1000s and 1000s of cases among all ages noting especially blood clots. She stated she wants to know it is passed and effective and be OK for everybody to take and nothing happens. She specified what she meant by nothing happens to mean nothing happens to people with blood disorder. The reporter stated she would love to provide the information to report her aunts experience but she does not trust anything going on and did not want to provide demographics for AE. She had questions about the Pfizer covid 19 vaccine. She asked if the vaccine is completely FDA approved, still under clinical trials or EUA. She wanted to know if the vaccine is through the clinical trials and can be given safely. She wanted to know if the vaccine is completely passed and 100 percent FDA approved. She stated the person she spoke to before said the clinical trials would end in 2023. She stated the person she spoke with earlier provided her the information about persons with medical conditions. She stated that one of the things on the list was having a bleeding disorder or on a blood thinner. The case was reported as non-serious. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: COUMADIN SODIUM; WARFARIN SODIUM

Current Illness:

ID: 1692124
Sex: F
Age:
State: WY

Vax Date: 12/18/2020
Onset Date: 01/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:150/100; Comments: her normal was 130's/80-90; Test Date: 20210622; Test Name: EKG; Result Unstructured Data: Test Result:abnormal with inverted T wave; Test Date: 20210823; Test Name: EKG; Result Unstructured Data: Test Result:Improved; Test Date: 20210622; Test Name: troponin level; Result Unstructured Data: Test Result:7.5 or something; Test Date: 20210823; Test Name: troponin level; Result Unstructured Data: Test Result:troponin is normal

Allergies:

Symptom List: Pain in extremity

Symptoms: heart attack; Didn't feel good; Dizzy; Disoriented feeling; Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection) in the morning via an unspecified route of administration, administered in arm left on 18Dec2020 (Batch/Lot Number: EK5730) (at the age of 66-years-old) as SINGLE for covid-19 immunization. Vaccine was not administered at (privacy) facility and It was provided that none of the other vaccine was administered on the same day as of Pfizer vaccine. Patient medical history included blood pressure and she did reacted to the pneumonia vaccine but she doesn't know the name of the product or any NDC, Lot or Expiry. She was suppose to get 2 doses but never got the second dose due to the reaction from an unknown date and unknown if ongoing. Patient concomitant medication(s) included carvedilol taken for blood pressure from 2006 to an unspecified stop date and her blood pressure was controlled. The patient did not receive any other vaccines within 4 weeks. Patient was asking whether the 2 doses protect against the delta variant. Responded variant was first detected in Mar2021. It was initially identified in Dec2020. So far, studies suggest that the current authorized vaccines work on the circulating variants. Scientists will continue to study these and other variants. Please call your vaccination provider or your healthcare provider if you have any questions about this topic or the safety or efficacy of Pfizer-BioNTech COVID-19 Vaccine. Furthermore, patient was asking what is the new name and what is that about. Responded COMIRNATY (COVID-19 Vaccine, mRNA) was an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech. It was approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It was also authorized under EUA to be administered to: prevent COVID-19 in individuals 12 through 15 years, and provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromised. On Jan2021, the patient experienced myocarditis, pericarditis. Patient was struggling all through the spring with heart pounding, BP going high, dizziness, just dizzy funny disoriented feeling which was started in first week of Jan. It would take a long time to slow down too. Her primary care changed blood pressure medication several times during the spring while she was following up related to the symptoms for which the patient had to visit Emergency Room and Physician Office. On an unspecified date, the patient also had chest pain and didn't feel good. Patient was hiking and she couldn't did it felt dizzy, not feeling safe, heart started pounding, it wouldn't slow down. She started with these symptoms till it progressed to this heart attack. Her symptoms started and she began writing down her blood pressures, she started doing that on 04Jan. She hiked and experienced dizziness and disoriented feeling. Responded as noted in the fact sheet for recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive another dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. The patient underwent lab tests and procedures which included blood pressure with high readings of 150/100 where her normal was 130's/80-90. She tracked this through the spring and started going to primary care to get checked. She visited her primary care related to this on 19Jan2021, 03Feb2021, 17Mar2021, 31Mar2021, and 01Jun2021. On 22Jun2021, had EKG which resulted in abnormal with inverted t wave and was improved on 23Aug2021. On 22Jun2021, her troponin was found to be 7.5 or something which was found to be normal on 23Aug2021. The patient did not received any treatment for the events. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds: CARVEDILOL

Current Illness:

ID: 1692125
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
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: a friends sister was so freaked out, got the vaccine, and stroked out; This is a spontaneous report from a non-contactable consumer (friend). A female patient of an unspecified age 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 NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. A friends sister was so freaked out, got the vaccine, and stroked out (medically significant) on an unspecified date with outcome of 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: 1692126
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: got sick; This is a spontaneous report from a contactable Consumer or other non-health care professional (Parent) reported for her daughter. A 43-years-old female bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; batch no/Lot number: not reported) via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and also received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; batch no/Lot number: not reported) via unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that patient had both doses and got severely hurt by Pfizer vaccine after first dose, and also stated fortunately she doesn't have long term effects. Caller stated she will not get the third shot definitely. She had the first one and had an adverse reaction that was when she really got sick, and she was warned but didn't pay attention to parent. She did not think it was severe enough to not get the second dose. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1692127
Sex: M
Age:
State: OH

Vax Date: 01/27/2021
Onset Date: 02/01/2021
Rec V Date: 09/11/2021
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: Developed a very red, very itchy rash on my chest/I got the 2nd dose and the rash was still on my body, arms, legs; Developed a very red, very itchy rash on my chest; Developed a very red, very itchy rash on my chest; It has all sorts of discoloration and flakiness; It has all sorts of discoloration and flakiness; Skin is mottled; This is a spontaneous report from a contactable pharmacist (patient). An 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), first dose on 27Jan2021 (Lot Number: EL3249) and second dose on 17Feb2021 (Lot Number: EL9264), both via an unspecified route of administration, administered in Arm Left at the age of 81-year-old as single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications included other medications (unspecified), medication (unspecified) for blood pressure. He took other medications and never had a rash with them. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any prior Vaccinations (within 4 weeks). The patient had no AE(s) following prior vaccinations. The patient previously took cefalexin (KEFLEX) and also Sulfa drugs and had a rash. It had been several years ago. Family medical history relevant to AE(s) was not provided. Caller states he received his 1st Pfizer Covid vaccine on 22Jan2020 (as reported) and his 2nd vaccine in February. Caller states 5 days after his 1st shot he developed a very red, very itchy rash on his chest. The patient went to urgent care, not the ED and got a Medrol Injection and a 7-day pack of prednisone. The rash continued and he got the 2nd dose and the rash was still on his body, arms, legs, he went to urgent care and got a Decadron injection and another 7 days of prednisone. The rash was better but still reoccured daily somewhere on his body arms, legs. His skin was mottled and it looked like he was beat up. The patient enquired if he should get the Moderna booster shot instead of Pfizer, since he still had this rash. Spoke to caller from the attached documents. He had the Pfizer COVID Vaccine, two doses. The first one was on 27Jan2021 and the second was on 17Feb2021. After he had the first dose, a week later, he had a reaction. He is sure it was due to the vaccine. He got a rash on his chest similar to a rash when he took an antibiotic in Feb2021. It was an itchy, red rash. He talked to the local people giving the vaccine and they recommended he still get the second dose even though the rash was going on. He went to a medical facility. He had been there before. They gave him an injection of Medrol and seven days of Medroxy Prednisolone tablets. That helped a lot, but then he got the second shot. He continued to have itchy rashes all over his body. He went back to the medical facility and they gave him a dose of Decadron steroid and another seven day package of Prednisolone. He called a dermatologist that he saw a couple of years ago. He couldn't get caller in and caller had a feeling he didn't want to deal with it. Caller got an appointment with another dermatologist and went to the office. He was seen by a PA. She took a paper out of the file cabinet and told him to not use dryer sheets and change detergents. He saw the PA with the dermatology practice in May2021. The appointment was around 10May2021. Caller clarified that it was not Medroxy Prednisolone it was Methylprednisolone that he took. He took Methylprednisolone both times for seven days. He kept the package. It was a 4mg tablet. Lot number: 20P0432. Expiry: May2022. Date filled was 05May2021, so the visit to the dermatologist was on the 10May2021. Caller clarified the product information for the Methylprednisolone was for the second seven day course that he took. Caller clarified that he does not have NDC, lot, and expiry to provide for the first seven day course of Methylprednisolone that he took. It was the one that starts with six tablets the first day at breakfast, lunch, and supper. Then he decreased it by one each day. So the second day it was five, then four, then three, and then one. It was a total of 21 tablets. Rash was not so bad today (26Aug2021), it was ongoing. It was different parts. Sometimes both legs would be itchy and then his back would be itchy. A lot of times it was in the legs. Here he was in September and periodically he still gets an itchy rash on different parts of his body. His skin looks like he had been in a battle. It had all sorts of discoloration and flakiness. He was concerned about taking the booster the shot. Caller confirmed he is looking for information about the booster shot with having rash after the first and second dose of Pfizer COVID Vaccine. The AE(s) did not require a visit to Emergency Room. The patient had Physician Office visit, he was seen at Urgent Care because they have open convenient hours and at the Dermatologist. They didn't do any test or bloodwork at the Urgent Care. Reporter assessed the event Rash as Medically significant. He takes other medications and never had a rash with them. The reporter assessed the reaction Rash as related to the vaccine. Outcome of the events was not recovered.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events rash, rash erythematous, rash pruritic and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1692128
Sex: F
Age:
State: SC

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 09/11/2021
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: Blurry vision; light headed; received a dose of the Pfizer COVID Vaccine on 14/Aug/2021 but actually received a dose of the Moderna vaccine on 23/Jul/2021; received a dose of the Pfizer COVID Vaccine on 14/Aug/2021 but actually received a dose of the Moderna vaccine on 23/Jul/2021; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0177; Expiration Date: Aug2021), dose 2 via an unspecified route of administration, administered in Arm Left on 14Aug2021 (at the age of 54 years) as dose 2 (initial Pfizer dose), single for covid-19 immunisationMedical history included High Blood Pressure from an unknown date and unknown if ongoing, allergy to seafood from an unknown date and unknown if ongoing. The patient concomitant medications were reported as she takes high blood pressure medication. Reportedly, patient received historical vaccine covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number was not reported, 027C21A, does not know if this is the lot number or not, it also says Clinic site LCHCS), via an unspecified route of administration in arm left on 23Jun2021 (at the age of 54 years), at dose 1, single for covid-19 immunisation and had soreness in left arm. On 15Aug2021, patient experienced blurry vision and light headed. The patient received a dose of the Pfizer covid vaccine on 14Aug2021 but actually received a dose of the Moderna vaccine on 23Jun2021. She mentioned that the nurse from her doctor's office specifically told her and it would not hurt. She was then called on a latter date and mentioned that it was not actually okay. She is asking if this is true. She mentioned that she received her vaccination from MUSC Health. Patient called about the Pfizer Covid 19 Vaccine. She was supposed to get vaccinated with the Moderna covid Vaccine for her second dose, but instead on 14Aug2021 when she came to the doctors she received the Pfizer covid 19 vaccine. She had already told the nurse that she had Moderna Covid Vaccine on 23Jun2021 as her first dose, but the nurse just dismissed her, that it was going to be okay. She was then later informed that it should not be like that. Nurse told her it would not matter if she got he Pfizer covid vaccine as her second dose. Patient stated that all of this is scary to her. Patient clarified that she got the first dose Moderna Covid Vaccine at her Primary Care doctors office, but the second dose Pfizer COVID Vaccine she received was like a pop up site, set up just to give out the vaccines at the (withheld) Community Center. It was a registered Nurse at the pop up site that told her getting the Pfizer Vaccine would be okay. It was later that her primary Care office that contacted her telling her that it should not be that way. Patient had took the Moderna first dose, she already had one dose of the Moderna and she give her the dose of the Pfizer, it should not have been mixed like that. Patient needed light and she could not see the doctor contact information. The patient reported that she has blurry vision for a couple hours. That's why she called the doctor they told her it would go away. She further clarified that the blurry vision was after receiving the Pfizer covid vaccine and it started the day after on 15Aug2021. She got the Pfizer vaccine she waited 15 minutes and she was fine then but it started to bother her Sunday evening, she was thinking to herself why was she light headed, maybe because of the shot. The Next day she had blurry vision on 15Aug2021 it was ongoing and getting worse and she does not know what was going on. Patient reported she takes high blood pressure medication, but it could not even be that or could it be her blood pressure. With the Moderna Vaccine she had no issues just that her arm was sore. Only thing she had was soreness in my left arm and she took Tylenol (Treatment). She took Tylenol for the soreness in her arm from the shot. Patient asked was her life in jeopardy for doing this, they told her sorry that the nurse told her that. She should have probably listened to her husband and that she was right in questioning it, but the lady had qualifications, she was a registered Nurse and told there would be no complications between the 2. Patient reported her blood sugar was not total out of control (further not clarified hence, not captured). Patient take one tablet in the morning for that. The most of the medicine she was on was high blood pressure (further not clarified). Patient asked her would it be effective if she had took the Moderna first dose and she wanted to have the Pfizer, would that be effective, would that be okay for me to take the Pfizer. The report was not related to a study or programme. Reporter seriousness was unspecified. Blurry vision was reported as worsened. The outcome of the event blurry vision was not recovered and light headed was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1692129
Sex: F
Age:
State: MN

Vax Date: 06/19/2021
Onset Date: 06/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data: Test Date: 202106; Test Name: Holter Monitor; Result Unstructured Data: Test Result:15% of the time was with PVCs %; Comments: Holter monitor which showed 15% of the time was with PVCs; Test Date: 20210801; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210807; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210728; Test Name: Saliva test-PCR; Test Result: Negative ; Comments: Other

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: feel prolonged and intense palpitations; prescribed a 48 hour Holter monitor which showed 15% of the time was with PVCs; This is a spontaneous report received from a contactable consumer (Patient). A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0181) via an unspecified route of administration in left arm on 19Jun2021 at 14:00 (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. Medical history included bee sting allergy and palpitations (I have had minimal palpitations for years) . The patient previously took sulfa [sulfanilamide] and experienced drug hypersensitivity. The patient was not pregnant at the time vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included daily multi vitamin. Patient did not have COVID prior to vaccination and it was yes covid tested post vaccination. It was reported that a few days after the first vaccine, I started to feel prolonged and intense palpitations. I have had minimal palpitations for years, but never the duration or intensity of these. About 2.5 weeks after dose 1, they hit the max intensity. My doctor prescribed a 48-hour Holter monitor which showed 15% of the time was with PVCs. The patient underwent lab tests and procedures which included Holter monitor (which showed 15% of the time was with PVCs) on Jun2021,sars-cov-2 test: negative on 01Aug2021 Nasal Swab, sars-cov-2 test: negative on 07Aug2021 Nasal Swab, sars-cov-2 test: negative on 28Jul2021 other (Saliva test). Patient did not receive any treatment for the events. Patient visits emergency room and physician office for the events. Outcome of all events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1692130
Sex: F
Age:
State:

Vax Date: 01/28/2021
Onset Date: 08/25/2021
Rec V Date: 09/11/2021
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: Test Date: 20210825; Test Name: Nasal Swab/covid test; Test Result: Positive

Allergies:

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

Symptoms: covid test result=Positive; Covid test date=25Aug2021,covid test result=Positive; body aches.; fever, HA/fever last night; Coughing; Feels like " hit by truck"; Felt like she was super tired; Went into work because she thought she just didn't get enough sleep; This is a spontaneous report from a non-contactable nurse. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), dose 1 via an Intramuscular route of administration, on 28Jan2021 (age at vaccination: 61), in left arm as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced covid test result as positive, body aches, fever, HA/fever last night, Coughing, feels like " hit by truck", felt like she was super tired, went into work because she thought she just didn't get enough sleep. Covid prior vaccination reported as unknown and post vaccination reported as yes. On 25Aug2021 the patient underwent lab test and procedure included SARS-CoV-2 test: positive. Treatment received reported as unknown. The patient had a physician office visit. The outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event COVID_19, Drug ineffective and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

ID: 1692131
Sex: M
Age:
State: FL

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/11/2021
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: the left side of my face felt numb like after i've been to a dentist but not severe enough I couldnt drink or had droopy features; the left side of my face felt numb like after i've been to a dentist but not severe enough I couldnt drink or had droopy features; minutes after shot my left foot fell asleep (Tingley); my left arm and hand fell asleep; This is a spontaneous report from a contactable other HCP (Patient). A 45-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 01Aug2021 11:00 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE (at the age of 45-year-old) for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included doxycycline (received within 2 weeks of vaccination) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated after minutes after shot his left foot fell asleep (Tingley), about 1 hour later my left arm and hand fell asleep. Also stated the left side of his face felt numb like after I've been to a dentist but not severe enough I couldn't drink or had droopy features on 01Aug2021 at 11:30. These symptoms lasted 3 days. Since the vaccination, the patient not tested for COVID-19. No treatment received for the events. The outcome of the events reported as recovered with sequelae on 04Aug2021. No follow-up attempts needed. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported event Facial paralysis cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: DOXYCYCLINE

Current Illness:

ID: 1692132
Sex: F
Age:
State: GA

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: severe pain in the center of my chest; severe heart burn borderline of blocking my air way; severe heart burn borderline of blocking my air way; I have g.e.r.d.s so I know what a flair up feels like. This was 1000 times worse than anything I've ever experienced; continuous belching; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old Non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3182 and Expiry date was not reported), via an un-specified route of administration on 21Aug2021 16:00 (at the age of 57-years-old) in Arm left as dose 2, single for covid-19 immunization. The Patient Medical history included ongoing gas-trooesophageal reflux disease G.E.R.D.S , hypertension from an unknown date and unknown if ongoing , osteoporosis from an unknown date and unknown if ongoing , drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Sulfa and directives , hypersen-sitivity from an unknown date and unknown if ongoing known allergies: Sulfa and directives. Concomitant medication(s) included tramadol (TRAMADOL); methocarbamol (ROBAXIN); omeprazole (OMEPRAZOLE); colecalciferol (VITAMIN D [COLECALCIFEROL]) all taken for an un-specified indication, start and stop date were not reported. The patient previously took codeine and experienced drug hypersensitivity, compazine [prochlorperazine maleate] and experienced drug hypersensitivity. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Batch/Lot Number: FA7485 and Expiry date was not re-ported), via an unspecified route of administration on 31Jul2021 16:00 (at the age of 57-years-old) in Arm left as dose 1, single for COVID-19 immunization. The Patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to COVID vaccine. The Patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination the patient had not tested for COVID-19. On 21Aug2021 16:00, the patient experi-enced severe pain in the center of her chest and severe heart burn borderline of blocking her air way, she have g.e.r.d.s so she know what a flair up feels like. This was 1000 times worse than any-thing she ever experienced. It was over an hour of continuous belching and chest pain before even the slightest relief was felt. The pain finally eased up, but came back full force that evening, and into the next day. Then it completely went away. Very scary. The pain was indescribable. The Patient did not received treatment for the adverse events. The outcome for the event severe pain in the center of her chest was recovered in August 2021 and for the events severe heart burn borderline of blocking her air way, she have g.e.r.d.s so she know what a flair up feels like. This was 1000 times worse than anything she ever experienced and over an hour of continuous belch-ing was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: TRAMADOL; ROBAXIN; OMEPRAZOLE; VITAMIN D [COLECALCIFEROL]

Current Illness: GERD (G.E.R.D.S)

ID: 1692134
Sex: F
Age:
State: MN

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 09/11/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Joint stiffness and pain; Joint stiffness and pain; reactive inflammatory arthritis from the vaccine; This is a spontaneous report from a contactable consumer. An 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown) via an unspecified route of administration on 12Feb2021 (at the age of 80-year-old) as single dose for COVID-19 immunization. Patient's medical history including any illness at time of vaccination was none. Family medical history relevant to AE was unknown. There were no concomitant medications. The patient had no prior vaccinations (within 4 weeks) and had no AE(s) following prior vaccinations. No additional vaccines administered on same date of the Pfizer suspect. In Feb2021, the patient experienced joint stiffness and pain and reactive inflammatory arthritis from the vaccine. Joint stiffness and pain started a little after her first vaccine and it got a lot worse after her second dose. Caller stated the patients first dose was in February and it started shortly after that and then it got worse after her second dose. The patient had no relevant tests. Outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am