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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1661178
Sex: M
Age:
State: TX

Vax Date: 03/04/2021
Onset Date: 08/11/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:30.2; Test Date: 20210811; Test Name: COVID-19 PCR test; Test Result: Positive.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: This is a spontaneous report from a contactable consumer. A 74-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6202, expiry date was unknown), via an unspecified route of administration on 04Mar2021 as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN5318, expiry date was unknown), via an unspecified route of administration, at an unknown administration site on 29Jan2021 as dose 1, single for covid-19 immunization, at physician's office. Medical history included liver transplant on an unknown date. It was unknown if the patient had concomitant medications or not. It was stated that, on 11Aug2021, the patient was tested positive for Covid virus, after being fully vaccinated. Covid positive was defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. The patient underwent lab tests and procedures which included COVID-19 PCR test on 11Aug2021, with positive results. There was an investigation assessment, and a product complaint was initiated. The outcome of the event was unknown at the time of report. Linked Report(s): US-PFIZER INC-202101076340 same reporter, drug, AE, different patients. US-PFIZER INC-202101076360 Same reporter, drug, AE, different patients. US-PFIZER INC-202101076361 Same reporter, drug, AE, different patients, US-PFIZER INC-202101076347 same reporter, drug, event, different patient. US-PFIZER INC-202101076349 Same reporter/ drug/ event for different patients; US-PFIZER INC-202101076357 same reporter/ drug /event, different patients; US-PFIZER INC-202101076351 Same reporter/ drug/ event for different patients; US-PFIZER INC-202101076372 Same reporter/ drug/ AE, different patients; US-PFIZER INC-202101076374 Same reporter/ drug/ AE, different patients; US-PFIZER INC-202101076371 Same reporter/ drug/ AE, different patients; US-PFIZER INC-202101076346 same reporter/ drug/ event, different patient. US-PFIZER INC-202101076369 Same reporter/ drug/ AE, different patients; US-PFIZER INC-202101076341 Same reporter/ drug/ event for different patients; US-PFIZER INC-202101076367 Same reporter/ drug/ AE, different patients; US-PFIZER INC-202101076364 Same reporter/ drug/ AE, different patients; US-PFIZER INC-202101076368 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076354 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076352 Same reporter/ drug/ AE, different patient; US-PFIZER INC-202101076359 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076366 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076348 Same reporter/ drug/ AE, different patient; US-PFIZER INC-202101076370 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076362 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076373 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076345 same reporter/drug/AE, different patients; US-PFIZER INC-202101076363 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076365 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076344 same reporter, AE and drug, different patient; US-PFIZER INC-202101076375 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076353 same reporter/drug/AE, different patient; US-PFIZER INC-202101076342 Same reporter/drug/AE, different patients; US-PFIZER INC-202101076355 Same reporter/ drug/ event for different patients; US-PFIZER INC-202101076350 Same reporter/ drug/ event, different patient; US-PFIZER INC-202101076343 same reporter/ drug/ AE, different patient; US-PFIZER INC-202101076356 Same reporter/ drug/ event for different patients.

Other Meds:

Current Illness:

ID: 1661179
Sex: M
Age:
State:

Vax Date:
Onset Date: 08/05/2021
Rec V Date: 09/01/2021
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: The patient was getting COVID despite of having had the Covid vaccine.; The patient was getting COVID despite of having had the Covid vaccine.; This is a non-interventional study report from a marketing program name not available received from a non-contactable consumer. A 64-year-old male patient (Age at vaccination 64 years) received BNT162B2 (BNT162B2), intramuscular, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history includes psoriasis. Concomitant medication included risankizumab (SKYRIZI [RISANKIZUMAB]) taken for psoriasis from an unspecified start date and ongoing. It was reported that the patient was getting covid despite of having had the covid vaccine on 05Aug2021. The events were reported as serious-medically significant. Outcome of the events was unknown. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events( Drug ineffective, Covid19) and the administration of the vaccine cannot be excluded.

Other Meds: SKYRIZI [RISANKIZUMAB]

Current Illness:

ID: 1661180
Sex: F
Age:
State: TX

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/01/2021
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: I swear of ulcerative colitis at my booster third shot; booster third shot has been administered; booster third shot has been administered; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: en0171) via an unspecified route of administration on 18Aug2021 (age at vaccination 44-years-old) as dose 3, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unspecified date as dose 1, single and dose 2 single for covid-19 immunization. On 19Aug2021, the patient stated that she swear of ulcerative colitis at her booster third shot. On 18Aug2021, the patient administered booster third shot. The outcome of the event of ulcerative colitis was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1661181
Sex: F
Age:
State: AL

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: I started my period; It has been very heavy, bright red and with clots; It has been very heavy, bright red and with clots; First dose 21Jul2021 and Second dose on 21Jul2021; hot flashes; This is a spontaneous report from a contactable consumer (reported herself). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), on 21Jul2021 17:00 (age at vaccination was 51-year-old, lot number: FA7484) as dose 1, single and on 21Jul2021 (lot number: FD8448) as dose 2, both via an unspecified route of administration, administered in arm right for covid-19 immunisation in pharmacy or drug store. Medical history included frequent hot flashes, after approximately 6 months with no menstrual cycle. The patient received concomitant medications which were unspecified, received within in two weeks of vaccination. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. It was reported that after approximately 6 months with no menstrual cycle and frequent hot flashes. The patient started her period on 05Aug2021. It has been very heavy, bright red and with clots. She was still bleeding as of today 19Aug2021. The patient had hot flashes on an unknown date in 2021. She was not having any cramping and her hot flashes have been gone since 02Aug2021. No treatment medication was received for the adverse events. The outcome of the event of Hot flashes was recovered on 02Aug2021 and all other events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661182
Sex: F
Age:
State: AR

Vax Date: 04/02/2021
Onset Date: 08/03/2021
Rec V Date: 09/01/2021
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: 20210803; Test Name: delta variant; Test Result: Positive; Test Date: 20210802; Test Name: quick test; Test Result: Negative; Test Date: 20210803; Test Name: quick test; Test Result: Positive.

Allergies:

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

Symptoms: tested positive for COVID-19 after the COVID-19 vaccination; tested positive for COVID-19 after the COVID-19 vaccination; This is a spontaneous report from a contactable consumer (patient herself). This consumer reported different events for 4 patients. This is 1 of 4 reports. A 64-year-old female patient received bnt162b2 (formulation: solution for injection; NDC number: unknown; expiry date: unknown), dose 1 via an unspecified route of administration on 12Mar2021 (Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 02Apr2021 (Lot number was not reported) as dose 2, single (at the age of 64 years) for covid-19 immunisation. Medical history included diabetes from 2014 and its ongoing. It has been about 7 years since she has had diabetes. She is not on insulin. She controls it with exercise and diet. There were no concomitant medications. The patient reported that she tested positive for covid-19 after the covid-19 vaccination on 03Aug2021. Patient confirms that she tested positive for the delta variant on 03Aug2021 and 16Aug2021 was the last day of her isolation. Her first dose was on 12Mar2021 and her 2nd dose was on 02Apr2021. Probed for NDC, lot number and expiry date and she say she has them in her phone, but she can't really read them. She sees that it says Pfizer, but she can't really see what it says beside that. Therapy start date populated as the date for the caller's first COVID vaccine and the therapy stop date populated as the date for the caller's second COVID vaccine. The reason that she got tested is because the caller's husband tested positive on 02Aug2021 and so herself got the quick test and it was negative on 02Aug2021 but then had tested positive on 03Aug2021 and had sore throat and symptoms. The patient underwent lab tests which included delta variant which showed positive on 03Aug2021 and quick test showed negative on 02Aug2021 and positive on 03Aug2021. The outcome of the event COVID-19 was recovered on 16Aug2021. Caller reporting on herself mentioned that she had her Pfizer COVID vaccines and then tested positive for the delta variant of COVID on 03Aug2021 and 16Aug2021 was the last day of her isolation. The caller's first dose was on 12Mar2021 and her 2nd dose was on 02Apr2021. Probed for NDC, lot number and expiry date and she says she has them in her phone but she can't really read them. She sees that it says Pfizer but she can't really see what it says beside that. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Linked Report(s): US-PFIZER INC-202101077101 Same reporter/ drug/ event for different patients; US-PFIZER INC-202101077103 Same reporter/ drug/ event for different patients.

Other Meds:

Current Illness: Diabetes

ID: 1661183
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 2021; Test Name: lactic acid; Result Unstructured Data: Test Result:4

Allergies:

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

Symptoms: my lactic acid was like 4; This is a spontaneous report from a Pfizer sponsored program. A contactable Other HCP (patient) reported for herself. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date of 2021 as dose 2, single for covid-19 immunization. The patient medical history included diabetes. The patient concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunization. On unspecified date of 2021, the patient reported that she was hospitalized after her second dose, stating "my lactic acid was like 4". Patient had a history of diabetes which is "not very controlled right now". She works in emergency medicine and was not sure what to do about receiving a 3rd dose. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event "lactic acid decreased" 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: 1661184
Sex: F
Age:
State: OH

Vax Date: 08/03/2021
Onset Date: 08/07/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:210; Comments: When sitting down, the highest heart rate got to was 210; Test Name: Heart rate; Result Unstructured Data: Test Result:170; Comments: Heart rate was 170 when she works out; Test Name: Heart rate; Result Unstructured Data: Test Result:170-210; Comments: Average heart rate is 170-210 when it spikes while she is sitting down; Test Name: Heart rate; Result Unstructured Data: Test Result:134; Comments: while resting heart rate was 134; Test Name: Heart rate; Result Unstructured Data: Test Result:82; Comments: Right now heart rate was 82

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Heart fluttering; Resting heart rate increase when sitting down; Tightness in chest; This is a spontaneous report from a contactable consumer (patient herself). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7485), via an unspecified route of administration on 03Aug2021 (age at vaccination: 46 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart fluttering, resting heart rate increase when sitting down and tightness in chest; all on 07Aug2021. It was reported that received first dose on 03Aug2021. Before vaccine she was fine. Resting heart rate is increasing when just sitting down. Having fluttering sometimes throughout the day. Get little tightness in her chest, not extreme, just a little it. When sitting down, the highest heart rate got to was 210. Heart rate was 170 when she works out. Average heart rate is 170-210 when it spikes while she is sitting down. It spike today and while resting heart rate was 134. Right now heart rate was 82. Really her heart rate should be 90-100 resting. Heart rate spikes throughout the day. Medical Intervention/treatment include she is going for an echocardiogram next Thursday. She hasn't worked out since this started because she is concerned. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661185
Sex: F
Age:
State: NY

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: tired; my face became flushed; This is a spontaneous report from a contactable consumer (patient). An 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in arm left (upper) on 05Mar2021 12:30 (Batch/Lot Number: EN6208) (at the age of 68-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included back pain and blood cholesterol from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL 12HOUR) taken for back pain from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol, start and stop date were not reported; glucosamine chondroitin pm (GLUCOSAMINE CHONDROITIN PM); monascus purpureus (RED YEAST RICE); colecalciferol (VIT D3); fish oil; and ubidecarenone (COQ-10). Historical vaccine included BNT162B2 dose 1 intramuscular in the left upper arm, on 12Feb2021 12:30 (at 68 years of age) (lot/batch number-EM9809) for COVID-19 immunisation and experienced swelling of face and swollen eyes. The patient experienced her face became flushed on 05Mar2021 11:00 with outcome of recovered in Mar2021 and tired on 06Mar2021 with outcome of unknown. It was reported that after the second vaccine, the patient's face became flushed at 11 am and in the evening the same day as the vaccine. She immediately took a BENADRYL and was just tired the next day. Therapeutic measures were taken as a result of her face became flushed (flushing). Follow-up attempts are completed. No further information is expected.

Other Meds: ADVIL 12HOUR; ATORVASTATIN; GLUCOSAMINE CHONDROITIN PM; RED YEAST RICE; VIT D3; FISH OIL; COQ-10

Current Illness:

ID: 1661186
Sex: M
Age:
State: IL

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 2 hours after the injection he developed pain in his left upper extremity which was not injected. The following morning he awoke with numbness and tingling in the right ring and small fingers as well; The following morning he awoke with numbness and tingling in the right ring and small fingers/numbness and tingling radiating up to the hypothenar area and to the forearm; The following morning he awoke with numbness and tingling in the right ring and small fingers/numbness and tingling radiating up to the hypothenar area and to the forearm; extreme pain in right hand; Medial and antecubital elbow pain too.; This is a spontaneous report from a contactable physician. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8735), via intramuscular route, administered in Right arm on 28Apr2021 at 19:00 as dose 1, single (at the age of 77-years-old), for covid-19 immunization. Medical history was not reported. It was unknown if the patient had known allergies or not. The patient was taking unspecified prescribed concomitant medications (Other medications in two weeks: prescription medications). It was unknown if patient was administered with other vaccine in four weeks. It was stated that, on an unspecified date in 2021, 02 hours after the injection, the patient developed pain in his left upper extremity which was not injected. The following morning, unknown date in 2021, he woke with numbness and tingling in the right ring and small fingers as well as extreme pain in right hand and medial and antecubital elbow pain too. It was described that ring and small numbness and tingling radiating up to the hypothenar area and to the forearm. The events were reported as serious with seriousness criteria as hospitalization (from unknown date in 2021 to unknown date in 2021). No. of days for hospitalization were 5. Adverse events also resulted in: doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not have covid prior vaccination and had not tested for covid post vaccination. No treatment was received for the events. The outcome for all the events was reported as not recovered, at the time of report. No FU attempts possible. No further information expected.; Sender's Comments: Based on the available information in the case, the causal association between the events pain in extremity, hypoesthesia, paresthesia, arthralgia 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: 1661187
Sex: U
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Four of my friends actually did get covid and they were all vaccinated; Four of my friends actually did get covid and they were all vaccinated; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer sponsored program. A patient of unspecified age and gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date 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 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that they had been fully vaccinated, her husband and her friends. It had a ninety plus efficacy rate and we were told with the Withheld study it's only at a 42 percent efficacy. She don't understand. On an unspecified date, Four of her friends actually did get covid and they were all vaccinated (medically significant). Our last vaccination was February the ninth. Advisable booster to be given eight months after the second shot, was that correct. Not at all immunocompromised. Not eight months after the second dose. We were told that the efficacy rate was 90/95 percent. We are in our 70s. Does the rate diametrically go down as time goes on. Clinic study says right it's at 42 percent at like 6 months after the second shot. Until when? Unknown efficacy rate after a certain amount of time. On 18Aug2021, withheld have announced a plan to begin offering COVID-19 booster shots in the fall.3 This is for a wider population (i.e., not limited to immunocompromised individuals). The Withheld does not currently recommend booster shots for this wider population. The clinical outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661188
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: have a friend who's daughter is positive, she is on day 8 and doing great; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was Reported that, The patient experienced have a friend whose daughter is positive; she is on day 8 and doing great on 2021 with outcome of recovering. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661189
Sex: F
Age:
State:

Vax Date: 08/06/2021
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
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: 20210809; Test Name: Heart rate; Result Unstructured Data: Test Result: 106; Comments: increase in heart rate and that it was 106 bmp at rest.; Test Date: 202103; Test Name: COVID 19; Result Unstructured Data: Test Result: had the COVID 19 virus; Comments: she previously had the COVID 19 virus in March2021.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Severe pain in the stomach; Increase in heart rate; her arm "hurt like hell"; Scared to death of COVID; Heartburn; Tired; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration on 06Aug2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 virus from Mar2021 to an unknown date. The patient's concomitant medications were not reported. On unknown date in Aug2021, the patient experienced scared to death of covid; heartburn; tired; her arm "hurt like hell"; On 09Aug2021, increase in heart rate; On 12Aug2021, severe pain in the stomach. The patient underwent lab tests and procedures which included heart rate: 106 on 09Aug2021 increase in heart rate and that it was 106 bmp at rest, sars-cov-2 test: had the covid 19 virus on Mar2021 she previously had the COVID 19 virus in March2021. It was reported that stated that she was looking for some information on the Pfizer COVID 19 vaccination and the symptoms she has experienced since her first dose. She stated that she previously had the COVID 19 virus in Mar2021. She stated that she is healthy and has no underlying conditions. She stated that she waited for 3-4 months after having COVID because she had antibodies. She stated that she's an elementary school teacher for younger children and she wanted to be fully vaccinated before school started back in September. She stated that she was "scared to death of COVID and did not think she will make it if she gets it again". Once she had her first dose she states that she was fine with the regular side effects and knew what to expect. She mentioned that her arm "hurt like hell" and that she was tied but that wasn't a problem because she was used to being tired. She got it on the 6th which was a Friday and on the 9th she reported having an increase in heart rate and that it was 106 bmp at rest. She reports that it was the same on the 10th. Elevated heart rate went away and she states that she figured her body was just making antibodies. She then reported on the 12th she began having severe pain in the stomach and it felt like bubbles and somewhat like heartburn. She stated that on the 13th it got worse and then started to level out on the 14th. On the 16th,17th,18th and today the 19th its gradually gotten better but still at a moderate level. She compares it to inflammation of the intestines and/or esophagus and that she was "beside herself". She relays that she spoke with her doctor and they asked if it could possible be something she ate that caused these symptoms. She stated that she had not had any foods that were out of the ordinary for her and had no tried any new foods or experimented with anything she provided an example of, "like, spicy Indian food or anything like that". The clinical outcome of event increase in heart rate was recovered on unknown date in Aug2021; outcome of severe pain in the stomach was recovering; while other events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661190
Sex: M
Age:
State: TX

Vax Date: 02/12/2021
Onset Date: 05/05/2021
Rec V Date: 09/01/2021
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: 20210505; Test Name: COVID-19 Test; Result Unstructured Data: Test Result: Positive.

Allergies:

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

Symptoms: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable consumer. A 22-years-old male patient received bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection) first dose (Lot number: EN5318) on 23Jan2021 and second dose (Lot number: EL9266) on 12Feb2021, both via unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 05May2021 (after 3 months of vaccination), patient was tested positive for COVID virus, after being fully vaccinated. Caller states that Covid positive is defined as having both vaccines, and testing positive for Covid longer than two weeks after both doses. Caller states they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. Lab test included positive COVID-19 test on 05May2021. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075254 same reporter, drug, AE different patient.

Other Meds:

Current Illness:

ID: 1661191
Sex: F
Age:
State: TX

Vax Date: 01/23/2021
Onset Date: 05/13/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210513; Test Name: PCR Covid test; Test Result: Positive.

Allergies:

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

Symptoms: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from contactable consumer. This consumer reported similar events for 37 patients. This report is for 6th of 37 patient. This consumer reported for a female patient. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: 31May2021), dose 1 via an unspecified route of administration on 23Jan2021 as dose 1, single, and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9266; Expiration Date: not reported), dose 2 via an unspecified route of administration on 12Feb2021 as dose 2,single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the caller stated about the Pfizer Covid 19 vaccine, the caller reported 37 breakthrough cases, for fully vaccinated patients testing positive for Covid. The Covid positive were defined as having both vaccines and testing positive for Covid longer than two weeks after both doses on13May2021. The caller stated they were monitoring and tracking the vaccine breakthrough cases in their area and the caller had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. The Caller stated, re-clarified later in report, she had 37 patients with partial identifiers. The Caller stated she cannot provide some identifying details and that she would need to check with her legal department first. The caller provided the details she was allowed to identify. The Caller stated she can provide, age, gender, BMI, medical conditions, if reported, and date they tested positive for Covid, and the type of Covid test utilized. The Caller later stated, she cannot provide the zip code. Upon follow-up on 20Aug2021, a Product Quality Complaint was received from a Product Quality Complaint Group for LOT EN5318. The conclusion included the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Further a brief Complaint Description: PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE - EN6200- Lack of Effect was received, the complaint was agreed with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number was valid, and an investigation will be performed. The patient underwent lab tests and procedures which included PCR Covid test: positive on 13May2021. Outcome of the event tested positive for Covid virus, after being fully vaccinated was reported as unknown at this time of the report. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 same reporter, AE and drug, different patient

Other Meds:

Current Illness:

ID: 1661192
Sex: F
Age:
State: TX

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

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

Lab Data: Test Date: 20210801; Test Name: BMI; Result Unstructured Data: Test Result:48.5; Test Date: 20210801; Test Name: NAAT Covid test; Test Result: Positive

Allergies:

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

Symptoms: she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 22nd of 37 patients. This consumer reported for a 38-year-old female patient. A 38-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318) via an unspecified route of administration on 26Jan2021 as dose 1, single and she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: N6203) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. On 01Aug2021 the patient experienced she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. the lot number provided (medically significant). It was reported that tested positive for COVID virus, after being fully vaccinated. Caller states that COVID positive was defined as having both vaccines and testing positive for COVID longer than two weeks after both doses. On 01Aug2021 the patient underwent lab tests and procedures which included body mass index (48.5) and sars-cov-2 test (positive). Reporter stated that an individual (non-HC) they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide to DSU upon transfer. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients

Other Meds:

Current Illness:

ID: 1661193
Sex: F
Age:
State: TX

Vax Date: 01/19/2021
Onset Date: 08/06/2021
Rec V Date: 09/01/2021
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: 20210806; Test Name: Antigen covid test; Test Result: Positive

Allergies:

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

Symptoms: Tested positive for Covid virus, after being fully vaccinated.; Tested positive for Covid virus, after being fully vaccinated.; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration on 19Jan2021 dose 1, single and received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection Lot Number: EN5318) via an unspecified route of administration on 05Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing thyroid disorder. Concomitant medications were not reported. The patient tested positive for COVID virus, after being fully vaccinated on 06Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Aug2021. The outcome of the events was unknown. Product Quality Complaint: Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients

Other Meds:

Current Illness: Thyroid disorder (Patient history: Thyroid issues (From: Unknown To: Ongoing))

ID: 1661194
Sex: M
Age:
State: TX

Vax Date: 02/23/2021
Onset Date: 08/08/2021
Rec V Date: 09/01/2021
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: BMI; Result Unstructured Data: Test Result:31.9; Test Date: 20210808; Test Name: NAAT Covid test; Test Result: Positive

Allergies:

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

Symptoms: Tested positive for Covid virus, after being fully vaccinated; Tested positive for Covid virus, after being fully vaccinated; This is a spontaneous report from a contactable Consumer or other non-HCP. This consumer reported similar events for 37 patients. This is 27th of 37 reports. A 61-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1), dose 2 via an intramuscular route of administration on 23Feb2021 (Lot Number: EL9266) as DOSE 2, SINGLE and dose 1 via an intramuscular route of administration on 28Jan2021 (Lot Number: EN5318; Expiration Date: 31May2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were not reported. on 08Aug2021, the patient experienced covid-19. On 08Aug2021, the patient was tested positive for Covid virus after being fully vaccinated longer than two weeks after both doses. The patient underwent lab tests and procedures which included body mass index: 31.9 on an unspecified date, NAAT Covid test (Nucleic Acid Amplification): positive on 08Aug2021. The patient outcome of the event was unknown at the time of this report. Assistant Director of Health (non-HC) calling today from a (state withheld) Health Department. She stated they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15 percent of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Lot number: (CR): EN5318: Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, Lot Size: 2856, Manufacturing Date (GMT): 19Dec2020, Package Date (GMT): 21Dec2020, Release Date (GMT): 18Jan2021 and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients;US-PFIZER INC-202101081272 similar report from same reporter

Other Meds:

Current Illness:

ID: 1661195
Sex: M
Age:
State: TX

Vax Date: 02/05/2021
Onset Date: 08/06/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: BMI; Result Unstructured Data: Test Result: 30; Comments: BMI: 30; Test Date: 20210806; Test Name: Antigen Covid test; Test Result: Positive.

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp, Report 29 of 37. A 52-years-old male patient received second dose of bnt162b2 (BNT162B2) PFIZER-BIONTECH COVID-19 VACCINE, (Lot Number: EN5318 Expiration Date: 31May2021) via an unspecified route of administration on 05Feb2021 as Dose 2, single for covid-19 immunisation. Medical history included covid-19 from 28Nov2020 to an unknown date, History of Covid. The patient's concomitant medications were not reported. Historical vaccine included dose 1 (Lot: EL3249 expiration: unknown) via unspecified route of administration on 15Jan2021 as a single dose for COVID-19 immunisation. Reporter stated they are monitoring and tracking the vaccine breakthrough cases in their area and she had some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The reporter at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide upon transfer. Reporter stated that Covid positive is defined as having both vaccines and testing positive for Covid longer than two weeks after both doses. Testing positive for Covid virus, after both vaccines. On 06Aug2021, tested positive for Covid. Description of complaint: Caller reporting on the Pfizer Covid 19 vaccine. Outcome of the events was unknown. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN5318 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN5318, fill lot EN5317, and the formulated drug product lot EN5316. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root causes were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075254 Same reporter, drug, AE, different patients.

Other Meds:

Current Illness:

ID: 1661196
Sex: F
Age:
State: VA

Vax Date: 04/28/2021
Onset Date: 07/29/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210729; Test Name: D-Dimer; Result Unstructured Data: Test Result:elevated

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: this means that she has tiny blood clots all in her body; has not been feeling well lately; very dizzy; vertigo; shortness of breath; her heart felt like it was racing; she felt really weird like out of body and did not feel right and her body did not feel right.; D-Dimer elevated; This is a spontaneous report from a contactable consumer (Patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8736), via an unspecified route of administration, administered in Arm Left on 28Apr2021 10:00 (at the age of 41-years-old) as dose 2, single for covid-19 immunization. Medical history included inflammation. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737), via unspecified route of administration, administered on 01Apr2021 (at the age of 41-years-old) as dose1, single for Covid-19 immunization. It was reported that Prior Vaccinations (within 4 weeks) was None. Family medical history relevant to adverse event was none. The patient experienced this means that she has tiny blood clots all in her body, has not been feeling well lately, very dizzy, vertigo, shortness of breath, her heart felt like it was racing, she felt really weird like out of body and did not feel right and her body did not feel right on Aug2021 and d-dimer elevated on 29Jul2021. Caller states she is calling about the Pfizer Covid-19 vaccine and states she has not been feeling well lately for three days of being very dizzy and her HCP did a test on her blood to see if she had elevated D-dimer enzymes or something like that and said this could be from the Pfizer Covid-19 vaccine. Caller states this means that she has tiny blood clots all in her body and she just wanted to report this. Caller states on her patient card it is written that she had the 1st dose of the Pfizer Covid-19 vaccine administered on 01Apr2022 and the 2nd dose administered on 28Apr2022; caller states this may be written incorrectly as she had the 1st dose on 01Apr2021 with lot ER8737 and the 2nd dose administered on 28Apr2021 with lot ER8736; states she does not see expiry dates or NDC numbers written on her patient card. Caller states the not feeling well began recently a couple of weeks ago around 04Aug2021 or 03Aug2021 and she went into urgent care on 07Aug2021 and was not feeling well and her symptoms were that she was very dizzy like vertigo, shortness of breath and her heart felt like it was racing and she felt really weird like out of body and did not feel right and her body did not feel right. States she still feels a little shortness of breath and she does not really know but knows something is wrong with her and does not know what it is but she is a pretty healthy person and does not have medical conditions or anything healthwise but feels like something is off and her shortness of breath is ongoing and is about the same as when it began. Caller states she had gone to her HCP previously before the urgent care visit and the HCP wanted to do the blood test on her knowing she had had the Pfizer COVID Vaccine after reading an article about the D-dimer enzyme being elevated and wanted to do this blood test on her and ended up saying that the caller was the HCP's first person ever that had the elevated D-dimer and the HCP just told the caller this yesterday. States she does not know what the next step will be and she guesses right now her HCP prescribed her low dose Aspirin to take care of the blood clots and it is 81mg a day and told her to start with that and she guesses in another month or so she will have another test to test the D-dimer; states she began taking the Aspirin yesterday. States she is also taking some anti-inflammation supplements at the moment and has not started taking Serration yet and did start taking Tumeric supplements with black pepper because that is supposed to be good for inflammation and the HCP said that is fine and she began taking the Tumeric yesterday. Emergency room visit was no. Therapeutic measures were taken with Lunesta one pill of 3mg a night and began taking that back in the beginning of Jun2021; states she takes Zoloft 1.5 to 2mg and increased that dose recently and right now takes 2mg and anti-inflammation supplements (Tumeric supplements with black pepper)as a result of event this means that she has tiny blood clots all in her body has not been feeling well lately, very dizzy, d-dimer elevated, vertigo, shortness of breath, her heart felt like it was racing, she felt really weird like out of body and did not feel right and her body did not feel right. The patient underwent lab tests and procedures which included D-Dimer (blood test): elevated on 29Jul2021. The outcome of event shortness of breath was not resolved and for rest of all events outcome was unknown. Follow-Up (23Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661197
Sex: F
Age:
State: FL

Vax Date: 04/20/2021
Onset Date: 06/01/2021
Rec V Date: 09/01/2021
Hospital: Y

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

Lab Data: Test Date: 20210713; Test Name: CT scan; Result Unstructured Data: Test Result:Unknown Result

Allergies:

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

Symptoms: I got blood clots in my lungs, both lungs about a month later; I got blood clots in my lungs, both lungs about a month later; she had a pulmonary emboli; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0151, expiry date: unknown) via unspecified route of administration in right arm on 20Apr2021 as dose 2, single for Covid-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot: ER8730) via unspecified route of administration in right arm, on 28Mar2021, as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient stated that she got the vaccine, the Pfizer vaccine in April and got both the shots and got blood clots in her lungs less in a month and a half, both lungs about a month later, on an un-specified date in Jun2021. She ended up into an emergency room and was in the hospital for 4 days since 16Jul2021 and was on blood thinners, now and they can't find any other reason for the blood clot. She also had a pulmonary emboli, several of them actually on an unspecified date in 2021. She noticed symptoms starting 24Jun2021 but it probably started before then. The caller stated she still had the blood clots. They just give a person medication for 6 months and hope they go away. She remarked this was likely to continue, she would probably continue to get them based on how blood clots work. She doesn't know why she was even allowed to get the shots. She wanted to report the event. She could not find any data on blood clot except for the 'TTS' (not clarified) and saw that the only list confirmed cases. So, she wanted to know how was the case confirmed to be caused by the vaccine? She went to the doctor on 12Jul2021 and then had a CT scan done on 13Jul2021 and then was sent straight to emergency room but the symptoms started in June. She got Lovenox in the hospital for three days. Caller explains she was in the hospital from 13Jul2021-16Jul2021. She was put on Eliquis as treatment after leaving the hospital. She wanted them to know that several of her friends and people she has heard about who have got the shot from different manufacturers who have gotten blood clots. They have had no history or cause that was known. It was alarming that none of this was talked about and seem to be discouraged to talk about it. She hoped she saved someone's life. The patient underwent lab test for CT scan on 13Jul2021, with unknown results. The outcome of events for "I got blood clots in my lungs, both lungs about a month later" was not recovered and rest was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661198
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 08/17/2021
Rec V Date: 09/01/2021
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: Test Date: 20210817; Test Name: SARS-CoV-2 test; Test Result: Positive.

Allergies:

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

Symptoms: Had the COVID Vaccine, but tested positive for COVID; Had the COVID Vaccine but tested positive for COVID; This is a spontaneous report received from a contactable consumer. This consumer reported for patient. A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE MANUFACTURER UNKNOWN; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the COVID vaccine, but tested positive for COVID on 17Aug2021. The reported was calling about the patient who had the COVID vaccine and was not sure which one she received. The patient underwent lab tests and procedures which included SARS-CoV-2 test positive on 17Aug2021. The outcome of the events was unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1661199
Sex: M
Age: 27
State:

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

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

Lab Data: None.

Allergies: none known

Symptom List: Unevaluable event

Symptoms: Vaccine was incorrectly diluted. It was diluted with 0.8 vice 1.8 ml dilutent. One dose of 0.3ml was drawn up and given.

Other Meds: unknown

Current Illness: none known

ID: 1661200
Sex: F
Age: 38
State: FL

Vax Date: 08/14/2021
Onset Date: 08/21/2021
Rec V Date: 09/01/2021
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: MA

Allergies: NA

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

Symptoms: 7 days after vaccination large, inflamed lump at injection site hit to touch 7 days after vaccination - started menestral cycle 7 days early while on birth control - menestral bleeding for10 days [normal cycle is 5 days]

Other Meds: Lessina Birth Control

Current Illness: NA

ID: 1661201
Sex: F
Age:
State: CA

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 09/01/2021
Hospital: Y

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: Menstrual cycle changed; Bell's Palsy; Lot of cramps before my cycle; Lymphnodes of the axillas enlarged; Renal impairment; Have lupus and it activated; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:30 (at the age of 46-years-old) as dose 2, single for covid-19 immunization. Medical history included lupus erythematosus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EE0164), via an unspecified route of administration, administered in Arm Left on 17Apr2021 09:30 (at the age of 46-years-old) as dose 1, single for covid-19 immunization. No known allergies. No other vaccine in four weeks. No covid prior vaccination and no covid tested post vaccination. On 21Apr2021 09:00, 4 days after the second dose of the vaccine, she woke up with Bells Palsy and with the lymph nodes of the axillas enlarged. Her menstrual cycle changed completely, and she started to feel a lot of cramps before her cycle. She had lupus and it activated after the vaccine with renal impairment. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care and hospitalization for 2 days. The patient was treated with Corticosteroids and blood thinners (Clexane). The outcome of all events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1661202
Sex: M
Age:
State: AR

Vax Date: 03/28/2021
Onset Date: 08/02/2021
Rec V Date: 09/01/2021
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: 20210802; Test Name: tested positive for the delta variant; Test Result: Positive.

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: This is a spontaneous report from a contactable consumer (patient) received from program. A 65-years-old male (reporter) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732), via an unspecified route of administration on 28Mar2021 as dose 2, single, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 07Mar2021 as dose 1, single, both (at the age of 65-years-old) for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD), he had been diagnosed for 3 years and he is on 3 different inhalers for it. Concomitant medications included BREO ELLIPTA, VENTOLIN, and SPIRIVA RESPIMAT all taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing. On 02Aug2021, the patient tested positive for the delta variant. It was reported that the reporter, patient, had Pfizer COVID vaccines and then tested positive for the delta variant on 02Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive for delta variant on 02Aug2021. The clinical outcome for the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075459 Same reporter, drug, event for different patients.

Other Meds: BREO ELLIPTA; VENTOLIN; SPIRIVA RESPIMAT

Current Illness: COPD (He has been diagnosed for 3 years and he is on 3 different inhalers for it)

ID: 1661203
Sex: M
Age:
State: AR

Vax Date:
Onset Date: 08/05/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210805; Test Name: tested positive for the delta variant; Test Result: Positive.

Allergies:

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

Symptoms: This is a follow-up spontaneous report from a contactable consumer received from Pfizer sponsored program COVAX US support. A 40-year-old patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date Apr2021 (age at vaccination 40-year-old) as single dose, and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. Medical history included ongoing adult ADHD (attention deficit hyperactivity disorder) he has had this for probably his entire life, but he was just diagnosed about a year ago. There were no concomitant medications. On 05Aug2021, the patient tested positive for the delta variant. It was reported that the reporter patient had their Pfizer COVID vaccines and then tested positive for the delta variant on 05Aug2021. The reporter stated that the patient got his second dose about 2 weeks after the reporter had hers. She confirms that patient got his last dose after she had her last dose which was on 28Mar2021.The patient underwent lab test and procedures which included sars-cov-2 test positive for delta variant on 05Aug2021. The clinical outcome for the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101075459 Same reporter, drug, event for different patients.

Other Meds:

Current Illness: ADHD

ID: 1661204
Sex: M
Age:
State: TX

Vax Date: 08/05/2021
Onset Date: 08/05/2021
Rec V Date: 09/01/2021
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: Seizures; This is a spontaneous report from a contactable consumer (patient's mother) A 26-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Aug2021 16:00 (Lot Number: EW0181) as single dose (at the age of 26) for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced seizures on 05Aug2021 (about an hour and a half or an hour and 20 minutes after the vaccine). She states her son has never had a seizure before. Caller states her son had 2 seizures minutes apart the day before yesterday. Then he had a seizure yesterday as well. Caller states that her son went to the emergency room and yesterday he went to his family doctor. Monday he is going to a neurologist so they can do testing to determine what type of seizures he is having.The outcome was not recovered. Follow-up (24Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661205
Sex: M
Age:
State: TX

Vax Date: 05/05/2021
Onset Date: 05/06/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: panic had atrial fibrillation of which I have never had any heart issues at all; I actually blacked out for several minutes; I woke up at 2:00 am with chills; panic had atrial fibrillation of which I have never had any heart issues at all; This is a spontaneous report from a contactable consumer (patient) A 58-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05May2021 14:45 (Lot Number: Ew0172) as single dose (at the age of 58) for covid-19 immunisation. The first dose (lot#Ew0158) was administered arm right on 12Apr2021 04:00 pm. Medical history included blood pressure (the patient received within 2 weeks of vaccination: Blood pressure meds). The patient experienced panic had atrial fibrillation of which i have never had any heart issues at all on 06May2021 02:00 am, i actually blacked out for several minutes on 06May2021 02:00 am, i woke up at 2:00 am with chills on 06May2021 02:00. No treatment received. The events outcome was recovered with sequelae. Follow-up (23Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661206
Sex: F
Age:
State: CT

Vax Date: 08/11/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
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: 20210813; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Comments: Negative

Allergies:

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

Symptoms: Hives; Itchiness; Big bumps; Sore arm; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3180), via an unspecified route of administration, administered in left arm on 11Aug2021 09:30 (at the age of 30-year-old), as dose 1, single for COVID-19 immunisation. Medical history included mild asthma from an unknown date. Patient had known allergies to shellfish and pineapples. Concomitant medications were reported as none. Prior vaccination, patient was diagnosed with COVID and reported as patient had no other vaccine in four week. The patient was not pregnant at the time of vaccination. On 12Aug2021, the patient experienced hives, itchiness, big bumps and sore arm. The patient underwent lab tests and procedures which included on 13Aug2021, SARS-COV-2 test, nasal swab: found negative. No treatment was given in response to the events. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1661207
Sex: F
Age:
State:

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

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

Lab Data: Test Date: 202106; Test Name: COVID-19 Test; Test Result: Positive; Comments: diagnosed with covid 19 end of June.

Allergies:

Symptom List: Nausea

Symptoms: This is a spontaneous report from a Contactable other HCP. A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date in Mar2021 (age at vaccination: 57-years) as dose number unknown, single for Covid-19 immunization. Medical history included ongoing rheumatoid arthritis since 11Jan2021. Co-suspect drug included ongoing Xeljanz XR 11 mg, daily, oral, taken since 11Jan2021, for rheumatoid arthritis. Concomitant medications were not reported. Patient reported she had been off of xeljanz xr during the time of receiving the pfizer covid 19 vaccine at the end of Mar2021, and when diagnosed with covid 19 end of Jun2021. Patient reported during the time she was without xeljanz xr she had pain but, when she had covid she didn't notice any pain. No exact dates, further details provided, and md is aware. The patient underwent lab test which included SARS-CoV-2 antibody test, with positive results on an unspecified date in Jun2021 (diagnosed with covid 19 end of June). The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, COVID-19 and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1661208
Sex: F
Age:
State: OH

Vax Date: 04/15/2021
Onset Date: 08/18/2021
Rec V Date: 09/01/2021
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: 20210819; Test Name: Covid 19; Test Result: Positive; Comments: Nasal Swab.

Allergies:

Symptom List: Injection site pain

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 51-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207, Expiry date was not reported) via an unspecified route of administration, administered in arm left on 15Apr2021 07:00 as dose 2, single and first dose via an unspecified route of administration, administered in arm left on 22Feb2021 07:00 (Lot Number: Ew0169, Expiry date was not reported) (age at the vaccination 51-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included PROBIOTICS taken for an unspecified indication, start and stop date were not reported. The patient had experienced covid test result as positive on 19Aug2021, 1st dose 22feb2021/2nd dose 15apr2021, cold like symptoms, cough, runny nose on 18Aug2021 05:00. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on 19Aug2021 Nasal Swab. The patient received probiotics medications in two weeks. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested positive since the vaccination. The outcome of the event Covid test result: Positive was unknown and rest of the events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: PROBIOTICS

Current Illness:

ID: 1661209
Sex: F
Age:
State: WI

Vax Date: 12/28/2020
Onset Date: 08/16/2021
Rec V Date: 09/01/2021
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: 20210816; Test Name: Nasal swab; Result Unstructured Data: Test Result:Positive

Allergies:

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

Symptoms: Contracted Covid on 16Aug2021; Contracted Covid on 16Aug2021; administration date=28Dec2020/other vaccine same date vaccine date=28Dec2020; This is a spontaneous report from a contactable Nurse(reporter). A 51-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration on 28Dec2021in right arm as DOSE 1, SINGLE and also received second dose (COMIRNATY, Solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration on 28Dec2021 in right arm as DOSE 2, SINGLE for covid-19 immunization (at the age of 51 years)at Workplace clinic. The patient medical history and concomitant medications were not reported. The patient had not any known history of allergies. The patient had not diagnosed with COVID-19 prior to vaccination. It was reported that patient did not take any vaccine within 4 weeks prior to Covid vaccine. On 16Aug2021 the patient had experienced Contracted Covid-19. The patient underwent lab tests and procedures, which included Nasal Swab and was diagnosed as having covid test Positive after vaccination on 16Aug2021. Therapeutic measures were taken as a result of adverse events. The outcome of the events were recovering; Sender's Comments: As there is limited information in the case provided, the causal association between the event drug ineffective and Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Other Meds:

Current Illness:

ID: 1661210
Sex: M
Age:
State:

Vax Date: 08/20/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: a very severe painful kidney reaction, pain is fluctuating; a very severe painful kidney reaction, pain is fluctuating; This is a spontaneous report from a contactable pharmacist. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 20Aug2021 (Lot Number: EW0918, Expiry date not reported) as dose 2, single for covid-19 immunization. The patient medical history included "hematochromia" (discrepantly reported). The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date (Lot Number: EW0191) as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced a very severe painful kidney reaction and the pain is fluctuating. It was reported the patient refused to go to emergency room. Treatment for the events was not reported. The outcome for the events was not reported.

Other Meds:

Current Illness:

ID: 1661211
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Covid; Result Unstructured Data: Test Result:Covid

Allergies:

Symptom List: Tremor

Symptoms: received her first dose of the Covid vaccine and then twelve days later was diagnosed with Covid; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient experienced received her first dose of the covid vaccine and then twelve days later was diagnosed with covid on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: covid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1661212
Sex: F
Age:
State: NY

Vax Date: 08/20/2021
Onset Date: 08/21/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: arm is swollen/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; arm is itchy/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; My arm is so sore/ Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; arm is red / Severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter; This is a spontaneous report from a contactable nurse (patient). A 73-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm right on 20Aug2021 10:00 (Lot Number: EW0170) (at the age of 73-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included 9/11 lung disease, penicillin allergy and contrast dye allergy. The patient did not receive any other medications within 2 weeks of vaccination. 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 and was not tested for COVID-19 since the vaccination. The patient stated that she just wanted to report a side effect from the COVID-19 vaccination as she had the reaction. The patient experienced severe swelling, redness, pain and itching of injection site approximately 8 centimeters in diameter on 21Aug2021 02:00 AM. The patient woke up on the morning of day of reporting and her arm was swollen, red and itchy. The adverse event led to doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse event. The outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1661213
Sex: M
Age:
State:

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

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

Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result: COVID; Comments: Contracted COVID after 4-5 months of receiving 2nd Pfizer COVID vaccine.

Allergies:

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

Symptoms: This is a spontaneous report from a non-contactable consumer (patient). A elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, both doses Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single and on an unspecified date as dose 2, single both for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown whether COVID was diagnosed prior vaccination. It was reported that, on an unspecified date, patient had contracted COVID, after 4-5 months of receiving 2nd dose. Post vaccination, the patient had been tested for COVID-19. The outcome of the event was recovering. No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1661214
Sex: M
Age:
State: FL

Vax Date: 08/05/2021
Onset Date: 08/08/2021
Rec V Date: 09/01/2021
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: Vasculitis in fingers and toes; fleshy part of fingertips got red/purple,seemed almost like a burn. As well as his big toes.; This is a spontaneous report from a non-contactable consumer (Patient). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 05Aug2021 (age at vaccination 12 years) as dose 1, single for covid-19 immunisation. The patient medical history was none. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient no allergies. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 08Aug2021 the patient experienced vasculitis in fingers and toes, fleshy part of fingertips got red/purple, seemed almost like a burn. as well as his big toes. Patient visited healthcare professional office/clinic visit. The patient received aspirin for treatment. The outcome of event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected

Other Meds: TYLENOL

Current Illness:

ID: 1661215
Sex: F
Age:
State: NC

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/01/2021
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: I have had Diarrhea Ever since; everything I eat I go straight to go loo.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 17Aug2021 (at the age 62-years-old) as dose 1, single for covid-19 immunization. Medical history included type 2 diabetes mellitus, blood cholesterol, slow blood flow and high blood. The patient's concomitant medications were not reported. Prior to vaccination, the patient did not receive any other vaccines. On Tuesday (17Aug2021) after the first dose of vaccine patient was having diarrhea. Patient reported everything she eats go straight to loo. 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: 1661216
Sex: U
Age:
State: AZ

Vax Date: 08/17/2021
Onset Date: 08/17/2021
Rec V Date: 09/01/2021
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 receiving my second dose of COVID-19 vaccine, my breastfed baby (4 mo) developed diarrhea.; The day after receiving my second dose of COVID-19 vaccine, my breastfed baby (4 mo) developed diarrhea.; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). This consumer or other non hcp reported information for both mother and baby. This is a baby report. A 04-month-old patient of unspecified gender was exposed to bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via transmammary route, administered in Left arm on 17Aug2021 as dose 2, single for covid-19 immunisation from the mother. The patient's medical history was not reported. Concomitant medication included citalopram (CITALOPRAM) taken for an unspecified indication, start and stop date were not reported received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Device Date : 20Aug2021. It was reported that the day after receiving her second dose of COVID-19 vaccine, her breastfed baby (4 mo) developed diarrhea on 18Aug2021. No treatment was received for adverse events. The reporter assessed events as non-serious with no seriousness criteria of resulting in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. Adverse events resulted in none of the above. The outcome of events was recovered on an unspecified date in 2021. The lot number for the vaccine,[BNT162B2], was not provided and will be requested during follow up.

Other Meds: CITALOPRAM

Current Illness:

ID: 1661217
Sex: F
Age:
State: CA

Vax Date: 03/24/2021
Onset Date: 03/01/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood tests; Result Unstructured Data: Test Result:Normal; Test Date: 202102; Test Name: Pregnancy test; Result Unstructured Data: Test Result:positive; Test Date: 2021; Test Name: ultrasound; Result Unstructured Data: Test Result:normal

Allergies:

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

Symptoms: heavy excessive vaginal bleeding; a lot of blood clots with her period; Miscarriage; Nausea; Dizziness / she feels dizzy; feeling sick; she couldn't get out of bed; felt like she couldn't walk; had her period longer than 3 weeks/had her period almost a month now; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This consumer reported information for both mother and fetus/baby. This is a maternal report. A 33-years-old pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: ER2613; Expiration Date: Jul2021), dose 2 via an unspecified route of administration in left arm on 24Mar2021 (age at the time of vaccination was 33 years) as dose 2, single for covid-19 immunisation at Medical Clinic. The vaccine was not administered at Military Facility. The patients Medical History (including any illness at time of vaccination) was reported as hypertension and obesity from an unknown date and unknown if ongoing. It was reported that the patient has already previously had covid. The patient concomitant medications were reported as no. Previously the patient had received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EN6199; NDC unknown, Expiration Date: Jun2021), dose 1 via an unspecified route of administration on 03Mar2021 (age at the time of vaccination was 33 years) for covid-19 immunisation. It was reported that the time when the vaccination was given was in the morning. History of all previous immunization with the Pfizer vaccine considered as suspect and additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as None. Prior vaccinations within 4 weeks and AE(s) following prior vaccinations were reported as none. On an unspecified date in 2021, the patient got the first vaccine and then ended up getting pregnant in february 2021, she couldn't get out of bed, had her period longer than 3 weeks/had her period almost a month now and felt like she couldn't walk. On 31Mar2021, the patient experienced a lot of blood clots with her period, miscarriage, dizziness / she feels dizzy and nausea. On an unspecified date in Mar2021, the patient was feeling sick. On an unspecified date in Aug2021, the patient experienced heavy excessive vaginal bleeding. The patient reported that the events has worsened. It was reported that the patient had been having side effects- extensive bleeding and a lot of blood clots with her period. She got the first vaccine and then ended up getting pregnant in February 2021. By March 2021 the patient had to take her second dose and when she did she had a miscarriage right after. The patient started feeling sick and went to the emergency room and they didnt know if it was from the miscarriage or not. The patient has had heavy excessive vaginal bleeding for a whole month. The patient called her primary care provider and when she went to the doctor she got a lot of tests done. The tests showed that the patient did not have a tube pregnancy when she went to the emergency room to make sure it was fine. The patient did an ultrasound and blood tests and it was normal, they just said it was a miscarriage. The patient was so sick with the side effects of the miscarriage. The patient had so much dizziness she could not get out of bed and felt like she could not walk. The patient reported, everything was moving, the patient was moving and everything was still and she feels dizzy. The patient has had her period longer than 3 weeks. The caller saw online that there were other people with long periods. The patients friend called her and said she has had a long period too. The patient was concerned because she has had her period almost a month now. At first the patient thought it was a normal long period after the miscarriage. It happened in March and then April and May was whatever. The miscarriage was not as even heavy as this month. The patients vaginal bleeding starts slowing down and then comes in heavy again. The patient had tests on her heart on 19Apr2021 to make sure everything was okay and it was normal, that was when she saw the cardiologist. Reportedly, on 30Mar2021 the patient went to her OB/GYN to see how the baby was doing and said they could not find the heartbeat. The patient went to the hospital a few days later to make sure things were okay, the patient thinks this was on 04Apr2021 or 05Apr2021. Reportedly, heavy excessive vaginal bleeding started this month(unspecified). After the miscarriage the patient went to doctor and they checked her tubes and uterus. Everything was fine and nothing was abnormal. When the patients period was longer than 3-4 weeks, the patient started thinking what was going on now. The patient realized she was pregnant in Feb2021 towards the end of the month, she had some blood work done and it said she was pregnant. The patient later clarified and confirmed that she received both doses of the vaccines in March. It was reported that, they used the camera to look inside her uterus. The patient had all of her medical records with all of the tests she had done and the results if Pfizer needs them. Reportedly the pregnancy test was done in Feb2021 and the result was positive. The patient later clarified and confirmed that she went to her OB/GYN on 31Mar2021 and that was when they could not find the babys heartbeat. Reportedly, the Adverse events required visit to emergency room/ physicians office. The mother reported she became pregnant while taking bnt162b2. On an unspecified date in 2021, the patient underwent lab tests and procedures which included blood test: normal and ultrasound scan: normal. On an unspecified date in Feb2021 the patient underwent lab tests and procedures which included pregnancy test: positive. The outcome of the events The caller got the first vaccine and then ended up getting pregnant in February 2021, a lot of blood clots with her period, miscarriage, heavy excessive vaginal bleeding, had her period longer than 3 weeks/had her period almost a month now, she couldn't get out of bed, felt like she couldn't walk and feeling sick was unknown. The outcome of the events nausea, Dizziness / she feels dizzy was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1661218
Sex: M
Age:
State: IA

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/01/2021
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: 20210819; Test Name: Fever; Result Unstructured Data: Test Result:High fever; Comments: High fever started 10 hours after shot lasted for 24 hours. 102-104.7 fever above 104 for 4 hours

Allergies:

Symptom List: Pain in extremity

Symptoms: High fever started 10 hours after shot lasted for 24 hours. 102-104.7 fever above 104 for 4 hours; This is a spontaneous report from a contactable consumer (patient). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0173), via an unspecified route of administration, administered in left arm on 19Aug2021 12:00 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. Medical history included allergies and asthma from an unknown date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration in left arm, on 29Jul2021 17: 30 (at the age of 12-year-old), as single dose for COVID-19 immunization. Patient had no known allergies. Concomitant medications included cetirizine hydrochloride (ZYRTEK) and fluticasone propionate (FLONASE ALLERGY RELIEF) both taken for an unspecified indication. Prior vaccination, patient was not diagnosed with COVID and did not receive other vaccine in four weeks. On 19Aug2021 22:00, the patient experienced high fever which started 10 hours after the shot, temperature was 102-104.7, where temperature was above 104 for 4 hours. The fever lasted for 24 hours. The event resulted in doctor's office visit/urgent care.. The patient was not tested COVID since vaccination. Therapeutic measures in response to the event included, alternate use of Ibuprofen 800 mg and Aspirin 600 mg. The outcome of the event was recovered on 20Aug2021 22: 00. Follow-up attempts are completed. No further information is expected.

Other Meds: ZYRTEK; FLONASE ALLERGY RELIEF

Current Illness:

ID: 1661219
Sex: M
Age:
State: NJ

Vax Date: 04/11/2021
Onset Date: 07/01/2021
Rec V Date: 09/01/2021
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: This is a spontaneous report from a contactable consumer, the patient. A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0153), via an unspecified route of administration, in the arm right on 11Apr2021 10:00 as dose 2, single (at the age of 35-years-old) for covid-19 immunization. Medical history included blood cholesterol increased and seasonal allergy. Concomitant medications included LIPITOR, CoQ 10, and FISH OIL. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EP7534), via an unspecified route of administration, in the arm right on 19Mar2021 as dose 1, single (at the age of 35-years-old) for covid-19 immunization. On 01Jul2021, the patient's upper lip was not moving correctly when he speak. Patient's upper lip felt rigid and not malleable when he speaks. Patient worried this was a case of bell's palsy. The patient seeing a doctor for the first time on 24Aug to evaluate this. Therapeutic measures were not taken for the events. The patient did not have covid prior to vaccination and did not tested for covid post vaccination. The patient visited the doctor or other healthcare professional office. The outcome of the events was not recovered.

Other Meds: LIPITOR; COQ 10; FISH OIL

Current Illness:

ID: 1661220
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: This is a spontaneous report from a contactable consumer (patient herself). An unspecified aged female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history includes she had an autoimmune disease and had a severe allergic reaction after a previous dose of this vaccine. Patient concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date patient stated that she developed a lump on her neck (she did not say swollen lymph node) and three days after both doses she broke out with raised red bumps on her arm, looked like chicken pox and itched. She went to a urgent care and received benadryl and steroid cream with little relief. She also shares that she has an autoimmune disease. The seriousness of the event she broke out with raised red bumps on her arm, looked like chicken pox, and itched was considered medically significant. The outcome of the events was recovering. Cannot assess causality between experienced side effect (lump on neck) and Pfizer COVID-19 vaccine. Because these reactions are reported voluntarily, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1661222
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/01/2021
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: Breast cancer; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported for a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced breast cancer but was not in active treatment. It was not clarified that the patient had breast cancer before taking either dose of the Covid vaccine. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Breast Cancer and the suspect BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Other Meds:

Current Illness:

ID: 1661223
Sex: M
Age:
State: NC

Vax Date: 02/03/2021
Onset Date: 08/12/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210813; Test Name: COVID-19; Test Result: Positive; Comments: Nasal Swab Covid positive 14Aug2021.

Allergies:

Symptom List: Vomiting

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), first dose on 15Jan2021 11:00 (Lot Number: EL3247) and second dose on 03Feb2021 14:00 (Lot Number: EL3247), both via an unspecified route of administration, administered in Arm Left as single dose at the age of 24-year-old for COVID-19 immunisation. The patient medical history was not reported. The patient had no covid prior vaccination. Concomitant medication(s) included ZOLOFT taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. Patient having allergies to Sulphur Drugs. The patient experienced covid since 12Aug2021 12.00AM. Patient underwent covid tested post vaccination (nasal swab) on 13Aug2021 and the result on 14Aug2021 was positive. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for AE. Outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: ZOLOFT

Current Illness:

ID: 1661224
Sex: F
Age:
State: MA

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/01/2021
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 Name: heart rate; Result Unstructured Data: Test Result:Rapid; Test Name: Milza test; Result Unstructured Data: Test Result:showed Molivern and nickel; Test Name: COVID test; Result Unstructured Data: Test Result:Negative; Comments: She had a test for Covid which was negative; Test Name: Thyroid test; Result Unstructured Data: Test Result:unknown

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: heart rate rapid; vision blurry; threw up; congestion in upper chest; She has not been feeling too good; could hardly talk; coughed a little; her feet swelled up; Her arm was killing her when she got up that Thursday morning after. She couldn't lift it right after; the left and right sides of her tongue started swelling and eventually the entire tongue; bitter taste in mouth; dizziness; goosebumps in her armpits; sweating; Fuzzy; Headache; arm pits sweating; lip swelling and they blew up; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC3181, Expiration date: not reported) via an unspecified route of administration in left arm on 18Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history included allergic to opioids from 2003, surgery on 08apr2021, goiter, allergic to rice, bees, itching, prickly rash. The patient previously took Ambien and Gabapentin and had an allergy to Ibuprofen and Tylenol. Concomitant medications included Synthroid, Cytomel taken for goiter, Omeprazole taken for acid, Zoloft taken for muscle twitches, Lorazepam taken when she can't sleep, Metronidazole gel taken as allergic to face masks. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to AE(s) was none. When She had her appendix out they had stapled her and she had adhesions. They did a metal test, a Milza test. She tried to get those records. The test showed Molivern and nickel. She can't remember what else. She had a food allergy test and is allergic to rice. She had a cough for over a year that nothing would clear up. Her PCP, (Name withheld) said to get an allergy test. She is also allergic to insulation and bees. With the insulation, she got a prickly rash and she does not mess with insulation anymore. On 18Aug2021, patient experienced Swelling of tongue, Taste bitter, Dizziness, Goose bumps, Sweating, Fuzzy, Headache, Sweating increased armpits, Lip swelling, Heart rate high, Blurry vision, Vomiting, Respiratory tract congestion, Feeling unwell, Speech disorder, Cough, Swelling of feet, Arm discomfort. Patient stated she had a reaction within the first 5 to 6 minutes, with the sides of her tongue swelling and a bitter taste and dizziness. It was at (Pharmacy name withheld). They told her to have a seat because she had allergies. 30 minutes later, she got goosebumps on her arm and her arm pits started sweating so bad that she had to go wash her hands. She was told by (Pharmacy name withheld), to start Benadryl 4 times a day, which she has done. If she misses anything she still gets swelling in her tongue and her lips are swelling and her veins blew up. She went urgent care in (town name withheld), (state name withheld) for a Covid test because her throat was red. She had a test for Covid which was negative and they went ahead and prescribed her with steroids. They were having a shortage of steroids but she did have it filled which was the right thing to do. She needed to take them. She had 6 of those, the pills, then starting with 5 pills today at 2PM and titrating down. She is still taking the Benadryl and her vision is blurry. She does not take a lot of medication. She has not been feeling too good and could hardly talk. She had some congestion in her upper chest. Only coughed a little. It seems like the steroid is clearing everything, along with the Benadryl. She got allergies and had been prescribed an Epi pen. She had it with her, it was new to her and she has never used it. Besides her tongue being swollen, and the bitter feeling, that is when the swelling continues to come back. She then threw up after she ate. Then, after that, Wednesday, 18Aug2021, her lip started swelling and the veins in her hands and feet were puffy and swollen. That night, when she was trying to sleep, her feet swelled up and her arm pits were sweaty. The sides of her tongue swelling and the bittery taste and the dizziness. Then, the goosebumps on her arms started sweating and she had to wipe her hands. She would say after 45 minutes, her body adjusted and she stopped sweating. The goosebumps went away but her tongue never stopped swelling up. It swelled up to the tip of her tongue and the bottom lip swelled up, she is waiting for it to peel and the upper lip was swollen as well. She has an allergy to Ibuprofen and Tylenol. It makes her lips swell. If she misses Benadryl, the sides of her tongue swell. Her arm was killing her when she got up that Thursday morning after. She couldn't lift it right after. She knows the first day, people that use inhalers and have trouble breathing, mentioned drinking black coffee. She started drinking coffee, which made the pain in the arm go away. It helped her tongue, but she couldn't continued with the caffeine. Aside from the Benadryl and steroids, she is on medications she takes daily. She takes Synthroid, Cytomel, Omeprazole, and Zoloft for muscle twitches. Her heart racing before and it started pretty much right away. She though it was nervousness. The heart racing occurred with the initial reaction. It wasn't really racing but, she could feel it getting more rapid. She figured it was because she was getting nervous about doing it. She had been quarantined for over a year. The Benadryl and steroids from (pharmacy name withheld) where she got the vaccination. She checked with the pharmacist each time something happened. She stuck out her tongue and went back each time before leaving. She showed them her arm with the goosebumps and that her arm pits were sweaty. She did get a headache. She felt 40 percent better after starting the Benadryl. Her headache, tongue and throat and neck glands started hurting around 4:45pm. She took 2 tablets of the Benadryl. The reactions first with the side of the tongue swelling was the vaccination, while at (pharmacy name withheld). She got something to eat and threw it up. She tried to sleep, when she realized her feet were swelling and she woke up. She started the steroids yesterday, the Prednisone, 10mg. She just took 6 pills yesterday. She will take 5 pills today but, she hasn't taken them yet. She takes it at 2pm. She will be titrating them down every day as directed, from 6 to 5, to 4 to 3 to 2 to 1. When queried start date of omeprazole She responds stating that she was taking another one and she just had an endoscopy. She does not remember the name of the other one. She had a colonoscopy and had like 20 biopsies. It was pre-cancerous. They just switched her in May2021. She does not have the bottle anymore so she does not know what she was on. It was a small square, white tablet. She took it for the same thing. They tried her on Ambien and she had seen a counselor for stress and differences in her marriage. The Ambien knocked her down and she can't take Gabapentin either she is just sensitive. She took one Gabapentin after a hand surgery. The tongue sides started swelling at 2:05pm and she got that dizzy, fuzzy feeling. The fuzzy and dizzy, she does not know if she got used to it but, it seemed like it went away during the day, that same day. She actually drove to get chicken parm. She felt like it was safe. Prior to the test, her throat was a little irritating. The outcome of event swelling of tongue, taste bitter, dizziness, goose bumps, sweating, fuzzy, headache, sweating increased armpits, lip swelling, heart rate high, blurry vision, vomiting, respiratory tract congestion, feeling unwell, speech disorder, cough, swelling of feet, arm discomfort was unknown.

Other Meds: SYNTHROID; CYTOMEL; OMEPRAZOLE; LORAZEPAM; ZOLOFT; METRON [METRONIDAZOLE]; PREDNISONE

Current Illness:

ID: 1661225
Sex: F
Age:
State: FL

Vax Date: 03/24/2021
Onset Date: 08/14/2021
Rec V Date: 09/01/2021
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: 20210814; Test Name: COVID-19 Test; Test Result: Positive.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 24Mar2021 (at the age of 38-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Other Vaccine as second dose (Batch/Lot Number: EWO 15800 Formulation: Unknown) via unspecified route of administration on 24Mar2021. The patient medical history and concomitant medications were not reported. On 14Aug2021, the patient reported that she did Covid test and was positive and experienced very bad symptoms and had fever, cough, body pain, and lost smell and taste. Patients feel very frustrated. Patient though being vaccinated she would not experience this nightmare. The patient underwent lab tests and procedures which included COVID-19 test, positive on 14Aug2021. Patient had Covid tested post vaccination and Covid prior vaccination was reported as yes. The patient took Tylenol as treatment for the event. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661226
Sex: F
Age:
State:

Vax Date: 08/21/2021
Onset Date: 08/01/2021
Rec V Date: 09/01/2021
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: Test Date: 20210821; Test Name: body temperature; Result Unstructured Data: Test Result:99

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: had aches; chills; low grade fever is the 99's; had diarrhea all day; light headed; not feeling well; not able to stay focused; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on 24Feb2021 as UNKNOWN, SINGLE for COIVD-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Aug2021 the patient experienced had aches, chills, low grade fever is the 99's, had diarrhea all day, light headed, not feeling well, not able to stay focused. On 22-AUG-2021 outcome of events was recovered. The patient underwent lab tests and procedures which included body temperature: 99 on 21Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1661227
Sex: F
Age:
State: MA

Vax Date: 02/18/2021
Onset Date: 08/15/2021
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID/ PCR: Nasal Swab: Positive; Breakthrough COVID-acidic mouth; burnt tongue sensation; scratchy throat; mild cold symptoms; cough/ dry hacking cough; Congestion/Nasal stuffiness; joint stiffness; low grade fever; limited taste and smell; limited taste and smell; fatigues; This is a spontaneous report from a contactable consumer or other non-HCP. A 57-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) intramuscularly on 28Jan2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9809) intramuscularly on 18Feb2021 as dose 2, single (at the age of 57-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination and was tested for COVID-19 post vaccination. Vaccination facility type was reported as Pharmacy or Drug Store. It was unknown if patient received any other vaccine in four weeks. The patient medical history and concomitant medications were not reported. The patient experienced break-through COVID-19, COVID/PCR (nasal swab) test with result as positive (COVID-19), breakthrough covid-acidic mouth, burnt tongue sensation, scratchy throat, mild cold symptoms, stuffy nose, cough/dry hacking cough, congestion, joint stiffness, low grade fever, limited taste and smell, fatigue on 15Aug2021 20:00. Patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included Sars Cov-2 PCR Test Nasal Test (reported as polymerase chain reaction (Nasal Swab)) with result as positive on an unspecified date in Aug2021. The outcome of events was resolved on an unspecified date in Aug2021. Follow-up (26Aug2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1661228
Sex: F
Age:
State: DE

Vax Date: 05/26/2021
Onset Date:
Rec V Date: 09/01/2021
Hospital:

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

Lab Data: Test Date: 20210528; Test Name: Nasal Swab; Result Unstructured Data: Test Result:positive

Allergies:

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

Symptoms: 26May2021: Dose Number: 1/ 28May2021:Nasal Swab: Positive; This is a spontaneous report from a contactable consumer. A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0182, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 26May2021 17:30 (Age at vaccination 37 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included venlafaxine (VENLAFAXINE); colecalciferol (VITAMIN D [COLECALCIFEROL]). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, patient been tested for COVID-19. The patient experienced 26May2021: dose number: 1/ 28May2021 nasal swab positive on an unspecified date. The patient underwent lab tests and procedures which included nasal swab test was positive on 28May2021. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: VENLAFAXINE; VITAMIN D [COLECALCIFEROL]

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am