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: 1743737
Sex: F
Age:
State: WA

Vax Date: 09/09/2021
Onset Date: 09/12/2021
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: Test Date: 20210912; Test Name: I was diagnosed; Result Unstructured Data: Test Result:pericarditis; Test Date: 20210912; Test Name: Nasal swab; Test Result: Negative ; Comments: Nasal swab

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: myocarditis; pericarditis; This is a spontaneous report from a non-contactable consumer (patient). A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 09Sep2021 10:00 (Batch/Lot number was not reported) as single dose (at the age of 33-years-old) for COVID-19 immunization. Medical history included none. The patient was not pregnant. No known allergies. Not diagnosed with COVID prior to vaccination. No other vaccines in four weeks. Concomitant medications included metoprolol and piroxicam (PAXIL [PIROXICAM]). The patient reported that, "On Sunday night I was diagnosed with pericarditis but was unconfirmed. Went to the ER and was confirmed with myocarditis." The event started on 12Sep2021 04:15 AM. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 1 day. The patient underwent lab tests and procedures which included investigation: pericarditis on 12Sep2021, SARS-CoV-2 test: negative on 12Sep2021 (Nasal swab). Therapeutic measures were taken as a result of the event which included Tylenol and colchicine and indomethacin. The outcome of the 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: METOPROLOL; PAXIL [PIROXICAM]

Current Illness:

ID: 1743738
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: thought she was having a stroke; in bed with a migraine; having an aneurysm; no one could touch her arm for 5 days; bed for 5 days with a headache; could not move her arm; This is a spontaneous report from a Pfizer sponsored Program from a contactable consumer reported for sister. A female patient of unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The reporter stated she knew a lot of people that had had been getting a lot sicker after getting the vaccine. She reported that the patient had an adverse event after the vaccine and was in bed for 5 days with a headache and thought she was having a stroke. The reporter said that the patient could not move her arm. The patient was in bed with a migraine, thought she was having an aneurysm, no one could touch her arm for 5 days. It was so severe and debilitating after she got her vaccine. The reporter said that she had had a bunch of family members that got the vaccine. The reporter confirmed that she had not received the vaccine. Outcome of the 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: 1743739
Sex: M
Age:
State: LA

Vax Date: 06/19/2021
Onset Date: 06/22/2021
Rec V Date: 09/29/2021
Hospital: Y

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: pseudo- dementia type symptoms; psychosis; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 19Jun2021 at 11:00 (at the age of 55-years-old) as dose 2, single for COVID-19 immunisation. Medical history included depression, high blood pressure, severe west Nile virus, and encephalitis (7 years earlier) all from an unknown date. The patient previously took LAMICTAL and experienced allergy. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included celecoxib (CELEXA), lisinopril and gabapentin (NEURONTIN) all taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 22May2021 at 12:00 (at the age of 55-years-old) for COVID-19 immunisation. On 22Jun2021 at 08:00, the patient experienced pseudo- dementia type symptoms and psychosis. The events resulted in Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, and disability or permanent damage. Therapeutic measures were taken as a result of the events which included multiple tests, antiseizure meds, and antipsychotics. Since the vaccination the patient has not been tested for COVID-19. The patient has not recovered from the events. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743740
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: RA Fare; This is a spontaneous report from a contactable nurse and a contactable consumer. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as a single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR, strength: 11mg), orally from 2016 (Batch/Lot number and expiration date were not reported) to an unspecified date, at 11 mg, daily for rheumatoid arthritis. The patient's medical history was not reported. Concomitant medications included MODERNA COVID-19 VACCINE taken for covid-19 immunisation; spironolactone (tablet); sertraline hydrochloride (ZOLOFT, tablet); rosuvastatin calcium (CRESTOR, tablet). The patient previously received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number and expiration date were not reported) as at age of 41 years old a single dose for covid-19 immunization. The patient experienced RA fare on an unspecified date. Clinical course: reported small RA flare after receiving the second covid vaccine that lasted one day. MD told patient to hold tofacitinib citrate (XELJANZ XR) for 1 week after covid vaccine. The action taken in response to the event for tofacitinib citrate was not applicable. The outcome of the event was recovered on an unspecified date. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds: MODERNA COVID-19 VACCINE; SPIRONOLACTONE; ZOLOFT; CRESTOR

Current Illness:

ID: 1743741
Sex: F
Age:
State: SC

Vax Date: 09/06/2021
Onset Date: 09/07/2021
Rec V Date: 09/29/2021
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: 20210809; Test Name: Eye exam; Result Unstructured Data: Test Result:Eye stye; Comments: Floaters-eye stye

Allergies:

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

Symptoms: eye styes; eye inflammation; swelling of eye; This is a spontaneous report from a contactable pharmacist (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 06Sep2021 15:15 (Lot Number: FC3182) as dose 2, single at the age of 59-years-old for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. No prior other vaccinations (within 4 weeks). No family medical history relevant to the events. The patient previously took first dose of bnt162b2 (Lot Number: FA7485, Expiration Date: 30Oct2021) in right arm on 06Aug2021 05:00 PM and experienced rapid heart rate (heart rate went up to 140) on 07Aug2021 with outcome of not recovered. The patient experienced eye styes, eye inflammation, swelling of eye, all on 07Sep2021 07:00 with outcome of not recovered. Seriousness criteria for all events was disability, medically significant. AE required visit to: physician office. Relevant tests: Eye exam on 09Aug2021: Eye sty (Floaters-Eye sty).

Other Meds:

Current Illness:

ID: 1743742
Sex: F
Age:
State: RI

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Suffered a sever stroke; This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient a sever stroke after getting vaccine there was nothing wrong with her till she was vaccinated. 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: 1743743
Sex: F
Age:
State: WY

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: high blood pressure; This is a spontaneous report from a Pfizer sponsored program, via a contactable consumer (patient). A 60-year-old female consumer patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 12Mar2021 (age at the time of vaccination 60-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, for COVID-19 immunization. On an unspecified date 2021, the patient experienced high blood pressure. Patient received medication as a treatment of adverse event. 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: 1743744
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Serum albumin; Result Unstructured Data: Test Result:3.4 g/dl; Test Name: Serum albumin; Result Unstructured Data: Test Result:3.8 g/dl; Comments: Day 2; Test Name: Serum albumin; Result Unstructured Data: Test Result:3.0 g/dl; Comments: Day 6; Test Name: Serum creatinine; Test Result: 0.54 mg/dl; Test Name: Serum creatinine; Test Result: 1.31 mg/dl; Comments: Day 2; Test Name: Serum creatinine; Test Result: 0.66 mg/dl; Comments: Day 6; Test Name: Oxford MEST-C score; Result Unstructured Data: Test Result:M0 E0 S0 T0 C0; Test Name: Representative glomerulus; Result Unstructured Data: Test Result:showing mild mesangial matrix expansion without me; Comments: showing mild mesangial matrix expansion without mesangial hypercellularity on periodic acid-Schiff stain, original magnification x40; Test Name: Immunofluorescence microscopy; Result Unstructured Data: Test Result:3+ granular mesangial reactivity for IgA, original; Comments: 3+ granular mesangial reactivity for IgA, original magnification x10. Bar 1/4 20 mm (A) and 50 mm (B).; Test Name: Urine protein-to-creatinine; Result Unstructured Data: Test Result:1.6; Comments: mg/mg; Test Name: Urine protein-to-creatinine; Result Unstructured Data: Test Result:1.07; Comments: Day 2 mg/mg; Test Name: Urine protein-to-creatinine; Result Unstructured Data: Test Result:0.86; Comments: Day 6 mg/mg

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: acute kidney injury; gross hematuria; This is a literature report in 2 pediatric patients after receiving the Pfizer COVID-19 vaccine. This Other Health Professional reported similar events for two patients. This is the first of two reports. To the editor: With great interest, we read the recent reports of IgA nephropathy (IgAN) flare-up presenting as macroscopic hematuria, following the second dose of coronavirus disease 2019 (COVID-19) vaccination in adult patients. The Food and Drug Administration granted an emergency use authorization for the Pfizer-BioNtech COVID-19 vaccination in Dec2020 for individuals aged $16 years; the emergency use authorization was recently expanded to include children aged 12 to 15 years on 10May2021. Herein, we report 2 pediatric patients with IgAN presenting with macroscopic hematuria <24 hours after Pfizer COVID-19 vaccination. Neither patient had COVID-19 infection before vaccination nor any history of reactions to any vaccinations. The first patient is a 13-year-old boy with a history of type 1 diabetes mellitus and known IgAN (IgAN with minor histomorphologic alterations on light microscopy. Representative glomerulus showing mild mesangial matrix expansion without mesangial hypercellularity on periodic acid-Schiff stain, original magnification x40. Immunofluorescence microscopy with 3+ granular mesangial reactivity for IgA, original magnification x10). His initial IgAN diagnosis was made 6 months before this event during an evaluation for subnephrotic proteinuria and microscopic hematuriawith normal renal function, and he was receiving treatment with lisinopril. Before COVID-19 vaccination: Microscopic hematuria and subnephrotic proteinuria noted on routine urine screening for diabetes, leading to IgAN diagnosis. Within 24 hours following the second dose of the COVID-19 vaccine, he developed new onset gross hematuria and acute kidney injury. His gross hematuria self-resolved, and his kidney function recovered without intervention within 1 week. Variables: Serum creatinine mg/dl, Before COVID-19 vaccination: 0.54; Following COVID-19 vaccination: Day 2: 1.31; Day 6: 0.66; Serum albumin, g/dl, Before COVID-19 vaccination was 3.4; Day 2: 3.8; Day 6: 3.0; Urine protein-tocreatinine ratio, mg/mg Before COVID-19 vaccination was 1.6; Day 2: 1.07; Day 6: 0.86. Oxford MEST-C score Before COVID-19 vaccination was M0 E0 S0 T0 C0. Stopped lisinopril on day 5.; Sender's Comments: Based on the review of available information, the causal relationship between the adverse reaction Acute Kidney Injury (AKI) and the suspect product Pfizer-BioNtech COVID-19 vaccination is assessed as possibly related. 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.,Linked Report(s) : 202101224443 Same article/ patient and different drug/event

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743745
Sex: U
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: dizziness; fatigue; extreme nausea; This is a spontaneous report from a contactable Consumer or other non-HCP reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, fatigue and extreme nausea. The reported stated that keep hearing and various communication sites that the side effects of the booster shot in 5 percent of the people are sore arms and swollen gland. I personally was down and out for three days with dizziness, fatigue and extreme nausea. Three of my friends had the same thing. The patient outcome of the events was unknown at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743746
Sex: M
Age:
State: AR

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 09/29/2021
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: Suicidal ideations; bumps all over his body; mood swings- angry, happy, crying, and wanting to kill himself; allergic reaction; feeling hollow and feeling numb; Hurting enough; He felt like he had been bit by ants all over; feels like his head is going to pop; Pounding headache/headache; This is a spontaneous report from a contactable consumer or other non-HCP (patient wife) via Medical Information Team. A 25-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FC3183) via an unspecified route of administration in left arm on 16Sep2021 as dose 1, single (at the age of 25-years-old) for COVID-19 immunization. Patient medical history included ongoing bipolar disorder, bipolar disorder prior to the vaccine, diagnosed in childhood. The concomitant medication included ongoing paliperidone palmitate (INVEGA SUSTENNA) via an unspecified route of administration in left arm at a dose of 900 mg every three months for bipolar disorder. The patient experienced bumps all over his body, mood swings including angry, happy, crying, and wanting to kill himself (suicidal ideations), allergic reaction, feeling hollow and feeling numb on 16Sep2021. The patient felt like his head was going to pop, headache, on an unspecified date in 2021. The reported seriousness of the events was non-serious. 25-year-old male husband received the first dose yesterday (16Sep2021) and had the following side effects, bumps all over his body treated with benadryl that went away, pounding headache that would not go away - felt like his head was going to pop, mood swings including angry, happy, crying, and wanting to kill himself. Suicidal ideations have resolved but his moods were still swinging. She wanted more information on side effects and if there is anything else he can take besides Tylenol for the headache because it has not relieved his headache. He takes an injection, 900mg of Invegasustenna, every 3 months. Yesterday morning he was fine. He got the vaccine, laid down, woke up and did not know where he was, would cry and then laugh. Their pharmacist said this was an allergic reaction and that his Invegasustenna had some of the same ingredients as the vaccine like hydroxybutyl, hexane, and hexyldecanoate. The pharmacist said that if she would have known that, she never would have given him the vaccine and wanted to know if he could take steroids for the allergic reaction. Patient had been taking since he was 8-years-old. She stated her husband had first dose of the Pfizer Covid vaccine yesterday (16Sep2021), stated now he was getting some adverse events, stated he was having some bumps, that he was growing angry sometimes, then he was happy and then crying sometimes, sometimes he said he wanted to kill himself, that he was feeling hollow and feeling numb and hurting enough on 16Sep2021. She confirmed the details provided by the states he was fine yesterday morning and since he had the shot he had not been. She confirmed the patient was no longer feeling like he would like to kill himself. Still felt hollow and numb. She stated he felt like he had been bit by ants all over, stated the bumps were all over his body, treated with Benadryl and bumps were gone as of this morning, but still felt like ants were crawling all over his body. Stated he was also having a headache, started about 15 to 20 minutes after shot, stated he felt like his head was going to pop. He was still having the headache, she wanted to know what should she do to help him. Description of product included Stated he had tried taking Tylenol and it was not working, bought it yesterday- stated it was called extra strength pain relief, the generic store brand, 500mg, (Lot number- AMV1928, Expiration Date - 27Aug2029). Product strength and count size dispensed: 100capsules. Therapeutic measures were taken as a result of bumps all over his body, headache. The outcome of the event bumps all over his body was resolved on 17Sep2021, outcome of the event suicidal ideations was recovering, outcome of the events feels like his head is going to pop, headache, allergic reaction, crawling sensation, hurting enough was unknown while that of other events was not resolved.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness: Bipolar disorder (Verbatim: Bipolar disorder prior to the vaccine, diagnosed in childhood)

ID: 1743747
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: Kidney biopsy; Result Unstructured Data: Test Result:consistent with IgAN with cellular glomerular cres; Comments: consistent with IgAN with cellular glomerular crescents and moderate to severe tubulointerstitial scarring suggesting an acute exacerbation of preexisting IgAN.; Test Name: Serum albumin; Result Unstructured Data: Test Result:3.8 g/dl; Comments: Day 9; Test Name: Serum creatinine; Test Result: 1.78 mg/dl; Comments: Day 6; Test Name: Serum creatinine; Test Result: 1.47 mg/dl; Comments: Day 9; Test Name: Serum creatinine; Test Result: 1.20 mg/dl; Comments: Day 22; Test Name: Immunofluorescence; Result Unstructured Data: Test Result:shows 2+ granular mesangial staining for IgA.; Comments: shows 2+ granular mesangial staining for IgA.; Test Name: Oxford MEST-C score; Result Unstructured Data: Test Result:M1 E1 S1 T1 C1; Test Name: Immunofluorescence microscopy; Result Unstructured Data: Test Result:shows electron-dense deposits in mesangium. Bar 1/; Comments: shows electron-dense deposits in mesangium.; Test Name: Urine protein-to-creatinine; Result Unstructured Data: Test Result:1.75; Comments: mg/mg Day 9

Allergies:

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

Symptoms: acute kidney injury; gross hematuria/macroscopic hematuria; Proteinuria; stage I hypertension; This is a literature report from the Medical Journal. This Other Health Professional reported similar events for two patients. This is the second of two reports. To the editor: With great interest, we read the recent reports of IgA nephropathy (IgAN) flare-up presenting as macroscopic hematuria, following the second dose of coronavirus disease 2019 (COVID-19) vaccination in adult patients. The Administration granted an emergency use authorization for the Pfizer-BioNtech COVID-19 vaccination in Dec2020 for individuals aged 16 years; the emergency use authorization was recently expanded to include children aged 12 to 15 years on 10May2021. Herein, we report 2 pediatric patients with IgAN presenting with macroscopic hematuria <24 hours after Pfizer COVID-19 vaccination. Neither patient had COVID-19 infection before vaccination nor any history of reactions to any vaccinations. The second patient is a previously healthy 17-year-old boy who presented with new-onset gross hematuria, proteinuria, and acute kidney injury <24 hours following the second dose of the vaccine. He had no family history of autoimmune disease, and he was not taking any medications. His gross hematuria self-resolved, but his kidney insufficiency persisted. Kidney biopsy performed 9 days later was consistent with IgAN with cellular glomerular crescents and moderate to severe tubulointerstitial scarring (IgAN with cellular glomerular crescents. Moderate interstitial fibrosis is evident on the trichrome stain. The glomerulus on the left shows a segmental cellular crescent, and the glomerulus on the right shows segmental mesangial hypercellularity with mild mesangial matrix expansion on periodic acid-Schiff stain. Immunofluorescence staining shows 2+ granular mesangial staining for IgA. Electron microscopy shows electron-dense deposits in mesangium), suggesting an acute exacerbation of preexisting IgAN. He received i.v. methylprednisolone pulses, and his follow-up serum creatinine level showed improvement. The mechanism by which COVID-19 vaccination may be associated with IgAN flares is unclear. We concur with previous authors statements that patients, including children, with IgAN should be monitored closely following COVID-19 vaccine, and COVID-19 vaccination may unmask previously undiagnosed glomerulonephritis in pediatric patients. Before COVID-19 vaccination: the patient had Foamy urine for several months. Following COVID-19 vaccination: New-onset macroscopic hematuria x 4 d and stage I hypertension. Variables: Serum creatinine mg/dl, Following COVID-19 vaccination: Day 6: 1.78, Day 9: 1.47, Day 22: 1.20 following corticosteroid treatment); Serum albumin g/dl Day 9: 3.8; Urine protein to creatinine ratio, mg/mg, Day 9: 1.75. Oxford MEST-C score Day 9: M1 E1 S1 T1 C1. Treatment for acute kidney injury included: Day 9: 1 g i.v. methylprednisolone daily x 3, followed by oral prednisone.; Sender's Comments: Based on the review of available information, the causal relationship between the adverse reaction Acute Kidney Injury (AKI) and the suspect product Pfizer-BioNtech COVID-19 vaccination is assessed as possibly related. 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.,Linked Report(s) : 202101224115 Same article/ patient and different drug/event

Other Meds:

Current Illness:

ID: 1743748
Sex: F
Age:
State: FL

Vax Date: 05/10/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital: Y

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

Lab Data: Test Name: Blood test: Clotting factor; Result Unstructured Data: Test Result:high with result of 104; Comments: They did a blood test and her clotting factor was high with result of 104, and the normal is 29-39, date unknown; Test Date: 202109; Test Name: scans; Result Unstructured Data: Test Result:blood clot found was one near the portal vein; Comments: They didn't find any other blood clots on any other scans done in the hospital during 11Sep2021-12Sep2021 admission. The only blood clot found was one near the portal vein to her liver.

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Trouble of pain in her right side which was diagnosed as blood clot near the portal vein to her liver; blood clot appeared/The only blood clot found was one near the portal vein to her liver; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EWO176, Expiration date: Aug2021) via an unspecified route of administration, in left arm on 10May2021 at 13:00 (at the age of 56-year-old) as dose 2, single for COVID-19 immunization and influenza vaccine (FLU, Lot number was not reported) on an unspecified date for immunization. The patient medical history included menopause, patient mentioned she was probably considered overweight. Concomitant medication(s) included estradiol (ESTROGEN) taken for menopause treatment, start and stop date were not reported; drospirenone, ethinylestradiol (VESTURA) taken for hormone replacement therapy from an unspecified start date and ongoing; quetiapine; levothyroxine sodium (SYNTHROID); bupropion hydrochloride (WELLBUTRIN), all taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8731, Expiration date: Jul2021) via an unspecified route of administration, in left arm on 19Apr2021 at 13:00 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization. The patient had the dose of the Pfizer Covid-19 vaccine in May2021 and the blood clot appeared in Sep2021. On 11Sep2021, she was admitted with trouble of pain in her right side which was diagnosed as blood clot near the portal vein to her liver. They did a blood test and her clotting factor was high with result of 104, and the normal is 29-39, date unknown. They were scheduling to check for more blood clots. They didn't find any other blood clots on any other scans done in the hospital during 11Sep2021-12Sep2021 admission. The only blood clot found was one near the portal vein to her liver. Patient reported that she recently received a flu shot and had taken estrogen therapy/HRT for "ten years or more" for menopause treatment. Caller asked if anyone had reported blood clotting with the vaccine and if there was any information from those reports of the onset of the clots. The patient shared additional studies she found regarding blood clots being linked to Pfizer covid 19 vaccine. It looks like the Pfizer vaccine does create a small risk of clots, so in her case it might not be her hormone therapy causing the clotting. The doctors may be thinking that taking hormone therapy is not a good idea; it's very possible or at least possible it was just from getting the vaccine and it is listed as a side effect on the Pfizer vaccine and a J&J vaccine there is a small risk of blood clots; mostly in women; this is problem, with the vaccine in women, that women may have increased risk of side effects. there was a death, they died of myocarditis; they're linking her death to the vaccine it looks like. Advised caller that myocarditis does have a risk too within the Pfizer Covid-19 Vaccine which is listed in the prescribing information; she encouraged patient to follow-up with her healthcare provider. Caller then goes on to explain that there was probably a difference between women and men. Women may be more vulnerable to the vaccine but may have fallen into a very small category of the risk category. that person died of myocarditis and they definitely linked it to the vaccine; caller does not know for sure but there seems to be a link between the two. There has been a recent increase in reporting these events. The article is a fact checked article; not necessarily relevant, obviously everybody has to get the vaccine, but in this case there is more frequently the risk shortly after the second dose of vaccine; generally effects are extremely mild with patients recovering in a short time. There is a link between myocarditis and the Pfizer jab. Agent advised caller again that they have had some reports of myocarditis and advised caller to address these concerns with her healthcare provider. Caller continued that rather than suggesting it may have been the hormone therapy, that with the vaccine she may have fallen into a small group. She doesn't get vaccines, she doesn't usually even get flu shots and they're saying that there may be additional risk so they're saying it could be 1700 cases of stroke among a huge population millions of people with that risk of stroke so a very small risk. There is slightly increased risk of appendicitis with Pfizer vaccine of 5 patients of 100000. This is possible; so this is something the healthcare provider needed to also put on the table, but the only thing they attacked was her estrogen hormone therapy other than that, but there in (name withheld) everyone is anti something. There is information regarding thromboembolism, thrombocytopenia which suggested it is with the Pfizer. There is a study and on (link withheld). Science daily does not have any information on whether there's side effects she wonders about information of a tiny group of women or young men who for some bizarre reason seem to be vulnerable to this particular vaccine. Caller said studied noted that blood clots from the vaccine could be found in 4 out of 1 million people and she said the possibility of developing a blood clot seems rare and that women's bodies respond differently than men to the vaccine. She will check back with healthcare provider, if there have been reported cases, she can go back to her healthcare provider who is just attacking her hormone therapy and say look there's a possibility this is something else. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected..

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743749
Sex: F
Age:
State: FL

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 09/29/2021
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: 20210903; Test Name: COVID-19 antibody test; Test Result: Negative

Allergies:

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

Symptoms: I felt just sore where the needle went in my arms; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EW0158,) via unspecified route of administration in arm on 13Apr2021 as dose 2, single (at the age of 45-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EN6208) via unspecified route of administration in arm on 23Mar2021 as dose 1, single (at the age of 45-year-old) for COVID-19 immunization. The patient was calling on behalf of herself and her husband. On an unspecified date in 2021, the patient felt sore where the needle went in her arms. On 03Sep2021, they went to see their HCP and had blood work done. They both who live with vulnerable people who are older than them, tested negative for antibodies on 2 different readings. She said their antibody test came back negative with zero antibodies and were questioning why. Their doctor told them that they are not protected at all. Patient wanted to know if there was any antibody testing that they can do, since Pfizer did do testing to determine if the vaccine was effective. And also wanted to know how Pfizer determines that the vaccine was effective, or should they just take your word on the vaccine working. She said on top of that, they thought maybe the ones she got were damaged or something, and then they were both negative for antibodies. The patient underwent lab that included SARS-CoV-2 antibody test: negative on 03Sep2021. Patient reported that her antibody test was collected 03Sep2021 and results were negative. She clarified that the test results read as SARS CoV 2, IgG NUCLEOCAP, IgM SPIKE, QL as the top one, then indented on the next line it says SARS CoV 2 AB (IgG), NUCLEOCAPSID, QL then SARS CoV 2 AB IGG for specific test with negative next to that, then another title that says negative as well. Patient mentioned that their tests both said negative as well for each result and her doctor said this morning if one of the two results for the test said positive it would be good, they just don't want both results on the test to say negative. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1743750
Sex: M
Age:
State: SC

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/29/2021
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: 20210730; Test Name: blood test for Covid antibodies; Result Unstructured Data: Test Result:has antibdoies

Allergies:

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

Symptoms: after first dose, was totally whacked out and was in bed for 24 hours; Had absolutely no energy the following night; I stayed in bed for 24 hours because I was just totally exhausted; Well the first one totally wiped out so I expected that. I wasn't surprised. I was in bed for 24 hours; This is a spontaneous report from a contactable consumer (patient himself). An 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3181, expiry date: unknown) via unspecified route of administration in left arm on 23Aug2021 (age at vaccination: 80-years) as dose 1, single for covid-19 immunisation. Medical history of patient included Diabetes, Moderate kidney disease, Cholesterol, High Blood pressure, blood pressure, and water pill from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide 25 mg, daily as water pill, amlodipine besilate, 10 mg daily for high blood pressure, atenolol 100 mg for blood pressure, omeprazole 20 mg daily for unknown indication, atorvastatin calcium 40 mg, daily for cholesterol. After first dose, patient had absolutely no energy the following night, Wednesday night, and stayed in bed for 24 hours because he was just totally exhausted on 23Aug2021. No additional vaccines administered on same date of the Pfizer suspect. Prior Vaccinations (within 4 weeks) was administered. Here was no emergency room visit or physicians office visit due to the adverse events. Patient underwent lab test which included blood test for Covid antibodies, with results: has antibodies, on 30Jul2021. The outcome of the events was unknown.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743751
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: He had soreness in the arm after receiving the 1st, 2nd, and 3rd dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 76-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Consumer said patient already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine. He said he had his 3rd dose a couple of weeks ago. However, on the 20th, he said they will be releasing the booster dose and he wanted to know if he should still receive it. He also mentioned that he had soreness in the arm after receiving the 1st, 2nd, and 3rd dose on unknow date. The outcome of the events was reported as unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743752
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: My elderly mother and I were superinfected by an unvaccinated nurse at the workplace. My mother was vaccinated with your vaccine and has not had to be hospitalized and is recovering.; My elderly mother and I were superinfected by an unvaccinated nurse at the workplace; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other-HCP reported similar events for 2 patients. This report is 2nd of 2 reports. A female patient of unspecified age received BNT162B2 (PFIZ-ER-BIONTEC COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Reported stated she was a Geriatric Psychiatric Nurse Practitioner and 322 of her patients die from COVID-19. Since her patients have been vaccinated with Pfizer vaccine none of them who have been superinfected with Delta have died. Also reported said My elderly mother and I were superinfected by an unvaccinated nurse at the workplace. My mother was vaccinated with your vaccine and has not had to be hospitalized. The outcome of the events was recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of covid19 and drug ineffective cannot be totally excluded.,Linked Report(s) : US-PFIZER INC-202101224473 same reporter, drug, event, different patient

Other Meds:

Current Illness:

ID: 1743753
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: He later found out the vaccine he received was undiluted; had a fever kind of thing; feeling under the weather or whatever; This is a spontaneous report from a contactable consumer (other health care professional). A 29-years-old male patient received second dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Batch/Lot number was not reported, expiry date: unknown), via an unspecified route of administration in Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date as DOSE 1, SINGLE for covid-19 immunisation. Patient received second dose two weeks ago and for 6 hours afterward had a fever kind of thing, feeling under the weather or whatever. He later found out the vaccine he received was undiluted. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1743754
Sex: F
Age:
State: IN

Vax Date: 01/26/2021
Onset Date: 01/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: egg shaped raised area on the left arm; swelling of left arm; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL3247; Expiration Date: 31May2021) via an unspecified route of administration, administered in Arm Left on 26Jan2021 as DOSE 1, SINGLE (at the age of 75-year-old) for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus Diabetic Type 2, drug hypersensitivity (Allergies: can't take penicillin's, antibiotics, sulfa). Concomitant medications included apixaban (ELIQUIS) taken for anticoagulant therapy. On Jan2021, the patient experienced egg shaped raised area on the left arm. On an unspecified date in 2021, patient experienced swelling of left arm. After second shot, patient got both shots in the left arm, patient got this thing that was kind of an egg shaped hard bump on her arm, it was big. After both shots in Mar2021, the left arm also started swelling, it slowly swelled over time. Patient has had 5 different procedures done and they don't know what's wrong with her arm, patient has to learn to live with it. The first 3 doctors patient saw said it has nothing to do with the Pfizer shot. The last doctor that patient saw which was like a vein specialist said that because they don't know enough about the shot, it could be from that. Caller stated that now patient cant get blouses, they have to be tapered on left arm because its so big. They are fitting her for a percussion sleeve and that was all they can do with it. Later in the call caller clarifies it is a compression sleeve not a percussion sleeve, patient misspoke. Patient was pretty sure it has to do with the Pfizer shot. Patient has a lot of allergies to different drugs. Caller stated that since after this happening with the Pfizer shot, Patient would still get the shot even if she knew this was going to happen. Now patient has to buy different clothes. Caller adds that it does pain sometimes because it was heavier than her right arm but it does not pain her, all the time, it's sore. Patient stated that she knows she got it in Mar2021 but on the card it says the first dose as 26Jan2021 and the second dose as 19Feb2021. She went to the hospital to receive the vaccine, she doesn't know why they have the date mixed up. The egg came the day after, the swelling patient didn't notice because it was so slow, patient recall that patient went to family doctor in May2021 and by then it was swelled up, the doctor didn't think it was important. The egg shaped area started at the end of Jan2021. Patient did not know when but it slowly went away. Patient recalls it being hard. Patient knows it was present in May2021 but she doesn't know when it started. It has just gotten bigger over the month, she thinks its stopped growing but it's not going down, it's just the same right now. Caller confirmed vaccine dose dates on her covid card are correct, and she had mistaken it for being sometime in Mar2021. First Dose: Lot EL3247 Expiry 31May2021 Second Dose: Lot EM9810 Expiry 30Jun2021. Investigation: In Jun2021 or Jul2021 she took a test to see if had a blood clots and that was negative. In Jul2021 she had a CT scan of her whole shoulder and it showed nothing. In Aug2021 she went to the vein specialist in which they put liquid in the vein to see if there was a clog and that was negative. All 3 procedures were negative. Treatment: There was nothing she can do about it, she did all the tests and nothing is wrong. The last thing she was fitted for is a compression sleeve, she is being fitted for it now. Caller confirmed in compression and not percussion. She has had to see Physicians, but has not had to go to the emergency Room. Prior to ending the call she asks that she would like to get the booster shot, should she get it in the same arm or in the right. On an unspecified date in 2021, vaccination site mass was resolved and outcome of swelling of left arm was not recovered.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness: Type 2 diabetes mellitus (Diabetic Type 2)

ID: 1743755
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/02/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: the patient was in a room with two other vaccinated individuals, in a meeting, without masks; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: 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 02Aug2021 the patient was in a room with two other vaccinated individuals, in a meeting, without masks. It was reported that on Thursday, 05Aug2021, the patient learned that one of the persons who had the Pfizer COVID vaccine had tested positive for Covid 19. 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: 1743756
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COVID side effects; I am having issues; COVID side effects; I am having issues; This is a spontaneous report from a contactable consumer (patient reported for self). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown and Expiration 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 COVID side effects; patient was having issues. Reporter stated that it was because of COVID, COVID side effects, patient was having issues and there was nobody to talk to. So, the patient wanted to speak to a supervisor. The outcome of the 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: 1743757
Sex: M
Age:
State: WA

Vax Date: 09/18/2021
Onset Date: 09/18/2021
Rec V Date: 09/29/2021
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: 2021; Test Name: COVID-19; Test Result: Negative ; Comments: Covid test type post vaccination=Unknown, covid test result=Negative

Allergies:

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

Symptoms: Temporary partial blindness; ringing in right ear; pale skin; sweating; dizziness.; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Sep2021 15:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Prior to vaccination, was the patient diagnosed with COVID-19, known allergies: numerous foods and environmental substances like trees and grass all from an unknown date and unknown if ongoing. Since the vaccination, has the patient been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. There were no concomitant medications. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: unknown) on 27Aug2021 12:00 PM at the left arm for COVID-19 immunization. It was reported that the patient experienced Temporary partial blindness, ringing in right ear, pale skin, sweating, dizziness on 18Sep2021 03:30 PM. The patient underwent laboratory procedure which includes covid test post vaccination (unknown covid test type), which was negative in 2021. The outcome of the events was recovered on 27Sep2021 12:00 PM. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743758
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: He had soreness in the arm after receiving the 1st, 2nd, and 3rd dose; He already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine; he already received 3 doses of the Pfizer-BioNTech Covid-19 Vaccine; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 76 year old male patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3,SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness in the arm after receiving the 1st, 2nd, and 3rd dose causing pain in extremity on an unspecified date with outcome of unknown, he already received 3 doses of the pfizer-biontech covid-19 vaccine leading to off label use and extra dose administered on an unspecified date with outcome of unknown. He wants to know if he should still receive booster dose. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743759
Sex: F
Age:
State:

Vax Date: 08/01/2020
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Abscess; Crohn's disease; Device issue; This is a solicited report based on the information received by Pfizer from agency (Manufacturer Control No: 21K-163-4081454-00). Solicited report from by a contactable 24-year-old female patient with events of might have Crohn's instead of ulcerative colitis due to abscesses and non-serious might have Crohn's instead of ulcerative colitis due to abscesses and pen misfire with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced might have Crohn's instead of ulcerative colitis due to abscesses and pen misfire. Pfizer biontech COVID-19 vaccine (Tozinameran) was also considered suspect. The patient was in hospital for abscesses. She thought that she might have Crohn's instead of ulcerative colitis due to abscesses. She had pen misfire. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 23May2021, patient received 1st dose COVID-19 vaccine manufactured by Pfizer. Primary reporter did not have the lot number information, because the packaging was discarded. The reporter's causality for the event(s) of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset and pen misfire was not provided. Agency's opinion is that there is no reasonable possibility that the events of might have Crohn's instead of ulcerative colitis due to abscesses unknown onset, might have Crohn's instead of ulcerative colitis due to abscesses unknown onset and pen misfire are related to Humira (Adalimumab). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Reported events of Abscess and Crohn's' disease are most likely intercurrent conditions and unrelated to BNT162B2 vaccine. Pen misfire was related to co-suspect medication Humira (Adalimumab). Case will be reassessed upon receipt of additional information.

Other Meds:

Current Illness:

ID: 1743760
Sex: F
Age:
State:

Vax Date: 08/25/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: her nose feeling stuffed and clogged; trouble breathing; heart palpitates; headache; fatigue; body aches; bumps on her face and body; bones hurt; throat hurts; her eye is red and itching; her eye is red and itching; She experienced an allergic reaction throughout her body; This is a spontaneous report from a contactable consumer via medical information team. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunization. Medical history included she went through COVID very bad last year from 2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her nose felt stuffed and clogged, trouble breathing, heart palpitates, this has been going on for 3 weeks, headache, fatigue, body aches, bumps on her face and body, bones hurt, throat hurts, her eye is red and itching, she experienced an allergic reaction throughout her body. Outcome of the 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: 1743761
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: deep thrombosis on both of her legs; "made her nerve shot"; diarrhea; can see but little hard to read small prints; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm in Apr2021 (batch/lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Caller (patient) said that she was on a blood thinner and has been for 2 years and they never mentioned anything about it when they gave her the vaccine. On her first shot of bnt162b2, she experienced increased heart rate (reached 133) and stomach ache. Caller also stated that her arm went sore but was not indicated whether it was on her first or second shot. On her second shot, she experienced deep thrombosis on both of her legs, diarrhea that comes and goes, "can see but little hard to read small prints", "made her nerve shot" in 2021. Patient also wanted to confirm if it would be advisable to administer the vaccine on the other arm if there is a cancer on one arm but did not state if she has this condition. Outcome of events was unknown. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1743762
Sex: M
Age:
State: CA

Vax Date: 02/17/2021
Onset Date: 09/14/2021
Rec V Date: 09/29/2021
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: 20210914; Test Name: RT-PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: Positive COVID-19 test via PCR 14Sep2021; COVID-like symptoms 10Sep2021; This is a spontaneous report from a contactable consumer or other non hcp ). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 17Feb2021 11:00 (at the age of 35-year-old) (Batch/Lot Number: EN5318) as dose 2, single, dose 1 intramuscular, administered in Arm Left on 28Jan2021 11:00 (at the age of 35-year-old) (Batch/Lot Number: EN5318) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 10Sep2021 16:00, the patient had COVID-like symptoms.On 14Sep2021, the patient had positive COVID-19 test via PCR. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Sep2021 Nasal Swab. No treatment received for the events. The adverse events were result in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743763
Sex: M
Age:
State: MD

Vax Date: 02/20/2021
Onset Date: 02/21/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:enlarged left atrium; Comments: enlarged left atrium.; Test Date: 20210221; Test Name: Heart beat; Result Unstructured Data: Test Result:increased; Comments: Rapid Heart Beat

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: He was diagnosed with the atrial fibrillation; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself) via Medical Information Team. An 80-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6200) via an unspecified route of administration in left arm on 20Feb2021 16:21 as dose 2, single (at the age of 80-years-old) for COVID-19 immunization. Patient medical history included, coronary artery disease from an unknown date and unknown if ongoing, high blood pressure/blood pressure measurement from an unknown date and he was treated for high blood pressure and was still being treated for it. It seemed to be bringing his blood pressure down to normal, heart bypass surgery (vascular graft) had in 2013 he believed, heart attack (myocardial infarction) from an unknown date, he guessed he has a couple of family members who have had heart attacks. He stated that when he was four years old, clarified as probably middle school age, he had a reaction to a tetanus shot, he believed they used horse serum at the time. He had a reaction to that, he does not think they use that same vaccine anymore he guesses. He had a couple of family members who have had heart attacks, stroke (cerebrovascular accident) from an unknown date and unknown if ongoing, his brother and mother and his father had a stroke, cholesterol (blood cholesterol). He did not have any prior vaccinations within 4 weeks. The concomitant medications included amlodipine, strength 10 mg was taking the 10 mg tablet dose for years taken for high blood pressure. He mentioned his doctor cut him back to half of a tablet taken, he stated that he guessed for high blood pressure, initially, it was supposed to be. The dose was changed after the incident. He guessed the dose was changed around the time he was put on the Amiodarone, ongoing rosuvastatin calcium (CRESTOR) at a dose of 20 mg a day taken for cholesterol (blood cholesterol) for years, acetylsalicylic acid (BABY ASPIRIN) taken at a dose of 81 mg for an unspecified indication from an unspecified start date and ongoing. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9264) via an unspecified route of administration in left arm on 30Jun2021 16:30 as dose 1, single for COVID-19 immunization. He knows that it had been some time, but he was concerned with the booster possibly coming out and he had an issue on whether he should get it or not, because he did have a reaction to the second shot that was on 20Feb2021. The following day on 21Feb2021, he had to go to the emergency room twice. He clarified he had a rapid heartbeat on 21Feb2021 and he ended up with a diagnosis of atrial fibrillation. He clarified he was only seen in the emergency room and was not admitted into the hospital that day and was treated for the condition and had an ablation procedure for A. Fib. He confirmd he was on Amlodipine prior to having the rapid heartbeat, diagnosis of A-fib. The patient said, he was wondering if how many cases have been reported with a connection between the vaccine and A. Fib, rapid heartbeat recovering. He had to follow up with his cardiologist and physio-somebody who does electro cardio shock treatment to get his heart back in rhythm. He later clarified that he had a regular cardiologist and an electrophysiologist. He had an ablation procedure to take care of the A-fib. It was a cardiac ablation. The patient provided the name for his general practitioner which is his main doctor. On 19Aug2021, the patient experienced cardiac ablation. He had a computerised tomogram (CT scan) before the ablation procedure, and it showed an enlarged left atrium. He had the ablation procedure on same day. He has a rather lengthy report from when he was released from the hospital. Stated he can provide a copy of this if needed. The patient mentioned that he was on Amiodarone. Since after the ablation, he was no longer on the Amiodarone as of 19Aug2021, when he had the procedure. He was on Xarelto. He clarified his general practitioner put him on Xarelto on 23Feb2021, after the event, to prevent stroke. The patient was told there was no evidence as of the state of any connection between that. He knows some people are reporting like an A-fib sometime after the actual vaccination and is there somewhere of how many reports have been about A-fib following injection. He confirmed he went to the ER for the rapid heartbeat on 21Feb2021, which was when he was diagnosed with the A-fib. He clarified he was only seen in the emergency room and was not admitted into the hospital. He had been treated and was still recovering from the ablation procedure. It was going to take a couple of months to get back to a normal heart rate. His heart rate has been improving. He mentions he is not a medical person. He had a CT scan before the ablation procedure and it showed an enlarged left atrium. He has a rather lengthy report from when he was released from the hospital. States he can provide a copy of this if needed. Caller was advised that it would be documented in this report that he has that information to provide and advised him that Pfizer may contact him if in need of this information. He had the ablation procedure 19Aug2021. The adverse events resulted in Emergency Room twice and a visit to the physician office. Therapeutic measures were taken as a result of he was diagnosed with the atrial fibrillation, rapid heartbeat. The outcome of the events atrial fibrillation and rapid heartbeat were recovering.

Other Meds:

Current Illness:

ID: 1743764
Sex: M
Age:
State: CA

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: He had dizziness/Dizziness when he gets up; This is spontaneous report from a contactable consumer (Caregiver; Friend). A 71-year-old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: 3Q135BA, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right (upper right arm) on 20Sep2021 at 10:05 (at the age of 70-year-old) as a DOSE 1, SINGLE for covid-19 immunisation at pharmacy. The patient medical history included thyroid cancer from 1962 to an unknown date reported as, he had thyroid cancer and had the tumor out in 1962, neck surgery in 1964; in 1964 he had another neck surgery to remove little tumors, blindness from 01Nov1950 and was ongoing, he was totally blind. When he was born one of his lungs broke and he doesn't know if he has two lungs. His dad said it broke, but his sister said his lung got weak and he had to be on a breathing machine. Patient clarified that he was born blind. The patient's concomitant medications were not reported. There was no other Products or patient History. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) and event following prior vaccinations were none. The patient experienced he had dizziness/dizziness when he gets up on 20Sep2021. Reporter was reporting for her friend who received his first dose of the Pfizer Covid vaccine this morning. She stated, "He's totally blind. He's a senior. He was experiencing dizziness. He got up to use the bathroom. He was all over the place. How long will this last? He has dizziness when he stands but when he sits, he's fine." Reporter stated there was information from what she got about tiredness and weakness and dizziness. What are the risks of Comirnaty (COVID-19 VACCINE, mRNA) and the Pfizer-BioNTech Covid-19 vaccine? that mentions "dizziness and weakness" but that's for "severe allergic reactions." Patient received his first dose this morning at 10:05 and while waiting for the 15-20 minutes and getting up to leave he had dizziness that has continued and stayed the same. The reporter stated the plan is to go to the doctor, but she wanted to see if someone different in MI could give her information about how long side effects will last; she stated that the previous MI agent didn't seem to have the information. Reporter further stated, he experienced dizziness when he gets up. She also said he was totally blind. He was a senior who was experiencing dizziness. She had to help him used the bathroom because he was all over the place. He was fine sitting right now. She had taken him to the bathroom twice and he was still experiencing it. They will try next time to stand him up and see how he was standing first. Reporter was his friend. His caregiver needed to leave and was concerned to reporter came over. They thought they would call the doctor to let him know what patient was experiencing. Patient was living alone. The dizziness hadn't improved yet at all. He was totally blind and if he falls no one will know. How long should he expect it to last? The pharmacist said a few hours. Medical Information did not answer her question and just transferred reporter to Drug Safety. Reporter had to read to the Medical Information agent on the paperwork that it says dizziness is a side effect because she didn't know it was a side effect. Reporter stated she didn't experience this, but she got Moderna. The vaccine was given at 10:05AM. They kept him there 15 to 20 minutes. When his caregiver said let's go, he got up and felt dizzy. He had home in his apartment. He was having trouble standing and walking to the bathroom still. He is still wobbly when he stands. He feels like he is going to fall. Patient is scheduled for second dose on 11Oct2021. Reporter said that the doctor advised him (patient) to get it over Moderna. He was 71 years. He had dizziness before, but not like today (date unspecified). Reporter said, if anyone could answer when the dizziness will stop, he would love a call. Event did not require a visit to Emergency Room or Physician Office. Family medical history Relevant to AEs was not provided. Relevant Tests done were none. PQC was not present. Outcome of the event was not resolved.

Other Meds:

Current Illness: Blind (He is totally blind. Patient clarified that he was born blind.)

ID: 1743765
Sex: F
Age:
State:

Vax Date: 09/17/2021
Onset Date: 09/18/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: lymph node swelling; pain in left armpit and a little above my left boob; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 49-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : FE3592 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 17Sep2021 12:00 as DOSE 2, SINGLE for Covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported.On 18Sep2021 the patient experienced lymph node swelling , pain in left armpit and a little above my left boob.The outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1743766
Sex: F
Age:
State:

Vax Date: 09/13/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: feeling a burning sensation between her elbow and wrist; Left arm was numb and sore; Left arm was numb and sore; swelling to her left arm; This is a spontaneous report from a contactable consumer (patient). This report is not related to a study or programme. A 34-years-old female patient received BNT162B2 (Comirnaty; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 13Sep2021 in the morning before 12:00 (at the age of 34-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications included none. She reported she was as healthy as could be, no diabetes, no nothing, and her family had no medical histories either. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/lot number: Unknown; Dose: Unknown strength/volume/dose injection) into left arm in the morning before 12:00 on 23Aug2021 (at the age of 34-years-old) for covid-19 immunisation and experienced sore left arm. The patient experienced left arm was numb and sore on 14Sep2021, swelling to her left arm on Sep2021, feeling a burning sensation between her elbow and wrist on 17Sep2021. After the second dose of Pfizer Covid Vaccine on 13Sep2021, the patient experienced left arm was numb and sore starting the next day, 14Sep2021. Her left arm was swollen for the next couple of days; and then by Friday, 17Sep2021 she started feeling a burning sensation in left arm between elbow and wrist which hadn't went away. She had experienced numbness, soreness, and swelling to her left arm. She verified that these events have not required a visit to the physician's office, emergency room or hospitalization. She asked for further information on these events relative to the Pfizer Covid Vaccine. She clarified the reason she called was because she no longer had insurance and she couldn't go to the doctor because it was going to come out of her pocket. The Caller took Pfizer Covid Vaccine as she was working in the education field so was required to have the vaccine. She did not want to pay for something that she didn't expect to happen and asked what kind of assistance or compensation was available for this. In response, provided information from the Fact Sheet "Side effects that have been reported with Comirnaty (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine include injection site swelling, arm pain." Spoke from the attached document no info under "adverse reaction/side effects in reference to the burning and numbness. Per Withheld caller also asked about legal information that had already addressed with the caller by providing the legal departments mailing address and fax information. Reason for no lot number of Pfizer Covid Vaccine stated as Caller did not have the CDC vaccine record card with her. No PQC was present in this report. Clinical outcome of burning sensation in left arm between elbow and wrist was not recovered and outcome of other events unknown. Information about lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1743767
Sex: M
Age:
State: CA

Vax Date: 09/14/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: swelling towards the arm pit, chest, slowly moving to the rib cage and stomach/ I'm actually swollen/ abnormal retention in the area/ Puffiness; swelling towards the arm pit, chest, slowly moving to the rib cage and stomach; The pain moved from my arm, chest/sore arm; The pain moved from my arm, chest; Drowsiness; Shoulder pain; Hard to set my arm to the side of my body; May be effecting Multiple lymph nodes, puffiness that can be seen; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2021, consumer experienced swelling towards the arm pit, chest, slowly moving to the rib cage and stomach. Consumer stated, He had initial swelling. He was a body builder. He has developed muscles. He noticed in the definition of his chest muscles. The pain moved from my arm, chest. He was actually swollen. Hard to set my arm to the side of my body. The swelling moves around. It's an abnormal retention in the area. (maybe affecting) Multiple lymph nodes; puffiness that can be seen. Previous to the vaccine everything was ok. There was swelling now. Pain in arm, lymphadenopathy from document "how long side effects last: Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. from VR no information on puffiness/abnormal retention that was moving from arms to chest, rib and stomach. Consumer stated that he was still experiencing. Added he did feel the typical sore arm; he noticed when he was working out, he was drowsy before lifting; he has some shoulder pain; then he noticed a swelling going toward his armpit and chest; now it was slowly moving to his ribcage and stomach. Adds he was fairly lean so maybe he can just see it; but he was asking is this normal? Therapeutic measures were taken as a result of all events. The outcome of events was not recovered. lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743768
Sex: F
Age:
State:

Vax Date: 09/17/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fatigue; light headed; weakness; had slept all day; fever; pain on the left lateral side; chills; her arm and her neck and it felt congested; her arm and her neck and it felt congested; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8729), dose 1 via an unspecified route of administration on 17Sep2021 09:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included crazy heart rhythm. There were no concomitant medications. Patient previously received hepatitis vaccines and experienced discomfort (The discomfort wasn't as great), Tetanus vaccines with long term issues, typhoid vaccine and The discomfort wasn't as great as it was with the typhoid, she was sick for about 3 months, arm being hugely swollen, red and painful, arm being hugely swollen, red and painful, had fever and fatigue, discomfort, she had arm swelling. Patient had had long term issues with other vaccines like Typhoid, hepatitis, and Tetanus after receiving them, so this not a surprise, but each on of those had a different duration and patient want to know in what classification this was. So she want to know about how long will it take for the symptoms to go away, as I did not expect them to last 4 days. The patient experienced chills on 17Sep2021, fever on 17Sep2021 14:30, pain on the left lateral side on 17Sep2021, fatigue on 18Sep2021 and she has been laying in bed a lot, light headed on 18Sep2021, weakness on 18Sep2021, had slept all day on 18Sep2021, her arm and her neck and it felt congested on Sep2021, her arm and her neck and it felt congested on Sep2021. She confirmed that all of her side effects began on 17Sep2021 except the fatigue, that didn't kick in until the next day, 18Sep2021. She had slept all day Saturday, off and on, and she was drifting and dozing yesterday. It has been 4 days since and she has been taking aspirin to treat her adverse reactions. Transfer agent provided that caller's age is 53 years old. The call did have questions regarding her experience such as how long these symptoms might last for her. She doesn't usually get vaccines. She had the typhoid vaccine and she was sick for about 3 months with symptoms similar to this. It was random and it was not 24/7 but it took her a long time to get over them and she had arm swelling. When caller was providing this information she was very hard to understand and this DSU agent asked her to repeat what she was saying and the caller provided that when she had the typhoid vaccine her side effects had started right away with her arm being hugely swollen, red and painful. She had the painful arm for a good while. She had residual fatigue and fever but it wasn't for 24/7. The typhoid thing lasted off and on for about 3 months. It wasn't 24/7 but it was pretty much every day that she had fever and fatigue. With her hepatitis it was weird because it is normal for her to have to get a couple of vaccines to get the titers up but with the hepatitis it took her 5 to get her titers up. The discomfort wasn't as great as it was with the typhoid but it was there for about a week. She doesn't well with vaccines so she wasn't looking forward to this one. This one was not as bad as the others and she has had no arm pain from the beginning to now. The chills started within no time and the fever and the fatigue have been dragging on. She knows it has only been about 4 days but to her it seems to be dragging on. She also does have a history of a crazy heart rhythm and it may raise but it is not an allergic reaction it is just her body doesn't like stuff sometimes. She was not alarmed when that happened, it did happen but it didn't alarm her. That has been better today. While she was there at the facility where she had her COVID vaccine the only thing that happened was in the first 15 minutes. She had a really sharp pain on the left lateral side. The precise spot is on her left rib about a hand width below her armpit and after that she had from that point along her arm she had something that she doesn't know how to describe. Actually it was not along her arm it went kind of up to the top part of her arm and her neck and it felt congested. You know how when someone pumps it up for your blood pressure to be taken and how it feels. Well the top of her arm and neck felt like that but that didn't last long, maybe 15 to 20 minutes. It wasn't even enough for her to go get anyone it was just interesting and then it went away and never came back. That was the only pain that she had but she has definitely never had that before so she knew it was vaccine related. After that she felt super fine, amazingly fine and she thought that she was off the hook. She had the COVID vaccine at 9:00 maybe and then around 2:30 she started having chills. Who she is staying with had went to the gym so she thought that he had turned down the air conditioner and she had went to turn it back up because she didn't think about the vaccine and the air conditioner wasn't low at all. Then it got worse and worse and she had to turn the air conditioner and the ceiling fans off and that has been the case for 3 to 4 days or whatever day this is now. That happened quickly, well it was 6 hours after and that's it. Then the fatigue set in pretty much then. At first she just didn't feel good because of the chills. The next morning when she went to get up she was light headed and then when she got up the weakness thing set in. She now has power at her house after the hurricane and she had bought some things to her car and she had opened the doors and the hatch and was putting stuff in her car and it was not a long distance, that was yesterday, and she had to lay down for 20 minutes without even closing her doors. She drove an hour to her house and she was okay sitting like that, she was not dizzy or anything. When she got there she made two trips inside her house and then had to leave the rest in the car and drive back. This morning she had got up and she was at an animal rescue and there are special needs animals so she was giving medication to them and she thought how she wasn't going to make it to walk today. She then took some aspirin and some vitamins thinking maybe that could help and 30 minutes after she had to go lay down. Her neighbor had knocked on the door and brought her something and checked on her. The caller had sat outside for about 30 minutes after that and thought she had to go lie down. She was sitting on the porch swing and then she would lay down on the porch swing and then she thought that she needed to go inside and lay down and that's how her day had been. She was knocked out cold at 12:30 when who she is living with had called to see how she was doing and she just woke up again today at 4:00. She had less of a fever and chills in the sense that she didn't take aspirin as often, it was kind of more like every 6 hours that she would feel the fever and chills come back and she would take aspirin and then it would get better. She was trying to fight the fatigue yesterday and do something. Not even for 24 hours could she try and take it easy but yesterday she needed to do stuff to move back to her place and she could just tell that it wasn't working and today it is not working. She was trying to push herself through and she can't quite get it. Maybe she is being wimpy and if this DSU agent says that people do better when they keep pushing through it, even though she doesn't feel like doing that, then she will do it if that's the best way to fight it. She doesn't know. She doesn't have anyone to call because the person that gave the COVID vaccine to her doesn't know her and then her chiropractor doesn't believe in the COVID vaccine in the first place so she will say that she had told the caller not to do that. caller states that she thinks that the fever and chills are better because she hasn't had to take aspirin as often. The longest that she went today was 6.5 hours without taking aspirin for the fever and chills. Inquired for fatigue outcome and she says it is the

Other Meds:

Current Illness:

ID: 1743769
Sex: F
Age:
State:

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/29/2021
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: First dose: Sore left arm; This is a spontaneous report from a contactable 34-years-old female consumer(patient). A 34-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 23Aug2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Aug2021, after the vaccination, the patient experienced a sore left arm right away. The outcome of the event was unknown. No follow-up attempts possible. No further information expected. Follow-up (PRD/SRD (23Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1743770
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: thought he had Covid earlier; thought he had Covid earlier; lost sense of smell. has regained some of it for some smells, but indicated his full sense of smell has not returned.; can smell some things like petroleum products; This is a spontaneous report from a contactable consumer(employee).A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, on unknown date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient had not received any other vaccine within 4 weeks. Patient had no known diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patients medical history and concomitant medications were not reported. No history of Additional Vaccines Administered on Same Date of the Pfizer Suspect.Pfizer employee stated he was not able to report this online for some reason, but he had a friend over this weekend who shared some information about the Comirnaty vaccine and he wanted to report it. On an unknown date the reporter stated that the patient had lost sense of smell, has regained some of it for some smells, but indicated his full sense of smell has not returned, can smell some things like petroleum products, thought he had Covid earlier. Reporter also stated that he thought he had Covid earlier but does not provide if it was before or after the vaccine administration and Pfizer employee unable to provide. No further details provided. The outcome of the event for can smell some things like petroleum products was not resolved. The outcome of the event for lost sense of smell. has regained some of it for some smells, but indicated his full sense of smell has not returned was recovering. And the outcome for the event thought he had Covid earlier was unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1743771
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Experienced Chest pains; enlarged heart, a stent put in; Found out has stage 4 colon cancer; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a female patient (neighbour). A female patient in her 70's received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 2, single on an unspecified date for covid-19 immunization. Medical history included overweight (as reported little fat, happens when you age) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller stated patient received first dose of vaccine a year ago and second dose was received 28 days after the first dose. Patient did not receive any other products (at the time report). Reporter stated that he did not go with the patient to receive the Pfizer Covid Vaccine. On unspecified date, the patient experienced chest pains after received Pfizer Covid Vaccine and went to the doctor with enlarged heart and had a stent put in. On unspecified date, patient found out now she had stage 4 colon cancer and now on chemotherapy. Caller visited the patient every day and could not see any more until and patient was safe to be around. Therapeutic measures were taken as a result of event stage 4 colon cancer with chemotherapy. At the time of this report, the outcome of events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up. Follow-up (22Sep2021): New information received from a same contactable consumer in response to Non-HCP letter sent via telephonic activity: consumer stated, 'you are working for a company who is giving out a vaccine like Moderna, your vaccine is not a vaccine, is not FDA approved, Consumer states 'is a poison, a depopulation media' No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1743772
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Diarrhea; This is a spontaneous report from a contactable male Pharmacist (patient). A male patient of unspecified age received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: unknown, Expiry date: Not provided), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient had diarrhea for the last two days. He had the shot nine days ago. He wants to know if this is a listed side effect. The clinical outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743773
Sex: F
Age:
State: PA

Vax Date: 04/23/2021
Onset Date: 04/24/2021
Rec V Date: 09/29/2021
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: Guillain Barre; muscle weakness/core/leg/hip weakness; fatigue; difficulty sit/stand/crouch/stand; problems with coordination of hands; Pins and needles hands; This is a spontaneous report from a contactable nurse or other health care professional. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 23Apr2021 11:00 (Batch/Lot Number: ER2731) as dose 2, single for covid-19 immunisation (at the age of 61-year-old). The patient medical history included incomplete spinal cord injury, spinal cord tumor from an unspecified date in 2008 and ongoing, she had an surgery on an unspecified date in 2008, the patient also had kyphosis, and cervical intervertebral disc disease from an unknown date since 2008 ,and she underwent unspecified surgery in Feb2020, the patient also had nerve injury left and nerve block on an unspecified date in 2014. The patient's concomitant medications included gabapentin (GABAPENTIN) taken for neuropathic pain via oral route on an unspecified date in 2008 and ongoing; bupropion (BUPROPION) taken for depression via oral route from an unspecified start date since 20 years and ongoing; tizanidine hydrochloride (ZANAFLEX) taken for muscle spasms via oral route from an unspecified date in 2008 and ongoing; zolpidem (ZOLPIDEM) taken for sleep via oral route from an unspecified start date since 15 years and ongoing; naproxen (NAPROXEN) taken for arthritis via oral route from an unknown date in Apr2020 and ongoing and acetaminophen (ACETAMINOPHEN) taken for arthritis via oral route from an unknown date in Apr2020 and ongoing. The patient did not have any relevant tests. The patient did not received any other vaccines prior to the covid 19 vaccine. Vaccination facility type was hospital. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on an 02Apr2021 11:00 (Batch/Lot Number: EP7533) as dose 1, single for covid-19 immunization. On 24Apr2021, the patient experienced muscle weakness and gullian barre and on an unspecified date, she also experienced fatigue, core/leg/hip weakness difficulty sit/stand, crouch/stand with 1 wk of things knocking, things over and pins and needles hands, problems with coordination of hands. Patient thought she have mild gullian barre and do not want to take a booster of the vaccine. The patient did not received treatment. The seriousness for the events muscle weakness and gullian barre was assessed as persistent/ significant disability/incapacity. The clinical outcome of the events was recovering. Comments: Fatigue, core/leg/hip weakness difficulty sit/stand, crouch/stand with 1 wk of things, knocking, things over. Pins and needles hands, problems with coordination of hands. I think I have mild gullian barre and do not want to take a booster of the vaccine; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events Guillain-Barre syndrome, Muscular weakness and suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034

Current Illness: Arthritis; Depression (Start date:>20 yrs); Muscle spasm; Neuropathic pain; Sleep disorder (Start date: >15 yrs); Spinal cord injury (Pertinent details: Surgery 2008); Tumor (Pertinent details: Surgery 2008)

ID: 1743774
Sex: F
Age:
State: TX

Vax Date: 03/19/2021
Onset Date: 03/01/2021
Rec V Date: 09/29/2021
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: Blood pressure; Result Unstructured Data: Test Result:used to spike; Comments: blood pressure used to spike; Test Name: Echocardiogram; Result Unstructured Data: Test Result:ok; Comments: doctor said it's ok didn't see any red flags; Test Name: EKG; Result Unstructured Data: Test Result:normal; Comments: her other EKG came out normal; Test Date: 20210331; Test Name: EKG; Result Unstructured Data: Test Result:Abnormal; Comments: Double heart beats. More information available (Y/N): No; Test Name: Heartbeat; Result Unstructured Data: Test Result:irregular; Comments: displays irregular heart beat

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: double heart beats and abnormal EKG; EKG which the nurse said was abnormal; Feeling sick; laid down and felt like she couldn't get up; Something didn't seem right almost every day; wrist blood pressure something not going right showing abnormality-has heartbeat symbol that displays irregular heart beat that it was showing; blood pressure used to spike; scared feeling; Palpitations; Really bad heart rate, it went really high; panic attack afterwards; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EP7534), dose 1 via an unspecified route of administration, administered in upper left arm on 19Mar2021 at 11:00-11:30 (at the age of 71 years) as dose 1, single for COVID-19 immunization. The patient's medical history was none. Concomitant medications included Bentyl for the stomach. After the first dose of Pfizer Covid-19 shot on an unspecified date in Mar2021 (week later, maybe onset of 25Mar2021 or 22Mar2021, she was not sure) she was feeling sick. Also, around midday she felt really sick, laid down and felt like she couldn't get up. On an unspecified date in 2021 the patient mentioned she had palpitations, really bad heart rate, it went really high. Shot made her go into panic attacks which she had never had before. On 31Mar2021 she made an appointment, had to go into the doctor's office. The doctor was not available, so the nurse took an EKG and said it was abnormal, she could hear the double heart beats. The nurse referred her to another doctor to get an echocardiogram to look at her heart, but he didn't see any red flags. This was scary. Something didn't seem right almost every day. When she took her wrist blood pressure something was not going right with showing of abnormality-the wrist blood pressure machine has a heartbeat symbol that displays an irregular heartbeat that it was showing. Blood pressure used to spike. Nothing seemed right, it was just erratic. No one called it inflammation, but she mentioned maybe it was inflammation of the heart. No other testing was performed, and her other EKG came out normal. Patient also received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EW0151), dose 2 via an unspecified route of administration on 09Apr2021 (at the age of 71 years) as dose 2, single for COVID-19 immunization and said she felt fine after taking it. Clonazepam was given as a therapeutic measure for panic attack. The panic attacks would happen randomly, and now has only occurred maybe 1 time in the last month, so panic attacks have improved. When she took clonazepam, it would go away. In the first few months it happened every 2 weeks where something would trigger the panic attacks. Atenolol was given as a therapeutic measure for blood pressure. Her blood pressure would spike and then the scared feeling she would get which has subsided significantly, it went ok. The outcome of the events was recovering except for the panic attacks which was not recovered. Patient believes these events started subsiding after her appointment with the doctor's office and saw the nurse on 31Mar2021. Follow-up attemps are completed. No further information is expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743775
Sex: M
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Off label use; Booster; I was out sick with the 3rd Covid Pfizer shot; This is a spontaneous report from a contactable consumer or other non-health care professional re-ported for a male consumer(patient). A male patient of an unspecified age received third dose of 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 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose and second dose of BNT162B2 for COVID-19 immunization. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced off label use, booster and i was out sick with the 3rd covid pfizer shot. The clinical outcome for all the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743776
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 09/29/2021
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 Name: Antibody test; Test Result: Negative ; Test Name: IGG test; Result Unstructured Data: Test Result:Unknown results; Test Name: IgG antibody level test; Result Unstructured Data: Test Result:Zero antibody; Test Name: COVID-19; Test Result: Negative

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient) via medical information team. A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date in Apr2021 (at the age of 65-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date (at the age of 65-year-old) as dose 1, single for COVID-19 immunisation. Caller was really upset because he had his IGG test done a few months from when he got the 2nd dose of the Pfizer BioNtech Covid-19 Vaccine (Apr2021) but still tested negative. Caller stated that "Pfizer has been very neglectful, it was possible that it was not a singular person's ability, and it was possible that the Pfizer BionTech Covid-19 Vaccine only had 1/3 of the amount of vaccine as compared to moderna. Moderna vaccine recipients have ample amount of antibodies as compare to Pfizer BionTech Covid-19 Vaccine recipients. It was frustrating and Pfizer must have information/statistics on how many people does not have antibodies after being fully vaccinated because Pfizer created the vaccine". Caller was wondering why Pfizer MI was providing data for vaccine efficacy 7 days after dose 2 when he already got the Pfizer BioNtech COVID-19 vaccine a few months ago. Caller wanted to know why he got a negative result for his IGG test result after getting 2 shots of the Pfizer BioNtech Covid-19 Vaccine. Caller also wanted to know if there are tests to check the quantity of antibodies after being fully vaccinated. Response: 5.5 Limitation of Effectiveness. The Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients. It was reported that we have the consumer on the other line. He was 65 years old, received the vaccine, he got both doses of Pfizer BioNTech Covid-19 vaccine. Second dose was last Apr2021 of this year and just a little bit head he was not really in good mood because he would like to report the lack of efficacy of the vaccine. He recently had antibody test and it tested negative this was something he would like to report to Drug Safety. And he had IgG (Blood immunoglobulin G), the name of the antibody IgT that was it and he also mention that there three other people took the vaccine of Pfizer who got zero antibody". When paraphrased the above concern, consumer stated, "That's correct, I took, a test if you are familiar with the IgG antibody level test. Did you ever hear IgG antibody level test? Well that I took twice both time they said did last week, both time it was said non-reactive, and I had actually zero antibody. You know what, if what you saying is I am going to give answer to your question, you are not going answer my question is that right? I have a question, my question is have you heard a people taken both vaccination and have no antibodies?". Consumer stated, "They couldn't answer the question because they put me to you. To people who have taken the Pfizer, other people don't have antibody after taking the double dose vaccination just the simple question". The case was reported as non-serious. The patient underwent lab tests and procedures which included antibody test result was negative, IGG test (blood immunoglobulin G) result was unknown result, IgG antibody level test (sars-cov-2 antibody test) result was zero antibody, COVID-19 result was negative; all were performed on an unknown date. 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: 1743777
Sex: M
Age:
State: NJ

Vax Date: 05/06/2021
Onset Date: 05/06/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 20210506; Test Name: Blood oxygen level; Result Unstructured Data: Test Result:very low; Comments: very low blood oxygen levels (oximeter); Test Date: 20210511; Test Name: COVID 19 Test; Test Result: Negative ; Comments: Nasal Swab; Test Date: 20210525; Test Name: COVID 19 Test; Test Result: Negative ; Comments: Blood test

Allergies:

Symptom List: Pain in extremity

Symptoms: Difficulty breathing, episodic shortness of breath; rapid or irregular heartbeat; chest pain; very low blood oxygen levels; coughing; lightheaded; weakness/very low energy; brain fog (equilibrium off); inability to focus and react in timely manner; fatigue; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose via an unspecified route of administration, administered in Arm Right on 06May2021 14:15 (Lot Number: ER8735, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation. Medical history included no Prior Health Problems or Issues and no past drugs. There were no concomitant medications. The patient previously received 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 15Apr2021 14:00 (Lot Number: ER8734, expiration date unknown) at age of 53 years old as a single dose for covid-19 immunisation. The patient experienced difficulty breathing, episodic shortness of breath, rapid or irregular heartbeat, chest pain, very low blood oxygen levels, coughing, lightheaded, weakness/very low energy, brain fog (equilibrium off), inability to focus and react in timely manner, fatigue, all on 06May2021 20:30. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included blood oxygen level: very low blood oxygen levels (oximeter) on 06May2021, COVID 19 test: negative on 11May2021 Nasal Swab, negative on 25May2021 Blood test. Treatment received for events was unknown. The adverse events result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient was no known allergies. The report was reported as serious for being life threatening and disabling/incapacitating. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.

Other Meds:

Current Illness:

ID: 1743778
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: Received the first, second and third dose of the Pfizer Comirnaty vaccine; Received the first, second and third dose of the Pfizer Comirnaty vaccine; Pressure on her head; Headache; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 66-years-old female patient received BNT162B2 (, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunizations. The patient medical history and concomitant medications were not reported. The patient experienced pressure on her head from horrific headache that lasted 9 days, received the first, second and third dose of the pfizer comirnaty vaccine. Caller wanted to know if this is a common side effect of the third dose. Caller stated that she feels better now and that her HCP has recommended treatment for her headache. The event outcome was unknown for off label use and extra dose administered and recovered for headache and Pressure on her head. Response: Spoke from attached document PI Table 4: Study 2 ? Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose ? Participants 56 Years of Age and Older. From an independent report in 99 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) the adverse event profile was like that after the second dose." The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1743779
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
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: white blood cell count; Result Unstructured Data: Test Result:Low

Allergies:

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

Symptoms: it hurt my arm where I got the shot; have a low white blood cell count; I have back pain; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program COVAX US support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced it hurt my arm where i got the shot, have a low white blood cell count, i have back pain. Question: Reporter is a consumer calling to ask about interaction between Celecoxib and the Pfizer Covid vaccine. Is there a test that I can take to see if the vaccine worked on me, I have a low white blood cell count, and because when I took the shot it hurt my arm where I got the shot, but that was it. my sister on the other hand was in bed for 2 days. Question: My doctor prescribed Celecoxib 200mg capsule, because I have back pain, and I want to know if taking it will affect the vaccine, since the medication is an anti-inflammatory. Can i use fever-reducing drugs or pain relievers before or after getting the vaccine. Question: When does the vaccine start to protect me after taking the second dose. The patient underwent lab tests and procedures which included white blood cell count: low on an unspecified date. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743780
Sex: F
Age:
State: PA

Vax Date: 07/29/2021
Onset Date: 09/16/2021
Rec V Date: 09/29/2021
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: 20210916; Test Name: Nasal Swab; Test Result: Positive

Allergies:

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

Symptoms: Patient tested positive for C-19 on 16Sep2021; Patient tested positive for C-19 on 16Sep2021/mild cough and scratchy throat for 2-3 days; This is a spontaneous report from a contactable Pharmacist. A 14-years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FA6780, Expiry date: unknown), via unspecified route of administration on 29Jul2021 (age at vaccination 14 years and non-pregnant at the time of vaccination) as DOSE 2, SINGLE and first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: FA6780, Expiry date: unknown), via intramuscular, administered in arm right on 08Jul2021 (age at vaccination 14 years and non-pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included known allergies seasonal allergies, pet dander. The patient's concomitant medications were not reported. Hospital was facility where the most recent COVID-19 vaccine was administered. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19. It was reported that the patient received both doses of PFE covid vaccine (08Jul2021-lot FA6780, 29Jul2021 lot FA6780). Patient tested positive for C-19 on 16Sep2021 with mild cough, scratchy throat for 2-3 days. Patient was fine now. The patient underwent covid test post vaccination (nasal Swab, covid test date on16Sep2021, covid test result was positive). The patient did not receive any treatment for the events. The outcome of event was recovered in 2021.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be completely excluded.

Other Meds:

Current Illness:

ID: 1743781
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: I got sick after receiving my 2 Covid shots; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for self). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced I got sick after receiving my 2 covid shots. Patient got sick after receiving 2 Covid shots and now I want to know if I am immunized enough against the Covid. Am I protected against someone who is not vaccinated. Why should I take the booster shot. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1743782
Sex: M
Age:
State: CO

Vax Date: 05/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: COVID test; Result Unstructured Data: Test Result:Unknown results; Comments: he is awaiting the results

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: taste and smell went away; taste and smell went away; Feeling bad; Nasal congestion; had a cold; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a 32-year-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 (at the age of 32-years-old) (Lot Number: EW0164; Expiration Date: Aug2021, NDC number: unknown) as DOSE 2, SINGLE for covid-19 immunisation. There were no patient medical history and concomitant medications. No adverse event following prior vaccinations. Patient previously took first dose of bnt162b2 (Lot number: ER8732; Expiration Date: Jul2021) administered in right arm on 10Apr2021 (at age of 32-year-old) for covid-19 immunisation. The patient was feeling bad on Thursday 09Sep2021. To clarified feeling bad he had no fever, no body chills, and no aches. He only had nasal congestion. That lasted from ninth, tenth, eleventh, and twelfth. On 13Sep2021, his taste and smell went away. That only lasted until 15Sep2021. Everything came back on 15Sep2021. He only had nasal congestion, no cough. His taste completely went away on 13Sep2021 and by 15Sep2021 he was able to smell and taste again. The patient had a cold on an unspecified date in Sep2021. None of additional vaccines administered on same date of the Pfizer Suspect. Patient did not require Emergency Room and Physician Office for the events. The patient underwent lab tests and procedures which included COVID test: unknown results (he is awaiting the results) on an unspecified date in 2021. It was reported that he valued human life. He was doing his part to protect himself and make sure he was not infecting other people in case he gets it. There were a lot of people that are immune suppressed. There were kids out there and old people who could be sick at any point and time by touching a countertop. Outcome of event Nasal congestion was recovered on 12Sep2021. Outcome of events feeling bad and had a cold were unknown while taste and smell went away were recovered on 15Sep2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101244374 same reporter/product, different patient / event.

Other Meds:

Current Illness:

ID: 1743783
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: my sister on the other hand was in bed for 2 days.; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer (Patient's sister) reported that a female patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced my sister on the other hand was in bed for 2 days. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1743784
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: lost all of my body hair; This is a spontaneous report from a contactable consumer. This male consumer (patient) of unknown age reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 24Mar2021 the patient lost all of his body hair. He had questions about the third vaccine shot and asked if reported side effect and if those individuals who have reported had received the third dose. The event outcome was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101253532 Pfizer

Other Meds:

Current Illness:

ID: 1743785
Sex: F
Age:
State: WI

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/29/2021
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: 20210921; Test Name: CVS PCR Test; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: COVID 19 infection was confirmed on 22Sep2021; COVID 19 infection was confirmed on 22Sep2021/scratchy throat/cough; other vaccine same date vaccine date=01Apr2021; This is a spontaneous report from a contactable Pfizer colleague. A 39-years-old non pregnant female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number ER2613, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 01Apr2021 (age at vaccination: 39 years non pregnant at the time of vaccination) as DOSE 2, SINGLE, and received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot number ER8734, Expiry date: unknown), via Intramuscular, administered in Arm Left on 01Apr2021 (age at vaccination: 39 years non pregnant at the time of vaccination) as DOSE 1, SINGLE for covid-19 immunisation. There was no medical history. Concomitant medication/ List of any other medications the patient received within 2 weeks of vaccination included ethinylestradiol, norethisterone acetate (Junel) taken for an unspecified indication. No known allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine administered was workplace clinic. On 19Sep2021, the patient started to experience symptoms of scratchy throat and cough. Since the vaccination, patient has been tested for COVID-19. Covid test post vaccination Nasal Swab on 21Sep2021, covid test result was Positive. COVID 19 infection was confirmed on 22Sep2021. No treatment was received for events. Outcome of events drug ineffective and Covid-19 was recovering and unknown for other event. Follow-up attempts are completed. No further information was expected.

Other Meds: Pfizer, Inc. EUA 027034

Current Illness:

ID: 1743786
Sex: F
Age:
State:

Vax Date: 07/31/2021
Onset Date:
Rec V Date: 09/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: got covid19 virus from someone at work.; got covid19 virus from someone at work.; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 31Jul2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced got covid19 virus from someone at work. (COVID-19) on an unspecified date. patient was asking when she can receive the second dose of the vaccine. she said one of her doctors told her 20 days after recovered while her other doctor said 1 month and the other 3 months. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am