VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1673368
Sex: M
Age:
State: CO

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: his first shot, it hurt for about an hour and a half and it was more intense in the second shot; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself) from a Pfizer sponsored program. A 66-year-old male patient 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 01May2021 (at the age of 66-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included, ongoing cervical stenosis, ongoing RA, ongoing COPD, ongoing emphysema. The patient's 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 10Apr2021 (at the age of 66-year-old) as dose 1, single for COVID-19 immunization and experienced first shot it hurt. On an unspecified date in May2021, the patient experienced his first shot, it hurt for about an hour and a half and it was more intense in the second shot. Verbatim and Event Description: Patient had both doses of the vaccine last 10Apr2021 and 01May2021. Patient mentioned that he has some health issues like cervical stenosis, RA, COPD and emphysema. He mentioned that when he got his first shot, it hurt for about an hour and a half and it was more intense in the second shot. Patient called in to know and get some advice when to take the follow up shot or 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.

Other Meds:

Current Illness: Cervical spinal stenosis (cervical stenosis); COPD; Emphysema; RA

ID: 1673369
Sex: F
Age:
State: GA

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

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

Lab Data: Test Date: 20210408; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; my tongue started burning, and progressed to my entire tongue, roof of my mouth and back of my throat; sense of metallic taste; sense of taste is altered; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:00 (Lot Number: EL 3249) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included very healthy (take no medicines, except topical vaginal estrogen), penicillin allergy, shellfish allergy. Concomitant medication included estradiol (ESTROGEN). The patient previously took Botox and levofloxacin (LEVAQUIN) and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that patient got the vaccine at on 20Jan2021 11 am. On 20Jan2021 at 2 pm, her tongue started burning, and progressed to her entire tongue, roof of her mouth and back of her throat. Patient told her doctor who said to take diphenhydramine hydrochloride (BENADRYL). Her tongue felt like it was on fire and that someone spilled no vaccine on it (also reported as someone spilled novocaine on it). Patient was diagnosed with burning tongue syndrome, and as of 23Aug2021, she still has a burning tongue with a sense of metallic taste in her mouth, and her sense of taste is altered. Some food makes it worse like salty foods and acidic foods. Events resulted in Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Patient was treated for all the events, she used a calming mouth wash, such as Closys. Patient was tested for COVID via nasal swab PCR post vaccination on 08Apr2021 with negative result. Patient had not recovered from the events, at the time of the report. Follow-up attempts are completed. No further information is expected.

Other Meds: ESTROGEN

Current Illness:

ID: 1673370
Sex: F
Age:
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: Progressed to symptoms of angioedema.; Systemic " itching "- head, arms, upper anterior thighs bilaterally, vaguely within about 20-30 minutes.; Facial swelling; red face; blotchy red patches arms, back, legs face; severe itchy (10) inside of ears (deep), eyes; severe itchy (10) inside of ears (deep), eyes; scratchy throat; Next morning, allergic reaction covered by medication; This is a spontaneous report from a contactable Nurse (patient). A 58-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 16Aug2021 19:00 (Lot Number: fc3181) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history included migraine headache (h/a), hypothyroid, latex allergy, penicillin (PCN) allergy. Concomitant medications included methylphenidate hydrochloride (CONCERTA); duloxetine hydrochloride (CYMBALTA); thyroid (ARMOUR THYROID). Facility type vaccine: Pharmacy or Drug Store. It was unknown if patient had COVID prior vaccination and was not tested for COVID post vaccination. On 16Aug2021 patient experienced progressed to symptoms of angioedema, systemic " itching "- head, arms, upper anterior thighs bilaterally, vaguely within about 20-30 minutes, facial swelling, red face, blotchy red patches arms, back, legs face, severe itchy (10) inside of ears (deep), eyes, scratchy throat, next morning, allergic reaction covered by medication. Events resulted in Doctor or other healthcare professional office/clinic visit. Clinical course was reported as follows: Systemic "itching "- head, arms, upper anterior thighs bilaterally, vaguely within about 20-30 minutes. Progressed to symptoms of angioedema. Facial swelling, red face, blotchy red patches arms, back, legs face, although much more severe itchy (10) inside of ears (deep), eyes, and scratchy throat. Patient had no food or anything else but water after the vaccination. These symptoms evolved over two hours, increasing in intensity. Patient had Benadryl and prednisone in her medicine box and took 75 mg Benadryl, (liquid) 50 ng prednisone at 10:00 pm. Was up until 12:00 midnight; symptoms quelled 80% by 12:30 am. Next morning, allergic reaction covered by medication. General practitioner (GP), notified and was documented. Patient was treated for the events. Patient was recovering from all the events, at the time of the report.

Other Meds: CONCERTA; CYMBALTA; ARMOUR THYROID

Current Illness:

ID: 1673371
Sex: F
Age:
State: TX

Vax Date: 05/10/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Normal; Test Name: EMG; Result Unstructured Data: Test Result:Normal; Test Name: MRI of brain and spinal column; Result Unstructured Data: Test Result:showed previous cervical fusion of C4-C5

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: the palms of her hands are itching; up past her wrists are tingling; doesn't have control of her hands anymore; This is a spontaneous report from a contactable nurse (patient). A 66-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0158, patient was 66-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 10May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing diabetes, ongoing Blood pressure high, ongoing High cholesterol, ongoing trigeminal neuralgia (states that all are controlled with medication.), spinal fusion surgery from 1998, she might need another surgery in that area of the cervical fusion, but she would have to get an Orthopedic surgeon, and she doesn't plan to do all that to an unknown date. The patient's concomitant medications were not reported. Reported that patient already written a letter that was sent to a patient advocate in the facility, but that was 2 weeks ago, and she hasn't heard anything yet. Patient was a retired LPN and employee. She was encouraged to take the vaccine because she travels a lot to visit her grand kids. Her next appointment with the Neurologist is in 2 weeks. So far he has told her what she doesn't have. She doesn't have Lupus, MS, or Withheld, but he couldn't tell her what she doesn't have. He told her to buy 2 lb weights and put them around her ankles, wrists, and deltoids for 4-5 hours a day. States that she did that and it almost killed her. States that her sister had to move in with her because she can't live by herself anymore due to her muscle failure. She saw her PCP's nurse recently and told her that she never urinates on herself, but now if she doesn't get up as soon as her brain tells her that she has to go to the bathroom, then she will urinate all over herself. State that the nurse sent pullups to her house and a walker that she can turn around and sit on. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0150, patient was 66-year-old at the time of vaccination), via an unspecified route of administration, administered in right arm on 19Apr2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced paralysed on her left side. Reported that her PCP said that in about 2 weeks it would go away and that it was just a side effect of the vaccine, and to just get the 2nd dose. Reported that after experiencing the events after vaccinated with second dose now she can't zip up her pants, button up her clothes, or pick up coins that fall on the floor or counter. States that she doesn't have control of her hands anymore. On an unspecified date in 2021, the patient experienced the palms of her hands are itching, up past her wrists are tingling, doesn't have control of her hands anymore. Events required to visit Physician Office to seen her PCP and a Neurologist regarding all symptoms. The patient underwent lab tests and procedures which included blood work, chest x-ray, EMG and all were resulted normal, MRI head: showed previous cervical fusion of C4-C5. States that she thinks they hit every nerve and every muscle in her body, but the Neurologist said that the test results were fine. After the EMG she was hurting everywhere from being poked for the test. She was telling the Neurologist that she now generates heat. For example, if she bends her arm at her elbow, it generates heat. Or if she bends her leg at her knee and puts her face or hand down there, she can feel the heat in the crease of her thigh at the back of her knee. States that the doctor told her that her mind is telling her body one thing, but her body is not listening to her mind. So they are going to start her in physical therapy she guesses for that. The outcomes of events were unknown.

Other Meds:

Current Illness: Blood pressure high (Verbatim: Blood pressure high); Diabetes (Verbatim: Diabetes); High cholesterol (Verbatim: High cholesterol); Trigeminal neuralgia (Verbatim: Trigeminal neuralgia)

ID: 1673372
Sex: M
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: needed heart surgery; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, three weeks after the shot, the patient needed heart surgery. At the time of the report the event outcome was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673373
Sex: U
Age:
State: NE

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

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

Lab Data: Test Name: COVID; Test Result: Positive ; Comments: I was covid positive after being fully immunized

Allergies:

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

Symptoms: i was covid positive after being fully immunized; i was covid positive after being fully immunized; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced covid positive after being fully immunized and was not contacted by anyone for follow up on unspecified date. All events are medically significant. The patient underwent lab tests and procedures which included COVID positive: positive on unspecified date. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673374
Sex: U
Age:
State: WV

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Had a seizure; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program Pfizer RXPathways. Forwarded as an Adverse Event by the Epsilon Escalation team on 23Aug2021. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included that patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, patient had a seizure shortly after getting the second dose of your vaccine. To date, doctors have found nothing, and all tests continue to result in negative and normal results. Patient was healthy up until got this crap put into body. Just more big pharma making money hand over fist. Are gullable and stupid sorry, but for one, would not put another Pfizer vaccine in body. The outcome of event seizure was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673375
Sex: U
Age:
State: NV

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

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

Lab Data: Test Date: 202007; Test Name: Covid-19 test; Result Unstructured Data: Test Result:COVID-19 Virus; Comments: COVID-19 Virus

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Damage to my kidneys; itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender 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 unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Medical history included, patient had COVID-19 virus on an unspecified date in Jul2020, about 2 weeks after patient stooped having symptoms on an unspecified date in 2020, and started to get itching on arms and other parts of body. Long story short, several months later doctor and patient determined that the virus damaged the kidneys. Patient was in stage 3 of kidney failure. Concomitant medications were not reported. In late Mar2021, Patient got the first dose of Pfizer vaccine. After a couple of days of vaccination on an unspecified date in 2021, Patient got more intense itching and also determined that the vaccine caused more damage to kidneys. Patient questioned how can patient help determine why it caused damage. The event damage to my kidneys was assessed as serious - Medically Significant. The patient underwent lab test and procedure which included COVID-19 test resulted as COVID-19 Virus on an unspecified date in Jul2020. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1673376
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Fine; Test Name: CAT scans; Result Unstructured Data: Test Result:fine; Test Name: ultrasound; Result Unstructured Data: Test Result:fine

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: started feeling fatigue, tired; dizziness; pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes.; She usually gets spasms but now they are more intense.; This is a spontaneous report from a contactable consumer or other non-health care professional (pa-tient), from a Pfizer-sponsored program. A 45-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunization and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspeci-fied route of administration on 10Aug2021 as dose 2, single for COVID-19 immunization. Medical history included covid-19 from May2021 to an unknown date she had COVID in May2021 and recovered fi-ne, but was treated in the hospital because she had COVID Pneumonia , cushing's syndrome, pre-diabetic from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date, and then out of the blue about 3 weeks ago the patient experi-enced started feeling fatigue, tired, dizziness, pins and needles sensation from her head (which was feeling tight) and a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes, a vibration throughout her body in her arms to her fingers down through her toes, which comes and goes and she usually gets spasms but now they are more intense. It was fur-ther stated that Caller was not sure if her symptoms that she has been having over the past two weeks now almost a month are almost a repeat of COVID. She does go to the Doctors because she does have Cushing's syndrome and is a pre-diabetic and on medication for that. She stated she was just trying to marrow a few things down, Had a sudden onset did not have these symptoms all along, just does not feel the same. She usually gets spasms but now they are more intense. And now why did this red bump appear a week later after getting the second vaccine and the itchiness at the site, like she just got the vaccine, is this a possible side effect? Stated she does have an appointment with her neurologist et up and her Cardiologist mentioned to her that she might be experiencing COVID long hauler. The patient underwent lab tests and procedures which included blood test: fine, comput-erised tomogram: fine, ultrasound scan: fine on an unspecified date. The clinical 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: 1673377
Sex: F
Age:
State: MN

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: She was experiencing chest pain and pressure; She was experiencing chest pain and pressure; This is a spontaneous report from a contactable consumer (parent). A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the dose 1 of BNT162B2 for Covid-19 Immunization on an unknown date and no events reported. On an unspecified date, patient was experiencing chest pain and pressure, so her pediatrician recommended a trip to the emergency room (ER). The patient advocate mentioned that Pfizer may want to further study these cases and/or enroll these patients in a clinical study (possibly with some compensation). The outcome of the event was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673378
Sex: M
Age:
State: AZ

Vax Date: 04/17/2021
Onset Date: 04/21/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:Unknown result

Allergies:

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

Symptoms: had ringing in his ears; ear infection; clogged ears; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for 51-year-old patient. A 51-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 17Apr2021 (at the age of 51-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced ringing in his ears 4 days later that turned into clogged ears and asks if people have experienced this. Caller states that this has been going on since the end of April until now. Caller states her husband is on his fourth ear infection and went to his primary care and second ENT in (city name withheld) today and has a MRI on Thursday and they don't know. Caller asks if there is something set up to record data. The patient lab data includes MRI on an unspecified date with unknown results. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1673379
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: nausea; headache; weakness; muscle pain; stiff neck; difficulty moving left arm (injection site Left deltoid); received her first dose of the Pfizer BioNTech Covid-19 Vaccine in April and her second dose in July; This is a spontaneous report from a contactable consumer (patient herself). A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left deltoid on an unknown date in April2021 as DOSE 1, SINGLE; dose 2 via an unspecified route of administration, administered in left deltoid on an unknown date in July2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced nausea, headache, weakness, muscle pain, stiff neck, difficulty moving left arm (injection site Left deltoid) for 3 weeks, received her first dose of the pfizer biontech covid-19 vaccine in april and her second dose in july (inappropriate schedule of product administration). The outcome of all the events was unknown. There was no product quality complaint (PQC) present.

Other Meds:

Current Illness:

ID: 1673380
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: diarrhea lasted 4-5 days was bloody towards the end; funny feeling in her brain, felt like a pulling sensation; metallic taste in mouth; oral inflammation; bottom lip white spot that looked like blister; both kidneys hurting bad; Raw red and very irritated; Raw red and very irritated; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient's Concomitant medication(s) included acetylsalicylic acid (BABY ASPIRIN). Patient stated that receiving her first dose of the Pfizer BioNTech Covid-19 vaccine experienced some normal side effects and others she would like to know if they are normal and if others have reported these- metallic taste in mouth, oral inflammation, raw red and very irritated, bottom lip white spot that looked like blister, both kidneys hurting bad, diarrhoea lasted 4-5 days was bloody towards the end funny feeling in her brain, felt like a pulling sensation. Patient stated that she saw her HCP for treatment, and he told her to stop taking baby aspirin, take Pepto Bismol and delay her second dose by a week. The Pepto Bismol stopped the diarrhea. The outcome of the events diarrhoea lasted 4-5 days was bloody towards the end was resolved on unspecified date in 2021, remaining events it was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: BABY ASPIRIN

Current Illness:

ID: 1673381
Sex: F
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Muscle pain and ache; Fever; Bad chills; Injection site pain; Fatigue all throughout that led her to sleep a lot; Fatigue all throughout that led her to sleep a lot; Pain all over her body and ribcage; Pain all over her body and ribcage; Headache including the muscles on it (the one that connects to the bone).; This is a spontaneous report received from a non-contactable consumer (Patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 19Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. On an unspecified date in Aug2021, the patient experienced muscle pain and ache, fever, bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, pain all over her body and ribcage and headache including the muscles on it. Patient got both doses of the COMIRNATY vaccine and had her 2nd dose 19Aug2021 (Thursday). Post vaccination up until today (5 days to date), she reported experiencing muscle pain and ache. Patient had alongside muscle ache, she also experienced fever and bad chills, injection site pain, fatigue all throughout that led her to sleep a lot, pain all over her body and ribcage, headache including the muscles on it (the one that connects to the bone). She generally reported being down all weekend that led her not to be able to come to work. Additionally, she reported she called urgent care to check if someone has reported to come in with the same AEs that she had. She was also concerned that AEs were because the dose she got was contaminated. The outcome of event was unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1673382
Sex: M
Age:
State:

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

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:Quickening; Comments: heart rate quickening

Allergies:

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

Symptoms: heart rate quickening; skin tingling; facial numbness; This is a spontaneous report from contactable consumer. This 44-year-old male consumer (patient) reported that: A 44-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is a 44-year-old male who received his first dose of the Pfizer BioNtech covid 19 vaccine and 17 minutes later experienced side effects of heart rate quickening, skin tingling, facial numbness. He stated this went on and off for about 15 minutes. Patient reported he has had side effects since. The patient underwent lab tests and procedures which included heart rate: quickening on an unspecified date heart rate quickening. 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: 1673383
Sex: F
Age:
State:

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

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

Lab Data: Test Name: covid-19 test; Test Result: Positive

Allergies:

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

Symptoms: COVID-19; COVID-19; This is a solicited report from a non-Pfizer sponsored program entitled (marketing program name "FACILITATED COLLECT") from a contactable consumer (patient), based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3898481-00). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 vaccination; and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date and ongoing at "Citrate Free" (as reported), for Moderate to severe rhematoid arthiritis and Moderate to severe chronic plaque psoriasis. The patient's medical history, other relevant history, concomitant drugs were Not Reported. It was unknown if patient was enrolled in a covid-19 Vaccine Trial. On an unspecified date, the patient experienced non-serious covid-19. The patient underwent lab tests and procedures which included covid-19 test: Positive on an unknown date. The action taken in response to the events for adalimumab was Dose Not Changed. The outcome of the event covid-19 was resolved on an unknown date. The reporter's causality for the event of covid-19 with adalimumab and bnt162b2 was not reported. The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for bnt162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective and Covid 19 cannot be completely excluded.

Other Meds:

Current Illness:

ID: 1673384
Sex: M
Age:
State:

Vax Date: 11/01/2020
Onset Date:
Rec V Date: 09/04/2021
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: after the second shot of covid-19 vaccine he had a stroke; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from AbbVie Inc. (MFR Control No. #21K-163-4017811-00) from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; glecaprevir, pibrentasvir (MAVYRET), oral from Nov2020 (Batch/Lot number was not reported) to an unspecified date, at unknown dose, 3x/day for an unspecified indication. The patient medical history was not reported. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for Covid-19 Immunization. The patient had other concomitant therapy of unspecified blood pressure medication. It was reported after the second shot of covid-19 vaccine he had a stroke on an unspecified date with outcome of unknown. On an unknow date, the aptient experienced stroke, Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. The patient Reported that 64 hours after the second shot of covid+19 vaccine he had a stroke. He did confirm that the stroke happened after the second dose of the Covid-19 vaccine but was not able to probe further.It was unknown if the patient was enrolled in the covid vaccine trail. On unknown, patient received 1st dose covid-19 vaccine manufactured by pfizer, lot number. The event was reported as serious as other medically important condition. The action taken for glecaprevir, pibrentasvir was Permanently Withdrawn on unknown date. Causality for Mavyret: The reporter's casualty for the event of the stroke was not provided. Abbvie's opinion is that there is no reasonable possibilities that the event of stroke is related to the Mavyret. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal association, a causal relationship between the event stroke and bnt162b2 cannot be completely excluded. Other risk factors to be considered include the patient advanced age and history of high blood pressure. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1673385
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Antibody tests; Test Result: Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Patient stated that she is on gilenya for MS; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as Dose 2,Single and dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. Concomitant medication(s) included fingolimod hydrochloride (GILENYA) taken for multiple sclerosis, start and stop date were not reported. The patient experienced antibody tests performed prior at a research clinic for ucsf, all came back negative for antibody (medically significant) on an unspecified. Patient stated that she is on gilenya for MS which research has shown affect the Pfizer vaccine effectiveness, because it is a an Immunosuppressive drug. She us a in a research at UCSF. I am afraid that the only way for me to get protection is to get off gilenya for 60 days and then get the vaccine again, and than get back on the gilenya, which when you been off it that long it take s all kinds of heart studies to get back on the drug again. Besides the fact that there are multiple reports of cases of people who go off that drug, and do not go immediately on another drug, there are increase exacerbation of MS, and 35 cases in the last 8 years, people have gone from being mobile and living a normal life to being in a wheelchair after who come off gilenya, within 12 weeks. The patient underwent lab tests and procedures which included antibody test: negative. 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: GILENYA

Current Illness:

ID: 1673386
Sex: M
Age:
State: AL

Vax Date: 02/24/2021
Onset Date: 08/21/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: COVID test; Test Result: Positive

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from contactable consumer via Pfizer Sales Representative. A 73-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 24Feb2021 at dose 2, single and first dose on 03Feb2021 at dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no serious underlying health conditions. The patient began feeling ill with symptoms of coughing, congestion, headache, body aches and fever on 21Aug2021. Patient went for COVID testing on morning of 23Aug2021 and COVID test was positive. The outcome of the event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673387
Sex: U
Age:
State: NJ

Vax Date: 04/01/2021
Onset Date: 08/22/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210822; Test Name: COVID; Test Result: Positive

Allergies:

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

Symptoms: has received two does of the Covid vaccine, and tested positive; has received two does of the Covid vaccine, and tested positive; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unknown date in Apr2021 (Lot number was not reported) as single dose and first dose via an unspecified route of administration on an unknown date in Apr2021 (Lot number was not reported) as single dose, both for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient had received two doses of the Covid vaccine in Apr2021 and tested positive for Covid on 22Aug2021 (reported as yesterday 8/22) through a rapid test waiting on. Outcome of the event was unknown. The lot number for bnt162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673388
Sex: F
Age:
State: IN

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hurting more in different joints now; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: FD8448, Expiration Date: not reported) via an unspecified route of administration in right arm on 19Aug2021 as dose 1, single for COVID-19 immunization (at the age of 64-year-old). Medical history included hurting and cataract. The patient's concomitant medications were not reported. The patient experienced hurting more in different joints now on an unspecified date in 2021. It was reported that, she took the first covid shot last Thursday, she wanted to find out if she could take tramadol. She saw something about anti inflammatory cannot be taken and she was just hurting. Patient clarified that, she had not consumed the tramadol or anti inflammatory yet, she didn't take anything because she was fine, she had only taken a Tylenol. Her hurting was something that was prior to receiving the covid vaccine, it was before. She was just hurting more in different joints now, she just did not think about it. She was more worried about what she saw on the internet that 4 weeks down the line, people getting moderna broke out in shingles. she was waiting to find out more information first. The outcome of the events was unknown. Additional information is requested. Follow-up attempts completed. No further information expected

Other Meds:

Current Illness:

ID: 1673389
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Rheumatoid Arthritis; has received the vaccinations has joint pain; This is a spontaneous report from a Pfizer sponsored Regulatory Authority support. A consumer (patient's father) reported for a female patient (reporter's oldest daughter). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller reported that, his oldest daughter, one who has received the vaccinations has joint pain, however he was uncertain if this joint pain was before or after receiving the injections. He was trying to call her during the INT but was not successful and stated he will call back to provide more clarity. He stated that she was having a lot of joint pain and they have diagnosed her with Rheumatoid Arthritis and the caller was unsure if it may had been vaccine related. The outcome of the event has received the vaccinations has joint pain was not resolved. The outcome of the event rheumatoid arthritis was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673390
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Vaccinated with Pfizer covid vaccine with second dose Feb 15. She was now diagnosed with covid on August 20; Vaccinated with Pfizer covid vaccine with second dose Feb 15. She was now diagnosed with covid on August 20; This is a spontaneous report from a contactable consumer. This report was received via a sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 15Feb2021 (Batch/Lot number was not reported) as dose 2, single, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with Pfizer covid vaccine with second dose on Feb 15 and was diagnosed with covid on 20Aug2021. Event took place after use of product. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673391
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: brain bleeds that happened 45 or 60 days after the vaccine.; This is a spontaneous report from a Pfizer sponsored program . A contactable Consumer (patient s wife) reported for a patient (reporter s husband). A male patient of 90-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9629, and Expiration date: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 89-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247, and Expiration date: Unknown), on 14Jan2021 (at the age of 89-year-old) for COVID-19 immunization. The caller (reporter) mentioned that her husband had "brain bleeds that happened 45 or 60 days after the vaccine" on an unspecified date in 2021. The caller had not been vaccinated she recently discovered she had an Iron overload in her blood. Asked if the Pfizer COVID-19 vaccine (COMIRNATY) was going to be toxic. No Information found regarding product medical question. Spoke from attached CONS document, referred to HCP, offered to email for review. The caller asked how she can get ingredient list and she was offered to email ingredient list. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1673392
Sex: F
Age:
State: PA

Vax Date: 08/22/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: blood work; Result Unstructured Data: Test Result:fine; Test Date: 202108; Test Name: full work up; Result Unstructured Data: Test Result:fine; Test Date: 202108; Test Name: neuro test; Result Unstructured Data: Test Result:fine

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: There's some funky drooping on this side of the caller's face/ Facial paralysis; really bad headaches; The pain is gone in the caller's right arm/ right arm was sore; Stomach pain; skin was being pricked from the inside out; her skin felt like it was burning from the inside out; She had a terrible feeling of her heart racing; Paralysis/ she had right side paralysis; This is a spontaneous report from a contactable consumer (Patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FC3184, Expiry date was not reported), (at the age 55-year-old) via an unspecified route of administration, administered in Arm Right on 22Aug2021 11am-12noon. as dose 1, 0.3 ML single for COVID-19 immunization at Pharmacy/drug store. Medical history included ongoing asthma had since she was 16 years old, ongoing reflux gastritis the last 10 years had for 7-8 years, ongoing Pre-diabetes 1-3years, not on treatment 3 years. The concomitant medications was not reported. Historical vaccine includes Flu shot on an unspecified date. On Aug2021 patient experienced paralysis/ she had right side paralysis, on 22Aug2021 there's some funky drooping on this side of the caller's face/ facial paralysis, really bad headaches, right side was still numb on the caller's face, the pain was gone in the caller's right arm/ right arm was sore, stomach pain, skin was being pricked from the inside out, her skin felt like it was burning from the inside out and she had a terrible feeling of her heart racing. Caller was very concerned about the Pfizer COVID-19 vaccine that she received in Aug2021 at withheld. She states that she was experiencing "a lot of side effects" and called VAERS to report her side effects and was told that the lot # she provided, FC3185, was not a valid lot number for the Pfizer COVID-19 vaccine. The caller has spoken with the withheld Pharmacy and two employees verified that this lot number written on her vaccination card was the "correct." The caller also states that maybe the lot # was actually FL3185 due to the inability to read the person's handwriting on the vaccination card. Placed caller on hold and spoke with withheld in Customer Service. withheld confirmed that neither FC3185 nor FL3185 are valid lot numbers for the Pfizer COVID-19 vaccine. Caller states that she will go to Pharmacy and see the vial and lot number for herself so that she can verify and will call back and report to Drug Safety. The caller was physically looking at the box and the vials. The caller originally thought the lot number was FC3185 but it was confirmed that that lot number was not a Pfizer lot number either according to VAERS and Pfizer. It was reported that the several hours after the vaccine she had side effects. It was reported that the event, right side was still numb on the caller's face, she had right side paralysis. It was reported that the caller had paralysis and really bad headaches, so she went to the emergency room. The caller's blood work was fine, neuro test was fine, and full work up was fine. Time the Vaccination Was Given: Between 11 and noon. No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The AE require a visit to emergency Room for 4 hours for observation. No prior vaccinations within 4 weeks. The caller declines to elaborate on the side effects that she experienced, as she has already reported this with VAERS. The caller was calling today to report the event involving the incorrect lot number. Caller was really concerned about side effects, she had a really miserable time after the first shot. How much protection does she have with just one dose. She also questioned the lot number, which lot number she actually got. She was having some facial paralysis on the right side face and it has her concerned. There was some numbness in her face. She has been to the doctor and they and they ruled out stroke. Also her heart and blood work was fine. She thinks it was bells palsy that was mentioned with the vaccine. The other concern was the pharmacy that gave her the shot doesn't have the proper lot number, they mis-represented the product given so she doesn't even know what she was given. Caller remarks she was in general good health. Caller explains they put the wrong lot on the card. She called and they told her it was right. She explains the Lot provided on the card was FC3185 but it should have been EC3185. It was given on 22Aug2021. The facial numbness on the right side started about an hour after getting the shot, it got worse but now it was about the same and she doesn't think it will get worse. She was hoping it will wear off and was just a normal side effect. Caller remarks she had loads of side effects but the only one she was concerned with was the facial paralysis. Caller reports after the shot her stomach was in a lot of pain, she had sharp pain in her stomach. It lasted a couple minutes then stopped, it just zipped through her gut. After the shot her skin felt like it was burning from the inside out. Caller clarified this as feeling like her skin was being pricked from the inside out. This started the first day but was better as of last night, 24Aug2021. She had a terrible feeling of her heart racing and almost wanted to faint, she doesn't think it was nerves either. This lasted about a 2-3 minutes after getting the shot and then resolved. It was hard to sit up in the chair after the shot because of this. She has had really bad headaches since getting the shot. The have been going on for 3 days but are getting better. She couldn't lay down without a headache but when she got up and walked around it felt better, it was bad. This was why they brought her in to confirm she wasn't having a stroke. Caller remarks that she got the shot in her right arm and it was sore, but it has resolved at this point. she went to the emergent care and they did a bunch of blood work, it was beautiful and was told she had a strong heart. She was in touch with the top people at withheld and she needs confirmation. It was specifically withheld in the town withheld, it was the only withheld in the town, the withheld number was withheld. She initially called to ask to see if the Lot number can be identified, Lot FC3184. If this was correct. She has photos of the vials and boxed; they all say Pfizer on them. She was able to provide pictures if needed. She has facial numbness that was different now; that was better but was still there. She has no other new events. Time of vaccination was reported as 11am-12noon. The patient underwent lab tests and procedures which included blood test was fine, laboratory test was fine and neurological examination was fine on an unspecified date Aug2021. The outcome of Paralysis/ she had right side paralysis was unknown, there's some funky drooping on this side of the caller's face/ Facial paralysis was not resolved and really bad headaches was recovering. On unspecified date in Aug2021, the events the pain is gone in the caller's right arm/ right arm was sore resolved. On 22Aug2021, the event Stomach pain and She had a terrible feeling of her heart racing resolved. 24-AUG-2021, the event skin was being pricked from the inside out and her skin felt like it was burning from the inside out was resolved. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101103855 Pfizer

Other Meds:

Current Illness: Asthma (had since she was 16 years old); Pre-diabetes (1-2 years, not on treatment 3 years); Reflux gastritis (the last 10 years had for 7-8 years)

ID: 1673393
Sex: F
Age:
State:

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

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

Lab Data: Test Name: Covid-19; Test Result: Negative ; Comments: She had a negative test there

Allergies:

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

Symptoms: hospitalized for a medical emergency she had two surgeries from sinus fluid leaking into her brain; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 04Apr2021 at unknown Dose 2, Single for Covid-19 immunization. Medical history include historical vaccine as first dose , asthma and diabetes. No concomitant medications reported. On 30Jun2021, the patient was hospitalized for a medical emergency she had two surgeries from sinus fluid leaking into her brain. The patient underwent SARS-CoV-2 test and found negative. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1673394
Sex: M
Age:
State: MI

Vax Date: 02/05/2021
Onset Date: 08/24/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210824; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: COVID-19 confirmed by positive COVID-19 test; Covid-19 Positive; This is a spontaneous report from a contactable other HCP (Nurse). A 50-year-old male patient received bnt162b2 (BNT162B2 Formulation; Solution for injection), dose 2 intramuscularly, administered in Arm Left on 05Feb2021 07:00 (Batch/Lot Number: EL3248) as DOSE 2, SINGLE (at the age of 49-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had covid prior vaccination. Historical vaccine included received first dose of bnt162b2 intramuscularly administered in Arm Left on 15Jan2021 07:00 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE (at the age of 49-year-old) for COVID-19 immunisation. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Aug2021, the patient had fever, congestion and coughing. The patient underwent lab tests and procedures which included Nasal Swab which was positive on 24Aug2021 (COVID positive post vaccination). The patient visited physician office due to the event. It was unknown if patient received treatment for event or not. The outcome of the events reported as recovering. No follow-up attempts needed. No further information expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Vaccination Failure, Covid-19) and the administration of the vaccine cannot be excluded.

Other Meds:

Current Illness:

ID: 1673395
Sex: M
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: fainting; Rt hand started hurting badly; Parsonage Turner Syndrome; weakness; This is a spontaneous report from a contactable consumer (Patient). A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported), via an unspecified route of administration, administered in arm left on 04Aug2021 (at the age of 52-Years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fainting, right hand started hurting badly, parsonage turner syndrome and weakness on an unspecified date. Patient had seen by orthopedic and diagnosed with Parsonage Turner Syndrome. He also had weakness and fainting on the fourth day for about three seconds. He thinks was caused from the pain. Patient questioned if he should take the second vaccine or not and If any other individuals reported the same thing. Outcome of the events was reported as unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673396
Sex: F
Age:
State:

Vax Date: 07/12/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: off label use; pain in the arm where she received the injection on Monday; fatigue; The caller reports patient having received 5 doses of the Pfizer COVID-19 Vaccines; The caller reports patient having received 5 doses of the Pfizer COVID-19 Vaccines; This is a spontaneous report from a contactable consumer. A 86-years-old female patient received fifth 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 16Aug2021 as a single dose for COVID-19 immunization. The patient had received fourth dose bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 12Jul2021 as a single dose for COVID-19 immunization. Medical history included amnesia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose was administered on 18Apr2021; the 2nd was given on 20May2021. the patient received a 3rd dose of the vaccine 26May2021.On an unknown date 2021, the patient experienced pain in the arm where she received the injection on Monday, fatigue. It was reported that Caller is the caretaker of an 86-year-old female patient whose birthday was yesterday 24Aug2021. The caller reports patient having received 5 doses of the Pfizer COVID-19 Vaccines. The caller was unaware that she had received this additional vaccines prior to her logging into her "My Chart" account. She states that she took the patient to get her 1st 2 doses of the vaccines. The first dose was administered on 18Apr2021, the 2nd was given on 20May2021. Those were the only ones the caller was aware the patient had received. Then she has now found out that the patient received a 3rd dose of the vaccine 26May2021, then a forth dose on 12Jul2021 and then another dose on 16Aug2021. Due to having received these vaccines, in excess in such a short period of time, the caller is concerned and wants to know what she should be watching or looking out for. The patient already suffers from short term memory loss and thus is causing this confusion. The caller reports that the patient will wander off "in the neighborhood" and go to places like a possible (Withheld) and ask to get a vaccine and they are just giving it to her with no clarification on past vaccinations. The caller reports the patient complaining of pain in the arm where she received the injection on Monday. She has also had fatigue where she wanted to just lie down and this is not like her. Safety report was filed with DSU. Adverse Reactions Adverse Reactions in Clinical Trials Adverse reactions following the Pfizer-BioNTech COVID-19 Vaccine that have been reported in clinical trials include injection site pain, fatigue, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, malaise, and lymphadenopathy (see Full EUA Prescribing Information).Adverse Reactions in Post Authorization Experience Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials. Myocarditis and pericarditis have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials. LAB-1450-12.0 Revised: 23Aug2021.Caller, who is a caretaker of the patient, wants to know if there is any way that we can "flag the system" so that the patient does not receive any more COVID vaccinations since she has inadvertently received a total of 5 currently. The patient has short term memory loss and will go into facilities and ask for a vaccination she states. The caller does think that one of the times the patient may have thought she was going for her flu shot but inadvertently got the COVID vaccine again. Caller wants to know why "all this information" is given when you go and get your vaccine if we are unable to stop her from getting another one. She states that people are able to go and get their 2nd shots and booster doses but this system is failing for her. The caller is not aware other than (withheld) where she may have received the other doses at and states she will have to do some searching but was hoping that Pfizer would be able to flag "the system. Advised the caller that there is no information available or a way that we can do this through Pfizer MI, however we would recommend that she reach out to her vaccination sites where the patient is able to access these vaccines and ensure they are aware and maybe it is something in their system they can do. The system, if pulled up by her demographic information, should show that she has been vaccinated in the registry.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: 1673397
Sex: F
Age:
State:

Vax Date: 04/01/2020
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: she was fully vaccinated with the Pfizer BioNtech covid 19 vaccines in March and April of last year. She now has the covid 19 infection; she was fully vaccinated with the Pfizer BioNtech covid 19 vaccines in March and April of last year. She now has the covid 19 infection; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 66-years-old female patient received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Apr2020 ,at the age of 66 years old,as Dose 2,single and dose 1 via an unspecified route of administration on Mar2020 (Batch/Lot number was not reported) as Dose 1,single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced after she was fully vaccinated with the pfizer biontech covid 19 vaccines in march and april of last year she now has the covid 19 infection on an unspecified date. The patient wanted to know if not feeling cold would have impacted the efficacy of vaccine. 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:

ID: 1673398
Sex: F
Age:
State:

Vax Date: 03/16/2021
Onset Date: 04/09/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: vaginal infection; This is a spontaneous report from a contactable physician received by Pfizer from (GL-052821-13037). A 49-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN; solution for injection, lot number, expiration date was not reported), via intramuscular route, on 16Mar2021, at dose 1, single for covid-19 immunization. Medical history included skin cancer and rosacea. She had no dental work in the past 6-12 months. The patient's concomitant medications were not reported. The patient experienced the vulva area removed (two weeks prior to 23Apr2021) and a vaginal infection post-surgery on 09Apr2021. The patient second dose of vaccination on 13Apr2021 for covid-19 immunization. Therapeutic measures included anti-biotics taken as a result of vaginal infection. The outcome of the events was unknown. The lot number for [bnt162b2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673399
Sex: F
Age:
State: MD

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

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

Lab Data:

Allergies:

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

Symptoms: Low immune system; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose and dose 2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced low immune system on an unspecified date. Patient due for a refill: Patient stated, "she had a low immune system and had taken both the shots for COVID-19. She was concerned if I had to get the booster dose." Patient was prescribed Xeljanz XR 11mg. Therapeutic measures were taken as a result of low immune system (immune system disorder). Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1673400
Sex: F
Age:
State:

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: Scan; Test Result: Negative ; Comments: they couldn't see cyst on her ovary

Allergies:

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

Symptoms: pain kind of like her hip area may be kind like at ovaries and by her hip; pains in the muscles; She is getting lot of pain; it was so bad; This is a spontaneous report from a contactable consumer (patient's mother). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 14Aug2021 (at the age of 17-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient's mother stated that her daughter got the first dose of the COVID Vaccine on not this Saturday, So about a week ago. A couple of hour after she got the COVID shot on the 14Aug2021, Saturday and couple of hour after on 14Aug2021 she started getting the pain kind of like her hip area may be kind like at ovaries and by her hip and just started like, some pains in the muscles whatever and anyways kind off and line and then by Friday a couple of days ago to the last Friday it was so bad. Patients mother actually took her up to the Emergency room and they done a bunch of test (further clarifications unknown) on her to see if she either had an UTI (further clarifications unknown), there was they did also scan on her. They did a bunch of test and everything all over blood work everything come back completely normal. They couldn't find anything going on but the pain started like a said about 12 after she got a COVID vaccine. So were she was just trying to find out if this the pain. She took the emergency room that was the case she was had the shot and this pain came on a couple hour after and they thought maybe it was UTI or maybe there was a cyst on her ovary that everything came back negative they couldn't see cyst on her ovary, all those things came back negative they can't see cyst on her ovary, they can't see her urine came back fine like everything was come back completely fine. So, we got to know what's going on and she had not got any better at all, it was like worse and worse and so she doesn't know this was a side effect of that vaccine or something that she can do as we checked but don't know because everybody they done as scan on her, they done blood work on her, they given an IV, they given her pain meds, they done everything and everything shows no but she was getting lot of pain on 14Aug2021. The patient underwent lab tests which included blood test showed normal on an unknown date in 2021; scan was negative (they couldn't see cyst on her ovary) on an unknown date in 2021. Therapeutic measures were taken as a result of pain kind of like her hip area may be kind like at ovaries and by her hip, pains in the muscles, she was getting lot of pain; it was so bad with IV and pain medications. The outcome of the events was mot recovered. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673402
Sex: F
Age:
State: NE

Vax Date: 04/14/2021
Onset Date: 08/25/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210825; Test Name: COVID test; Test Result: Positive

Allergies:

Symptom List: Tremor

Symptoms: COVID incident after being fully vaccinated; COVID incident after being fully vaccinated; This is a spontaneous report from a contactable physician. A 47-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0151), dose 1 via an unspecified route of administration on 14Apr2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration and on 05May2021 (Batch/Lot Number: ER8735) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced a breakthrough COVID incident after being fully vaccinated. Symptoms were mild included runny nose, congestion, loss of taste and smell and a positive COVID test received on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 25Aug2021. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1673403
Sex: F
Age:
State: NE

Vax Date: 05/05/2021
Onset Date: 08/25/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210825; Test Name: Covid; Test Result: Positive

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: positive COVID test; positive COVID test; This is a spontaneous report from a contactable physician (patient). A 47-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05May2021 (lot Number: ER8735) as single dose, and dose 1 via an unspecified route of administration on 14Apr2021 (Lot: EW0151) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced positive covid test on 25Aug2021. As reported, Breakthrough mild COVID symptoms (runny nose, congestion and loss of smell and taste and positive COVID test) was reported. The patient was weighed 168 lbs. The patient experienced a breakthrough COVID incident after being fully vaccinated. Symptoms were mild included runny nose, congestion, loss of taste and smell and a positive COVID test received on 25Aug2021. She was vaccinated on 05May2021 for the second dose. The patient underwent lab tests and procedures which included COVID-19 of positive on 25Aug2021. The outcome of the event was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events vaccination failure and COVID-19 cannot be totally excluded.

Other Meds:

Current Illness:

ID: 1673404
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: bad headache; felt lethargic; This is a spontaneous report received from a contactable consumer or other non hcp. A 45-years-old male patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration on Aug2021,at the age of 45 years old, as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced he had bad headache on Aug2021 and felt lethargic on Aug2021.The outcome of the event was recovered.Upon followup received on 26 aug 2021,The patient stated that he took the first shot 3 weeks ago and within 15 mins he got a real bad headache for 3 days with being real lethargic.After second shot of Pfizer vaccine,the headache started 15 to 20 minutes after and he didn't feel right.The patient didn't visit the doctor.His employer said he would get fired if he didn't have a shot. Now he feels terrible and he doesn't know what to do. Response received from DSU end was,6 OVERALL SAFETY SUMMARY In clinical studies, adverse reactions in participants 16 years of age fatigue (62.9%), headache (55.1%), chills (31.9%), and fever (14.2%). LAB-1457-12.0 Revised: 23 August 2021 Follow-up (26Aug2021): This is a follow-up spontaneous report received from a contactable consumer. This 45-year-old male consumer (patient) reported for himself that Dates for same experience, only worse and the headache start 15 to 20 minutes after was unspecified,He just wants to make someone aware and to see if its normal. His left side of his head down to his neck and face is on fire.Patient wanted to know whether these adverse events are related to the Pfizer covid vaccine.Address, Alternative Telephone, Email address - Caller declined to provide at this time. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673405
Sex: M
Age:
State: MA

Vax Date: 02/15/2021
Onset Date: 08/21/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210825; Test Name: PCR test; Test Result: Positive ; Comments: Nasal Swab; Test Date: 20210823; Test Name: rapid test; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. Was PCR tested CV19 positive on 25Aug2021; received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. Was PCR tested CV19 positive on 25Aug2021; This is a spontaneous report from a contactable other HCP. A 38-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via intramuscular route of administration, in the left arm, on 15Feb2021 (at the age of 38-year-old), as single dose and received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via intramuscular route of administration, in the left arm, on 27Jan2021 (at the age of 38-year-old), as single dose, both the doses for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Unknown if other vaccine in four weeks and Unknown if other medications in two weeks. Unknown if COVID prior vaccination. On 21Aug2021, reporter staes patient received full 2-dose series of CV19 vaccine #1 on 27Jan2021 and #2 on 15Feb2021. patient was PCR tested CV19 positive on 25Aug2021. Event resulted in doctor or other healthcare professional office/clinic visit. Unknown if patient received treatment for events. The patient underwent the lab tests and procedure which included the rapid test (Nasal Swab): result was positive on 23Aug2021 and PCR test (Nasal Swab): result was positive on 25Aug2021. Outcome of the event was recovering. No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events vaccination failure, COVID-19 and suspect drug BNT162B2 cannot be excluded.

Other Meds:

Current Illness:

Date Died:

ID: 1673406
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: breakthrough infection and died; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The consumer stated that on the website, it says that it's not FDA approved, as well as voicemails. She went on to say that it only takes a minute to update those things, and she would think with something this large, they would have been ready. She stated that she was aware that the VAERS website contains side effects and things that have happened. She stated that other vaccines have been halted after 1 to 2 deaths. She is aware of a couple of people dying as a direct result of the Pfizer BioNTech vaccine, as well as as friend that had a breakthrough infection and died on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: breakthrough infections and has died

Other Meds:

Current Illness:

ID: 1673407
Sex: F
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: severe headache; numbness on the right side of her face; lot number on her vaccination card did not match any Pfizer inventory of the vaccine; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3184; Expiration Date: Oct2021), via an unspecified route of administration on an unspecified date of 2021 (Sunday) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient experienced severe headache and numbness on the right side of her face. Patient stated that she learned that the lot number on her vaccination card did not match any Pfizer inventory of the vaccine. She said she confirmed the number with Walmart (even showing us a photo of the vial and box: FC3184, expiration Oct2021) and also reported the matter to Pfizer. Eventually, some time on 25Aug2021 (yesterday), a representative of either Pfizer or Walmart (got this information third hand because patient spoke with an editor on this specific piece of info) contacted her to say that yes, the vaccine was legitimate and that there was an unexplained mix up with the Lot number. Reporter asked to confirm this incident with respect to the lot number and what was the mix up and how was this matter resolved. The events were subsiding but have not fully gone away. The outcome of the severe headache and numbness on the right side of her face was recovering.

Other Meds:

Current Illness:

ID: 1673408
Sex: M
Age:
State:

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: physical and lab test; Result Unstructured Data: Test Result:showed no protect/antibodies in the blood; Test Date: 2021; Test Name: SARS-CoV-2 antibody test; Test Result: Negative

Allergies:

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

Symptoms: ulcerative colitis; They think it was because he was on that medication. The test didn't show any antibodies; They think it was because he was on that medication. The test didn't show any antibodies; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the first single dose of bnt162b2 on 04Feb2021 for covid-19 immunisation. He reported he received 2 doses of the Pfizer COVID vaccine. The first one on 04Feb2021, and the second one on 25Feb2021. He had physical and lab test done a few weeks ago in 2021. Lab results showed no protect/antibodies in the blood. He had ulcerative colitis in 2021 and take azathioprine (IMURAN) 150mg daily. It is an immunosuppressant medication. They think it was because he was on that medication. The test didn't show any antibodies in 2021. He was going to take the booster dose. Patient wanted to know about time period he should stop or change the dose of azathioprine before he took the booster dose of Pfizer covid vaccine. The doctor's said that the test that was done at a local lab might not be accurate in judging what protection he did or didn't have. His doctor told him to call Pfizer to find a test that would be accurate. The previous agent said they have no information on what kind of test is accurate. That blows his mind. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test with negative in 2021. Outcome of events was unknown. The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1673409
Sex: M
Age:
State: NY

Vax Date: 08/16/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: COVID-19 Test; Test Result: Positive

Allergies:

Symptom List: Pain in extremity

Symptoms: husband tested positive for Covid-19 infection after the first dose of the vaccine; not feeling well; their arms were sore and tender; fever; chills; cold; coughing; diarrhea; Tension headache; This is a spontaneous report from contactable consumer (Patient's wife). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Aug2021 (age at the time of vaccination was 55-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 infection after the first dose of the vaccine on 23Aug2021, not feeling well, their arms were sore and tender, fever, chills, cold, coughing, diarrhea, tension headache. It was reported that the Comirnaty vaccine and she had questions for herself and mentioned that her husband got it a week and a half ago and he tested positive after getting the 1st vaccine. Caller stated that they both had their Pfizer COVID vaccine on Monday 16Aug2021 and her husband tested positive for Covid on 23Aug2021. States they are scheduled for the 2nd dose 06Sep2021. The patient takes no medication and was very healthy, that if it was not for working with, that with his way of life. The patient normally would not have taken the vaccine but because of he did what was required. Caller stated that the patient was fine and she thought it was Thursday night into Friday he started not feeling well and he doesn't take any medications and was very healthy. Caller stated after they got their vaccines they sat for half an hour and they both were ok, their arms were sore and tender on the 2nd day they had very tender arms. States her husband did not feel anything and he thought it was just symptoms until Saturday and it was more severe Saturday into Sunday or Sunday into Monday he had chills, was cold, coughing, diarrhea and fever. Caller states her husband was very healthy and had a strict way of eating and living and he wears a mask, sometimes too much for her. Caller states they did get documents, information along with their card and was did not go into great detail and it was worrisome and it was not approved and did not consider how long after the 1st injection, it could be up to 7 days for side effect and it was still in clinical trials. States that now he felt warm today and was resting and has a tension headache since last night on the sides of his head. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 23Aug2021. The outcome for all 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: 1673410
Sex: F
Age:
State: NY

Vax Date: 02/24/2021
Onset Date: 08/25/2021
Rec V Date: 09/04/2021
Hospital:

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

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

Allergies:

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

Symptoms: lack of efficacy- contracted COVID-19; lack of efficacy- contracted COVID-19; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular administered in Arm Right on 05Feb2021 (Lot Number: EM9810) at age of 37-year-old, dose 2 intramuscular, administered in Arm Right on 24Feb2021 (Lot Number: EN6202) at age of 37-year-old, both at single dose for covid-19 immunisation. Medical history included asthma. It was unknown if covid prior vaccination. Concomitant medications included bifidobacterium bifidum, bifidobacterium lactis, lactobacillus acidophilus, lactobacillus brevis, lactobacillus bulgaricus, lactobacillus casei, lactobacillus paracasei, lactobacillus plantarum, lactobacillus rhamnosus, lactobacillus salivarius (PROBIOTIC 10). The patient previously took amoxicillin and experienced drug hypersensitivity. No other vaccine in four weeks. The patient experienced lack of efficacy- contracted covid-19 on 25Aug2021. Events resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 25Aug2021. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: PROBIOTIC 10

Current Illness:

ID: 1673411
Sex: F
Age:
State: WI

Vax Date: 07/30/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: numbness and tingling in both right and left arm from elbow down; numbness and tingling in both right and left arm from elbow down; weakness in right arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that a 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3180; Expiration Date: 31Oct2021), intramuscular, administered in deltoid right on 30Jul2021 (age at vaccination: 30-years-old) as dose 1, 0.3 ml, single for COVID-19 immunisation. Medical history included ongoing Lupus, Covid virus from Nov2020. The patient was immunosuppressed. Concomitant medication included ongoing chloroquine taken for Lupus. Historical vaccine included Hepatitis B, as dose 1, single and Second dose of Hepatitis B Series that was not administered at their location was given 10 days prior to Covid vaccine. The patient was received first dose of Pfizer Covid 19 vaccine on 30Jul2021 and no second dose to date. On an unknown date in Aug2021, within 5 to 7 Days she developed numbness and tingling in both right and left arm from elbow down. It was less in left arm and experiencing weakness in right arm. No weakness in her left arm. This was bilateral from the elbow down and not involving the shoulder. The patient experienced side effects after dose 1 of Pfizer Covid 19 vaccine but not the second dose as to date. During conversation between agent and Pharmacist timing of second dose noted. Pharmacist noted that he would refer to HCP and was aware that second dose could be given as late as 42 days. The patient was also immunosuppressed and the patient would like to get the second and third dose. The events of numbness and tingling in both right and left arm from elbow down and weakness in right arm were considered as serious (Medically significant) by reporter (pharmacist). The pharmacist has chosen medical significant since weakness was a part of it. The patient was not visited emergency Room and Physician Office. Relevant tests were none. The outcome of the all events was recovered on an unknown date in Aug2021. Causality was unknown. Post marketing reports for paresthesia as of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. "Please note, however, that accumulated case reports cannot be used to calculate incidence or estimates of drug risk for the following reasons: 1) the number of reports received may not be reflective of the actual number of cases that have occurred, 2) the actual number of patients receiving Pfizer-BioNTech COVID-19 vaccine at any time point is not known, and 3) a causal relationship between Pfizer-BioNTech COVID-19 vaccine and these cases has not been established. Pfizer is unable to make any recommendations regarding the treatment of paresthesia following administration of Pfizer/BioNTech COVID-19 Vaccine; clinical judgment based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken." Post marketing reports for paresthesia as of 02Jul2021, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 Vaccine revealed that we have received spontaneous reports of Guillain-Barre syndrome since the market introduction (including conditional marketing authorization and/or emergency use authorization) of Pfizer-BioNTech COVID-19 Vaccine. Please note, however, that accumulated case reports cannot be used to calculate incidence or estimates of drug risk for the following reasons: 1) the number of reports received may not be reflective of the actual number of cases that have occurred, 2) the actual number of patients receiving for Pfizer-BioNTech COVID-19 Vaccine at any time point is not known, and 3) a causal relationship between for Pfizer-BioNTech COVID-19 Vaccine and these cases has not been established. MANAGEMENT GUIDELINES: Pfizer does not have any recommendations regarding the management of Guillain-Barre syndrome in patients who have received Pfizer-BioNTech COVID-19 Vaccine. Clinical judgement based on the medical history and the clinical status of a specific patient should dictate the appropriate actions to be taken".; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events tingling, numbness and weakness of arm and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: CHLOROQUINE

Current Illness: Lupus erythematosus

ID: 1673412
Sex: M
Age:
State: NY

Vax Date: 02/24/2021
Onset Date: 08/16/2021
Rec V Date: 09/04/2021
Hospital:

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

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

Allergies:

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

Symptoms: lack of efficacy- contracted COVID-19; lack of efficacy- contracted COVID-19; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular administered in Arm Right on 05Feb2021 (Lot Number: EM9810) at age of 39-year-old, dose 2 intramuscular administered in Arm Right on 24Feb2021 (Lot Number: EN6202) at age of 39-year-old, both at single dose for covid-19 immunisation. Medical history included asthma. No covid prior vaccination. There were no concomitant medications. The patient previously took cefaclor (CECLOR) and experienced drug hypersensitivity. No other vaccine in four weeks. The patient experienced lack of efficacy- contracted covid-19 on 16Aug2021. Events resulted in [Doctor or other healthcare professional office/clinic visit]. No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Rapid Nasal Swab): positive on 25Aug2021. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1673413
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Heart arrhythmias; This is a spontaneous report from a contactable pharmacist via Pfizer-sponsored Regulatory Authority Support via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Her patient stated she was experiencing heart arrhythmias after the Pfizer covid-19 vaccine. She had a medical question. She wanted to know why was there potassium chloride in the Pfizer COVID-19 vaccine. Her patient wanted to know why would they put something in it that will kill her. The outcome of the event was unknown. This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Arrhythmia cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1673414
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face; fever; chills; headache; burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 45-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 45-years) on 25Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization and experienced bad headache and felt lethargic. On an unspecified date in Aug2021, the patient experienced worse side effects including a burning/warm sensation on the left side (same side where he got the shot of the vaccine) of his head down to neck including the face, fever, chills and headache. It was further reported that caller wanted to know if headache, feeling of lethargic, fever, chills, and feeling warm from the left side of his head down to his neck including the face is a reported adverse events after getting the Pfizer BionTech Covid-19 Vaccine. In clinical studies, adverse reactions in participants 16 years of age fatigue (62.9%), headache (55.1%), chills (31.9%), and fever (14.2%). LAB-1457-12.0. No information specific to warm sensation on the left side of the body.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: 1673415
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: got both doses in late Apr2021 and in the middle of Jul found out I have a heart murmur now; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored Regulatory Authority Support and medical information team. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECG COVID-19 mRNA VACCINE), via an unspecified route of administration in Apr2021 (Lot number and Expiry date was not reported) as dose 2, single for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 via an unspecified route of administration in Apr2021 (Lot number and Expiry date was not reported) as dose 1, single for Covid-19 immunization. It was reported, the patient had both doses in late Apr2021 and in the middle of Jul2021 the patient found out he have a heart murmur now (at the time of report). It was reported, he had undergone some tests and scheduled to have mitral valve replacement surgery because of this in the upcoming week (at the time of report). It was reported he got moved to front of the list (further details not specified) because it was so bad. The outcome for the event was not reported. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673416
Sex: F
Age:
State: TX

Vax Date: 08/13/2021
Onset Date: 08/16/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: backaches; extreme fatigue; leg and body aches; leg and body aches; recurring headaches; This is a spontaneous report from a contactable consumer reporting for granddaughter (patient) via medical information team. A 14-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route administered on 13Aug2021 (at the age of 14-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown) administered via unknown route on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. The patient had no history of adverse events with any previous vaccines. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Reporter stated that patient received her second dose of the vaccine on 13Aug2021, after which she developed backaches on 26Aug2021, leg and body aches, recurring headaches, and extreme fatigue on 16Aug2021. The back ache was intermittent. Reporter stated that the extreme fatigue vary from tired to very tired and it is persistent with some extreme fatigue and that it goes up and down. It was reported that no medical treatment was given and patient just took Tylenol. No further details provided. The outcome of all the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1673417
Sex: F
Age:
State:

Vax Date: 08/23/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rectal bleeding; This is a spontaneous report from a contactable Pharmacist. An adult female Pharmacist (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experiencing rectal bleeding (medically significant). The outcome of event was unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rectal Bleeding. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1673418
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: injured his back; 3rd dose of the Pfizer covid vaccine booster; 3rd dose of the Pfizer covid vaccine booster; This is a spontaneous report from a contactable consumer (caregiver). A male 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 on an unspecified date in 2021, as dose 3, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first and 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 1 and 2, single for COVID-19 immunization. The reporter stated that on an unspecified date in 2021, the patient received the 3rd dose of the Pfizer covid vaccine booster. The patient injured his back and was at the physical therapist along with the reporter. The patient was prescribed Prednisone and a Muscle relaxant during a telemedicine visit for the event injured his back and did not tell the doctor that he had received the vaccine. The outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am