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: 1647263
Sex: M
Age:
State: NJ

Vax Date: 03/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
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: having slight discomfort at the site of injection; cancer; This is a spontaneous report from a contactable physician (patient) from a Pfizer-sponsored program. This male patient of unspecified age reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route in Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via unspecified route in Mar2021 as a single dose for COVID-19 immunization and experienced slight discomfort at the site of injection. The patient was diagnosed with cancer in May2021. He was treated with chemo and radiation. Today (13Aug2021) was the last dose of both chemo and radiation. He stated he will go to his oncologist Monday. Patient reported that he received both doses of the Pfizer Covid-19 vaccine in Mar2021, reports having no side effects other than having slight discomfort at the site of injection. The patient reported that his cancer was not related to the vaccine itself. It was HPV related. The patient inquired about the timing of the booster after chemo being given. He just finished treatment (chemotherapy and radiation) today (13Aug2021) and his oncologist suggested he wait a couple weeks to "perk up". He saw his oncologist for a consult in terms of the vaccine. His doctor said they could wait two weeks and reassess and see if he has any antibodies. He did get the vaccine in Mar2021. He just doesn't know if he has antibodies from Mar2021. So his doctor said to wait a couple of weeks before getting any vaccine. The outcome of the events was unknown. The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: There is no reasonable possibility of causal association between the event of Neoplasm malignant and BNT162b2. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101048314 same patient, same drug, different AE, different dose of vaccine

Other Meds:

Current Illness:

ID: 1647264
Sex: F
Age:
State: WI

Vax Date: 08/09/2021
Onset Date:
Rec V Date: 08/28/2021
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 Name: CAT scan; Result Unstructured Data: Test Result:normal

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: ears sounds like talking like in a tin can like there was static in head; Ringing in the ears; This is a spontaneous report from a contactable consumer, reporting for herself. A 28-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: FA7485), intramuscularly in the right upper arm on 09Aug2021 at a single dose for covid-19 immunisation. Medical history included on a beta blocker for heart. Concomitant medications included atenolol (MANUAFCTURER UNKNOWN) taken for heart. The patient experienced ears sounds like talking like in a tin can like there was static in head and ringing in the ears on an unspecified date. The events were further described as: after receiving the vaccination dose one, last week, she has been experiencing an adverse effects of ringing in the ears. She described the side effects as better in the morning and almost gone awake when she wakes up but then it progressed throughout the day. She states that it was static like and sounded like she was talking into air or into a tin can and its all day long. She stated that she has been to her doctor and had a CAT scan and that everything came back normal on an unknown date. No therapeutic measures were taken as result of the events. The clinical outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: ATENOLOL

Current Illness:

ID: 1647265
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Had an issue with the lining of my heart; myocarditis; pericarditis; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that: A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. On an unspecified date, the patient experienced had an issue with the lining of my heart, myocarditis, pericarditis. Patient asked if she was eligible to take the booster or third shot. Went to pharmacist and had to fill out a form Number 14 says a history of myocarditis, inflammation of the heart, and pericarditis She got myocarditis and pericarditis three weeks ago after her first two COVID-19 shots. Her shots were fine. Is was said that she should not get the booster if she has pericarditis. Clarified her myocarditis and pericarditis have nothing to do with her COVID-19 vaccines. It happened at the Withheld. She was on a lot of blood thinners. Patient was on Colchicine and 3000mg of Aspirin (Intent: treatment). Therapeutic measures were taken as a result of had an issue with the lining of my heart, myocarditis, pericarditis. Events were considered as serious (medically significant). Patient received treatment with Colchicine and 3000mg of Aspirin. The clinical outcome of events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647266
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Had loss of hearing I still have loss of hearing; I was little upset right now because this morning I still haven't have my hearing and I am not really happy I am, it's very upsetting; This is a spontaneous report from a non-contactable consumer(patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date in 2021, as single dose for covid-19 immunization. Medical history included ongoing hearing loss. concomitant medications were not reported. On an unspecified date in 2021, an hour after patient got shot, patient had loss of hearing and still have loss of hearing this morning. The patient stated that already have hearing loss and then when I got the shot all of a sudden I have, I can't hear. The patient further stated that patient was little upset right now because this morning still haven't have hearing and was not really happy and it's very upsetting. It was stated that the patient would call somebody Monday morning and see what they going to do about this. If this was correct, then patient don't know whether they get the second shot. The clinical outcome of event was unknown. No follow-up attempts were possible; information about lot/batch number could not be obtained. No further information was expected.

Other Meds:

Current Illness: Hearing loss

ID: 1647267
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Person had the first dose of Pfizer vaccine and now have Parkinson's; This is a spontaneous report from a non-contactable consumer reported that a patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of Pfizer vaccine and now have Parkinson's (unspecified date). The 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: 1647268
Sex: U
Age:
State:

Vax Date: 08/09/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Lot of itchy skin and it continued; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Aug2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. On 11Aug2021 the patient experienced lot of itchy skin and it continued. Therapeutic measures were taken as a result of lot of itchy skin and it continued. Patient stated that: I have taken a Benadryl (treatment) and I don't know if that's enough or do I need to go to see an Urgent Care person. The clinical outcome of the event 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: 1647269
Sex: F
Age:
State: PA

Vax Date: 08/14/2021
Onset Date: 08/14/2021
Rec V Date: 08/28/2021
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: Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; Half hour from injection, vision started to become unfocused. Vision off and headache. Lightheaded; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Batch/Lot Number: FC3180) via an unspecified route of administration, administered in Arm Left on 14Aug2021 at 10:00 (Age at vaccination: 58-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient had no allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. On 14Aug2021 at 10:30, The patient experienced half hour from injection, vision started to become unfocused. vision off and headache,Lightheaded. Hospitalization Prolonged was reported as no. Treatment received was reported as no. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1647270
Sex: F
Age:
State: CA

Vax Date: 04/02/2021
Onset Date: 04/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Since getting the second dose, my periods have been essentially nonexistent when they use to be super regular, now I'll randomly have a blood clot fall out; Since getting the second dose, my periods have been essentially nonexistent when they use to be super regular, now I'll randomly have a blood clot fall out; Nerve pain in both arms; This is a spontaneous report from a contactable other hcp. A 24-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, right arm on 02Apr2021 (at the age of 24-years-old) as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included allergies to Latex from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not with diagnosed with COVID-19. Since the vaccination, the patient was not with diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, in left arm on 12Mar2021 (at the age of 24-years-old) as single dose for COVID-19 immunisation. It was reported that since getting the second dose on 22Apr2021 the patient's periods had been essentially non-existent when they use to be super regular, now patient randomly have a blood clot fall out. The patient also been experiencing nerve pain in both arms. The patient did not receive any treatment for the events. The patient was not recovered from the events. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event Blood clot and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1647271
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Covid test; Test Result: Positive

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: tested positive for Covid-19 after receiving the vaccine; tested positive for Covid-19 after receiving the vaccine; This is a spontaneous report from a contactable consumer (Pfizer employee). An adult female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was believed to have received the Pfizer vaccine to completion, but on an unspecified date, patient was still tested positive for Covid-19 after receiving the vaccine. Patient believed she had a sinus infection, but then tested positive for the COVID-19. The events were reported as non-serious by the reporter. This information was received second hand (not from impacted individual) from individual's friend who happens to be a healthcare professional. Since the vaccination, the patient has been tested for COVID-19.The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647272
Sex: F
Age:
State: NC

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: BP; Result Unstructured Data: Test Result: Increased; Test Date: 20210811; Test Name: Heart rate; Result Unstructured Data: Test Result: Increased.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Loss of consciousness; Tightness in chest; Confusion; Flushing; Diarrhea; Increased BP; Increased Heart rate; Breathing labored and often forgot to labor; Headache; Nausea; Vomiting; Coughing; This is a spontaneous report from a contactable consumer (Patient) reporting for herself. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Aug2021 at 14:15 (age at vaccination: 49-year-old and non-pregnant) as DOSE 1, SINGLE for covid-19 immunization at a doctor's office/urgent care. Medical history included mast cell activation syndrome and sjogren's: both from an unknown date and unknown if ongoing. There were no concomitant medications (list of any other medications the patient received within 2 weeks of vaccination: no). Patient had known allergies to latex and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Aug2021 at 14:15, patient experienced loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing with 50 mg Benedryl, orally. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events loss of consciousness, tightness in chest, confusion, flushing, diarrhea, increased BP (blood pressure) and heart rate, breathing labored and often forgot to labor, headache, nausea, vomiting and coughing was recovered on an unspecified date in Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647273
Sex: F
Age:
State: RI

Vax Date: 05/16/2021
Onset Date: 05/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Heart monitor; Result Unstructured Data: Test Result:results unknown; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:results unknown; Test Date: 20210706; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: severe pains in my heart/squeezing pains in my heart; more heart flutters and palpitations; more heart flutters and palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 23-years-old, non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 16May2021 (at the age of 23-years-old) as dose 2, single for Covid-19 immunization in other facility. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Since the vaccination, the patient has not been tested for Covid-19. Medical history included depression, anxiety, ptsd (Post-traumatic stress disorder), lactose intolerance, temporal lobe seizures, migraines, known allergies: lithium, Covid-19 (prior to vaccination). Concomitant medication(s) included fluoxetine hydrochloride (PROZAC); vitamin B6; cannabidiol (CBD OIL). The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171, Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 25Apr2021 (at the age of 23-years-old) as dose 1, single for Covid-19 immunisation in other facility and experienced trouble focusing and developed a big headache, her eyes had trouble focusing, she was experiencing severe depersonalization, her legs lost function and she could hardly walk, the rest of her body felt weak but kept doing involuntary movements (like hand opening and closing), she struggled to think or talk, it felt like her body was forgetting how to work, she have been having seizures. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has been tested for Covid-19. On 20May2021, the patient experienced severe pains in her heart/squeezing pains in her heart, more heart flutters and palpitations, shortness of breath. It was reported that, four days after her second shot, she experienced severe pains in her heart and shortness of breath, which brought her back to an ER. Since then, she still has squeezing pains in her heart, but not as frequent nor with shortness of breath as much. Yet she does have more heart flutters and palpitations. The heart pains were very regular and intense for about two weeks after the second dose, where she almost went to the ER several times. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included heart monitor: results unknown and MRI: results unknown on an unspecified date in 2021, nasal Swab: negative on 06Jul2021. Therapeutic measures were taken as a result of the events with IV fluids, benadryl, Reglan. The outcome of the events was not resolved.

Other Meds: PROZAC; VITAMIN B6; CBD OIL

Current Illness:

ID: 1647274
Sex: F
Age:
State: CA

Vax Date: 08/10/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: COVID-19; Test Result: Positive ; Comments: if_covid_prior_vaccination: Yes

Allergies:

Symptom List: Rash, Urticaria

Symptoms: fluttering in chest; headache; fatigue; diarrhea; swollen lymph nodes; This is a spontaneous report from a non-contactable consumer or other non hcp. A 58-years-old female patient received bnt162b2 (BNT162B2) solution for injection dose 1 (Lot Number: FA7485 expiry date was unknown) via an unspecified route of administration at arm left on 10Aug2021 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing if covid_prior_vaccination: Yes. Concomitant medication(s) included alprazolam (XANAX), vitamin d (vitamin d nos), multivitamins and HRT. No pregnancy at time of Vaccination. The patient had received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Xanax, multivitamins, vitamin D, HRT. Prior to vaccination the patient had diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Patient had no known allergies. On 11Aug2021 07:00 the patient experienced fluttering in chest, headache, fatigue, diarrhoea and swollen lymph nodes. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date patient had covid_prior_vaccination. No treatment was given. Outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: XANAX; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1647275
Sex: F
Age:
State: VA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 08/28/2021
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: lost conscious; siziures; Extreme sweats; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration on 25Mar2021 at 11:30 at the age of (65-years-old at time of vaccination) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient 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 did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was did not diagnosed with covid-19. Since the vaccination, the patient was did not diagnosed with covid-19. It was reported that on an unspecified date in 2021 the patient experienced extreme sweats, lost conscious, seizures. The patient was not hospitalized due to these events. The patient did not receive any treatment for the events. The patient visited physician office due to these events. The outcome of the events was unknown at the time of report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647276
Sex: F
Age:
State: WA

Vax Date: 05/01/2021
Onset Date: 05/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210504; Test Name: Blood sugar; Result Unstructured Data: Test Result:Increased; Comments: 450-500 range that persisted for 2.5 weeks

Allergies:

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

Symptoms: very high blood sugar in the 450-500 range that persisted for 2.5 weeks; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration, administered in left arm on an unspecified date in May2021 12:00 (at the age of 57-year old), as dose 1, single for COVID-19 immunisation. Medical history included patient was diabetic and had known allergies to Keflex. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks. The patient received unspecified concomitant medications given within two weeks of vaccination. Another unspecified vaccine with lot number ER87311 was given on the same date of vaccination in May2021 (pending clarification). On 04May2021 12:00, the patient reported that she was diabetic, but the shot gave her very high blood sugar in the 450-500 range that persisted for 2.5 weeks. In other times, her sugar levels were in control. She used a tracking app for her food, so she knew what her numbers were on and verified this with finger sticking. The adverse event resulted in doctor or healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure taken as a result of the event included additional use of insulin glargine. The outcome of the event was recovered in May2021. The lot number for BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1647277
Sex: U
Age:
State: KY

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 08/28/2021
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: 2021; Test Name: COVID-19; Result Unstructured Data: Test Result:Positive

Allergies:

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

Symptoms: Tested positive for Covid virus after being fully vaccinated with Pfizer vaccine on 3/10/21 and 4/01/21; Tested positive for Covid virus after being fully vaccinated with Pfizer vaccine on 3/10/21 and 4/01/21; This is a spontaneous report from a contactable other hcp (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Apr2021 as DOSE 2, SINGLE and first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 10Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive for covid virus after being fully vaccinated with Pfizer vaccine on an unspecified date in 2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in 2021. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and a close association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of COVID-19 and drug ineffective.

Other Meds:

Current Illness:

ID: 1647278
Sex: U
Age:
State:

Vax Date: 03/16/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: before was a regular layer of Tinnitus, it got acute ; the acute stage is more worse; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on 16Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history included ongoing tinnitus and reported that patient already had a mild case of Tinnitus. The patient concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, administered on unspecified date as a single dose for covid-19 immunisation. It was reported that patient had second shot on 16Mar2021 of this year and patient previously had a mild case of Tinnitus. After getting the second shot, patient would say within 2-3 days something or maybe its 3-4 days, patient noticed a profound increase in the Tinnitus and patient waited for a long. patient had before was a regular layer of Tinnitus, but this time it got acute now the regular. The patient further reported that if normal layer of Tinnitus, the acute stage it was more worse. Patient went to see an ENT and he doesn't see anything that would had been causing it structurally and now also went see an Audiologist it was nothing that they could do about it. Anyhow patient had been reading that there are people reporting this not in huge amount, what the experiences they occur, or any information can give to patient about expecting it to decrease or patient was concerned about getting a booster shot if that were to be necessary. The patient was not recovered from the event. Outcome of the event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness: Tinnitus (I already had a mild case of Tinnitus)

ID: 1647279
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: I finally did get vaccinated but only out of stupidity; vaccine is only 40% effective; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient get vaccinated but only out of stupidity; vaccine is only 40% effective (drug ineffective) on an unspecified date. The outcome of the event was unknown. Description of Product Complaint: Consumer stated, "Well here is what to do. I have called here before they took my address yesterday. They were interested in what I had to say unless you people just say you are interested and you, really not. You know I got forensic work for Pfizer because I went to (withheld) grad school for chemistry so, some of the guys in my lab had worked for your company. Anyhow here is the problem I am having now with this vaccine stuff. I finally got, I did get vaccinated but only out of stupidity ok cause I got a question here and here is the question. I took the COVID vaccine (Suspect not clarified hence captured as unspecified vaccine in tab) in Biochemistry the withheld you know with the organic chemistry. I want to know with the rise in this supposedly delta variant virus. It appears to be rising with the degree of vaccination. Consumer stated, "No I want to inform you and that is the reason I am talking to you that, that Medical Technology Department goes like this 'all lines are busy goodbye' they won't talk. Do not delude yourself that, that department is honest it is not. It is not talking. I will tell you why it is not talking, it is not talking because these really prove that your vaccine is only 40% effective (Further clarification was unknown) but I am not calling about that. What I am asking a general question of drug vaccine safety. Okay, just listen a minute if you have a wrong vaccine, when I used the word wrong that it produces neutralizing antibodies that are not killing the virus. Not the worth is it is not directing the virus to the T- cells and the B- cells. That all it is doing is taking our (Incomplete Sentence). Product Details(LOT#, NDC, UPC, Expiration Date) cannot be probed hence checked unknown in tab. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.

Other Meds:

Current Illness:

ID: 1647280
Sex: F
Age:
State:

Vax Date: 07/23/2021
Onset Date: 08/02/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210802; Test Name: Covid-19 test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: She got the first Pfizer Vaccine on 7/23 and then she got COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 23Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Aug2021, patient got COVID and and she got the antibody infusion on 03Aug2021, so did not recommended to wait 90 days past antibody infusion and to get a dose of COVID vaccine and she already got her first dose and then they did not recommend doing more than 42 for your second dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on 02Aug2021. 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: 1647281
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

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

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: She recently developed flu-like symptoms and had a positive COVID-19 test. Fever, headache and nasal congestion are her symptoms; She recently developed flu-like symptoms and had a positive COVID-19 test. Fever, headache and nasal congestion are her symptoms; This is a spontaneous report from a non-contactable consumer (patient) received via a company representative. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unspecified date as dose 1, single and via an unspecified route of administration on 01Mar2021 at the age of 52 years (Lot number and Expiry dates was not reported for both doses) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported, she recently (at the time of report) developed flu-like symptoms and had a positive COVID-19 test on an unspecified date. Fever, headache, and nasal congestion were reported as her symptoms. Treatment for the event was not reported. Outcome for the event was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647282
Sex: F
Age:
State: TN

Vax Date: 07/25/2021
Onset Date:
Rec V Date: 08/28/2021
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: 2021; Test Name: Covid-19; Test Result: Positive.

Allergies:

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

Symptoms: she is positive and infected with the delta variant which is the new virus right now; she is positive and infected with the delta variant which is the new virus right now; This is a spontaneous report received from a Pfizer sponsored program from Regulatory Authority. A contactable consumer reported for a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, NDC number, UPC number: Unknown) via an unspecified route of administration on 25Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient would be having the 2nd dose tomorrow that would be 15Aug2021 and unfortunately, she was positive and infected with the delta variant which is the new virus right now (on an unspecified date in 2021) and she was wondering if she could continue getting the Pfizer vaccine tomorrow or she needs to wait for it, she stated that she cannot read it's (lot number) RR what was it SA7485. The events were considered as serious (Medically Significant). The patient underwent lab test and procedure which included Covid-19: Positive, on an unspecified date in 2021. The outcome of the event she is positive and infected with the delta variant which is the new virus right now was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647283
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
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: I was diagnosed with a carcinoma; This is a spontaneous report from a non-contactable other Health Professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that, "I got my Pfizer vaccine by the end of March. In May I was diagnosed with a carcinoma. I completed my treatment today. I saw that Pfizer is now doing a booster third shot treatment. I have been under chem and radiation. My company made the recommendation for me to get the booster shot. I propose that I wait a few weeks. They recommended that I call Pfizer. I have already spoken with medical information and safety as well in regards what to get. No one seems to know anything. My question is in the trials what information does Pfizer have to include immunocompromised." Therapeutic measures were taken as a result of the event. The outcome of the event was unknown. The event was considered as serious (medically significant). No follow-up attempts are possible; information about lot/batch cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event carcinoma) and the suspect vaccine COMIRNATY 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: 1647284
Sex: M
Age:
State: IN

Vax Date: 08/12/2021
Onset Date: 08/14/2021
Rec V Date: 08/28/2021
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: retinal hemorrhage; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in left arm on 12Aug2021 10:30 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included Hypertension(controlled with medication), Hypercholestremia (controlled with medication), and allergies with Mango fruit. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced retinal hemorrhage on 14Aug2021 08:00. The patient reported that she has not had one before to her knowledge. It has been examined and is resolving. There was no blunt force trauma. She was just sitting in a chair when the event occurred spontaneously. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No treatment was given in response to the event. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1647285
Sex: M
Age:
State: NC

Vax Date: 07/31/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Normal; Test Name: temperature; Result Unstructured Data: Test Result:101; Test Name: temperature; Result Unstructured Data: Test Result:99.0; Test Name: color of stool; Result Unstructured Data: Test Result:normal; Test Name: liver panel with bilirubin; Result Unstructured Data: Test Result:Normal; Test Date: 20210814; Test Name: Covid test; Test Result: Negative ; Test Name: Urine test; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: I started getting pains in stomach, pain in my intestine; I started getting pains in stomach, pain in my intestine; Diarrhoea; Exhausted and tired; I ended up having like a 101 temperature; Throwing up; Nausea; My stool turned yellow; my pee was dark; I had yellow eyes; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FA6780) at 50-years-old as DOSE 1, SINGLE for COVID-19 immunisation; adalimumab (HUMIRA), via an unspecified route of administration on 08Aug2021 (Batch/Lot Number: 1146119) at DOSE NUMBER UNKNOWN, SINGLE for arthritis. Medical history included arthritis from an unknown date and unknown if ongoing. There were no concomitant medications. On unspecified dates, the patient experienced: I started getting pains in stomach, pain in my intestine (non-serious), diarrhoea (non-serious), exhausted and tired (non-serious), I ended up having like a 101 temperature (non-serious), throwing up (non-serious), nausea (non-serious), my stool turned yellow (non-serious), my pee was dark (non-serious), I had yellow eyes (non-serious); all of which required a physician office visit. The patient stated, "I just wanted to let you guys know about the reaction possible with another drug." Name of the medication: patient stated, "Humira." The patient stated, "I think I had a reaction to it. I took my first shot (COVID vaccine) on 31Jul2021 so I waited a week and took a Humira shot 7 days later alright and then 3 days after that which was Wednesday night I started getting pains in stomach, pain in my intestine and I don't know I am 50, I had some kind of reaction then I ended up having like a 101 temperature, throwing up and then it disappeared so I don't know if taking Humira shot close to, taking Humira shot and having the COVID shot is good or bad. I talked to my doctor and he said there is, you can do it 7 days later, but I am actually had an adverse reaction to it I think." The patient confirmed the name of the products as COVID-19 Vaccine and HUMIRA vaccine. When paraphrased, the patient stated, "I am having diarrhea, my stool turned yellow. I am going to my doctor tomorrow to talk to him about it. It seems like I had a like, it's like it could be before that like it's like after I took it. I had no reaction to the shot whatsoever I was perfectly fine with the vaccine, but I do not know taking HUMIRA and then working and then I ask 3 different doctors if it was okay to take it. I even called this HUMIRA pharmacy and they said there is no problem, but I don't know if it just by chance if ended up with 101 fever, throwing up and nausea." When informed about the Pfizer Medical Information Department for the concern, the patient stated, "Well, I will call my doctor tomorrow. I am just letting you know because research article, I have called to let you know I have something weird come up so. It was weird because I had the fever and the next day it was gone. I mean the next day I was exhausted and tired, but it was gone, the fever was gone." Anatomical site of vaccination (Pfizer covid-19 vaccine), consumer stated, "Right" Other medical condition, consumer stated, "I have arthritis, that's why I take HUMIRA and that's all." Treatment for the side effects, consumer stated, "No, like I said when I was taking HUMIRA straight up, I never had that kind of issue, when I was taking just straight Humira." Upon follow-up on 18Aug2021, the patient stated, "I spoke to safety already. I had my first shot of the Pfizer COVID-19 vaccine on 31Jul2021. Couple of days later, I have noticed that on Wednesday I had pain in my intestine on Thursday night it got worst. Friday morning it was tremendous pain. I had 99.0 temperature which went to 101 and I vomited. I felt nauseous. I had chills. I had issues going to the rest room. My stool color had changed to yellow and my pee was dark. I got a COVID test done on Saturday which came back negative. I had no fever no other things. I had discomfort in my intestine, but it has subsided now. Monday, I went to see my doctor he said I was fine. I had yellow eyes. He did my blood work and liver panel with bilirubin. It all came back normal. My urine test came back normal. My color of stool is normal. I want to understand what may have caused the symptoms is it the fact that I've taken the HUMIRA shot with the vaccine. My doctor had advised me to take the HUMIRA shot seven days after the Pfizer COVID-19 vaccine, but I took it on the 8th day could that have caused me to feel this way." The patient underwent lab tests and procedures which included blood work: normal on an unspecified date, temperature: 101 on an unspecified date, temperature: 99.0 on an unspecified date, color of stool: normal on an unspecified date, liver panel with bilirubin: normal on an unspecified date, COVID test: negative on 14Aug2021, urine test: normal on an unspecified date. The action taken in response to the events for adalimumab was not applicable. The clinical outcome of the events: stool discoloration, gastrointestinal pain, pyrexia was recovered on an unspecified date, while the clinical outcome of the other events was unknown.

Other Meds:

Current Illness:

ID: 1647286
Sex: F
Age:
State: NY

Vax Date: 06/18/2021
Onset Date: 08/03/2021
Rec V Date: 08/28/2021
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: heart attack; couldn't take a breath/she couldn't breathe; passed out a few times; couldn't walk or make use of her legs; got so cold; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jun2021 08:00 (Batch/Lot number was not reported) at the age of 33-year-old as single dose for covid-19 immunization. The patient's medical history was none, no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28May2021 08:00 AM at the age of 33-year-old, administered in Right arm for covid-19 immunization. On 10Aug2021, she woke up at 2 am and felt like she was having a heart attack; she couldn't take a breath/she couldn't breathe, and she passed out a few times. She also couldn't walk or make use of her legs so her husband had to carry her around. Her breathing eventually returned but she was not breathing properly for the next few minutes that followed. After a while, she got so cold like she was stuck in a deep freezer and nothing was successful in warming her up. This episode lasted for about an hour before it passed. She asked her husband to hold off on calling the ambulance because she knew they could not afford the cost but she scheduled a full physical with her doctor the next day because she knew something was very wrong. The events resulted in [Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event)]. No treatment received for the events. The outcome of the events was recovered on an unspecified date. No covid prior vaccination, no covid tested post vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647287
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: stage 4 breast cancer; This is a spontaneous report from a contactable consumer (patient herself) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 1, single and via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient called to ask if she needed to get the booster or third shot of the Pfizer BioNtech COVID-19 vaccine. The patient stated that she already took the first and second dose of the vaccines and that she had stage 4 breast cancer on an unspecified date. The outcome of the event was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647288
Sex: M
Age:
State:

Vax Date: 04/01/2021
Onset Date: 08/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210816; Test Name: test positive for covid this morning; Test Result: Positive

Allergies:

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

Symptoms: test positive for covid this morning; test positive for covid this morning; This is a spontaneous report received from a non-contactable consumer (patient) received via a sales representative. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ep7533), via intramuscular route of administration on 01Apr2021 (at the age of 48-year-old), as dose 2, single in left arm; and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: en6208), via intramuscular route of administration on 11Mar2021 (at the age of 48-year-old), as dose 1, single in left arm for COVID-19 immunization. The patient's medical history included allergy to shellfish. Concomitant medications received within in two weeks of vaccination included atorvastatin calcium (LIPITOR), cetirizine hydrochloride (ZYRTEC) and celecoxib (CELEBREX); all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no COVID prior vaccination and was not tested COVID post vaccination. On 16Aug2021 at 08:00, 4 months 15 days and 8 hours after vaccination, the patient tested positive for COVID this morning. No treatment medication was received for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 16Aug2021. The clinical outcome of the event COVID-19 was resolving.

Other Meds: LIPITOR; ZYRTEC; CELEBREX

Current Illness:

ID: 1647289
Sex: M
Age:
State: MI

Vax Date: 08/10/2021
Onset Date: 08/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Arthritic joint pain, stating "it's inflamed my arthritis in my joints like 3 fold/joint pain; It's inflamed my arthritis in my joints like 3 fold." "My left hand was worse; Already have arthritis it's inflamed it by 3 times the pain level; Can't even pick up anything from my left hand/he couldn't hold anything over a few ounces; Arthritis/Joint pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) reported for himself. A 62-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA7484), via an intramuscular route of administration in Left on 10Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included Type 1.5 diabetes, HIV infection (I have like HIV from past 20 or somewhat years), osteoarthritis, arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient did not received any other vaccines prior to the COVID vaccine. Patient stated he received his first dose. 4 days later on 14Aug2021 he developed arthritic joint pain, stating "it's inflamed my arthritis in my joints like 3 fold. On unknown date 2021 my left hand was worse. It's joint pain, I already have arthritis it's inflamed it by 3 times the pain level, the first shot later, the joint pain in my Arthritis refill. I mean I can't even pick up anything from my left hand/ he couldn't hold anything over a few ounces until today. He states it was dissipating. Everything I had read so far, said a second shot may increase the side effects. I am leery now about getting a second shot unless somebody could tell me that usually these side effects dissipate over time. Consumer stated, I just called, I had 3 called you guys, and all just got ran away. Okay I am not even sure anymore I said, I called this number five times it bounced around and they told to call the medical and option 3, I went to them talk to somebody that bounced back to somebody who was a Pharmacist assistant, who then took some information to make a report and then told me to call back if I have other question and hit option 3, so I did option 3 but I get nowhere so, I come back to option 1 because I just wanted some information about the side effects, I had the shot, I got side effects and I just want to know if there was any historical data so far in your system this said how long things should last. Consumer stated, I wanted to know that they said that, whatever the thing was out, whatever the thing 'gene'. All I tried to find out if you have the historical data cover after a year of collecting information, was something that generally disappear. Yeah, I mean do they generally in you historical data disappear because it said the second shot, which I had not received yet was worked. Consumer stated, I had no idea, it was there in the car. I do not had it with me right this minute, it was in the car. Patient received treatment for events as gabapentin and aspirin. The outcome of the events arthralgia, arthritis, inflammation was reported as recovering and while other events was unknown.

Other Meds:

Current Illness:

ID: 1647290
Sex: M
Age:
State: WA

Vax Date: 04/08/2021
Onset Date: 04/12/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Name: rheumatology results; Result Unstructured Data: Test Result: pointing towards RA, Sjogren's syndrome & lupus.

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: After getting my 1st shot I began experiencing severe symptoms of ASIA syndrome, a sudden onset of multiple autoimmune disorders; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; I have rheumatology results from June pointing towards RA, sjogren's syndrome & lupus; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) dose 1, via an unspecified route of administration, administered in arm right on 08Apr2021 14:00 (45-year-old at vaccination) as single dose for COVID-19 immunisation. Facility type vaccine was Public Health Clinic/Veterans Administration facility. Medical history included morbid obesity. No other vaccine in four weeks. Other medications in two weeks included levothyroxine. No Covid prior vaccination. Shortly after getting his 1st shot, he began experiencing severe symptoms of autoimmune/inflammatory syndrome induced by adjuvants (ASIA) syndrome, a sudden onset of multiple autoimmune disorders. He had rheumatology results from June pointing towards rheumatoid arthritis (RA), sjogren's syndrome & lupus. Adverse event start date was 12Apr2021. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. Number days hospitalization was 1. Treatment for AE included steroid injection. He got his 2nd shot of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Apr2021 at 11:00 AM in right arm, because he didn't correlate his issues with the shot at that time. The patient was not recovered from the events. It was unknown if covid tested post vaccination. The lot number for BNT162B2, was not provided and will be requested during follow up

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1647291
Sex: M
Age:
State: MI

Vax Date: 08/06/2021
Onset Date: 08/15/2021
Rec V Date: 08/28/2021
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: Dizziness; room spinning; Loss of balance; Nausea; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE,solution for injection; lot number- EW0176 and expiry date not reported) via an unspecified route of administration into Left arm on 06Aug2021 15:00, at the age of 65-year-old,dose1, single for COVID-19 immunization in a Pharmacy or Drug Store. Relevant medical history includes allergies to Indocin and Tramadol. Concomitant medications include allopurinol and Synthroid. The patient did not receive other vaccine in four weeks. The patient did not have prior COVID vaccination and was not tested post vaccination. On 15Aug2021 9:00,the patient experienced dizziness, room spinning,loss of balance and nausea. The patient did not receive treatment in response to the events. The outcome of the events was not recovered at the time of report.

Other Meds: ALLOPURINOL; SYNTHROID

Current Illness:

ID: 1647292
Sex: M
Age:
State:

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 08/28/2021
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: Moles were gone/ COVID 19 vaccine helped eliminate the moles; This is a spontaneous report from a contactable consumer (patient) and physician (dermatologist). A 81-year-old male patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot number was not reported) dose 1 via an unspecified route of administration on Jan2021 (at the age of 81 years old) as dose 1, single and dose 2 via an unspecified route of administration on 15Feb2021, lot number was not reported as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. On an unspecified date of 2021 the patient experienced moles were gone/ covid 19 vaccine helped eliminate the moles. The clinical outcome of the event was recovered on an unspecified date of 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1647293
Sex: F
Age:
State: TX

Vax Date: 08/12/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: nausea; bronchitis like cough that is bringing up flim; This is a spontaneous report from a contactable Consumer (patient). A 40-year-old female received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 12Aug2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history included Cold (she had a cold she had just gotten over before receiving the vaccine.) on an unknown date and not ongoing. The concomitant medications were not reported. On Aug2021 patient had experienced nausea and bronchitis like cough that is bringing up flim and also reported that, are these normal side effects following the vaccine. The clinical outcome of the events were unknown . Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1647294
Sex: F
Age:
State: FL

Vax Date: 08/08/2021
Onset Date: 08/08/2021
Rec V Date: 08/28/2021
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: This is a spontaneous report from a contactable consumer (patient). A 61-year-old (non-pregnant) female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection, batch/lot#, expiration date not reported), at age 61, via an unspecified route of administration, left arm, on Aug 8, 2021, 13:00, single dose, for COVID-19 immunization at a pharmacy or drug store. Medical history included heart stents. The patient has no known allergies. The patient's concomitant medications not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and no other medications administered within two weeks. The patient has not tested with COVID-19 since the vaccination. The patient was extremely tired and weak, low-grade fever, cough, short-of-breath, nauseated and diarrhea on Aug 8, 2021; 13:00. No treatment received for the events, with outcome of recovering. The lot number for BNT162B2: not provided (will be requested during follow-up).

Other Meds:

Current Illness:

ID: 1647295
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: he ended up in the hospital with Paracydis/The side effect listed should be: Pericarditis; This is a spontaneous report from a Pfizer-sponsored program reported by a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution 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 previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unspecified date, after the 2nd dose the patient ended up in the hospital with pericarditis which was supposedly a common side effect of the vaccine. The patient wanted to know what Pfizer recommends and if this should be reported. 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: 1647296
Sex: F
Age:
State: TN

Vax Date: 01/01/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: She was diagnosed with covid-19; She was diagnosed with covid-19; This is a spontaneous report from a contactable nurse and a contactable consumer (patient) via Pfizer-sponsored program. A 41-year-old female patient (unknown if pregnant) received tofacitinib citrate (XELJANZ XR 11 mg; Expiration date: 28Feb2023), oral from 2019 to an unspecified date, at 11 mg, daily for Illness unspecified (as reported). Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: unknown), via an unspecified route of administration, in Jan2021 at single dose for covid-19 immunisation .The patient medical history and concomitant medications were not reported. The patient previously took infliximab (REMICADE) and experienced allergy. The patient was diagnosed with covid-19 on 05Aug2021. Patient stated she received monoclonal antibodies for treatment. The outcome of the event was not recovered. The action taken in response to the event for tofacitinib citrate was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 cannot be excluded for events drug ineffective and COVID-19 infection. A contributory role of tofacitinib cannot be fully excluded in the development of event COVID-19 based on its immunomodulatory properties. However, the temporal association is unclear based on the currently available information. Of note, there is an increased risk for COVID-19 infection overall in light of the current pandemic. Event drug ineffective is related to BNT162B and is unrelated to tofacitinib. This case will be reassessed upon receipt of additional information.

Other Meds:

Current Illness:

ID: 1647297
Sex: F
Age:
State: PA

Vax Date: 03/31/2021
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
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: 20210808; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: I got COVID. First symptoms appeared 05Aug2021.; I got COVID. First symptoms appeared 05Aug2021.; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in arm left on 10Mar2021 at 13:00 (age at vaccination 27-year-old) as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8737) via an unspecified route of administration, administered in arm left on 31Mar2021 at 13:00 (age at vaccination: 27-year-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. No medical history was reported and no known allergies. No other vaccines were administered in four weeks of vaccination. The patient received birth control (unspecified) in two weeks of vaccination. The patient had no covid prior vaccination. The patient got covid, first symptoms appeared on 05Aug2021 at 03:00 AM. The patient had a vaccination failure. No treatment was received for the events. The patient was tested for covid post vaccination. The patient underwent lab tests and procedures which included PCR (polymerase chain reaction) which was positive on 08Aug2021 (Nasal Swab). The outcome of the events was recovered on an unknown date in Aug2021. No follow-up attempts are possible, no further information is expected.

Other Meds:

Current Illness:

ID: 1647298
Sex: F
Age:
State:

Vax Date: 08/12/2021
Onset Date:
Rec V Date: 08/28/2021
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: heavy periods; earaches; I got my period on July 30th and then I got the vaccine and it started again; This is a spontaneous report from a contactable consumer (patient herself). A 41-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 on 12Aug2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced heavy periods, earaches, got her period on 30Jul2021 and then got the vaccine and it started again. The reporter wanted to know if these were side effects from the vaccine. The outcome of all the events was unknown. There was no product quality complaint (PQC) present. The lot number for the vaccine was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647299
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: shortness of breath/ after talking or walking up the stairs; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 48 hours after receiving the first dose of the vaccine, the patient experienced shortness of breath that lasted a few hours and then the next day she had shortness of breath, which was not significant. The event happened sometimes after talking or walking up the stairs. She also stated she did not experienced any arm soreness at all. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1647300
Sex: M
Age:
State: IL

Vax Date:
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
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: 20210812; Test Name: SARS COVID-19 test; Test Result: Positive.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Tested positive for COVID on 12Aug2021 after receiving last vax dose; Tested positive for COVID on 12Aug2021 after receiving last vax dose; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single and on 21Apr2021 (Lot Number: ER2613) (at the age of 23-years-old) as dose 2, single for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD). Concomitant medication included pantoprazole taken daily for gastrooesophageal reflux disease. The patient tested positive for COVID on 12Aug2021 after receiving last vaccine dose. The patient experienced loss of taste and smell, headache, stuffy nose, sore throat and fatigue. The outcome of the events was unknown.

Other Meds: PANTOPRAZOLE

Current Illness:

ID: 1647301
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: headache; felt sluggish; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient had received the first dose of BNT162B2 on 21Jan2021 and experienced numbness at injection site, swelling and itchy, then dizziness and little taste in mouth. There were no medical history and concomitant medications. It was reported that the night of second vaccine the patient had headache that lasted overnight and felt sluggish the whole day the day after. Admission to hospital due to the event was reported. Treatment was not received. The patient was fine at the time of reporting. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021100456 Same reporter/patient/product, different dose/AE.

Other Meds:

Current Illness:

ID: 1647302
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:Negative; Comments: pregnancy test 3x and the results were negative - she's not pregnant

Allergies:

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

Symptoms: menstrual irregularities/she only had one period after receiving the vaccine; This is a spontaneous report from a contactable Pharmacist reported for herself. A 48-year-old non-pregnant female pharmacist received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 29Jan2021 (at the age of 47-year-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historic vaccine included bnt162b2 in Jan2021 as dose 1, single for COVID-19 immunisation. She had her both doses of the vaccine last Jan2021, she was 47 years old when she got the vaccine and now, she's 48-years old. She got her 2nd dose on 29Jan2021. She's asking for additional information regarding the menstrual irregularities on an unknown date in 2021. She only had one period after receiving the vaccine - there's no hot flushes, she did pregnancy test 3x and the results were negative - she's not pregnant, and she stated that it's unusual for her to be late. The 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: 1647303
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Pain in extremity

Symptoms: almost killed my fiance; This is a spontaneous report from a Pfizer-sponsored program via 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 single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported: "The vaccine almost killed my Fiance I assume you need to know things like that please contact so we can have a dialog. Others know I have contacted you in case something happens to me." 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:

Date Died: 08/15/2021

ID: 1647304
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: internal bleeding; cardio issues; This is a spontaneous report from a non contactable consumer. An 86-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. It was reported: "Consumer calling about her Mother in law dying from the side effects of the Pfizer Covid Vaccine at 3:00 am Sunday, 15Aug2021. Caller asked How many deaths have there been called that they believe was caused by the Pfizer vaccine? My MIL was 86 y/o and she had just started PT in the hospital. She started having cardio issues and internal bleeding and now she is dead. She had started PT and was up walking, so her doctor suggested she get the this because she was having PT, then she started having internal bleeding and cardio issues and now she's dead. With in 48 hours of taking that vaccine. She developed symptoms where there was blood gushing out of her mouth and my father in law saw this. They couldn't stop the bleeding because of her health condition." The patient experienced internal bleeding, cardio issues on an unspecified date. The outcome of events was fatal. The patient died on 15Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: internal bleeding; cardio issues

Other Meds:

Current Illness:

ID: 1647305
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/28/2021
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: diabetes; high blood pressure; kidney disease; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Feb2021 as dose 1, single and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was seeking information on the booster dose of the Pfizer COVID-19 vaccine. He stated that he received both doses of the Pfizer COVID-19 vaccine back in Feb2021. On an unspecified date 2021, the patient experienced high blood pressure, diabetes and kidney disease and stated that he really needs the booster dose. Referred to health care professional (HCP) for further guidance and medical recommendation. The outcome of the events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647306
Sex: M
Age:
State: OH

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 08/28/2021
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: kidney biopsy; Result Unstructured Data: Test Result:stage three kidney failure; Comments: His biopsy report included membraneous glomerulopathy, NELL+ L1, antigen is one-third NELL+, working to see underlying malignancy is warranted, sclerosis 5, intestinal fibrosis mild, focal segmental glomerulosclerosis absent, and anterior hilalnosi mild

Allergies:

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

Symptoms: stage three kidney failure; biopsy report included membraneous glomerulopathy; leg muscle pain; swelling in his legs; tired; shortness of breath; Severe cramps in legs, arms, hands.; This is a spontaneous report from a contactable consumer (patient). An 89-year-old male patient received bnt162b2 (Comirnaty, solution for injection; Lot Number: EL9264; NDC and expiry date: unknown), dose 2 via an unspecified route of administration, administered in left arm on 10Mar2021 at 15:30 (at the age of 89-year-old) as dose 2, single for COVID-19 immunization. Medical history included heart attack (from 5 or 6 years ago; had last heart attack at Thanksgiving, unsure of the date) and stated he had several heart attacks and several strokes but he is unsure of the dates; stroke; ongoing asthma and allergies from an unknown date. Patient historical vaccine included first dose bnt162b2 (solution for injection) at on 10Feb2021 at 15:30 PM (at the age of 89 years) in left arm for covid-19 immunisation. Concomitant medication included albuterol [salbutamol] takes off and on a puff a day; allopurinol taken for gout at 100 mg, once daily by mouth oral route; aspirin [acetylsalicylic acid] at 325 mg, once daily by mouth, orally to keep the blood thin; azelastine taken for asthma and allergy; 0.1 mg take two spray in the evening to the nostrils via nasal spray; clopidogrel orally at 75 mg, once a day (once daily by mouth) taken for heart; fluticasone via nasal route at 50 mg, daily two sprays by nostril daily for allergic asthma; levothyroxine sodium orally at 75 ug, once daily by mouth; metoprolol tartrate via oral route at 25 mg, once daily by mouth; rosuvastatin taken orally 200 mg, once daily by mouth; spironolactone taken orally 25 mg, once daily by mouth; tizanidine orally at 4 mg, once daily by mouth; calcium carbonate/ colecalciferol (VITAMIN D 2000); fluticasone propionate/ salmeterol xinafoate (WIXELA INHUB) once daily; fish oil orally at 100 mg, twice a day (1000 twice daily by mouth) prescribed by cardiologist; losartan at 25 mg might be one he has not taken; multivitamins (vitamins NOS) once a day; thinks this is for reflux and he stopped it for some reason. Patient had received first and second dose of the Pfizer BioNTech Covid 19 vaccine on 10Feb2021 and 10Mar2021. Subsequent to that he developed leg muscle pain, swelling in his legs, shortness of breath, and being really tired on an unknown date in 2021, the exact timeliness was unknown. He saw the cardiologist to rule out heart issues. DSU agent said he was diagnosed with kidney cancer, but patient then clarified he had stage three kidney failure on an unknown date. He has a past medical history of stroke. His biopsy came back this week and started seeing the nephrologist a month or two ago. His biopsy report included membraneous glomerulopathy, NELL+ L1, antigen is one-third NELL+, working to see underlying malignancy is warranted, sclerosis 5, intestinal fibrosis mild, focal segmental glomerulosclerosis absent, and anterior hilalnosi mild. His son is a physician and an associate vice chancellor of medication and research. His son told him to call to see if there are any cases or reports of this and what was used to treat it. Patient went to physician office visit to the cardiologist for the shortness of breath. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated the reason for calling was he had been diagnosed with stage three kidney failure and as far as he can go back a lot of it started after getting one of the Pfizer Vaccine shots. He had all kinds of tests including a biopsy of the kidney and would like to let Pfizer know he has a certain type of kidney disease and would like to know if Pfizer has any research or if anyone else has reported this? Product: Pfizer COVID 19 vaccine; treatment first dose reported as 12Feb2021 but corrected to 10Feb2021 at 15:30PM in the left arm; lot ES1686 or EJ1686; second dose reported as possibly 12Mar2021 or 13Mar2021 then corrected to 10Mar2021 at 15: 30PM in the left arm; lot EL9264. Patient stated as far as he can recall he believes this all started after he got the COVID vaccination. Caller reported he just got the biopsy results in the last two weeks but he first noticed swelling in his legs that was odd. He unsure of whether is was after the first or second dose or exactly when he noticed it but that all this stuff happened after the vaccination. Adds he put up with that without doing anything until he started to get other symptoms. Next he noticed shortness of and felt really tired. Adds recently he has had severe cramps in his legs, arms, hands. Reports his legs are still swelling up though slightly improved; he has not had the shortness of breath for a month and a half; but he is still really tired, sometimes he has to find a chair to sit-down because it comes on suddenly after climbing up steps or just walking to the kitchen. The patient underwent lab tests which included kidney biopsy which showed with stage three kidney failure on an unknown date and his biopsy report included membraneous glomerulopathy, NELL+ L1, antigen is one-third NELL+, working to see underlying malignancy is warranted, sclerosis 5, intestinal fibrosis mild, focal segmental glomerulosclerosis absent, and anterior hilalnosi mild. Unclear if the biopsy showed cancer or confirmed his kidney failure. Adds he has a blood test every month. After the first month there was a decline in his protein, and he was glad to hear that. Therapeutic measures were taken as a result of stage three kidney failure and shortness of breath. When he got the shortness of breath, he saw the cardiologist who did a month of workups and said his heart was certainly alright and recommended he see a nephrologist. He saw the nephrologist after a month or two and has been working with him for a couple of months. He thinks it was Jun2021 or Jul2021 when he saw the nephrologist and got his diagnosis of stage three kidney failure. Mentions he is on some medications now and that is where he is. States he is on three water pills a day to get rid of the doses of liquid. and his legs still swell up. Reports about a month after the reports to his kidney, the nephrologist started him on Tacrolimus 1 mg twice daily by mouth; caller cannot recall the water pills and thinks maybe the Levothyroxine was also started recently. The outcome of the events fatigue and dysphonea was recovering; muscle spasm was not recovered and Swelling of legs, leg pain and kidney failure was unknown. Follow up attempts are completed. No further information is expected.

Other Meds: ALBUTEROL [SALBUTAMOL]; ALLOPURINOL; ASPIRIN [ACETYLSALICYLIC ACID]; AZELASTINE; CLOPIDOGREL; FLUTICASONE; LEVOTHYROXINE SODIUM; METOPROLOL TARTRATE; ROSUVASTATIN; SPIRONOLACTONE; TIZANIDINE; VITAMIN D 2000; WIXELA INHUB; FISH OIL; LOSARTAN

Current Illness: Asthma

ID: 1647307
Sex: M
Age:
State: FL

Vax Date: 07/13/2021
Onset Date: 08/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210804; Test Name: tested positive; Test Result: Positive ; Comments: he tested positive on 04Aug2021

Allergies:

Symptom List: Vomiting

Symptoms: missed his second dose scheduled; he tested positive on 04Aug2021; he tested positive on 04Aug2021; This is a spontaneous report contactable consumer (patient) from a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 13Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced he tested positive on 04aug2021, missed his second dose on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 04Aug2021 he tested positive on 04Aug2021. Medical Information was yes. Customer and/or medical inquiry forwarded or referred to MI. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1647308
Sex: M
Age:
State: TX

Vax Date: 02/04/2021
Onset Date: 02/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: exam; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: lymph node swelling on the right side of my neck; Lung Adenocarcinoma with spread to the lymphs; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Lot Number: EL9265) at the age of 74-year-old as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. Concomitant medication included fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2(lot number: EL3249) on 14Jan2021 at the age of 74-year-old at left arm for covid-19 immunisation. There was no other vaccine in four weeks. By end of February the patient noticed lymph node swelling on the right side of his neck. When he questioned it he was told that lymph swelling a common side effect and should subside in 4 to 6 weeks. In the interim rather than subsiding they increased in number of nodes and in size. When he reported it to his PCP, he look at them and assured him that it was not cancerous because they were mobile. They did not test or investigate as a precaution. On 06Aug2021, the patient was given a cancer diagnosis of lung adenocarcinoma with spread to the lymphs. It seemed the vaccine triggered something to get the cancer process rolling. He lost valuable time adhering to the guidance pertaining to the 4 to 6 week waiting period for the lymphs to go down. He believed that line should be discarded and replaced with more proactive wording to prevent future situations. Right now, his life was possibly on the line for waiting. And he really could use some assistance in this battle. Adverse events start date was 25Feb2021. Events resulted in: Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Treatment received for the events. AE treatment reported as exam and diagnosis. The outcome of the events was not recovered. The patient had no COVID prior vaccination. No COVID tested post vaccination. Follow-up attempts are completed. No further information is expected.

Other Meds: WIXELA INHUB

Current Illness:

ID: 1647309
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 08/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210816; Test Name: Covid test; Test Result: Positive ; Comments: was tested last (11Aug2021) and received the positive result 16Aug2021.

Allergies:

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

Symptoms: patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date, as single dose, both for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter reported that, patient was in a nursing home and on 16Aug2021, patient tested positive for Covid despite having gotten both doses of the Pfizer BioNTech Covid-19 vaccine. The patient underwent the lab test and procedure which included tested for covid last Wednesday (11Aug2021) and received the positive result today 16Aug2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1647310
Sex: M
Age:
State: TX

Vax Date: 08/12/2021
Onset Date: 08/13/2021
Rec V Date: 08/28/2021
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: vertigo; blood pressure a little bit higher; This is a spontaneous report from a contactable consumer or non health care professional. A 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3180), dose 1 via an unspecified route of administration on 12Aug2021 Thursday (Age at vaccination: 61 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing hypertension Verbatim: High Blood Pressure. Concomitant medications included Low dose high blood pressure pill. Prior vaccinations within 4 weeks were None. Reporter states that her husband takes this on an as needed basis. The patient experienced vertigo and blood pressure a little bit higher (condition aggravated) on 13Aug2021. Reporter wants to know if these symptoms are associated with Pfizer COVID-19 vaccine. Reporter says that her husband blood pressure has been fluctuating since before the vaccine; but since the vaccine it has been higher. Patient was taking low dose high blood pressure pill. The outcome of the events was not recovered.

Other Meds:

Current Illness: Blood pressure high (Verbatim: High Blood Pressure)

ID: 1647311
Sex: M
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Heart beating; Result Unstructured Data: Test Result: Weird + fast; Comments: Heart beating weird + fast.

Allergies:

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

Symptoms: Pressure on chest; Hard time breathing/ got winded even talking; Heart beating weird + fast; heart felt like it was palpitating; This is a spontaneous report from a contactable other healthcare professional (medical assistant). This other healthcare professional reported similar events for two patients. This is the second of two reports. A 15-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date, the patient experienced pressure on chest, hard time breathing/got winded even talking, heart beating weird + fast, and heart felt like it was palpitating. The events were considered serious, medically significant. Outcome of the events was unknown. Information on lot/batch number has been requested.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100956501 same reporter, drug and events/ different patient

Other Meds:

Current Illness:

ID: 1647312
Sex: F
Age:
State:

Vax Date: 03/04/2021
Onset Date:
Rec V Date: 08/28/2021
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: complete kidney failure in DKA; can hardly breathe; coughing up blood; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EL9267) as dose 1, single; dose 2 via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: EN6200) as dose 2, single for Covid-19 immunization. Medical history included DKA (diabetic ketoacidosis). The patient's concomitant medications were not reported. The patient experienced complete kidney failure in DKA and can hardly breathe along with coughing up blood on an unspecified date. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am