VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1791311
Sex: F
Age:
State: NY

Vax Date: 03/24/2021
Onset Date: 04/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 202109; Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: pulmonary embolism; one sided debilitating migraines; headaches; paresthesia; numbness; weakness on the entire right side of body; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2) at 23-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 18:00 (Batch/Lot Number: ER8730) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Historical Vaccine included BNT162B2 for COVID-19 immunization on 03Mar2021 at the age of 23-year-old (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. Reported Event: started with one sided debilitating migraines and headaches, paresthesia, numbness, and weakness on the entire right side of body. Then hospitalized with a pulmonary embolism. The event onset date was Apr2021. The adverse event result in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. The events received treatment included Heparin drip. The events were serious due to hospitalization, life threatening. The patient was hospitalized for events for 3 days. Since the vaccination, the patient had been tested for COVID-19: PCR on Sep2021 Negative (Nasal Swab). The event outcome was recovered with sequelae. Follow-up (13Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Date Died:

ID: 1791312
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: died 2 weeks after getting the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's aunt) that a female patient of unspecified age received BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Caller mentioned that there patients who passed away after taking the vaccine but no proof if caused by the vaccine. Caller said she knows someone in her 30s and her aunt who died 2 weeks after getting the vaccine. The patient died on an unspecified date. Outcome of the event was fatal. It was unknown if an autopsy was done. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202101352464 Same reporter/ drug/ event for different patients; Reported Cause(s) of Death: died 2 weeks after getting the vaccine

Other Meds:

Current Illness:

Date Died:

ID: 1791313
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Pfizer gave the covid vaccine to the caller''s 37 year old cousin who died; This is a spontaneous report from a contactable consumer (reporter's cousin). A 37-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, Pfizer gave the COVID vaccine to the reporter's 37 year old cousin who died The patient died on an unspecified date. It was not reported if an autopsy was performed. Description of Product Complaint: The caller knows a nurse and said the only people in her 3 different shifts who have not been sick are all unvaxxed, all of the people who have been vaccinated are the ones with the virus. 11 percent of people in withheld are vaccinated and no one has COVID. 96 percent of people in withheld are vaccinated and 98 percent of them have COVID. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pfizer gave the covid vaccine to the caller''s 37 year old cousin who died

Other Meds:

Current Illness:

ID: 1791314
Sex: F
Age:
State: WI

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210114; Test Name: complete blood count; Result Unstructured Data: Test Result:all values WNL; Comments: Hgb 13.8 g/dL; Test Date: 20210114; Test Name: Stool study; Result Unstructured Data: Test Result:no infections findings

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: bloody bowel movement; Diarrhea; Headache; Fatigue at activity; nausea; This is a spontaneous report from a contactable pharmacist (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL0142, expiration date: not reported), first dose via intramuscular route of administration, administered in Deltoid Left on 11Jan2021 13:00 (at the age of 44 years) as 0.3 ML single for covid-19 immunization. Medical history included abnormal uterine bleeding and iron deficiency anaemia from 27May2020 and ongoing, migraine from 28Aug2019 and ongoing. Concomitant medication(s) included ascorbic acid, glucose (500 mg) and ergocalciferol (4000 units) taken for an unspecified indication from an unspecified start date and ongoing; ferrous bisglycinate (IRON GLYCINATE) taken for anaemia oral from 27May2020 and ongoing; rizatriptan (10 mg) daily taken for migraine from 23Jul2019 to an unspecified stop date and oral multiavitamin. Patient had no Prior vaccinations (within 4 weeks). On 13Jan2021 07:00, the patient experienced bloody bowel movement, headache on 11Jan2021 13:00, diarrhea on 12Jan2021, fatigue at activity on 11Jan2021, nausea. Bloody bowel movement was reported as medically significant. Had a CBC, stool culture and imaging (x-ray of abdomen)-all were normal/unremarkable. Adverse events required visit to Physician office. Patient had no Prior vaccinations (within 4 weeks). The patient underwent lab tests and procedures which included full blood count had all values wnl on 14Jan2021 Hgb 13.8 g/dL and stool analysis had no infections findings on 14Jan2021. No treatment is required for headache, fatigue and diarrhea. Clinical outcome of the event was reported as recovered on 26Jan2021 for bloody bowel movement, recovered for headache, nausea on an unspecified date of 2021, recovered for diarrhea on 26Jan2021, recovered with sequel for fatigue on 15Jan2021. Comments/Narrative: Patient states experiencing headache & abdominal discomfort post vaccine immediately. States GI effects lasted 3-4 days. Despite claim of bloody bowel movement, no indication of this in lab work.; Sender's Comments: Based on the information in the case report, a possible causal association between the event haematochezia 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: ASCORBIC ACID [ASCORBIC ACID;GLUCOSE]; ERGOCALCIFEROL; IRON GLYCINATE; RIZATRIPTAN; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Abnormal uterine bleeding; Iron deficiency anemia; Migraine

ID: 1791315
Sex: F
Age:
State:

Vax Date: 08/28/2021
Onset Date:
Rec V Date: 10/16/2021
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: patient experienced COVID Symptoms; patient experienced COVID Symptoms; This is a solicited report based on information received by Pfizer from regulatory authority (MFR Control No.: 21K-163-4111720-00). A contactable consumer (patient) reported that a 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly on 07Aug2021 (Batch/Lot number was not reported) at age of 25 years old as a single dose, 2nd dose intramuscularly on 28Aug2021 (Batch/Lot number was not reported) at age of 25 years old as a single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneously from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for an unspecified indication. The patient's medical history was not reported. There were no concomitant medications. The patient experienced covid symptoms in 2021 with outcome unknown. The action taken in response to the event for adalimumab was dose not changed. Solicited report from the (country) by a consumer of a 25 years old female with an event Of non-serious covid symptoms with Humira (adalimumab). There was no reported Medical history. In 2021, the patient experienced covid symptoms. Pfizer biontech covid-19 Vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 07Aug2021, she received first dose covid-19 vaccine manufactured by Pfizer biontech. On 28Aug2021, she received second dose covid-19 vaccine manufactured by Pfizer BioNTech. Causality for Humira(adalimumab): The reporter's causality for the event of covid symptoms was not provided. The reporter's assessment of the causal relationship of all event with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, the reported event is possibly related to the suspect drug in terms of drug ineffective.

Other Meds:

Current Illness:

ID: 1791316
Sex: F
Age:
State: MS

Vax Date: 10/09/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: Third dose:a slight headache; Third: slightly sore throat; Third dose: sharp pain in the kidney area; Third dose: shoulder pain; Arm is a little sore; heat is coming out of it, it's so hard/its so hard she can feel the heat from it; Third dose: arm is sore; Third dose: little red spots at the injection site; Third dose: the area is hard like a rock; Third dose: chills, she was very cold; Third dose: chills, she was very cold; This is a spontaneous report from a contactable consumer, the patient reported for herself. A 66-years-old female patient received third/booster dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0151), via an unspecified route of administration, administered in Left arm on 09Oct2021 (age at vaccination 66-years-old) as dose 3 (booster), 0.3 ml single for covid-19 immunization. She told the reason she got the booster dose, because from the information she gathered, the ones she took was going to wear off and she would not be covered, so she would have a bigger chance of catching it (COVID). Medical history included ongoing arthritis (she knew she had arthritis in her joints, stated she did not take medicine, she just takes Tylenol or something, she had knee problems, diagnosed in the last 10 years or so, ongoing high blood pressure diagnosed in the last 10 years. There were no concomitant medications. There were no other vaccines administered on same date with the Pfizer vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9266 Expiry Date: May2021), via an unspecified route of administration, administered in right shoulder on 25Feb2021 as dose 1, 0.3 ml single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ENU199), via an unspecified route of administration, administered in left shoulder on 12Mar2021 as dose 2, 0.3 ml single, for covid-19 immunization and did not experienced any adverse effect. There were no prior vaccinations (within 4 weeks) prior to the first. The patient previously received sulfur and experienced rash and drug hypersensitivity. The patient reported that, on unspecified dates in Oct2021, her arm was a little sore, heat was coming out of it, it was so hard. At first when it was sore, she thought that was normal, but then the next day, it became hard and like heat was coming out. On unspecified dates in Oct2021, she experienced little red spots at the injection site, the area was hard like a rock, experienced chills, she was very cold, slightly sore throat, sharp pain in the kidney area and shoulder pain. On 11Oct2021, she had a slight headache. As per additional details of clinical course, she stated that, it began 10Oct2021 or 11Oct2021, confirmed all symptoms began Oct2021. Headache was noticed last night on 11Oct2021 and she woke up in the middle of the night. She stated that was ongoing and had worsened, it had not improved. She told that her slight sore throat was like she having with the chills, that probably related. She stated, she took Tylenol but that did not appear to help, it just put her to sleep. She took Tylenol 500mg, two last night and went right to sleep and woke up the same way (corrective for events). She just surprised, she did not have any reaction with the first and second one. It seemed to her that she had a sharp pain in the kidney area, did not know if anybody else that had that. Confirmed, that it began Oct2021 and ended in Oct2021. That happened a few days after the shot, a sharp pain came and went, stated she had recovered completely, it did happen, she did not know if that because of the Tylenol or because of this shot. There was no emergency room or physician office visit. There were no relevant tests done. The clinical outcome of the event sharp pain in the kidney area was recovered on unspecified date in Oct2021 and the outcome for the rest of the events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness: Arthritis (she knows she has arthritis in her joints diagnosed in the last 10 years or so); Blood pressure high (diagnosed in the last 10 years)

ID: 1791317
Sex: M
Age:
State: PA

Vax Date: 10/02/2021
Onset Date: 10/11/2021
Rec V Date: 10/16/2021
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: 20211011; Test Name: Temperature; Result Unstructured Data: Test Result:High

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: tremors; cold sweat; cough; high fever; chills; This is a spontaneous report from a contactable pharmacist. A 64-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 02Oct2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 11Oct2021 (9 days after vaccination), the patient experienced high fever, chills, tremors, cough and cold sweat. The patient's body temperature was high when tested on 11Oct2021. Patient wanted to know if these side effects were reported 9 days after they got the vaccine. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1791318
Sex: M
Age:
State:

Vax Date: 06/23/2021
Onset Date: 08/05/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210805; Test Name: Covid Test; Test Result: Positive

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Rheumatoid arthritis flare up; Intentional misuse; Frustration; Anxiety; COVID-19; COVID-19; Night sweats; Weight loss; Loss of energy/no energy; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie (Mfr. Control No.#: 21K-163-4110316-00). A 66-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number unknown), intramuscular on an unspecified date as single dose for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from 2016 (Batch/Lot number was not reported) to 23Jun2021, at 40 mg (40 mg, 1 in 2 wk) for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown dates, the patient experienced frustrated, possible misuse, anxiety and rheumatoid arthritis flare-up. In 2021, the patient experienced weight loss, no energy, night sweats and covid 19. The patient was treated with Prednisone. The patient underwent lab tests and procedures which included covid test: positive on 05Aug2021. The action taken in response to the event(s) for adalimumab was permanently withdrawn on 23Jun2021. Outcome of event weight loss, rheumatoid arthritis flare-up was not recovered; other events was unknown. The reporter's causality for the event(s) weight loss, no energy, frustrated, possible misuse, night sweats, anxiety, covid 19 and rheumatoid arthritis flare-up was not provided for suspect Humira and was reported as possible for suspect BNT162b2. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1791319
Sex: M
Age:
State:

Vax Date: 10/11/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 202110; Test Name: Body temperature; Result Unstructured Data: Test Result:104; Comments: Fever

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Nausea; Body aches; Fever, it is at 104 and it kind of went down but it is going back up; Lower back pain; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer (parent) reported that a 16-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 11Oct2021 as DOSE 1, SINGLE for covid-19 immunisation at the age of 16 years old. The patient medical history and concomitant medications were not reported. The patient experienced nausea on 11Oct2021 with outcome of unknown and fever, it is at 104 and it kind of went down but it is going back up, lower back pain and body aches, above on Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included body temperature: 104 on Oct2021. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1791320
Sex: U
Age:
State:

Vax Date: 10/11/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FF2589), via an unspecified route of administration, on Oct 11, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient got the booster shot yesterday and felt absolutely terrible (Oct 2021). The patient was a little worried, because it didn't feel like this after the 2nd shot (unspecified date). The patient's heart was racing, had a fever and was just hurting all over. The patient knew this was some of the side effect, and asked if this is normal. "So what does a person do that is having an adverse reaction?" The patient didn't think they needed a hospital but needed to know if this was normal. Patient further added, "Can you tell me because I am having reaction with this (further not clarified hence event captured as per verbatim), is this something that's gonna go away? Is this normal, is all I am asking, is it normal?" The outcome of the events: unknown.

Other Meds:

Current Illness:

ID: 1791321
Sex: M
Age:
State: IL

Vax Date: 02/17/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 20210511; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: I came down with bells palsy which runs in the family; i started getting uncoordinated; double vision; This is a spontaneous report from a contactable consumer (patient). This 38-year-old male patient received dose 2 of BNT162B2 via an unspecified route of administration on 17Feb2021 (at the age of 38-years-old) as a single dose for COVID-19 immunization. Medical history included family history of Bell's palsy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on 26Jan2021 as a single dose for COVID-19 immunization. On 01Mar2021 the patient came down with Bell's palsy which runs in the family so he ignored that. That went away and he started getting uncoordinated which turned into double vision. The patient visited an emergency room/department of urgent care for the events. The patient was hospitalized for 5 days for the events. The patient received treatment with steroids for the events. The outcomes of Bell's palsy, uncoordinated, and double vision were recovered with lasting effects. It was also reported that since the vaccination the patient was tested with a nasal swab for COVID-19 on 11May2021 with result of negative. The lot number for BNT162B2 was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1791322
Sex: F
Age:
State: TN

Vax Date: 01/23/2021
Onset Date: 07/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20201211; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210302; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210413; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210507; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210511; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210608; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210615; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210622; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210629; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210706; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210713; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210720; Test Name: Ultrasound; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Maternal exposure during pregnancy; Fetal Distress; This is a spontaneous report from a contactable consumer (parent). A female fetus received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EH9899) via transplacental on 02Jan2021 (gestational period at time of initial exposure: 02 months, 1st trimester) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EL3248) via transplacental on 23Jan2021 (gestational period at time of initial exposure: 02 months, 1st trimester), both as a single dose for COVID-19 immunization. Medical history was not reported. Maternal medical history included diabetes mellitus type 2, PCOS, depression, cholesterol and GERD. The mother had two previous pregnancies and the outcome of previous pregnancies was miscarriage. The mother did not smoke, drunk alcohol or use illicit drugs during the pregnancy. The mother did not have any treatment for infertility. First day of last menstrual period was reported as 25Oct2020. Estimated date of conception was reported as 10Nov2021. Estimated delivery date was reported as 01Aug2021. Paternal relevant history was reported as environmental allergies. The father did not smoke, drink alcohol or use illicit drugs during the mother's pregnancy. Paternal exposure to products was reported as: multivitamin (Centrum men's), 1 tab daily; mesalamine ER for IBS, 4 tab in AM; Zyrtec for allergy, 1 tab daily; symista for allergy, 2 sprays daily and hyosayamine for IBS, 0.125mg 3-4 times daily, start date for all was reported as prior. Concomitant medications included escitalopram oxalate (LEXAPRO) via transplacental taken for depression on unspecified dates at 20mg, daily; acetylsalicylic acid (ASPIRIN BAYER) via transplacental take to prevent preeclampsia from 12Jan2020 to an unspecified date at 81 mg, daily; minerals NOS/vitamins NOS (PRENATAL VITAMINS; tablet) via transplacental for pregnancy from 12Jan2020 to an unspecified date at 1 DF, daily; insulin glargine (LANTUS) via transplacental taken for type 2 DM (diabetes mellitus) from 02Jan2020 to 09Aug2021 at 12-24 units bedtime; fish oil (FISH OIL OMEGA 3; tablet) via transplacental taken for cholesterol on unspecified dates at 2 DF, daily and famotidine (PEPCID AC) via transplacental taken for GERD on unspecified dates at 20 mg, daily. On 27Jul2021, that patient experienced fetal distress and on an unspecified date the patient experienced maternal exposure during pregnancy. The outcome of the pregnancy was reported as full term live birth. Date of outcome of pregnancy was reported as 27Jul2021. Gestation age at birth in weeks was 39 weeks. The outcome of infant was reported as normal newborn; Apgar Score: 1min 1; 5min 7. Malformation/anomalies diagnosed were none. Developmental assessment was normal-47th percentile. The patient underwent ultrasounds on 11Dec2020, 02Mar2021, 13Apr2021, 07May2021, 11May2021, 08Jun2021, 15Jun2021, 22Jun2021, 29Jun2021, 06Jul2021, 15Jul2021 and 20Jul2021, all with unknown results. The clinical outcome of the events fetal distress and maternal exposure during pregnancy were unknown.

Other Meds: LEXAPRO; ASPIRIN BAYER; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; LANTUS; FISH OIL OMEGA 3; PEPCID AC

Current Illness:

ID: 1791323
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: miscarriages; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's friend) reporting same event under the same suspect product for four patients. This is one of four reports. A female patient of unspecified age received bnt162b2 (Pfizer covid vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, Caller unwilling to complete the report) as dose number unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was pregnant. The patient blamed her miscarriage on the vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101343886 same report/drug/AE, different patients

Other Meds:

Current Illness:

ID: 1791324
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: miscarriages; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's friend) reporting same event under the same suspect product for four patients. This is one of four reports. A female patient of unspecified age received bnt162b2 (Pfizer covid vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, Caller unwilling to complete the report) as dose number unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was pregnant. The patient blamed her miscarriage on the vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101343886 same report/drug/AE, different patients

Other Meds:

Current Illness:

ID: 1791325
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: miscarriages; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's friend) reporting same event under the same suspect product for four patients. This is one of four reports. A female patient of unspecified age received bnt162b2 (Pfizer covid vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported, Caller unwilling to complete the report) as dose number unknown, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was pregnant. The patient blamed her miscarriage on the vaccine. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101343886 same report/drug/AE, different patients

Other Meds:

Current Illness:

ID: 1791326
Sex: F
Age:
State: NC

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 10/16/2021
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: labs; Result Unstructured Data: Test Result:unknown; Comments: Labs done on 3month diabetic check

Allergies:

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

Symptoms: more joint pain than before.; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL9266) via an unspecified route of administration in arm left on 11Feb2021 (age at vaccination 87 year) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (age at vaccination 87 year) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced more joint pain than before. The patient underwent lab tests and procedures which included laboratory test, result was unknown (labs done on 3 month diabetic check). The outcome of the event more joint pain was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1791327
Sex: F
Age:
State: FL

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Lab test; Result Unstructured Data: Test Result: it wasn't Shingles; Test Date: 2021; Test Name: Lab test; Result Unstructured Data: Test Result: They identified it as a dermatitis; Test Date: 2021; Test Name: Weight; Result Unstructured Data: Test Result: 132 lbs.

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9267, Expiry date: not reported) via an unspecified route of administration on 19Feb2021 (at the age of 88 years old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included: BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9263, Expiry date: not reported) via an unspecified route of administration, on unspecified date as dose 1, single for COVID-19 immunization. Calling about the COVID vaccine. Was fortunate to get the first shot after much anguish and with time, and was scheduled for the second shot, she understood it was recommended be given three weeks after the first shot, her appointment was for 4 weeks after. Calling to find out, would it be just as effective as the recommended three weeks. On an unspecified date in 2021, Shortly often receiving the second dose of the Covid vaccine the patient developed a rash. Her dermatologist thought it might be Shingles. The rash had little blisters and itched. Lab test showed it wasn't Shingles. They identified it as a dermatitis. She had not had negative reaction to other vaccines. The rash had gone away. The patient underwent lab tests and procedures which included laboratory test: Lab test showed it wasn't Shingles. They identified it as a dermatitis in 2021, weight: 132 lbs. in 2021. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1791328
Sex: M
Age: 72
State: KY

Vax Date: 09/23/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Ear pain, Hypoaesthesia

Symptoms: High heart rate

Other Meds: Aspirin Atorvastatin Clopidogrel Furosemide Isosorbide Lisinopril Metoprolol Omeprazole Vitamin d Finasteride Glipixide

Current Illness: No

ID: 1791329
Sex: F
Age: 63
State: NY

Vax Date: 10/01/2021
Onset Date: 10/15/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies: Propylthiouracil, Cobalt

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Fever, aching joints, headache, sensitivity to light (eyes), loss of appetite, inflammation of injection site in LEFT arm from prior Covid Vaccination (September 3, 2021 - Moderna Lot 939901), Hyperinflammation - pain and swelling - continuing in LEFT knee, hyperinflammation in RIGHT knee started several days later and persists in both knees; Hyperinflammation - pain, some swelling - at site of 1st vaccination (LEFT arm) persists.

Other Meds:

Current Illness:

ID: 1791330
Sex: M
Age: 62
State: NY

Vax Date: 04/30/2021
Onset Date: 05/02/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: None

Allergies: Adrenaline/Epinephrine

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

Symptoms: I was home on days 3, 4, and 5 after the vaccination. Day 3, at night. My symptoms: 1) constant coughing 2) tightness in my chest, some difficulty breathing 3) I couldn't sleep that night self-help treatments: 1) I took 500 mgs. of aspirin over 3 hours. 2) I drank a pint of grapefruit juice and a pint of lime juice to alleviate my symptoms. Day 4, at night. My symptoms: 1) constant coughing 2) tightness in my chest, some difficulty breathing 3) I was able sleep for 2 hours self-help treatments: 1) I took 500 mgs. of aspirin at one time. 2) I drank some grapefruit juice and some lime juice, but less than Day 3. Day 5, at night: My symptoms: 1) less coughing 2) less tightness in my chest 3) I slept normally self-help treatments: 1) I took 250 mgs. of aspirin at one time.

Other Meds: None

Current Illness: None

ID: 1791331
Sex: M
Age: 41
State: TX

Vax Date: 10/13/2021
Onset Date: 10/15/2021
Rec V Date: 10/16/2021
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: LABS, CTA CHEST, CT HEAD, CARDIAC MONITORING, EKG.

Allergies: NONE

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

Symptoms: HEADACHE, ELEVATED BLOOD PRESSURE, ELEVATED HEART RATE, CHEST PAIN, PALPITATIONS

Other Meds: TESTOTERONE

Current Illness: NONE

ID: 1791332
Sex: F
Age: 67
State: MI

Vax Date: 09/01/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: In hospital for one week

Allergies: none

Symptom List: Unevaluable event

Symptoms: afib, brain fog

Other Meds: tylenol, albuterol, budesonide, cholecalcifroxine, diazpam, colace,prozac,mucinex,levothyroxine,lovastatin,meclizine, mepolizumab,montelukast, vitamin b ,prednisone, senna, tiotropium

Current Illness: asthma

ID: 1791333
Sex: F
Age: 37
State: SD

Vax Date: 08/05/2021
Onset Date: 08/06/2021
Rec V Date: 10/16/2021
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: Sulfa and kenolog

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

Symptoms: Bleeding lower back pain, miscarriage of my baby in 3 days of shot.

Other Meds: Pre natal biotin

Current Illness: No

ID: 1791335
Sex: F
Age:
State: GA

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210121; Test Name: Run a 103 fever; Result Unstructured Data: Test Result:103; Test Date: 20201209; Test Name: covid virus; Test Result: Positive ; Test Date: 20201221; Test Name: covid pneumonia both lungs; Test Result: Positive ; Test Date: 20201224; Test Name: covid pneumonia both lungs; Test Result: Positive

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: sore arm; tired; Didn't feel good; run a 103 fever; This case has been considered invalid initially upon follow up information case was processed as valid file This is a spontaneous report from a contactable other health care professional (patient herself) via medical information team. A 77-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3249), via intramuscularly, administered in Left arm on 20Jan2021 02:15 PM (at the age of 77-year-old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 09Dec2020 to Jan2021. The patient's concomitant medications were not reported. On 21Jan2021, the patient experienced sore arm, tired, didn't feel good, run a 103 fever. The patient underwent lab tests and procedures which included covid-19 resulted as positive on 09Dec2020, covid-19 pneumonia resulted as positive on 21Dec2020, covid-19 pneumonia resulted as positive on 24Dec2020. It went away in a couple of hours on its own. Clinical outcome of the event was reported as recovered on unspecified date Jan2021 events went away in a couple of hours on its own. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1791336
Sex: F
Age:
State: CA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 10/16/2021
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: 15 hours after vaccine vomited/Vomiting; 12 hours after vaccine experienced chills; swelling; fever; nausea; headache; Lymphadenopathy with considerable swelling and tenderness evident in ipsilate; Patient recived dose 1 on 08Jan2021 and dose 2 on 25jan2021; Respiratory distress; Generalized pruritus without skin rash; This is a spontaneous report received from a contactable other-healthcare professional (patient). A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: EL3246, Expiry date: Not reported) via an unspecified route of administration in the left arm on 25Jan2021 at 17:15 (at the age of 25-years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included environmental allergies to pollen, mold and dust from an unknown date. No history of Anaphylaxis. Concomitant medications included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19 and not received any other vaccines within four weeks. Since the vaccination, the patient had not been tested for COVID-19. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Lot Number: EL3246, Expiry date: not reported) via an unspecified route of administration in left arm on 08Jan2021 at 17:45 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. On 26Jan2021 at 05:15, 12 hours after second vaccination, the patient experienced chills, fever, nausea, headache, swelling, and lymphadenopathy with considerable swelling and tenderness evident in ipsilateral axillary and supraclavicular lymph nodes. Patient 15 hours after vaccine at 08:15, vomited or had vomiting. Fever, chills, and headache persisted from 12-32 hours after vaccination. On an unspecified date in 2021, after vaccination, patient experienced Respiratory distress and Generalized pruritus without skin rash. It was reported that, Swelling was only seen in ipsilateral super clavicular lymph nodes. No anaphylactic reaction occurred. The patient did not require medical intervention. Patient had no emergency department visit, no hospitalization and not admitted to intensive care unit as result of events. The patient did not receive any treatment for the events. The clinical outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information was expected. Follow-up (29Mar2021): This is a follow-up spontaneous report from a contactable consumer. This 25-years-old female consumer (patient) reported that, New information includes: Added Medical history (Allergies), New events, Event details, and Clinical information. No follow-up attempts are possible; No further information was expected.; Sender's Comments: Based on the available information in the case, the causal association between the event respiratory distress and the 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: ALLEGRA

Current Illness:

ID: 1791337
Sex: M
Age:
State: GA

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a Pfizer-sponsored program via contactable consumer. This consumer reported for both himself and his wife. This is for the reporter. A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in right arm on 11Feb2021 at 12:30 (at the age of 74-years) as dose 2, single for covid-19 immunization. The patient medical history included none. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in right arm on 21Jan2021 at 11:15 (at the age of 74-years) as dose 1, single for covid-19 immunization. There were no concomitant medications. The patient had not received any other vaccine within 4 weeks. After second vaccination, on an unspecified date in Feb2021, the patient had experienced a little bit soreness on their right arm where the vaccine was administered. Therapeutic measures were taken as a result of arm soreness and included treatment with Advil and Tylenol. The outcome of the event was unknown at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1791338
Sex: F
Age:
State: CO

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 10/16/2021
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: Fatigue; Slight temperature; In initial report (PRD 11Feb2021), this case was considered as invalid as there was no indication that the patient experienced an event under BNT162b2. Upon follow-up #2 on (PRD 15Apr2021) the case becomes valid due to new event reported. This is a spontaneous report from a contactable consumer or non-healthcare professional (patient) via Pfizer sponsored program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route of administration on 04Feb2021 as dose 1, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267) via an unspecified route of administration on 25Feb2021 as dose 2, single both for COVID-19 immunization. Medical history included cold sore. Concomitant medication(s) included acyclovir (ACYCLOVIR) 400 mg taken for cold Sores. On an unspecified date in 2021, the patient experienced fatigue and slight temperature for a day or two. It was reported that, the patient got her first dose of the Pfizer COVID Vaccine on 04Feb2021. Everything was fine. She was reading online, and it said, if you are taking an antiviral when getting the vaccination, it may reduce the effectiveness of vaccine. Well, she had a cold sore and thinks was taking Acyclovir at the time she had the vaccine. Now she was panicking and hoping the shot was still good. She enquired should she be concerned about having taken the Acyclovir the same time she got the shot. She was unsure when she started the Acyclovir but it was before the vaccine. She might have been still taking it when she got the vaccine, she could not remember. She was unsure, but there was a good chance she was still taking it when she got the vaccine. She called Pfizer because she heard it was maybe a problem to take anti-viral that it would cause shot to be in affective. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: ACYCLOVIR [ACICLOVIR].

Current Illness:

ID: 1791339
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: for a cold he was experiencing both before and after the second dose; This is a spontaneous report from a contactable consumer or other non-health professional. An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. It was reported that on unspecified date patient states he received his second dose of the Pfizer Covid vaccine but was given prednisone to take for a cold he was experiencing both before and after the second dose. Patient clarified that had a cold prior to receiving the second COVID-19 Vaccine. Patient enquired got a little bit of a cold. Patient enquired to know if it hurts anything to take Prednisone. He wants to know if this lessened the effectiveness. The Outcome of the event was unknown. No follow-up attempts are possible; informationabout lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1791340
Sex: M
Age:
State: AZ

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 10/16/2021
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: his voice is a little raspy; diarrhea; nausea; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 18Feb2021 at 10:30 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medication was not reported. It was reported that the patient would be off the blood thinner (unspecified) very soon. On 18Feb2021, same day of vaccination at 23:30, the patient experienced diarrhoea, nausea, and on 19Feb2021, his voice was a little raspy. The patient reported that his voice is a little raspy on the day of reporting. He got his 1st dose of the vaccine about 10:30 am yesterday (18Feb2021), and after getting the shot they gave him a packet of information. States that they really should have given him the information before giving the injection because he discovered that the packet says to tell someone if you are on blood thinners. States that no one asked him if he was on a blood thinner, and he didn't know that was something he should have told them. Will that make a difference since he already had the shot. States that he will be off the blood thinner very soon. Also states that about 11:30 pm that night, 13 hours post vaccination, he started having diarrhea and was nauseous. It might have been something he ate but could those be side effects from the vaccine and if so, can anyone else catch his side effects. Patient wants to know if these side effects are related to the vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1791341
Sex: F
Age:
State: NC

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 10/16/2021
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: I saw dizzy, I wasn't dizzy; I saw nauseated, I wasn't nausea; I felt a strange and eerie weird feeling/feeling came up from bottom of stomach to top of head, strange, eerie; This is a spontaneous report from a contactable nurse. A 82 years old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/lot number: EL3247, Expiry Date: 31May2021) via Intramuscular route of administration in right upper arm on 30Jan2021 (at the age of 82 years) 09:00 as dose 1, 0.3 ml, single for covid-19 immunization. Patient medical history included diabetic since 22 years, high blood pressure 30 plus years , High cholesterol More than 20 years ago, arthritis since childhood all were from unknown date and still ongoing. Patient's concomitant medication included Rosuvastatin 20mg one tablet daily by mouth at night from (Start: Unspecified Stop: Ongoing). On 30Jan2021 patient experienced feeling came up from bottom of stomach to top of head, strange, eerie, nausea, dizzy on unspecified date. Patient's first vaccine on 30Jan2021, I am do for the second one tomorrow, the question that I had. Patient was reading the information, the adverse reaction patient had, patient didn't see it listed, within 15 minutes of the injection. Mine was about 5- 6 minutes after the vaccine feeling welled up from stomach to my head and lasted for 5 minutes. Patient felt a strange and eerie weird feeling, it passed on and patient hadn't felt it since. Could that be serious or was that nothing to be worried about, patient saw dizzy, patient wasn't dizzy, patient saw nauseated, patient wasn't nausea. Patient called a nurse, she said since it happened so fast, it probably wasn't an effect of the vaccine. Patient was interested because she didn't see it listed, has anyone else felt like that, she saw that people felt nauseous or stomach felt full. When querying causality, she thought it was related to vaccine, stating she had never that feeling before. She didn't feel that way before she took it and has never had that medication before. It lasted no more than 10 minutes. And never felt like that before and felt well after that. Patient talked to her primary care physician's nurse on 16Feb2021 and the nurses' feeling was that she didn't think a reaction came from the injection because 5-6 minutes wasn't time enough for the Covid 19 vaccine to circulate through her system. The caller's thing is that they tell you that a reaction can happen within the first 15 mins. That fell within that. Treatment: no, she came on home and did what she normally does. She wanted to know for her-self if anyone else had that experience and if other's did experience it maybe it could be documented somewhere, that it's a side effect someone could have. She didn't feel sick or anything. Seriousness Criteria: She doesn't know. She does not think it was life threatening, states it is un-known. Patient did not received treatment for I felt a strange and eerie weird feeling/feeling came up from bottom of stomach to top of head, strange, eerie. The outcome of I felt a strange and eerie weird feeling/feeling came up from bottom of stomach to top of head, strange, eerie was recovered on 30Jan2021 while other events were unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: ROSUVASTATIN

Current Illness: Arthritis (Verbatim: arthritis /Additional Information for Other Conditions: since childhood); Blood pressure high (Verbatim: high blood pressure/Additional Information for Other Conditions: 30 plus years); Diabetic (Verbatim: diabetic /Additional Information for Other Conditions: 22 years); High cholesterol (Verbatim: high cholesterol /Additional Information for Other Conditions: More than 20 years ago.)

ID: 1791342
Sex: M
Age:
State: NY

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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: flu like symptoms; body aches and pains; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-year-old male patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EL9267 and expiration date was not reported), dose 1 intramuscular, administered in left arm on 12Feb2021 at 07:30 AM (Age at vaccination was 73 years) as dose 1, single for covid-19 immunisation. Medical history included arthritis also stated that, which was pretty normal for his age, cancer caller states he does have a compromised immune system from previous cancer treatment from an unknown date and unknown if ongoing. Concomitant medication(s) included paracetamol (TYLENOL) taken for arthritis, start and stop date were not reported. On an unspecified date in Feb2021 the patient experienced body aches and pains and on an unspecified date patient also experienced flu like symptoms. It was also explained that patient says, body aches and pains, flu-like symptoms and things like that, which he know are all normal. Patient was asking if he can take Tylenol to treat symptoms because he read you should not take it before the vaccine. Patient was asking if he needs to stop taking Tylenol before the next dose. Patient stated he was still getting body and aches and pains. Patient wanted to know is it pretty much normal to still be experiencing this. The patient stated he started to get body aches and pains a couple of days after the shot. The relevant test was none. The outcome of event body aches and pains was not recovered and outcome of flu like symptoms was unknown. No follow-up attempts are possible; No further information is expected.

Other Meds: TYLENOL

Current Illness:

ID: 1791343
Sex: F
Age:
State: NY

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 10/16/2021
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: headache; Bad fatigue/a lot of fatigue; sore arm/little soreness in the arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 38-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EM9809, Expiration date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 10Feb2021 (age at vaccination 38-year-old) as dose 2, single for COVID-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EL324, Expiration date: 31May2021), on 20Jan2021 (age at vaccination 38-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced sore arm/little soreness in the arm. On 14Feb2021 the patient experienced headache and bad fatigue/a lot of fatigue. Caller stated she had a question, stated she got the second dose of the Pfizer vaccine on 10Feb2021, did not feel anything but a little soreness in the arm when she got the vaccine, stated this past Monday, she started to feel like she had a headache and a lot of fatigue that lasted through Wednesday, stated it was a little better on Thursday, and today, Friday, felt a lot better. Caller wanted to know if it was possible to have a delayed reaction to the vaccine. Outcome of the events headache and bad fatigue/a lot of fatigue was recovering and for sore arm/little soreness in the arm outcome was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1791344
Sex: F
Age:
State: GA

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fever; Head ache; Chills; This is a spontaneous report from a contactable other-HCP (patient). A 57-year-old female patient received and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EN6205) via an unspecified route of administration on 24Feb2021 14:20 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EL3247) via an unspecified route of administration on 27Jan2021 14:15 as dose 1, single for covid-19 immunization. It was reported, patient missed her appointment for the second dose on 17Feb2021. On 24Feb2021, the patient experienced fever, headache and chills. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1791345
Sex: F
Age:
State:

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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: pain; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EN5318, expiry date: 31May2021), via an unspecified route of administration in left arm on 12Feb2021 (at the age of 77-years) as dose 1, single for COVID-19 immunization. Medical history includes bad fall, operation and broke her left collarbone (she fell 4 years ago, broke her left collarbone, and had a titanium rod placed). About 4 years ago, she had a bad fall taking care of an old gentleman. The patient had a titanium plate placed because her collar bone was pretty bad off and had no trouble or pain with the titanium plate since it was placed; the only thing was that one of the screws in the plate stuck out a little bit, it did not hurt, just almost felt like something stuck upward. Concomitant medications were not reported. It was reported that on Feb2021 (starting 16Feb2021 or 17Feb2021), the titanium plate the patient had placed about 4 years ago was visible and hurts. It was almost like the flesh was being sucked underneath the titanium plate, there was like no blood or anything but there was a hole and it was kind of scary. The patient did not know if that was coincidental or related to Pfizer COVID-19 Vaccine but wanted to ask if it was possible it could be related to the Pfizer COVID-19 Vaccine. The patient said her 86 y/o (year-old) sister received the vaccine and her arm was very sore 5 days after receiving it. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1791346
Sex: F
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: foot so swollen can barely walk; foot so swollen can barely walk; This is a spontaneous report from a contactable consumer (Patient) report from a Pfizer-sponsored program COVAX US SUPPORT. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included autoimmune disorder and arthritis: from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient's foot was so swollen that can barely walk. The patient is scheduled to receive the second dose of the Pfizer COVID-19 vaccine on an unspecified date. She reported that she is also scheduled to receive a cortisone injection in her foot because it was so swollen that she can barely walk at this time. When the patient spoke with the doctor, doctor advised that it would be okay to receive the second dose of the Pfizer COVID-19 vaccine as scheduled along with the cortisone injection in her foot. The patient wanted to know if Pfizer has any information on whether this cortisone injection would interact with the vaccine. The patient reported that she has an autoimmune disorder and takes a biologic medication and understands that the vaccine may not work as well for her due to having an autoimmune disorder and taking immunosuppressants. It was reported that the reporter is not a Healthcare Professional (HCP). The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1791347
Sex: M
Age:
State: NV

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 10/16/2021
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: This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 35-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9267; Expiration Date: 31May2021) via an unspecified route of administration, administered in Arm Right on 13Feb2021, at 15:45 (at the age of 35 years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypoxia from an unknown date and unknown if ongoing. There were no concomitant medications reported. patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medication within 2 weeks. On 13Feb2021, 23:30 patient experienced symptoms of vertigo, blurry vision, tinnitus, anxiety. on 14Feb2021 patient experienced tired, dizzy, drowsy, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know how long it will take for his body to feel normal again, he feels like if his brain is not 100% like a person who takes a lot of drugs. He would like to know if he reschedules his second dose instead of 3 weeks after the first dose to 4 or 6 weeks will side effects be less severe once he takes the second dose. He would like to know if he decides not to receive the second dose of the vaccine if one dose will be enough for him to be protected against Covid-19, and if he takes both doses how long he will be protected (6 months, 1 year, 2 years). Patient did not received treatment for the events. The events vertigo, blurry vision, tinnitus, anxiety resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The outcome for the events experiencing tired, dizzy and drowsy and he feels like if his brain is not 100% like a person who takes a lot of drugs was unknown. The outcome for events vertigo, blurry vision, tinnitus, anxiety was not recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1791348
Sex: F
Age:
State: NY

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 10/16/2021
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: my left arm at the injection site began to feel slightly sore.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL3247) an unspecified route of administration, administered in left arm on 19Feb2021 11:30 (age at vaccination 48 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma. Other vaccine in four weeks was reported as no. The patient had known allergies: seasonal allergies, pets, various foods and dust. Patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Concomitant medications included Vitamin D, fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), triamcinolone acetonide (NASACORT) and unspecified multivitamin taken for unspecified indication from an unknown date. The patient reported that on the day of vaccination on 19Feb2021 19:00, towards the evening, her left arm at the injection site began to feel slightly sore. The patient was not received any treatment for event. The outcome of the event was recovered on an unspecified date in Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds: VITAMIN D [VITAMIN D NOS]; ALLEGRA D; NASACORT

Current Illness:

ID: 1791349
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 02/09/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Fatigue; muscle soreness; swollen lymph nodes under arm 24 hrs after vaccination; This is a spontaneous report from a contactable consumer. An adult male patient of an unspecified age (Age: 58, unit: unknown) received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular route of administration, administered in left upper arm on 08Feb2021 as dose 2, single for COVID-19 immunisation and first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an intramuscular route of administration, on an unspecified date as dose 1, single for COVID-19 immunisation. The patients medical history and family medical history was reported as unknown. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Feb2021, the patient experienced fatigue, muscle soreness and swollen lymph nodes under arm 24 hrs after vaccination. The event fatigue, started within 24 hours of vaccination. Facility type vaccine was reported as nursing home or senior living facility. The patient did not receive treatment for the events. These events did not require the initiation of new medication or other treatment or procedure. The clinical outcome of events was reported as recovered on unspecified date. Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1791350
Sex: M
Age:
State: NC

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Migraines; general body achiness; exhaustion 12 hours after receiving the shot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in left arm on 18Feb2021 13:45 (at the age of 27-year-old) as dose 2, single for COVID-19 immunization at clinic. Medical history was reported as none. Patient had no known allergies. Concomitant medications included Escitalopram via an unspecified route of administration from an unknown date and unknown if ongoing for an unspecified indication. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in right arm on 28Jan2021 13:45 (at the age of 27-Year-old) as dose 1, single for COVID-19 immunization at clinic. It was reported that on 19Feb2021 01:00, the patient experienced migraines, general body achiness, and exhaustion 12 hours after receiving the shot. Patient did not receive any treatment for the events. The outcome of all events was resolving. No follow up attempts are possible. No further information is expected.

Other Meds: ESCITALOPRAM

Current Illness:

ID: 1791351
Sex: M
Age:
State: MI

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 10/16/2021
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:

Allergies:

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

Symptoms: He had a sore arm/my arm was sore; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced he had a sore arm/my arm was sore on an unspecified date. The event outcome was reported as unknown. No follow up attempts are possible; Information about Lot and batch number could not be obtained.

Other Meds:

Current Illness:

ID: 1791352
Sex: F
Age:
State: FL

Vax Date: 02/10/2021
Onset Date: 02/14/2021
Rec V Date: 10/16/2021
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: Vomited; This is a spontaneous report from a contactable consumer (patient) and from a Pfizer-sponsored program. A female patient of (Age: 79 Unit: unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had her last dose on last 10Feb the second one and now she is reporting that she is having an adverse reaction(vomiting)last 14Feb2021 and 19Feb2021. And she is asking if it is because of Covid-19 vaccine. 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: 1791353
Sex: M
Age:
State:

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 10/16/2021
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: slight skin sensitivity; Injection arm became very sore; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- EL3247) via unspecified route of administration, in left arm on 19Feb2021 14:45 as dose 2, single (at the age of 23-years-old) for COVID-19 immunization in other facility. The patient medical history and concomitant medication were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3247), via unspecified route of administration, in left arm on 29Jan2021 02:45 PM (at the age of 23-years-old) as a dose 1, single for covid-19 immunization in other facility. Patient did not have any known allergies. Patient did not have any other vaccine in four weeks and no other medications in two weeks. Patient not had COVID prior to vaccination and was not tested for COVID post vaccination. On 19Feb2021 22:00 the patient experienced injection arm became very sore. On 20Feb2021 the patient experienced slight skin sensitivity. The patient did not receive any treatment for the reported events. Outcome of all the reported events was recovering. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1791354
Sex: F
Age:
State: CA

Vax Date: 02/15/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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: Headache/teeny-tiny headache /last night and have a terrible headache; Arm soreness; Nauseated; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, on 15Feb2021 (Lot Number: EN6201, at the age of 47-year-old), as single dose for COVID-19 immunization. Medical history included psoriasis from an unknown date and unknown if ongoing. Concomitant medications included clarithromycin (CLARITIN [CLARITHROMYCIN]) and vitamins taken for an unspecified indication, start and stop date were not reported. 19Feb2021, she had headache/teeny-tiny headache /last night and have a terrible headache. Unknown date in Feb2021, she had arm soreness, nauseated. Monday at 11 in the morning, the patient had just really mild symptoms nothing unmanageable at all, just arm soreness and maybe just a teeny-tiny headache and a little bit nauseated, but not bad at all. The patient could go to work and do everything, but the patient went to bed last night and had a terrible headache this morning think so, and the patient did not usually get headaches. The patient reported that it was been five days. The patient was asking if it was possible to be side effect, five days later. It feels migraineish. The patient reported that it was a little better now and that the patient took some Advil (treatment) to help. So, the patient just wondered how long after the vaccine could expect to possibly have symptoms. Therapeutic measures were taken as a result of headache/teeny-tiny headache /last night and have a terrible headache. The clinical outcome of headache/teeny-tiny headache /last night and have a terrible headache was not recovered while not arm soreness, nauseated was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: CLARITIN [CLARITHROMYCIN]

Current Illness:

ID: 1791355
Sex: F
Age:
State: NJ

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: back pain; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Mother) that: A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation and acetylsalicylic acid (BABY ASPIRIN), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) daily (Everyday) for blood pressure abnormal. Medical history included drug hypersensitivity (allergic to penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced back pain. The patient has back pain which she said was unrelated to the vaccine. The reporter wanted to know if it was safe for the patient to take painkillers like Aspirin. The patient also takes a baby aspirin everyday for her BP. Someone told the patient not to take this medicine. The reporter wanted to know if it is okay to take it. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: The causal association between the event back pain and the suspect vaccine is assessed as related . The case will be reassessed once new information is available.

Other Meds:

Current Illness:

ID: 1791356
Sex: F
Age:
State: CT

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: her arm was uncomfortable; but she had difficulty raising and lowering her arm; her arm from her should to her thumb felt very tight. Felt like she was getting her blood pressure taken; This is a spontaneous report from a Contactable consumer (patient). A 66-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6200 and expiry date was not reported), via an unspecified route of administration, in Arm right, on 17Feb2021 at 9:15 approximately, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization (Age at vaccination: 66 years). The patient medical history and concomitant medications were not reported. Historical vaccine included Flu shot on an unspecified date and experienced arm was sore. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received additional vaccines administered on same date of pfizer suspect. The patient wanted to report an experience with Pfizer COVID-19 Vaccine, which she had on 17Feb2021. Within two hours her arm was uncomfortable, which she expected and was not concerned and within three to three and a half after the COVID-19 Vaccine her arm from her should to her thumb felt very tight. Felt like she was getting her blood pressure taken. It was her whole arm, by four hours after the COVID-19 Vaccine, she took a couple Aleve, but that didn't touch it. By 6PM -6:30PM she the pressure started relieving a little bit, but that night and the next day she was very uncomfortable. The tight pressure relieved itself, but she had difficulty raising and lowering her arm. Had to use the opposite hand to support her arm. The patient asked if this is out of the ordinary and What will happen with the next shot. The patient stated this was a debilitating experience and her husband had the COVID-19 Vaccine with her and had no reaction, which is why she was concerned. The patient wants to know how long it's going to last and when will it happen again and she stated that she felt fine today and is back to normal and stated her experience was with the injection arm, the right arm. Wondering if it was injected too high. The patient Cousin had the shot the weekend before her, she was told not to take any anti-inflammatories for 4 hours after the vaccine and asked any documentation on this. The AE did not result in emergency room or physician office visit. The patient cousin had the COVID-19 Vaccine. Cousin was told she should take Ibuprofen, but to wait four hours after the COVID-19 Vaccine and patient stated Pfizer advice should be available to everyone. No further details provided. By the time patient took two Aleve when she got home which was 4 hours later (Lot: 84573353, Expiry date: Apr2023, provided: NAA8L9E, which doesn't know if that is the lot number) and it didn't touch it. Outcome of the events were recovered on 19Feb2021. Description of Product Complaint (Aleve): Description of complaint: Arm was uncomfortable and very tight. Took two Aleve and it didn't touch it. Dose: Took two capsules when she got home, which was 4 hours later, Lot: 84573353, Exp: Apr2023, Provided: NAA8L9E, which doesn't know if that is the lot number. UPC: discarded box Provided: 87109917 from back of bottle, Product strength and count size dispensed: 24 capsule count; 220mg. No sample of the product available to be returned, if requested. Packaging sealed and intact. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1791357
Sex: F
Age:
State:

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: when I move it hurts. I was tired and ache when I move, but I have no temperature; when I move it hurts. I was tired and ache when I move, but I have no temperature; This is a spontaneous report from a Pfizer-sponsored program . This is a spontaneous report from a contactable consumer reported for herself. A 68 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date were unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 20Feb2021 10:00 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were unknown. On 20Feb2021, the patient experienced when I move it hurts. I was tired and ache when I move, but I have no temperature. The events accessed as a non serious. The outcome of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1791358
Sex: F
Age:
State: NY

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: back pain; neck pain; This is a spontaneous report from a contactable consumer (Patient) from a medical information Team. A consumer (caregiver) mother received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation : Solution for injection , Batch /Lot number : Not reported) dose 2, Via an unspecified route of administration on Feb2021 as a single dose for COVID-19 immunisation. Patient medical history and concomitant medication were not reported. She was taking Oxycodone before for her chronic back pain. Historical vaccine include bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation : Solution for injection , Batch /Lot number : Not reported) dose 1, Via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Patient experienced back pain for back and neck pain on an unspecified date in 2021. Outcome of the events was Unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1791359
Sex: F
Age:
State: KY

Vax Date: 02/19/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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: Dizziness mostly head swimming; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the right arm on 19Feb2021 at 15:45 (at the age of 70-year-old) as dose 1, single for COVID-19 immunization at Hospital. Medical history included stoke 10 years before (unspecified date) and COVID-19, Prior to the vaccination, the patient was diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medications were not reported, patient received other medications within 2 weeks of vaccination (unspecified). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Feb2021, at 15:00, the patient experienced dizziness mostly head swimming. The outcome of the event was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1791360
Sex: M
Age:
State: OH

Vax Date: 02/11/2021
Onset Date: 02/12/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 33 hours after second shot: tired, dizzy. Continuing through today (10.5 days later); 33 hours after second shot: tired, dizzy. Continuing through today (10.5 days later); This is a spontaneous report from a contactable consumer (Patient). A 82-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 07:00 as dose 2, single (At the age of 82-years) for covid-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included leukaemia and allergic to penicillium, anti-inflamatories. from an unknown date and unknown if ongoing. No other vaccine given in four weeks. Prior to vaccination, patient was not diagnosed with covid-19. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXINE SODIUM), amlodipine (AMLODIPINE), lisinopril (LISINOPRIL), sulfamethoxazole, trimethoprim (BACTRIM) and glucose (GLUCOS) all taken for an unspecified indication, start and stop date were not reported. On 12Feb2021 at 14:00 the patient experienced 33 hours after second shot: tired, dizzy. continuing through today (10.5 days later). Since the vaccination, patient has not been tested for covid-19. Patient did not receive any treatment for the events. The outcome of the event was not recovered. Follow-up attempts completed. No further information expected.

Other Meds: LEVOTHYROXINE SODIUM; AMLODIPINE; LISINOPRIL; BACTRIM; GLUCOS

Current Illness:

ID: 1791361
Sex: F
Age:
State: OH

Vax Date: 02/17/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
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: his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; his wife is experiencing "a bump underneath her skin, red, and its painful."/redness and a little bump and lot of pain; This is a spontaneous report from a contactable consumer (Patient's husband) via Medical Information Team. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6200; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in right arm on 17Feb2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history included a broken arm couple of years ago and lost the use of that arm and the hand anyways, that's why we have to put the shot in her right arm and reporter does not know about treatment. The patient takes a lot of unspecified concomitant medications. On an unspecified date in Feb2021, the patient experienced a bump underneath her skin, red, and its painful, redness and a little bump and lot of pain. The reporter clarified that his wife was experiencing this at the injection site and has been going on for the last two days and has been taking Advil PM for this reaction. The patient was scheduled to have second dose on 10Mar2021. The reporter asked if patient would react differently with the second dose. The patient received treatment for the events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am