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: 1707407
Sex: F
Age: 78
State: WA

Vax Date: 03/24/2021
Onset Date: 03/27/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: three days later from each time, I had horrible, horrible reaction; vertigo; so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction), DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to) and VERTIGO (vertigo) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to). On an unknown date, the patient experienced VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction) and VERTIGO (vertigo). At the time of the report, VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction), DIZZINESS (so dizzy, couldn't even walk to the bathroom,She had no balance whatsoever. Her dizziness was so bad that she had to) and VERTIGO (vertigo) outcome was unknown. No concomitant medication were provided by the reporter No treatment medication were provided by the reporter This case was linked to MOD-2021-311397, MOD-2021-311050, MOD-2021-311042 (Patient Link).

Other Meds:

Current Illness:

ID: 1707408
Sex: F
Age:
State: VA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from the vaccine). At the time of the report, VACCINATION COMPLICATION (side effects from the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. This case was linked to MOD-2021-311281.

Other Meds:

Current Illness:

ID: 1707409
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/17/2021
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: First dose 8 months ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago). In February 2021, PRODUCT DOSE OMISSION ISSUE (First dose 8 months ago) had resolved. Concomitant medications were not reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707410
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Wrong expiration; Incorrect lot number; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (wrong expiration) and PRODUCT LOT NUMBER ISSUE (incorrect lot number) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (wrong expiration) and PRODUCT LOT NUMBER ISSUE (incorrect lot number). On 04-Sep-2021, EXPIRED PRODUCT ADMINISTERED (wrong expiration) had resolved and PRODUCT LOT NUMBER ISSUE (incorrect lot number) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707411
Sex: F
Age: 61
State: MA

Vax Date: 02/03/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210903; Test Name: Body temperature; Result Unstructured Data: 103.5- F : High

Allergies:

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

Symptoms: Body aches; Pyrexia; Cold; Migraine; She felt like a dish rag.; She was so sick; Right arm hurt where I got the shot; Nauseated; Chills; Full body sweats; Light-headed; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine) and FEELING ABNORMAL (She felt like a dish rag.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20VT, 010A21A and 032L20VT) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced HYPERHIDROSIS (Full body sweats) and DIZZINESS (Light-headed). On 03-Sep-2021, the patient experienced NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), ILLNESS (She was so sick), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills) and PYREXIA (Pyrexia). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 04-Sep-2021, ILLNESS (She was so sick) had resolved. At the time of the report, HYPERHIDROSIS (Full body sweats), DIZZINESS (Light-headed), NASOPHARYNGITIS (Cold), MIGRAINE (Migraine), FEELING ABNORMAL (She felt like a dish rag.), VACCINATION SITE PAIN (Right arm hurt where I got the shot), NAUSEA (Nauseated), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Pyrexia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Sep-2021, Body temperature: 103.5 f (High) 103.5- F : High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant medications were not reported. It was reported that patient took two Tylenol medication at night. This case was linked to MOD-2021-311278 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional information received and updated suspect product start date and event details (start date and event outcome ).

Other Meds:

Current Illness:

ID: 1707412
Sex: F
Age: 66
State: TX

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 09/17/2021
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: tingling in the right arm/ tingling from arm to hand; The tingling in from arm to hand and it bothering; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering). At the time of the report, PARAESTHESIA (tingling in the right arm/ tingling from arm to hand) and LIMB DISCOMFORT (The tingling in from arm to hand and it bothering) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Patient reported that she was not allergic to any ingredients of the vaccine as far as she known. Patient tried to get some medical evaluation and treatment at local emergency room. At the local emergency room patient was not evaluated and told to reach out to her HCP.

Other Meds:

Current Illness:

ID: 1707413
Sex: F
Age: 63
State: DE

Vax Date: 04/07/2021
Onset Date: 05/06/2021
Rec V Date: 09/17/2021
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: 20210506; Test Name: Body temperature; Result Unstructured Data: 102 Fahrenheit

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Tingling right leg after second shot; Numbness right leg after second shot; High Fever (102 F) after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling right leg after second shot), HYPOAESTHESIA (Numbness right leg after second shot) and PYREXIA (High Fever (102 F) after second shot) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 027B21A) for COVID-19 vaccination. Previously administered products included for an unreported indication: ANTACID [CALCIUM CARBONATE] (Antacids prior to vaccination). On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (High Fever (102 F) after second shot). On 13-May-2021, the patient experienced PARAESTHESIA (Tingling right leg after second shot) and HYPOAESTHESIA (Numbness right leg after second shot). On 09-May-2021, PYREXIA (High Fever (102 F) after second shot) had resolved. At the time of the report, PARAESTHESIA (Tingling right leg after second shot) and HYPOAESTHESIA (Numbness right leg after second shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Body temperature: 102 (High) 102 Fahrenheit. Concomitant medication was not provided Treatment information was not reported Patient has seen several doctors and has done tests that were normal.

Other Meds:

Current Illness:

ID: 1707414
Sex: F
Age: 55
State: PA

Vax Date: 08/07/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: I have runny nose sore throat on and off; I have runny nose sore throat on and off; I was only able to work four days and have not been able to work since then; This has totally raised my anxiety level; dizziness; I am generally feeling unwell; swelling and redness in her arm which is warm; she feels extremely fatigued and have headaches; swelling and redness in her arm which is warm; swelling and redness in her arm which is warm; extremely fatigued and have headaches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level) and DIZZINESS (dizziness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no specified medical history was reported. Concomitant products included GABAPENTIN, CLONIDINE, ALPRAZOLAM (XANAX) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches). At the time of the report, OROPHARYNGEAL PAIN (I have runny nose sore throat on and off), RHINORRHOEA (I have runny nose sore throat on and off), IMPAIRED WORK ABILITY (I was only able to work four days and have not been able to work since then), ANXIETY (This has totally raised my anxiety level), DIZZINESS (dizziness), VACCINATION COMPLICATION (I am generally feeling unwell), VACCINATION SITE WARMTH (swelling and redness in her arm which is warm), FATIGUE (she feels extremely fatigued and have headaches), VACCINATION SITE SWELLING (swelling and redness in her arm which is warm), VACCINATION SITE ERYTHEMA (swelling and redness in her arm which is warm) and HEADACHE (extremely fatigued and have headaches) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not reported.

Other Meds: GABAPENTIN; CLONIDINE; XANAX; ZYRTEC ALLERGY

Current Illness:

ID: 1707415
Sex: F
Age: 79
State:

Vax Date: 07/23/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Had a sore arm for a couple of days; Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. No medical history provided. Concomitant products included ATORVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN + HIDROCLOROTIAZIDA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST, ACARBOSE, AMLODIPINE, FUROSEMIDE, GABAPENTIN and GLIMEPIRIDE for an unknown indication. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.). At the time of the report, PAIN IN EXTREMITY (Had a sore arm for a couple of days) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive their second dose of the Moderna COVID-19 vaccine for more than 36 days.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided

Other Meds: ATORVASTATIN; LOSARTAN + HIDROCLOROTIAZIDA; ASPIRIN (E.C.); MONTELUKAST; ACARBOSE; AMLODIPINE; FUROSEMIDE; GABAPENTIN; GLIMEPIRIDE

Current Illness:

ID: 1707416
Sex: F
Age:
State:

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

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

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

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell). At the time of the report, COVID-19 (Got covid 11 days after 1st dose/symptoms of covid-19 such as no taste and smell) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported by reporter Treatment information was not provided This case was linked to MOD-2021-311265 (Patient Link).

Other Meds:

Current Illness:

ID: 1707417
Sex: F
Age: 75
State: WA

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Few hard small pimples in their face; Swelling at the injection site; Injection site hurt; Injection site got red; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red). At the time of the report, ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The consumer stated that she received second dose of Moderna vaccine on 03Feb2021. She experienced swelling at the injection site, and it got red and hurt. The consumer stated that around a month ago or maybe a little longer she noticed a few hard small pimples on the face. No concomitant product use was provided by the reporter. No treatment medications were reported. This case was linked to MOD-2021-073303 (Patient Link).

Other Meds:

Current Illness:

ID: 1707418
Sex: F
Age: 67
State: NC

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Relevant concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1707419
Sex: U
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: week; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Heart disease aggravated. Concurrent medical conditions included Diabetic. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (week). At the time of the report, ASTHENIA (week) outcome was unknown. Not Provided No concomitant medication was reported. No treatment history was reported.

Other Meds:

Current Illness: Diabetic

ID: 1707420
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: A fever of 102; Test Name: Heart rate; Result Unstructured Data: 120-130; Test Name: Oxygen levels in the 80s for 6 hours; Result Unstructured Data: Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose

Allergies:

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

Symptoms: Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose; Heart rate between 120-130; A fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102). At the time of the report, HYPOXIA (Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose), TACHYCARDIA (Heart rate between 120-130) and PYREXIA (A fever of 102) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) A fever of 102. On an unknown date, Heart rate: 120-130 (High) 120-130. On an unknown date, Oxygen saturation: low (Low) Oxygen levels in the 80s for 6 hours of the first 10 after injection with the 3rd dose. No relevant concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-311180 (Patient Link). Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of hypoxemia was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria was classified as Non-serious. No further information is expected since consent for follow up has been denied.

Other Meds:

Current Illness:

ID: 1707421
Sex: F
Age: 65
State: NC

Vax Date: 09/06/2021
Onset Date: 09/05/2021
Rec V Date: 09/17/2021
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: Expired vaccine administered beyond 12 hours expiration for punctured vial; Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) and PRODUCT STORAGE ERROR (Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021 at 11:00 AM, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM). On 06-Sep-2021 at 4:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, PRODUCT STORAGE ERROR (Vial was first punctured on 05-Sep-2021 at 11:00 AM and was kept in refrigerator/ was discarded on 06-Sep-2021 after 04:30 PM) had resolved. On 06-Sep-2021 at 4:30 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No Treatment information was provided. The vial was initially stored in the refrigerator on 31-Aug-2021. The vaccine was administered at room temperature. The vial did not undergo any previous temperature excursions. The reporter stated that the total amount of time the vial was exposed to room temperature range 46? to 77? F was from 06-Sep-2021 9:00 AM. This case was linked to MOD-2021-311383 (Patient Link).

Other Meds:

Current Illness:

ID: 1707422
Sex: M
Age:
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: High fever; chills; shakes; vertigo a few times; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times). At the time of the report, PYREXIA (High fever), CHILLS (chills), TREMOR (shakes) and VERTIGO (vertigo a few times) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not reported. Treatment medication not reported.

Other Meds:

Current Illness:

ID: 1707423
Sex: F
Age:
State: VA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I have corneal fluid; Also some nerve issues; Most of the reactions I had to the first one were the normal ones same with second one; This spontaneous case was reported by a consumer and describes the occurrence of CORNEAL OEDEMA (I have corneal fluid), NERVE INJURY (Also some nerve issues) and VACCINATION COMPLICATION (Most of the reactions I had to the first one were the normal ones same with second one) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced CORNEAL OEDEMA (I have corneal fluid) and NERVE INJURY (Also some nerve issues). In 2021, the patient experienced VACCINATION COMPLICATION (Most of the reactions I had to the first one were the normal ones same with second one). At the time of the report, CORNEAL OEDEMA (I have corneal fluid) and NERVE INJURY (Also some nerve issues) had not resolved and VACCINATION COMPLICATION (Most of the reactions I had to the first one were the normal ones same with second one) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-311222 (Patient Link).

Other Meds:

Current Illness:

ID: 1707424
Sex: M
Age:
State: GA

Vax Date: 03/01/2021
Onset Date: 08/07/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) and DRUG INEFFECTIVE (Drug ineffective) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Aug-2021, the patient experienced COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) and DRUG INEFFECTIVE (Drug ineffective). On 07-Sep-2021, COVID-19 (Contracted COVID-19 after both doses of the Moderna COVID-19 vaccine) had resolved. At the time of the report, DRUG INEFFECTIVE (Drug ineffective) outcome was unknown. No relevant concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-311270 (Patient Link).; Sender's Comments: This case concerns an 50-year-old, male subject medical history of asthma, who experienced the non-serious unexpected events of COVID 19 and Drug ineffective. The event occurred approximately four months after the second dose of Spikevax. The event Drug ineffective was considered as related to the product per the reporter's assessment. Rechallenge was unknown since there's no information. The association between the event of COVID-19 and mRNA-1273 is assessed as not applicable. The benefit risk relationship of spikevax is not affected by this report.

Other Meds:

Current Illness: Asthma

ID: 1707425
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: felt the effects; low grade fever for Tuesday and some of Wednesday; Sunday and still having sinus like symptoms; mild to moderate headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (felt the effects), PYREXIA (low grade fever for Tuesday and some of Wednesday), SINUS DISORDER (Sunday and still having sinus like symptoms) and HEADACHE (mild to moderate headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (felt the effects), PYREXIA (low grade fever for Tuesday and some of Wednesday), SINUS DISORDER (Sunday and still having sinus like symptoms) and HEADACHE (mild to moderate headaches). At the time of the report, VACCINATION COMPLICATION (felt the effects), PYREXIA (low grade fever for Tuesday and some of Wednesday), SINUS DISORDER (Sunday and still having sinus like symptoms) and HEADACHE (mild to moderate headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient took booster shot last Monday afternoon and felt the effects including low grade fever for Tuesday band some of Wednesday. It is Sunday and still having sinus like symptoms along with mild to moderate headaches. Concomitant medication use was not provided Treatment information was not provided,

Other Meds:

Current Illness:

ID: 1707427
Sex: M
Age: 40
State: FL

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Came down with covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Came down with covid) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with covid). At the time of the report, COVID-19 (Came down with covid) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medication was not reported. The patient stated that got the regeneron antibody infusion treatment which was composed of 4 shots. The patient stated that was unsure of the waiting time after the antibody infusion whether it is 30 days or 90 days. and a nurse even told him that he may need to be restarted on the vaccination series.

Other Meds:

Current Illness:

ID: 1707428
Sex: F
Age: 54
State: TX

Vax Date: 08/04/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: vial was opened at 5:24 PM on 01Sep2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 007D21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vial was opened at 5:24 PM on 01Sep2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medication was not reported. The treatment medication was not provided. This case was linked to MOD-2021-311050, MOD-2021-311042 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up appended contains no new information

Other Meds:

Current Illness:

ID: 1707429
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Congestion; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Congestion) and OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Congestion) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, NASAL CONGESTION (Congestion) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported.

Other Meds:

Current Illness:

ID: 1707430
Sex: M
Age:
State: NY

Vax Date: 12/01/2020
Onset Date: 09/05/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: COVID-19; Test Result: Positive; Result Unstructured Data: positive.

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Father got Moderna, and he has coronavirus), ILLNESS (Had it for a couple days and he is very sick.) and COVID-19 (Covid positive) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced DRUG INEFFECTIVE (Father got Moderna, and he has coronavirus). On an unknown date, the patient experienced ILLNESS (Had it for a couple days and he is very sick.) and COVID-19 (Covid positive). At the time of the report, DRUG INEFFECTIVE (Father got Moderna, and he has coronavirus), ILLNESS (Had it for a couple days and he is very sick.) and COVID-19 (Covid positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) positive. No relevant concomitant medications were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Follow-up received on 08-SEP-2021 contains significant information: Event Covid positive; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, lot # unknown with adverse events. Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.

Other Meds:

Current Illness:

ID: 1707431
Sex: M
Age: 70
State: CA

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were provided. No treatment medications were reported. This case was linked to MOD-2021-311212, MOD-2021-311337 (Patient Link).

Other Meds:

Current Illness:

ID: 1707432
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication information was provided. No Treatment medication s were provided.

Other Meds:

Current Illness:

ID: 1707433
Sex: U
Age:
State:

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 09/17/2021
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: hot flashes day and night; experienced a side effect; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect). At the time of the report, HOT FLUSH (hot flashes day and night) and VACCINATION COMPLICATION (experienced a side effect) outcome was unknown. No concomitant medications were reported No treatment information was provided

Other Meds:

Current Illness:

ID: 1707434
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Fever; Chills; Headache; Nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical history was provided. Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment medications were provided.

Other Meds: OCREVUS

Current Illness:

ID: 1707435
Sex: U
Age:
State: WI

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Dose administered from vial over 12 hours after vial puncture.; temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from vial over 12 hours after vial puncture.) had resolved and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided. No Treatment medications were provided.

Other Meds:

Current Illness:

ID: 1707436
Sex: M
Age: 49
State: AZ

Vax Date: 05/07/2021
Onset Date: 06/08/2021
Rec V Date: 09/17/2021
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: he feels an effect of light headedness; Dizziness; feels like he is losing his balance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (he feels an effect of light headedness), DIZZINESS (Dizziness) and BALANCE DISORDER (feels like he is losing his balance) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03321A and 023C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced DIZZINESS (he feels an effect of light headedness), DIZZINESS (Dizziness) and BALANCE DISORDER (feels like he is losing his balance). At the time of the report, DIZZINESS (he feels an effect of light headedness), DIZZINESS (Dizziness) and BALANCE DISORDER (feels like he is losing his balance) outcome was unknown. Patient stated that he took his first dose of vaccine on 7MAY2021 with lot-023C21A through intramuscular but he reports that he did not have any adverse events. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1707437
Sex: F
Age:
State: MA

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 09/17/2021
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: Frozen shoulder; is still having problem moving her arm behind her head; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder) and LIMB DISCOMFORT (is still having problem moving her arm behind her head) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (Frozen shoulder) and LIMB DISCOMFORT (is still having problem moving her arm behind her head). At the time of the report, PERIARTHRITIS (Frozen shoulder) was resolving and LIMB DISCOMFORT (is still having problem moving her arm behind her head) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications were provided by reporter. She has been taking vitamins to help with the numbness and she got steroid for the frozen shoulder. Some improvement with the neurological symptoms but with the shoulders, not so much. This case was linked to MOD-2021-311486 (Patient Link).

Other Meds:

Current Illness:

ID: 1707438
Sex: F
Age: 61
State: KY

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 09/17/2021
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: had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell). At the time of the report, BALANCE DISORDER (had balance issues for 4 months after her 2nd sho/If she turned a certain way, you could tell) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication was reported No treatment Drug was reported

Other Meds:

Current Illness:

ID: 1707440
Sex: F
Age: 56
State: NC

Vax Date: 09/06/2021
Onset Date: 09/06/2021
Rec V Date: 09/17/2021
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: Expired vaccine administered beyond 12 hours expiration for punctured vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial). On 06-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered beyond 12 hours expiration for punctured vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Other information related to product is vial was initially stored in the refrigerator on 31-AUG-2021. Product first punctured on 05-SEP-2021 11AM Kept in Refrigerator. Total amount of time the vial was exposed to room temperature range (46? to 77? F): "From 06SEP2021 9:00AM and discarded vial after 4:30PM.

Other Meds:

Current Illness:

ID: 1707441
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Feel like I have a sunburn; Running a fever; Ache all over; Headache; Very nauseass; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (Feel like I have a sunburn), PYREXIA (Running a fever), MYALGIA (Ache all over), HEADACHE (Headache) and NAUSEA (Very nauseass) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUNBURN (Feel like I have a sunburn), PYREXIA (Running a fever), MYALGIA (Ache all over), HEADACHE (Headache) and NAUSEA (Very nauseass). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, SUNBURN (Feel like I have a sunburn), PYREXIA (Running a fever), MYALGIA (Ache all over), HEADACHE (Headache) and NAUSEA (Very nauseass) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. CONCOMITANT drugs were not provided. Patient drank lot of water as treatment. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707442
Sex: F
Age: 78
State: WA

Vax Date: 03/24/2021
Onset Date: 04/24/2021
Rec V Date: 09/17/2021
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: three days later from each time, I had horrible, horrible reaction/the second time, it happened exactly in the same number of days with the same result; so dizzy/dizziness was so bad that I had to spend the day in bed, had no balance whatsoever, the only time I'm not dizzy is when I lie down; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (so dizzy/dizziness was so bad that I had to spend the day in bed, had no balance whatsoever, the only time I'm not dizzy is when I lie down), VERTIGO (vertigo) and VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction/the second time, it happened exactly in the same number of days with the same result) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Light headedness (has been dealing with lightheadedness and imbalance for years,). On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (so dizzy/dizziness was so bad that I had to spend the day in bed, had no balance whatsoever, the only time I'm not dizzy is when I lie down) and VERTIGO (vertigo). On an unknown date, the patient experienced VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction/the second time, it happened exactly in the same number of days with the same result). At the time of the report, DIZZINESS (so dizzy/dizziness was so bad that I had to spend the day in bed, had no balance whatsoever, the only time I'm not dizzy is when I lie down) had not resolved, VERTIGO (vertigo) was resolving and VACCINATION COMPLICATION (three days later from each time, I had horrible, horrible reaction/the second time, it happened exactly in the same number of days with the same result) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter stated that she had been dealing with lightheadedness and imbalance thing for years, and after various testing, they figured out it's probably an emotional thing. No concomitant medication information were provided. No treatment information were provided. This case was linked to MOD-2021-311221 (Patient Link).

Other Meds:

Current Illness: Light headedness (has been dealing with lightheadedness and imbalance for years,)

ID: 1707443
Sex: U
Age:
State:

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

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: heart rate; Result Unstructured Data: 36

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: heart rate of 36; a lot of missed beats; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate of 36) and PALPITATIONS (a lot of missed beats) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRADYCARDIA (heart rate of 36) (seriousness criteria hospitalization and medically significant) and PALPITATIONS (a lot of missed beats) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to BRADYCARDIA and PALPITATIONS. At the time of the report, BRADYCARDIA (heart rate of 36) and PALPITATIONS (a lot of missed beats) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 36 (Low) 36. No concomitant was provided. patient was in hospital for 3 days about 10 days after 2nd shot of moderna patient was with heart rate of 36 and had a lot of missed beats. Now on meds to help control it. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1707444
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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 spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster. Is there any chance the booster can cause Covid-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster. Is there any chance the booster can cause Covid-19). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (I had two Pfizer shots and 2 weeks ago a Moderna booster. Is there any chance the booster can cause Covid-19) had resolved. Concomitant medications were not provided.Treatment medication was not provided. Patient had two doses of Pfizer vaccine and received the Moderna booster dose two weeks ago.

Other Meds:

Current Illness:

ID: 1707445
Sex: F
Age: 67
State: GA

Vax Date: 01/27/2021
Onset Date: 08/06/2021
Rec V Date: 09/17/2021
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: Received 3rd dose, not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received 3rd dose, not immunocompromised) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No medical history information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OFF LABEL USE (Received 3rd dose, not immunocompromised). At the time of the report, OFF LABEL USE (Received 3rd dose, not immunocompromised) had resolved. Concomitant medications included chronic hormones as the patient was a transgender. The treatment information was not provided. It was reported that patient received the third shot of vaccine from a pharmacy and then scheduled her for a fourth shot on 09-Sep-2021. She didn't present her initial vaccination card upon receiving the third dose, and stated that she did not qualify as immunocompromised.

Other Meds:

Current Illness:

ID: 1707446
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: allergy reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergy reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (allergy reaction). At the time of the report, ALLERGY TO VACCINE (allergy reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1707447
Sex: U
Age:
State: SD

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we used vials that had been at refrigerated temperature for 32 days, 12 doses were given from vials had been refrigerated for 31 & 32 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Pharmacist reporting that 12 doses were given within the 12 hour time limit from time of first puncture from 3 refrigerated vials, but the 3 vials had been refrigerated for 31 & 32 days. Concomitant product use was not provided. Treatment product information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Significant Follow-up received on 07-Sep-2021. Reporter's Salutation, fax number and phone number were updated. Patient Initials, Patient's notes were changed. Batch/lot number for suspect product was added. Action taken, Re-challenge and De-challenge of suspect product were updated. Outcome of event was updated. Product event details were updated. Narrative from the source was added

Other Meds:

Current Illness:

ID: 1707448
Sex: M
Age:
State: NY

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 09/17/2021
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 returned to work with the vaccination card he was told You no longer work here; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here). At the time of the report, LOSS OF EMPLOYMENT (he returned to work with the vaccination card he was told You no longer work here) outcome was unknown. Concomitant medication was not provided Treatment information was not reported. It was reported that, Consumer had called to find out if there was something wrong with the Moderna vaccine. Patient was fully vaccinated.

Other Meds:

Current Illness:

ID: 1707449
Sex: F
Age: 76
State: FL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: arm feels worse; Redness/armpit is red; Swelling; arm became red around injection site/upper arm was red; itchy; Settling in armpit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red) and PRURITUS (itchy) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills). The patient was treated with CORTISONE at a dose of 1 dosage form. At the time of the report, LIMB DISCOMFORT (arm feels worse), ERYTHEMA (Redness/armpit is red), SWELLING (Swelling), INJECTION SITE ERYTHEMA (arm became red around injection site/upper arm was red), PRURITUS (itchy), AXILLARY PAIN (Settling in armpit) and CHILLS (Chills) outcome was unknown. No concomitant medications were reported. Ice were reported as treatment medication.

Other Meds:

Current Illness:

ID: 1707450
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: On going migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (On going migraine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (On going migraine). At the time of the report, MIGRAINE (On going migraine) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported by reporter Treatment information was not provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707451
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Just began methotrexate therapy 25 MG per week for arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis). The patient was treated with METHOTREXATE for Arthritis, at a dose of 25 mg,per week. At the time of the report, ARTHRITIS (Just began methotrexate therapy 25 MG per week for arthritis) outcome was unknown. Concomitant product use was not provided by the reporter. Patient stated that she vaccinated with both series of moderna Covid shots 6 months ago. she just began methotrexate therapy 25 MG per week for arthritis. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1707452
Sex: F
Age:
State: MA

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 09/17/2021
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: Frozen shoulder; Problem moving her arm behind her head; Neurological symptoms/Numbness in the face / Numbness in the arm; Pins and needles; Drooping; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 032B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping). The patient was treated with ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) for Numbness, at an unspecified dose and frequency and STEROIDS for Frozen shoulder, at an unspecified dose and frequency. At the time of the report, PERIARTHRITIS (Frozen shoulder), MOBILITY DECREASED (Problem moving her arm behind her head), HYPOAESTHESIA (Neurological symptoms/Numbness in the face / Numbness in the arm), PARAESTHESIA (Pins and needles) and DROOPING SHOULDER SYNDROME (Drooping) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-311359.

Other Meds:

Current Illness:

ID: 1707453
Sex: F
Age:
State: IL

Vax Date: 09/04/2021
Onset Date:
Rec V Date: 09/17/2021
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: Soreness and swelling on her arm; Soreness and swelling on her arm; body aches, pain and her body hurt; Muscle pain/Body ache/ pain / body hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt). At the time of the report, PAIN IN EXTREMITY (Soreness and swelling on her arm), PERIPHERAL SWELLING (Soreness and swelling on her arm), PAIN (body aches, pain and her body hurt) and MYALGIA (Muscle pain/Body ache/ pain / body hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was reported by reporter.

Other Meds:

Current Illness:

ID: 1707454
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment information was not provided. This case was linked to MOD-2021-310807.

Other Meds:

Current Illness:

ID: 1707455
Sex: U
Age:
State:

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

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

Lab Data: Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: tested positive for Covid-19

Allergies:

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

Symptoms: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: other positive (Positive) tested positive for Covid-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product was provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1707456
Sex: U
Age:
State:

Vax Date: 05/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/17/2021
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: I have been having trouble catching my breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I have been having trouble catching my breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced DYSPNOEA (I have been having trouble catching my breath). At the time of the report, DYSPNOEA (I have been having trouble catching my breath) outcome was unknown. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.

Other Meds:

Current Illness:

ID: 1707457
Sex: F
Age: 37
State: FL

Vax Date: 08/31/2021
Onset Date:
Rec V Date: 09/17/2021
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: Body aches; Hot when I touch it; The husband help her to undress; From the injection site to the neck; Couldn't really move it/an't move the neck/couldn't really move the neck; Has like a nerve all the way through the neck; All that part is tender/Light pain; The eyes were hurting so much; Pain from the arm all the way to the neck is still having them/Sharp pain/pain in arm; Neck was really stiff; Chills; Headache; The arm where got the vaccine got really red; where got the vaccine got really red and tender; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), VACCINATION SITE WARMTH (Hot when I touch it), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The husband help her to undress), NECK PAIN (From the injection site to the neck) and MOBILITY DECREASED (Couldn't really move it/an't move the neck/couldn't really move the neck) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches), VACCINATION SITE WARMTH (Hot when I touch it), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The husband help her to undress), NECK PAIN (From the injection site to the neck), MOBILITY DECREASED (Couldn't really move it/an't move the neck/couldn't really move the neck), NEURALGIA (Has like a nerve all the way through the neck), PAIN (All that part is tender/Light pain), EYE PAIN (The eyes were hurting so much), VACCINATION SITE PAIN (Pain from the arm all the way to the neck is still having them/Sharp pain/pain in arm), MUSCULOSKELETAL STIFFNESS (Neck was really stiff), CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (The arm where got the vaccine got really red), VACCINATION SITE PAIN (where got the vaccine got really red and tender) and VACCINATION SITE SWELLING (Swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), VACCINATION SITE WARMTH (Hot when I touch it), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (The husband help her to undress), NECK PAIN (From the injection site to the neck), MOBILITY DECREASED (Couldn't really move it/an't move the neck/couldn't really move the neck), NEURALGIA (Has like a nerve all the way through the neck), PAIN (All that part is tender/Light pain), EYE PAIN (The eyes were hurting so much), VACCINATION SITE PAIN (Pain from the arm all the way to the neck is still having them/Sharp pain/pain in arm), MUSCULOSKELETAL STIFFNESS (Neck was really stiff), CHILLS (Chills), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (The arm where got the vaccine got really red), VACCINATION SITE PAIN (where got the vaccine got really red and tender) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication details were provided. No Treatment medication details were provided.

Other Meds:

Current Illness:

ID: 1707458
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/07/2021
Rec V Date: 09/17/2021
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: stomach is off; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, ABDOMINAL DISCOMFORT (stomach is off), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. No Concomitant information was reported. No treatment information was reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am