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: 1643442
Sex: F
Age:
State:

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Has Not received the Second shot, 6 months post First vaccine; Had Issues after First Shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had Issues after First Shot) and PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine) 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 December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2020, the patient experienced VACCINATION COMPLICATION (Had Issues after First Shot). On 25-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine). At the time of the report, VACCINATION COMPLICATION (Had Issues after First Shot) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Has Not received the Second shot, 6 months post First vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.

Other Meds:

Current Illness:

ID: 1643443
Sex: F
Age: 57
State: NC

Vax Date: 05/11/2021
Onset Date: 06/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: feeling tired; almost flu-like; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired), INFLUENZA LIKE ILLNESS (almost flu-like) and MALAISE (feeling sick) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced FATIGUE (feeling tired) and INFLUENZA LIKE ILLNESS (almost flu-like). 10-Jun-2021, the patient experienced MALAISE (feeling sick). At the time of the report, FATIGUE (feeling tired), INFLUENZA LIKE ILLNESS (almost flu-like) and MALAISE (feeling sick) outcome was unknown. Concomitant medications include Zenpak. No treatment medication were provided.

Other Meds:

Current Illness:

ID: 1643444
Sex: M
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: depressed; acquaintance of his was depressed, had anger spells was not the same; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same) 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. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same). At the time of the report, DEPRESSION (depressed) and ANGER (acquaintance of his was depressed, had anger spells was not the same) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1643445
Sex: F
Age: 54
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: swelling in the injection arm; arm reaction; Pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm). At the time of the report, PERIPHERAL SWELLING (swelling in the injection arm), VACCINATION SITE REACTION (arm reaction) and VACCINATION SITE PAIN (Pain in the injection arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter This case was linked to MOD-2021-237309 (Patient Link).; 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: 1643446
Sex: M
Age: 32
State: TX

Vax Date: 05/27/2021
Onset Date: 06/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Around 10:00 am 99.7-101.9F

Allergies:

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

Symptoms: Headache; Muscle Pain; Chills; Fever (101.9F); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills) and PYREXIA (Fever (101.9F)) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 051C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LISINOPRIL and OMEPRAZOLE for an unknown indication. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Jun-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills) and PYREXIA (Fever (101.9F)). At the time of the report, HEADACHE (Headache), MYALGIA (Muscle Pain), CHILLS (Chills) and PYREXIA (Fever (101.9F)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7-101.9f (High) Around 10:00 am 99.7-101.9F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LISINOPRIL; OMEPRAZOLE

Current Illness:

ID: 1643447
Sex: M
Age: 57
State: MI

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received an expired Moderna Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment medications were unknown. This case was linked to MOD-2021-237427, MOD-2021-237470 (Patient Link).

Other Meds:

Current Illness:

ID: 1643448
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: was just depressed; had covid-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms) 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 DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms). At the time of the report, DEPRESSION (was just depressed) and SUSPECTED COVID-19 (had covid-like symptoms) 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 information was provided

Other Meds:

Current Illness:

ID: 1643449
Sex: F
Age: 55
State: GA

Vax Date: 05/03/2021
Onset Date: 05/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Alanine aminotransferase; Result Unstructured Data: ALT 224 which was high; Test Name: Aspartate aminotransferase; Result Unstructured Data: aspartate aminotransferase 214 which was high; Test Name: Blood alkaline phosphatase; Result Unstructured Data: alkaline phosphate was 144-abnormal; Test Name: Liver enzyme abnormal; Result Unstructured Data: spiked liver enzymes/Huge spike in liver enzymes.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: sick for couple of days; doctor suspected as Bronchitis; abdominal pain /ache in her abdomen and bloating still remains; Bloating /ache in her abdomen and bloating still remains; chest cold and doctor suspected as Bronchitis; felt weaker; fever; Nausea; Chills; body aches; sweats; painful stomach; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of LOWER RESPIRATORY TRACT INFECTION (chest cold and doctor suspected as Bronchitis) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (painful stomach), NAUSEA (Nausea), CHILLS (Chills) and MYALGIA (body aches). On an unknown date, the patient experienced LOWER RESPIRATORY TRACT INFECTION (chest cold and doctor suspected as Bronchitis) (seriousness criterion medically significant), ASTHENIA (felt weaker), ILLNESS (sick for couple of days), BRONCHITIS (doctor suspected as Bronchitis), ABDOMINAL PAIN (abdominal pain /ache in her abdomen and bloating still remains), ABDOMINAL DISTENSION (Bloating /ache in her abdomen and bloating still remains) and PYREXIA (fever). The patient was treated with ONDANSETRON ongoing since an unknown date at a dose of 8 mg; FAMOTIDINE ongoing since an unknown date at a dose of 20 mg; PANTOPRAZOLE ongoing since an unknown date at a dose of 40 mg and DICYCLOVERINE HYDROCHLORIDE (DICYCLOMINE [DICYCLOVERINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 20 mg. At the time of the report, LOWER RESPIRATORY TRACT INFECTION (chest cold and doctor suspected as Bronchitis), ASTHENIA (felt weaker), ILLNESS (sick for couple of days) and BRONCHITIS (doctor suspected as Bronchitis) outcome was unknown, HYPERHIDROSIS (sweats), ABDOMINAL PAIN UPPER (painful stomach), NAUSEA (Nausea), CHILLS (Chills), MYALGIA (body aches) and PYREXIA (fever) had resolved and ABDOMINAL PAIN (abdominal pain /ache in her abdomen and bloating still remains) and ABDOMINAL DISTENSION (Bloating /ache in her abdomen and bloating still remains) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase: 224 (High) ALT 224 which was high. On an unknown date, Aspartate aminotransferase: 214 (High) aspartate aminotransferase 214 which was high. On an unknown date, Blood alkaline phosphatase: 144 (abnormal) alkaline phosphate was 144-abnormal. On an unknown date, Hepatic enzyme abnormal: spiked (High) spiked liver enzymes/Huge spike in liver enzymes. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not provided. Patient's GI doctor did her blood work and chest x-ray, and blood work came with spiked liver enzymes. No Hepatitis was found during the diagnosis. Doctor originally ordered Hyda scan for gall bladder and pancreas but then said don't need it now and will monitor her blood work, and check her in a month. Agent received all this information from Moderna Customer Care. When the transfer was made the agent lost the call and was unable to ask the caller for consent. This case was linked to MOD-2021-237304 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: No new information was provided.

Other Meds:

Current Illness:

ID: 1643450
Sex: F
Age:
State:

Vax Date: 05/21/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd dose) 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 21-May-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 PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a month over due for 2nd dose) 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. No Relevant concomitant medications was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1643451
Sex: M
Age:
State: MA

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: flaring up psoriasis, a fairly localized reaction, primarily on the groin area; This spontaneous case was reported by a physician and describes the occurrence of PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ADALIMUMAB (HUMIRA), LEVOTHYROXINE and SILDENAFIL CITRATE (VIAGRA) for an unknown indication. 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 PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area). At the time of the report, PSORIASIS (flaring up psoriasis, a fairly localized reaction, primarily on the groin area) 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 treatment medication was provided

Other Meds: HUMIRA; LEVOTHYROXINE; VIAGRA

Current Illness:

ID: 1643452
Sex: F
Age:
State: CO

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

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

Lab Data:

Allergies:

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

Symptoms: Swelling of mouth, jaw and throat; Swelling of mouth, jaw and throat; Swelling of mouth, jaw and throat; This spontaneous case was reported by a pharmacist and describes the occurrence of MOUTH SWELLING (Swelling of mouth, jaw and throat), SWELLING FACE (Swelling of mouth, jaw and throat) and PHARYNGEAL SWELLING (Swelling of mouth, jaw and throat) 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 MOUTH SWELLING (Swelling of mouth, jaw and throat), SWELLING FACE (Swelling of mouth, jaw and throat) and PHARYNGEAL SWELLING (Swelling of mouth, jaw and throat). At the time of the report, MOUTH SWELLING (Swelling of mouth, jaw and throat), SWELLING FACE (Swelling of mouth, jaw and throat) and PHARYNGEAL SWELLING (Swelling of mouth, jaw and throat) 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 treatment/concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1643453
Sex: M
Age:
State: NC

Vax Date: 05/11/2021
Onset Date: 05/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: flu-like later that night,similar to the mild flu, but; achy that night; real tired for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination. Concomitant products included CARVEDILOL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 11-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like later that night,similar to the mild flu, but), PAIN (achy that night) and FATIGUE (real tired for 3 days) 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. No treatment medication was provided. Med info agent: Caller states that after second dose patient was more tired and achy that night, but the next day was okay. Consent to follow-up from safety team if needed. Caller provide name of vaccination facility and name of health care provider. This case was linked to MOD-2021-237320 (Patient Link).

Other Meds: CARVEDILOL; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness:

ID: 1643454
Sex: F
Age: 76
State: PA

Vax Date: 04/30/2021
Onset Date: 06/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Consumer missed second dose, on 55th day today; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Consumer missed second dose, on 55th day today) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1643455
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: muscle cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (muscle cramps) 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 MUSCLE SPASMS (muscle cramps). At the time of the report, MUSCLE SPASMS (muscle cramps) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1643456
Sex: F
Age: 36
State: MI

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was reported. Treatment Information was not provided by Reporter. This case was linked to MOD-2021-115609, MOD-2021-115643, MOD-2021-115655, MOD-2021-115657, MOD-2021-115659, MOD-2021-115661, MOD-2021-115662, MOD-2021-115665, MOD-2021-115666, MOD-2021-115667, MOD-2021-115691, MOD-2021-115695, MOD-2021-115701 (Patient Link).

Other Meds:

Current Illness:

ID: 1643457
Sex: F
Age: 64
State: CA

Vax Date: 06/13/2021
Onset Date: 06/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash on the right side of shoulder blade; Itching at the injection site; Swelling of the injection site to the size of a knot; Fine rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site). At the time of the report, RASH (Rash on the right side of shoulder blade), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE SWELLING (Swelling of the injection site to the size of a knot) and VACCINATION SITE RASH (Fine rash at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were reported. No treatment information was reported

Other Meds:

Current Illness:

ID: 1643458
Sex: M
Age:
State: NC

Vax Date: 05/11/2021
Onset Date: 06/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: more tired and achy that night; more tired and achy that night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] and CARVEDILOL for an unknown indication. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night). At the time of the report, PAIN (more tired and achy that night) and FATIGUE (more tired and achy that night) outcome was unknown. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-237314 (Patient Link).

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; CARVEDILOL

Current Illness:

ID: 1643459
Sex: M
Age: 21
State: ME

Vax Date: 05/27/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Arm numbness when raises arm; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 051C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain). At the time of the report, HYPOAESTHESIA (Arm numbness when raises arm) and VACCINATION SITE PAIN (injection site pain) outcome was unknown. No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1643460
Sex: F
Age: 70
State: FL

Vax Date: 03/11/2021
Onset Date: 04/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Bad rash; itching; Palpitations; Erythema; Painful rash/severe rash on front torso front to waist/up my spine and on my back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Bad rash), PRURITUS (itching), PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031621A and 044A21A) for COVID-19 vaccination. Previously administered products included for Antiviral prophylaxis: shingles vaccine (Shingrix / Hives on torso) since 2017. Past adverse reactions to the above products included Hives with shingles vaccine. Concurrent medical conditions included Penicillin allergy (Penicillin/ hives), Drug allergy (Sulfa / hives), Allergy to antibiotic (levaquin / Numbness of hand and feet) and Drug allergy (Codeine / nausea). On 11-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PRURITUS (itching), PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back). On an unknown date, the patient experienced RASH PRURITIC (Bad rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. On 30-Apr-2021, PRURITUS (itching) outcome was unknown, PALPITATIONS (Palpitations), ERYTHEMA (Erythema) and RASH (Painful rash/severe rash on front torso front to waist/up my spine and on my back) had resolved. At the time of the report, RASH PRURITIC (Bad rash) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment Medication included anti-itch cream and ice packs for the pain. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up information was received from initial reporter: Patient's medical history, new events erythema, palpitations and start date and end date were added

Other Meds:

Current Illness: Allergy to antibiotic (levaquin / Numbness of hand and feet); Drug allergy (Sulfa / hives); Drug allergy (Codeine / nausea); Penicillin allergy (Penicillin/ hives)

ID: 1643461
Sex: F
Age:
State: TN

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient who received a dose of the Moderna vaccine that had expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jun-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient who received a dose of the Moderna vaccine that had expired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment medications were unknown. The health care professional thinks that the vaccine administered was the patient?s first dose, not completely sure.

Other Meds:

Current Illness:

ID: 1643462
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: 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: Moderna vaccine second dose was administered past it's 12 hour window; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine second dose was administered past it's 12 hour window) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine second dose was administered past it's 12 hour window). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine second dose was administered past it's 12 hour window) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1643463
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: started feeling different; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (started feeling different) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 FEELING ABNORMAL (started feeling different). At the time of the report, FEELING ABNORMAL (started feeling different) outcome was unknown. No concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1643464
Sex: M
Age: 80
State: GA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202103; Test Name: Spike protein antibody; Result Unstructured Data: negative; Test Date: 202106; Test Name: Spike protein antibody; Result Unstructured Data: negative

Allergies:

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

Symptoms: mildly sore left arm; I have received 4 shots of the Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mildly sore left arm) and ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN, MAGNESIUM OXIDE, FISH OIL, CENTRUM VITAMINTS, PANTOPRAZOLE, FINASTERIDE, TAMSULOSIN, AMLODIPINE, FERROUS SULFATE and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine). On 14-Jan-2021, the patient experienced MYALGIA (mildly sore left arm). On 15-Jan-2021, MYALGIA (mildly sore left arm) had resolved. On 10-May-2021, ACCIDENTAL OVERDOSE (I have received 4 shots of the Moderna vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 antibody test negative: Negative. In June 2021, SARS-CoV-2 antibody test negative: Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received 2 more shots of the Moderna COVID-19 vaccine, as he thought that the negative test he took to test for the spike protein antibody in Mar 2021 was due to his autoimmune condition, which he thought was why he was not responding to the first 2 doses of the vaccine. He received the 3rd dose of the COVID-19 vaccine (Lot #: 036B21A) on 13 Apr 2021 and the 4th dose (Lot #: 048B21A) on 10 May 2021. He then got tested again for the spike protein antibody in early Jun 2021, which came back negative again. He said that the only adverse reaction he experienced was a mildly sore arm for 24 hours, 2 days after receiving the vaccination shots. No treatment information was provided by the reporter. This case was linked to MOD-2021-238058 (Patient Link).

Other Meds: ATORVASTATIN; MAGNESIUM OXIDE; FISH OIL; CENTRUM VITAMINTS; PANTOPRAZOLE; FINASTERIDE; TAMSULOSIN; AMLODIPINE; FERROUS SULFATE; BABY ASPIRIN

Current Illness:

ID: 1643465
Sex: M
Age: 48
State: MA

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.; has not received the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not recieve the vaccine within the recommended 28 days, and was also past the manufacturer's 42 day extension for proper vaccine scheduling between doses.) and PRODUCT DOSE OMISSION ISSUE (has not received the 2nd dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient did not have an adverse reaction to the vaccine, nor was the vaccine expired. Concomitant medication was not provided. Treatment information was not provided. This case was linked to MOD-2021-237452 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up information included patient's demographics, date of first dose, second dose details and earlier events removed and one event added.

Other Meds:

Current Illness:

ID: 1643466
Sex: F
Age: 33
State: VA

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: More than 35 days between the First and the Second Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between the First and the Second Moderna Covid-19 vaccinations) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment medications were reported. This case was linked to MOD-2021-237460 (Parent-Child Link). See case MOD-2021-237460 for details regarding the child case.

Other Meds:

Current Illness:

ID: 1643467
Sex: F
Age: 33
State: TN

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021). On 20-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Has Not Received the Second Dose, 62 days after first dose of Moderna COVID-19 vaccine on 20APR2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1643468
Sex: M
Age:
State:

Vax Date: 04/17/2021
Onset Date: 06/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021) 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. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021). On 24-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (He got his 1st dose on 17/Apr/2021 and his second dose on 24Jun2021) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications or treatment details were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643469
Sex: F
Age:
State:

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: didn't receive the second dose in the appropriate timeframe; if they did receive an additional dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) and EXTRA DOSE ADMINISTERED (if they did receive an additional dose) 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 02-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) and EXTRA DOSE ADMINISTERED (if they did receive an additional dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (didn't receive the second dose in the appropriate timeframe) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 02mar2021, post vaccination, the patient reported that she didn't receive her second dosage of the vaccine in the proper timeframe. No other reactions reported. Patient declined to provide any other information No treatment information was provided No concomitant information was provided

Other Meds:

Current Illness:

ID: 1643470
Sex: F
Age: 87
State: IL

Vax Date: 03/16/2021
Onset Date: 06/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Left Leg More Painful than the Right Leg; Left Leg is more swollen than the Right leg; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Previously administered products included for Product used for unknown indication: flu vaccine in 2014 and Prednisone (Patient stated that years ago she had leg swelling following the use of oral Prednisone); for Swelling face: Clindamycin (Oral Antibiotic treated for 7 days after receiving a high dose Flu Vaccine) in 2014. Past adverse reactions to the above products included Swelling face with flu vaccine; and Swelling of legs with Prednisone. Concurrent medical conditions included Drug allergy (Prednisone) and Allergy to vaccine (Flu high dose). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR), PARACETAMOL (TYLENOL), ESOMEPRAZOLE SODIUM (NEXIUM) and IBUPROFEN for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jun-2021, the patient experienced PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg). The patient was treated with POTASSIUM ongoing since an unknown date at a dose of 1 dosage form and FUROSEMIDE (LASIX) ongoing since an unknown date for and COVID-19 vaccination, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Left Leg More Painful than the Right Leg) and PERIPHERAL SWELLING (Left Leg is more swollen than the Right leg) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Once patient stated that all tests were normal. Another time she stated that she did not do any tests after vaccination and those tests were from years ago and her kidney function tests were normal from years ago. Concomitant medication also included High blood pressure medications. This case was linked to MOD-2021-228465 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received and contains no new information. Corrections made from initial source document reporter address, relevant history, Updated initial event coding from Myalgia to Peripheral swelling.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR; TYLENOL; NEXIUM; IBUPROFEN

Current Illness: Allergy to vaccine (Flu high dose); Drug allergy (Prednisone)

ID: 1643471
Sex: M
Age: 29
State: NJ

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Deviation from dosing schedule; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. no medical history was provided by reporter. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Deviation from dosing schedule) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment drugs were not reported.

Other Meds:

Current Illness:

ID: 1643472
Sex: F
Age: 59
State: MI

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications was reported. Treatment information was not provided. This case was linked to (Patient Link).

Other Meds:

Current Illness:

ID: 1643473
Sex: M
Age: 24
State: MI

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received an expired Moderna Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jun-2021, the patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired Moderna Vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment medications were unknown. This case was linked to MOD-2021-237427 (Patient Link).

Other Meds:

Current Illness:

ID: 1643474
Sex: F
Age:
State: MA

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccine administered from the syringe that was withdrawn the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant & treatment medications were reported by the reporter.

Other Meds:

Current Illness:

ID: 1643475
Sex: M
Age:
State: GA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The patient's past medical history included Surgery (left arm). On 19-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 PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. No treatment information was provided. This case was linked to MOD-2021-237353 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received and contains no new information.

Other Meds:

Current Illness:

ID: 1643476
Sex: M
Age:
State: GA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Bones in his arm hurts; His legs clamp up at night; Having vision issues; No energy; not feeling well since getting the 2nd shot; Bones in his knee hurts; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy) and MALAISE (not feeling well since getting the 2nd shot) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy), MALAISE (not feeling well since getting the 2nd shot) and ARTHRALGIA (Bones in his knee hurts). At the time of the report, BONE PAIN (Bones in his arm hurts), MUSCLE SPASMS (His legs clamp up at night), VISUAL IMPAIRMENT (Having vision issues), ASTHENIA (No energy), MALAISE (not feeling well since getting the 2nd shot) and ARTHRALGIA (Bones in his knee hurts) had not resolved. Concomitant medication includes unspecified pain medication. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable. This case was linked to MOD-2021-237349 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contains significant information - added event(feeling unwell) and updated event outcome as not recovered.

Other Meds:

Current Illness:

ID: 1643477
Sex: F
Age: 63
State: CA

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

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

Lab Data: None

Allergies: Penicillin, erythromycin, morphine, codeine, naproxen, gadolinium (MRI contrast.)

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

Symptoms: Arm swelling followed by diffuse red warm areas. Headache. Rigors late evening the vaccine was given. Rapid heartbeat late evening the vaccine was given, Fever for 24 hours. Facial flushing and swelling 24 hrs after vaccine (still present after 48 hours.)

Other Meds: Letrozole, Claritin, Flonase, viviscal, liquid collagen, melatonin, calcium

Current Illness: None

ID: 1643478
Sex: F
Age:
State: MA

Vax Date: 06/25/2021
Onset Date: 06/25/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Vaccine administered from the syringe that was withdrawn the day before; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from the syringe that was withdrawn the day before) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1643479
Sex: F
Age: 42
State: MO

Vax Date: 08/26/2021
Onset Date: 08/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Insomnia, pain in arm

Other Meds: Losartin potassium 50mg, methamizole, 10mg

Current Illness:

ID: 1643480
Sex: F
Age: 55
State: CT

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: More than 35 days after the first dose without receiving the second dose; She was sick; had a cold; she got tired; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (She was sick), NASOPHARYNGITIS (had a cold) and FATIGUE (she got tired) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. Concurrent medical conditions included COPD and Kidney disorder (She has kidney problems since 1 year). On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced FATIGUE (she got tired). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (She was sick) and NASOPHARYNGITIS (had a cold). On 23-Mar-2021, FATIGUE (she got tired) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (She was sick) and NASOPHARYNGITIS (had a cold) 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. Patient stated that she was sick and could not assist to the second dose. She stated that she had a cold which she usually has as she has COPD, and she has many conditions and it was horrible for her to go out of her house. She stated that she may have a surgery on Monday, or maybe not. Patient reported that she takes 16 concomitant medications for her conditions. No treatment information was provided.

Other Meds:

Current Illness: COPD; Kidney disorder (She has kidney problems since 1 year)

ID: 1643481
Sex: M
Age: 76
State: CA

Vax Date: 01/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: The wart over his eye on his eyelid, which had started to impede vision, started to slough off; Wart over his eye on his eyelid; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Wart (Large wart on his wrist/upper hand which had been present for years). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid). At the time of the report, VISUAL IMPAIRMENT (The wart over his eye on his eyelid, which had started to impede vision, started to slough off) and SKIN PAPILLOMA (Wart over his eye on his eyelid) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. The patient also had a large wart on his wrist/upper hand which had been present for years that at this point has almost disappeared.

Other Meds:

Current Illness:

ID: 1643482
Sex: F
Age:
State: MA

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Cyst/mass around her pancreas region after second dose; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CYST (Cyst/mass around her pancreas region after second dose) in a 90-year-old female patient 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CYST (Cyst/mass around her pancreas region after second dose). At the time of the report, CYST (Cyst/mass around her pancreas region after second dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up added and updated patient contact details(Email and Fax).

Other Meds:

Current Illness:

ID: 1643483
Sex: M
Age: 52
State: NJ

Vax Date: 04/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Second dose was scheduled for 22May2021. Patient missed the second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jun-2021 and was forwarded to Moderna on 25-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was scheduled for 22May2021. Patient missed the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1643484
Sex: M
Age: 64
State: NC

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

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

Lab Data:

Allergies:

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

Symptoms: This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021). At the time of the report, OFF LABEL USE (This patient received 1 dose of Pfizer COVID 19 vaccine in January, 2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1643485
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: experienced vertigo; tightness on the chest; 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 VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Flu shot in September 2020. 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 VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest). At the time of the report, VERTIGO (experienced vertigo) and CHEST DISCOMFORT (tightness on the chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1643486
Sex: F
Age: 49
State: NC

Vax Date: 12/15/2020
Onset Date: 12/15/2020
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: forgot to get the second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2020, the patient experienced PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (forgot to get the second dose of the Moderna COVID-19 vaccine) 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. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1643487
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: arm was sore; arm had a rash was red and itchy; arm had a rash, was red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was provided. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red). In 2021, PAIN IN EXTREMITY (arm was sore), RASH PRURITIC (arm had a rash was red and itchy) and RASH ERYTHEMATOUS (arm had a rash, was red) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was provided by the reporter. No concomitant medication was provided by the reporter. No lab data was provided by the reporter.

Other Meds:

Current Illness:

ID: 1643488
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: First dose of Vaccine more than 6 weeks ago; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Vaccine more than 6 weeks ago) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Vaccine more than 6 weeks ago). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Vaccine more than 6 weeks ago) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided by the reporter. No treatment details were provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643489
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: around the injection site It is hard; around the injection site It is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (around the injection site It is hard) and VACCINATION SITE ERYTHEMA (around the injection site It is red) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (around the injection site It is hard) and VACCINATION SITE ERYTHEMA (around the injection site It is red). At the time of the report, VACCINATION SITE INDURATION (around the injection site It is hard) and VACCINATION SITE ERYTHEMA (around the injection site It is red) outcome was unknown. Concomitant medications details not available. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1643490
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of ageusia (I received my second Moderna vaccine in April, since then I have lost my sense of taste. Have you had this reported before?) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. April 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. April 2021, patient had ageusia (I received my second Moderna vaccine in April, since then I have lost my sense of taste. Have you had this reported before?). At the time of the report, ageusia (I received my second Moderna vaccine in April, since then I have lost my sense of taste. Have you had this reported before?) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1643491
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: second dose scheduled 25 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (second dose scheduled 25 days after first dose) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OFF LABEL USE (second dose scheduled 25 days after first dose). At the time of the report, OFF LABEL USE (second dose scheduled 25 days after first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product information reported. No treatment medication information given. Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am