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: 1718038
Sex: U
Age:
State: TX

Vax Date: 06/25/2021
Onset Date:
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) 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 23-Jul-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 EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. 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: 1718039
Sex: F
Age: 77
State:

Vax Date: 07/21/2021
Onset Date:
Rec V Date: 09/21/2021
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: more than 36 days have passed since the first dose and patient did not receive the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and patient did not receive the second dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 21-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 PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and patient did not receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days have passed since the first dose and patient did not receive the second 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 concomitant and medication information provided. No treatment information provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718040
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Reaction in his arm; Little red round; little tender; Itchy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction in his arm), ERYTHEMA (Little red round), TENDERNESS (little tender), PRURITUS (Itchy) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 VACCINATION COMPLICATION (Reaction in his arm), ERYTHEMA (Little red round), TENDERNESS (little tender), PRURITUS (Itchy) and CHILLS (Chills). At the time of the report, VACCINATION COMPLICATION (Reaction in his arm), ERYTHEMA (Little red round), TENDERNESS (little tender) and PRURITUS (Itchy) was resolving and CHILLS (Chills) outcome was unknown. No concomitant medications were provided by the reporter. The patient had a dermatological cream which he has used to treat the symptoms. The patient mentioned that the circle was little bigger than the one he got after his second dose. This case was linked to MOD-2021-142236 (Patient Link).

Other Meds:

Current Illness:

ID: 1718041
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: loss of appetite; loss of taste,; loss of energy; so dizzy; couldn't stand; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste,), ASTHENIA (loss of energy), DIZZINESS (so dizzy) and DYSSTASIA (couldn't stand) in an 87-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. 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 DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste,), ASTHENIA (loss of energy), DIZZINESS (so dizzy), DYSSTASIA (couldn't stand) and MYALGIA (body aches). At the time of the report, DECREASED APPETITE (loss of appetite), AGEUSIA (loss of taste,), ASTHENIA (loss of energy), DIZZINESS (so dizzy), DYSSTASIA (couldn't stand) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. The treatment information was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718042
Sex: F
Age:
State:

Vax Date:
Onset Date: 09/03/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Positive COVID-19; 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 SARS-COV-2 TEST POSITIVE (Positive COVID-19) 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 03-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient tested positive for COVID-19 one week before scheduled second dose. Concomitant and treatment medication was not provided. No treatment medication information was provided

Other Meds:

Current Illness:

ID: 1718043
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/21/2021
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: Issue with prostate infection; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE INFECTION (Issue with prostate infection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Prostate infection in 2016. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PROSTATE INFECTION (Issue with prostate infection). At the time of the report, PROSTATE INFECTION (Issue with prostate infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . The patient reported that the patient took the first dose of moderna 32 days ago. The second dose is pending. The patient also mentioned that two weeks back again patient experienced the same symptom. The patient is not clear that if this was a side effect of the vaccine. The patient is taking antibiotics currently.; Sender's Comments: This case concerns a patient of unknown age and gender conservatively taken as "male" due to the medical history of prostate infection who experienced the unexpected event of prostate infection. The event occurred after the first dose of Spikevax. The medical history of prostate infection remains a confounder. The benefit-risk relationship of drug Spikevax is not affected by this report. The event prostate infection doesn?t seem to be serious by medical judgement and from a clinical or regulatory standpoint.

Other Meds:

Current Illness:

ID: 1718044
Sex: U
Age:
State: TX

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and POOR QUALITY PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) 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 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and POOR QUALITY PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and POOR QUALITY PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. 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. Date refrigerated on 20-Apr-2021.

Other Meds:

Current Illness:

ID: 1718045
Sex: F
Age: 16
State: FL

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/21/2021
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: a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) 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 13-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old). On 13-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a patient who presented to them for their 2nd dose of the Moderna Covid-19 Vaccine, and she's 16 years old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug was provided. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718046
Sex: F
Age: 33
State: OH

Vax Date: 04/07/2021
Onset Date: 04/01/2021
Rec V Date: 09/21/2021
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: Only recieved one dose; Arm started getting itchy in left arm which was injection arm; Had a red circle; Swelled up bigger than golf ball, took up her whole arm / three days later it started to puff up again; Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy; She had a bruise it's not just a bruise, it's itchy; It was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy), CONTUSION (She had a bruise it's not just a bruise, it's itchy), VACCINATION SITE WARMTH (It was warm to touch), PRODUCT DOSE OMISSION ISSUE (Only recieved one dose) and VACCINATION SITE PRURITUS (Arm started getting itchy in left arm which was injection arm) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRURITUS (Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy), CONTUSION (She had a bruise it's not just a bruise, it's itchy), VACCINATION SITE WARMTH (It was warm to touch), VACCINATION SITE PRURITUS (Arm started getting itchy in left arm which was injection arm), VACCINATION SITE ERYTHEMA (Had a red circle) and VACCINATION SITE SWELLING (Swelled up bigger than golf ball, took up her whole arm / three days later it started to puff up again). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Only recieved one dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. In April 2021, VACCINATION SITE WARMTH (It was warm to touch) had resolved. At the time of the report, PRURITUS (Other parts of her body were getting itchy, like her head and arms and legs / bruise was itchy) and VACCINATION SITE ERYTHEMA (Had a red circle) had not resolved and CONTUSION (She had a bruise it's not just a bruise, it's itchy), PRODUCT DOSE OMISSION ISSUE (Only recieved one dose), VACCINATION SITE PRURITUS (Arm started getting itchy in left arm which was injection arm) and VACCINATION SITE SWELLING (Swelled up bigger than golf ball, took up her whole arm / three days later it started to puff up again) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. The patient reported that three days post the events the region again started to puff up and itchiness keeps her awake at night. This was seen once a week since the first time she had swelling in arm.

Other Meds:

Current Illness:

ID: 1718047
Sex: M
Age: 71
State: IL

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Pain on his neck; Chills; Headache; Pain on his shoulder at the same arm of injection site; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain on his neck), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain on his shoulder at the same arm of injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN and PANTOPRAZOLE for an unknown indication. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced NECK PAIN (Pain on his neck), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain on his shoulder at the same arm of injection site). At the time of the report, NECK PAIN (Pain on his neck), CHILLS (Chills), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain on his shoulder at the same arm of injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided by the reporter. No treatment information was provided.

Other Meds: LIPITOR; LOSARTAN; PANTOPRAZOLE

Current Illness:

ID: 1718048
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/21/2021
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: Missed the 2nd shot (7 months post 1st shot); Had side effects after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had side effects after first shot) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot (7 months post 1st shot)) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION COMPLICATION (Had side effects after first shot). On 10-Sep-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot (7 months post 1st shot)). On 10-Sep-2021, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot (7 months post 1st shot)) had resolved. At the time of the report, VACCINATION COMPLICATION (Had side effects after first shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication provided. No treatment information mentioned. Patient called in to report that she missed the second dose and it has been 7 months since. Mentioned having some side effects to first dose and says she reported it so did not provide details now. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718049
Sex: U
Age:
State:

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Patient today who received their first Covid vaccine dose today however the vial had been in the refrigerator for 31 days/it was 1 day past beyond use date; 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 (Patient today who received their first Covid vaccine dose today however the vial had been in the refrigerator for 31 days/it was 1 day past beyond use date) 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 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient today who received their first Covid vaccine dose today however the vial had been in the refrigerator for 31 days/it was 1 day past beyond use date). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient today who received their first Covid vaccine dose today however the vial had been in the refrigerator for 31 days/it was 1 day past beyond use date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718050
Sex: F
Age: 16
State: IL

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Dose administered 20 hours after punctured; Dose administered to 16 year old; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 20 hours after punctured) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 20 hours after punctured) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to 16 year old). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 20 hours after punctured) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Dose administered to 16 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. It was reported that vial was initially punctured on 09-Sep-2021 at 3 P.M . It was stored at room temperature post puncture for about 20 hours. The vial did not undergo any temperature excursions. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1718051
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: COVID-19; COPD; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) 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 COVID-19 (COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). At the time of the report, COVID-19 (COVID-19) and CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) outcome was unknown. No concomitant medication is provided by reporter. No treatment was provided.

Other Meds:

Current Illness:

ID: 1718052
Sex: U
Age:
State: ND

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/21/2021
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: administered 9 doses of expired Moderna to patients; 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 (administered 9 doses of expired Moderna to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 9 doses of expired Moderna to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 9 doses of expired Moderna to patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718053
Sex: F
Age: 43
State: MD

Vax Date: 09/10/2021
Onset Date:
Rec V Date: 09/21/2021
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: Numbness in left leg; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (Numbness in left leg) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-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 an unknown date, the patient experienced HYPOAESTHESIA (Numbness in left leg). At the time of the report, HYPOAESTHESIA (Numbness in left leg) outcome 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 information was reported. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up contains Reporter's Email address Updated.

Other Meds:

Current Illness:

ID: 1718054
Sex: F
Age: 56
State: TX

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

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

Lab Data: Test Date: 20210407; Test Name: Body Tempearture; Result Unstructured Data: high; Test Name: Heart beat; Result Unstructured Data: irregular

Allergies:

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

Symptoms: Runny nose after 2nd shot; Radiating pain after 2nd shot; Fever 102 F after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose after 2nd shot), PAIN (Radiating pain after 2nd shot) and PYREXIA (Fever 102 F after 2nd shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The patient's past medical history included Cardiac arrhythmia (NOS). Concurrent medical conditions included Immunocompromised and Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Asthma. On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced RHINORRHOEA (Runny nose after 2nd shot), PAIN (Radiating pain after 2nd shot) and PYREXIA (Fever 102 F after 2nd shot). The patient was treated with PARACETAMOL (TYLENOL) on 07-Apr-2021 for Pain, at an unspecified dose and frequency. On 08-Apr-2021, RHINORRHOEA (Runny nose after 2nd shot) and PYREXIA (Fever 102 F after 2nd shot) had resolved. On 09-Apr-2021, PAIN (Radiating pain after 2nd shot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Body temperature: 102 (High) high. On an unknown date, Heart rate: abnormal (abnormal) irregular. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had radiating pain for 2.5 days This case was linked to MOD-2021-315707, MOD-2021-315546 (Patient Link).

Other Meds: PROAIR HFA; SPIRIVA

Current Illness: Asthma; Immunocompromised

ID: 1718055
Sex: F
Age: 57
State: TX

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

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

Lab Data: Test Date: 20210909; Test Name: Body Temperature; Result Unstructured Data: Fever 102F

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Back pain is bad and waking her up last night, radiating pain; Chest hurts after 3rd shot; Chest feels tight after 3rd shot; Feel cold after 3rd shot; Chills after 3rd shot; Body Aches after 3rd shot; Fever 102F after 3rd shot; Headache after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain is bad and waking her up last night, radiating pain), CHEST PAIN (Chest hurts after 3rd shot), CHEST DISCOMFORT (Chest feels tight after 3rd shot), FEELING COLD (Feel cold after 3rd shot) and CHILLS (Chills after 3rd shot) in a 57-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. The patient's past medical history included Heart rate abnormal (irregular heart beat) and COVID-19 in January 2021. Concurrent medical conditions included Asthma and Immunocompromised (not specified). Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for Asthma. On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced BACK PAIN (Back pain is bad and waking her up last night, radiating pain), CHEST PAIN (Chest hurts after 3rd shot), CHEST DISCOMFORT (Chest feels tight after 3rd shot), FEELING COLD (Feel cold after 3rd shot), CHILLS (Chills after 3rd shot), MYALGIA (Body Aches after 3rd shot), PYREXIA (Fever 102F after 3rd shot) and HEADACHE (Headache after 3rd shot). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back pain is bad and waking her up last night, radiating pain), CHEST PAIN (Chest hurts after 3rd shot), CHEST DISCOMFORT (Chest feels tight after 3rd shot), FEELING COLD (Feel cold after 3rd shot), CHILLS (Chills after 3rd shot), MYALGIA (Body Aches after 3rd shot), PYREXIA (Fever 102F after 3rd shot) and HEADACHE (Headache after 3rd shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: 102 (High) Fever 102F. This case was linked to MOD-2021-315546, MOD-2021-315706 (Patient Link).

Other Meds: PROAIR HFA; SPIRIVA

Current Illness: Asthma; Immunocompromised (not specified)

ID: 1718056
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: I would like to know whats the side after getting the first dose and time of those effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I would like to know whats the side after getting the first dose and time of those effects) 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 VACCINATION COMPLICATION (I would like to know whats the side after getting the first dose and time of those effects). At the time of the report, VACCINATION COMPLICATION (I would like to know whats the side after getting the first dose and time of those effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication were reported. No concomitant medication were reported.

Other Meds:

Current Illness:

ID: 1718057
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: had my first dose of moderna today and im 17; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (had my first dose of moderna today and im 17) in a 17-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (had my first dose of moderna today and im 17). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (had my first dose of moderna today and im 17) had resolved. No concomitant medication reported. No treatment medication reported.

Other Meds:

Current Illness:

ID: 1718058
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT) 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 CHEST PAIN (I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT). At the time of the report, CHEST PAIN (I had my third shot yesterday ND MY CHECT IS VERY SORE TODAYCAN'T EVEN TOUCH IT) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718059
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/21/2021
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: Sore arm; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) 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 March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue) outcome was unknown. No Concomitant medications were reported. No Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718060
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: large welt in the injection site; sore in the arm; fever (101,5 ?F); chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (large welt in the injection site), PAIN IN EXTREMITY (sore in the arm), PYREXIA (fever (101,5 ?F)), CHILLS (chills) and FATIGUE (fatigue) 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 INJECTION SITE URTICARIA (large welt in the injection site), PAIN IN EXTREMITY (sore in the arm), PYREXIA (fever (101,5 ?F)), CHILLS (chills) and FATIGUE (fatigue). At the time of the report, INJECTION SITE URTICARIA (large welt in the injection site), PAIN IN EXTREMITY (sore in the arm), PYREXIA (fever (101,5 ?F)), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. No concomitant medications was provided by the reporter. The patient had a temperature of 101.5. No treatments medications was provided by the reporter.

Other Meds:

Current Illness:

ID: 1718061
Sex: M
Age: 16
State: GA

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 09/21/2021
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: 2nd dose administered to a 16 year old; 1st dose administered to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 16 year old) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2nd dose administered to a 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 16 year old). On 10-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2nd dose administered to a 16 year old). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to a 16 year old) had resolved. On 10-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2nd dose administered to a 16 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718062
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/21/2021
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: side effects were minor; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects were minor) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Crohn's disease (auto immune ptoblems) and Inflammation (inflamation in her eyes and head). Concurrent medical conditions included Immune disorder (NOS) (krones and inflamation in her eyes and head). On 01-Mar-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 an unknown date, the patient experienced VACCINATION COMPLICATION (side effects were minor). At the time of the report, VACCINATION COMPLICATION (side effects were minor) outcome was unknown. No concomitant medications reported. Treatment information not reported. This case was linked to MOD-2021-315273 (Patient Link).

Other Meds:

Current Illness: Immune disorder (NOS) (krones and inflamation in her eyes and head)

ID: 1718063
Sex: U
Age:
State: TX

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) 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 medication information not provided by the reporter. Date refrigerated: 20-Apr-2021. Temperature changes (in F): 40. Treatment information not provided by the reporter.

Other Meds:

Current Illness:

ID: 1718064
Sex: U
Age:
State: TX

Vax Date: 08/06/2021
Onset Date: 08/06/2021
Rec V Date: 09/21/2021
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: Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 06-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1718065
Sex: F
Age: 59
State: OK

Vax Date: 09/10/2021
Onset Date:
Rec V Date: 09/21/2021
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: Received a dose from a vial first punctured more than 12 hours ago; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose from a vial first punctured more than 12 hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow up received on 10-Sep-2021 updated suspect lot number and expiration date.

Other Meds:

Current Illness:

ID: 1718066
Sex: U
Age:
State: TX

Vax Date: 06/11/2021
Onset Date:
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-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 EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Per reporter, some doses of the Moderna COVID Vaccine had been administered past the 30-day refrigeration time, with temperature fluctuations between 42-43 degrees Fahrenheit. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718067
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 09/21/2021
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: constantly getting sick/ after second dose felt sick after a couple hours; Sore throat; It is like he is sweating every pinch of liquid out of his body; Headache; Fever; Cold chills; Fatigue; body pain; felt sick came back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (felt sick came back). On an unknown date, the patient experienced ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours), OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain). At the time of the report, ILLNESS (constantly getting sick/ after second dose felt sick after a couple hours) had resolved and OROPHARYNGEAL PAIN (Sore throat), HYPERHIDROSIS (It is like he is sweating every pinch of liquid out of his body), ILLNESS (felt sick came back), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Cold chills), FATIGUE (Fatigue) and MYALGIA (body pain) outcome was unknown. No concomitant drug information was provided. No Treatment drug information was provided. On 26-Aug-2021, the patient went to the emergency room, and they told him he does not have COVID. He was good for a week, then the symptoms came back.

Other Meds:

Current Illness:

ID: 1718068
Sex: U
Age:
State: TX

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/21/2021
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: administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Treatment information not reported.

Other Meds:

Current Illness:

ID: 1718069
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Tremendous increase in aggression; This spontaneous case was reported by a consumer and describes the occurrence of AGGRESSION (Tremendous increase in aggression) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products RISPERIDONE tablet for Irritability, Aggression and Autism and RISPERIDONE tablet for Irritability, Aggression and Autism. Concurrent medical conditions included Autism, Intellectual disability, Irritability and Aggression. Concomitant products included CLONAZEPAM for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, RISPERIDONE (Oral) 2 milligram once a day and RISPERIDONE (Oral) .5 milligram once a day. In 2021, the patient experienced AGGRESSION (Tremendous increase in aggression). At the time of the report, AGGRESSION (Tremendous increase in aggression) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that on an unknown date ("for ages"), the patient started treatment with risperidone 2mg and 0.5mg for irritability and aggression related to autism. On an unknown date, the patient received the COVID-19 vaccine (Moderna). On an unknown date in 2021, during his last 90-day supply of risperidone, the patient experienced a tremendous increase in aggression, which had increased gradually over time, while taking that specific 90-day supply of risperidone. He reportedly broke furniture and attacked his mother in the car. The patient's mother originally thought the aggression was related to receiving the Moderna COVID-19 vaccine, but eventually she realized it was not likely related. On an unspecified date in 2021, the patient got a new bottle of risperidone 2mg, and within a couple days of taking the new bottle, the patient was back to normal. His mother attributed the increase in aggression specifically to the risperidone 2mg tablets and thought maybe they did not have enough of the active ingredient in them. She spoke with the patient's psychiatrist, but no changes in therapy were made. As of 27-Aug-2021, treatment with risperidone 2mg and 0.5mg was ongoing.

Other Meds: CLONAZEPAM; RISPERIDONE

Current Illness: Aggression; Autism; Intellectual disability; Irritability

ID: 1718070
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Got COVID-19 and Miserable with symptoms exactly like we have virus again; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again) 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 (Got COVID-19 and Miserable with symptoms exactly like we have virus again). At the time of the report, COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. This case was linked to MOD-2021-315958.

Other Meds:

Current Illness:

ID: 1718071
Sex: U
Age:
State: TX

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/21/2021
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: Administered past the 30 day refrigeration time; Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Administered past the 30 day refrigeration time) had resolved. 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: 1718072
Sex: F
Age: 26
State: OK

Vax Date: 08/11/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
Hospital:

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

Lab Data: Test Date: 20210910; Test Name: Body temperature; Result Unstructured Data: Fever of 102.2 degrees Fahrenheit

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Body aches; Fever of 102.2 (degrees Fahrenheit); This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (Fever of 102.2 (degrees Fahrenheit)) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced MYALGIA (Body aches) and PYREXIA (Fever of 102.2 (degrees Fahrenheit)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 UNK. At the time of the report, MYALGIA (Body aches) was resolving and PYREXIA (Fever of 102.2 (degrees Fahrenheit)) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2021, Body temperature: 102.2 (High) Fever of 102.2 degrees Fahrenheit. No concomitant medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1718073
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: received my 3rd Moderna vaccine yesterday and my armpit is tender; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY PAIN (received my 3rd Moderna vaccine yesterday and my armpit is tender) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced AXILLARY PAIN (received my 3rd Moderna vaccine yesterday and my armpit is tender). At the time of the report, AXILLARY PAIN (received my 3rd Moderna vaccine yesterday and my armpit is tender) outcome was unknown. No treatment medications were provided. No concomitant medications were provided. Patient received 3rd Moderna vaccine yesterday, which resulted in tender armpit and enquiring whether that was normal? or not and denied to be followed by safety Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718074
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 09/21/2021
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: Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A, 042620A and 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer (On chemo). On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy). At the time of the report, DIZZINESS (Dizzy) outcome was unknown. No concomitant medication was provided by reporter. No treatment information was provided by reporter.

Other Meds:

Current Illness: Cancer (On chemo)

ID: 1718075
Sex: U
Age:
State: TX

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 09/21/2021
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: Administered past the 30 day refrigeration time; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No medical history was reported. On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) 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 information was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1718076
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) 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 VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) 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: 1718077
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: events are ongoing; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (events are ongoing) 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 VACCINATION COMPLICATION (events are ongoing). At the time of the report, VACCINATION COMPLICATION (events are ongoing) had not resolved. Not Provided 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 was injected with Restylane Kysse in the lips. Three months later the patient had a touch up with Restylane Defyne. Five weeks post injection with Defyne, the patient experienced delayed onset nodules to the injection area. Treated with steroids and products dissolved. Concomitant medications was not reported. Treatment medications was not reported.

Other Meds:

Current Illness:

ID: 1718078
Sex: F
Age: 57
State: TX

Vax Date: 08/12/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: administration of a vaccine from a vial that was punctured more than 12hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of a vaccine from a vial that was punctured more than 12hours ago) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The patient's past medical history included COVID-19. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of a vaccine from a vial that was punctured more than 12hours ago). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administration of a vaccine from a vial that was punctured more than 12hours ago) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. The vial was first punctured on 03-Sep-2021, and put back in the fridge after the initial puncture. The vaccine was administered on 10-Sep-2021. The patient was observed for 25 minutes and did not experience any adverse events. Treatment medications was not provided.

Other Meds:

Current Illness:

ID: 1718079
Sex: M
Age: 46
State: SC

Vax Date: 08/31/2021
Onset Date: 09/02/2021
Rec V Date: 09/21/2021
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: not been able to breath for days/difficulty breathing; voice has change; difficulty to talk; felling scare; throat swollen; Chills; body aches; sly fever; cough; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to talk), FEELING ABNORMAL (felling scare) and COUGH (cough) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052e21a) 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) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced COUGH (cough). On 03-Sep-2021, the patient experienced DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), SPEECH DISORDER (difficulty to talk), FEELING ABNORMAL (felling scare), PHARYNGEAL SWELLING (throat swollen), CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. On 06-Sep-2021, CHILLS (Chills), MYALGIA (body aches) and PYREXIA (sly fever) had resolved. At the time of the report, DYSPNOEA (not been able to breath for days/difficulty breathing), DYSPHONIA (voice has change), COUGH (cough) and PHARYNGEAL SWELLING (throat swollen) had not resolved and SPEECH DISORDER (difficulty to talk) and FEELING ABNORMAL (felling scare) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1718080
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Funny taste in my mouth; Right back of neck sore; 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 TASTE DISORDER (Funny taste in my mouth) and NECK PAIN (Right back of neck sore) 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 TASTE DISORDER (Funny taste in my mouth) and NECK PAIN (Right back of neck sore). At the time of the report, TASTE DISORDER (Funny taste in my mouth) and NECK PAIN (Right back of neck sore) 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. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718081
Sex: U
Age:
State: TX

Vax Date: 08/13/2021
Onset Date: 08/13/2021
Rec V Date: 09/21/2021
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: This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (past the 30-day refrigeration time) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 047B21A) for COVID-19 immunization. No medical history reported. On Aug 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Aug 13, 2021, patient administered expired product (past the 30-day refrigeration time). On Aug 13, 2021, administered expired product (past the 30-day refrigeration time) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. Date of refrigeration of the vial reported as Apr 13, 2021 and temperature changes reported to be 40-42 F. Sender's comments: This case of expired product administered in a patient (unknown age and gender) with no associated events. The patient administered Moderna COVID-19 vaccine (past the 30-day refrigeration time). The re-challenge not applicable. The causality for the event expired product administered will be considered not applicable. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 vaccine not affected by this report.

Other Meds:

Current Illness:

ID: 1718082
Sex: F
Age: 80
State: FL

Vax Date: 08/06/2021
Onset Date: 09/05/2021
Rec V Date: 09/21/2021
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: it itches like crazy; the area is a little bit swollen; red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (it itches like crazy), VACCINATION SITE ERYTHEMA (red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm) and VACCINATION SITE SWELLING (the area is a little bit swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-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 VACCINATION SITE ERYTHEMA (red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm). On 10-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (it itches like crazy) and VACCINATION SITE SWELLING (the area is a little bit swollen). At the time of the report, VACCINATION SITE PRURITUS (it itches like crazy) and VACCINATION SITE SWELLING (the area is a little bit swollen) outcome was unknown and VACCINATION SITE ERYTHEMA (red around the injection site. Today it is still real red around the injection site, is worse than it was to begin with, and the redness is drifting away from injection site to the under side of her arm) had not resolved. No Concomitant and Treatment medications were reported.

Other Meds:

Current Illness:

ID: 1718083
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/21/2021
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: Eye lid was black; 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 EYE CONTUSION (Eye lid was black) 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 EYE CONTUSION (Eye lid was black). At the time of the report, EYE CONTUSION (Eye lid was black) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was reported. Treatment medications was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1718084
Sex: F
Age: 56
State: LA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 09/21/2021
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: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (soreness in arm) and product dose omission issue (didn't get her 2nd shot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot 027A21A) for COVID-19 vaccination. Concomitant products included furosemide for an unknown indication. On Mar 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 19, 2021, patient experienced pain in extremity (soreness in arm) and product dose omission issue (didn't get her 2nd shot). On Mar 19, 2021, product dose omission issue (didn't get her 2nd shot) resolved. On Mar 23, 2021, pain in extremity (soreness in arm) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. Other concomitant medications included blood thinner and inactive thyroid medicines. No treatment medication reported.

Other Meds: Furosemide

Current Illness:

ID: 1718085
Sex: M
Age: 47
State: FL

Vax Date: 08/10/2021
Onset Date: 09/09/2021
Rec V Date: 09/21/2021
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: Patient received dose from punctured vial after 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose from punctured vial after 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1718086
Sex: F
Age:
State: MN

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/21/2021
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: Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received 3rd dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medication reported No Treatment medication reported.

Other Meds:

Current Illness:

ID: 1718087
Sex: M
Age: 41
State: IN

Vax Date: 08/12/2021
Onset Date:
Rec V Date: 09/21/2021
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: Intense arm pain/Pain in arm was really bad really intense; Earlier I was so cold then hot then cold/body temperature fluctuations; I can't sleep; Tendons are tightening up hands are clawing up; Talking takes up all energy; Feel like laying down; Hands forming claws; extreme fatigue/I am so tired talking is a lot of work, sitting up is hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up) and ASTHENIA (Talking takes up all energy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT) for an unknown indication. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-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 PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Intense arm pain/Pain in arm was really bad really intense), FEELING OF BODY TEMPERATURE CHANGE (Earlier I was so cold then hot then cold/body temperature fluctuations), INSOMNIA (I can't sleep), TENDON DISCOMFORT (Tendons are tightening up hands are clawing up), ASTHENIA (Talking takes up all energy), FEELING ABNORMAL (Feel like laying down), HAND DEFORMITY (Hands forming claws) and FATIGUE (extreme fatigue/I am so tired talking is a lot of work, sitting up is hard) outcome was unknown. This case was linked to MOD-2021-316009.

Other Meds: NASACORT

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am