VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1820412
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of an expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820413
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 10/04/2021
Rec V Date: 10/27/2021
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: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced administration of expired vaccine. On 04-OCT-2021, the patient experienced out of specification product use. On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine, incorrect product storage and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049577, 20211049738 and 20211049203.

Other Meds:

Current Illness:

ID: 1820414
Sex: M
Age:
State: NH

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 10/27/2021
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: SORE ARM, ARM NOT PAINFUL, FEELS DISCOMFORT AND AWARENESS, EXPERIENCES SORENESS; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced sore arm, arm not painful, feels discomfort and awareness, experiences soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, arm not painful, feels discomfort and awareness, experiences soreness. This report was non-serious. This case, from the same reporter is linked to 20211049491 .

Other Meds:

Current Illness:

ID: 1820415
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 10/06/2021
Rec V Date: 10/27/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 and expiry: 29-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049577, 20211049738 and 20211049134.

Other Meds:

Current Illness:

ID: 1820416
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: AN UNEVALUABLE EVENT; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced an unevaluable event, and had to be hospitalized. It was got so bad that patient had been relocated an hour and a half away to a bigger, more adequate hospital. Number of days hospitalized and discharge information was not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of an unevaluable event was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter was linked to 20211045102.; Sender's Comments: V0:20211049317-COVID-19 VACCINE AD26.COV2.S-An unevaluable event. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1820417
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: Test Name: Lab test; Result Unstructured Data: no blood clot in legs and lungs

Allergies:

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

Symptoms: SWELLING IN LOWER LEGS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced swelling in lower legs. Laboratory data (dates unspecified) included: Lab test (NR: not provided) no blood clot in legs and lungs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling in lower legs. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820418
Sex: U
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: HAIR FALLING OUT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced hair falling out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair falling out was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820419
Sex: F
Age:
State: NH

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: FEVER; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced fever. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever. This report was non-serious. This case, from the same reporter is linked to 20211049191.

Other Meds:

Current Illness:

ID: 1820420
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 09/30/2021
Rec V Date: 10/27/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816027, and expiry: 29-SEP-2021) dose was not reported, administered on 30-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049203, 20211049134 and 20211049738.

Other Meds:

Current Illness:

ID: 1820421
Sex: U
Age:
State: AZ

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/27/2021
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: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced incorrect product storage. On 21-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820422
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: CAN NOT MOVE LEFT ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced can not move left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not move left arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820423
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: Unknown

Allergies:

Symptom List: Rash, Urticaria

Symptoms: SEVERE REACTION OF MUCUS BUILD ON BRAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe reaction of mucus build on brain. Laboratory data (dates unspecified) included: MRI (NR: not provided) Unknown. The action taken with covid-19 vaccine was not applicable. The outcome of severe reaction of mucus build on brain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820424
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 10/06/2021
Rec V Date: 10/27/2021
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: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049134, 20211049203 and 20211049577.

Other Meds:

Current Illness:

ID: 1820425
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 03/04/2021
Rec V Date: 10/27/2021
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: ACHINESS; HEMATOMA AT INJECTION SITE; JOINT PAIN; CHILLS; FATIGUE; LOW GRADE FEVER; This spontaneous report received from a patient concerned an 82 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 23-AUG-2021) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the patient experienced achiness. On 04-MAR-2021, the patient experienced hematoma at injection site. On 04-MAR-2021, the patient experienced joint pain. On 04-MAR-2021, the patient experienced chills. On 04-MAR-2021, the patient experienced fatigue. On 04-MAR-2021, the patient experienced low grade fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from achiness, joint pain, chills, fatigue, and low grade fever on 06-MAR-2021, and hematoma at injection site on 25-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820426
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: SOME REACTIONS FROM VACCINE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced some reactions from vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some reactions from vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820427
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 10/25/2021
Rec V Date: 10/27/2021
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: VIAL WAS PUNCTURED AND LEFT OVERNIGHT (OVER 6 HOURS); This spontaneous report received from a pharmacist concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-OCT-2021 11:40 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced vial was punctured and left overnight (over 6 hours). The action taken with covid-19 vaccine was not applicable. The outcome of vial was punctured and left overnight (over 6 hours) was not reported. This report was non-serious. This case, from the same reporter is linked to 20211050252.

Other Meds:

Current Illness:

ID: 1820428
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 10/27/2021
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: 20210412; Test Name: Body temperature; Result Unstructured Data: Under 102

Allergies:

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

Symptoms: BODY ACHES; SEVERE FATIGUE OR LETHARGY; FELT DEHYDRATED; SEVERE CHILLS OR SHAKING; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not really had a medical history. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced body aches. On 12-APR-2021, the patient experienced severe fatigue or lethargy. On 12-APR-2021, the patient experienced felt dehydrated. On 12-APR-2021, the patient experienced severe chills or shaking. On 12-APR-2021, the patient experienced headache. On 12-APR-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Under 102. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, severe chills or shaking, and fever on 13-APR-2021, severe fatigue or lethargy, and headache on 14-APR-2021, and felt dehydrated. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820429
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: BODY ACHES; FEVER; DIARRHEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, fever, and diarrhea. The action taken with covid-19 vaccine was not applicable. The patient recovered from body aches, fever, and diarrhea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820430
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 10/25/2021
Rec V Date: 10/27/2021
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: INCORRECT PRODUCT STORAGE; ADMINISTRATION OF VACCINE FROM PUNCTURED VIAL LEFT OVERNIGHT (OVER 6 HOURS); This spontaneous report received from a pharmacist concerned a 61 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 25-OCT-2021 11:14 for prophylactic vaccination. No concomitant medications were reported. On 25-OCT-2021, the patient experienced administration of vaccine from punctured vial left overnight (over 6 hours). On an unspecified date, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine from punctured vial left overnight (over 6 hours) and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20211049878.

Other Meds:

Current Illness:

ID: 1820431
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 10/27/2021
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: BLOOD CLOTS; PARALYZED FROM THE TAILBONE DOWN; This spontaneous report received from a consumer via social media concerned a male of unspecified age of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date in JUL-2021, the patient was paralyzed from the tailbone down and soon after was treated for several blood clots during emergency surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed from the tailbone down, and the outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211050258-covid-19 vaccine ad26.cov2.s -paralyzed from the tailbone down,blood clots . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1820432
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: ARM TISSUES AND BONES STILL BRUISED; MUSCLE TISSUE WERE DAMAGED; This spontaneous report received from a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm tissues and bones bruised and the doctor said that the patient's muscle tissues were damaged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm tissues and bones still bruised, and muscle tissue were damaged. This report was non-serious.

Other Meds:

Current Illness:

ID: 1820433
Sex: F
Age: 59
State: MS

Vax Date: 07/25/2021
Onset Date: 07/29/2021
Rec V Date: 10/27/2021
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: disrupted her sleep; On and off; Chest pain subsided; Bubble popping; Extreme chest pain; shortness of breath; chest would "squeeze tight for a few minutes"; feeling like burping; possible bad heartburn; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (possible bad heartburn), CHEST PAIN (Extreme chest pain), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes") and ERUCTATION (feeling like burping) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Systemic lupus erythematosis in 2005, Shellfish allergy, Drug allergy (Erythromycin), Cholesterol and Hypertension. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and BELIMUMAB (BENLYSTA) for an unknown indication. On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced DYSPEPSIA (possible bad heartburn). On 02-Aug-2021, the patient experienced CHEST PAIN (Extreme chest pain), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes"), ERUCTATION (feeling like burping) and EAR DISCOMFORT (Bubble popping). On an unknown date, the patient experienced SLEEP DISORDER (disrupted her sleep), ON AND OFF PHENOMENON (On and off) and NON-CARDIAC CHEST PAIN (Chest pain subsided). At the time of the report, DYSPEPSIA (possible bad heartburn), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest would "squeeze tight for a few minutes"), ERUCTATION (feeling like burping), SLEEP DISORDER (disrupted her sleep), EAR DISCOMFORT (Bubble popping) and ON AND OFF PHENOMENON (On and off) outcome was unknown, CHEST PAIN (Extreme chest pain) had resolved and NON-CARDIAC CHEST PAIN (Chest pain subsided) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication provided by reporter. Lab data included The caller stated that she had a echocardiogram procedure yesterday (10Aug2021) but the results have not come back yet. On follow-up patient repprted that she is doing much better. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow-up received, Chest pain event outcome updated from unknown to recovering and added information in inarrative.From initial Source Document- Captured reporter contact number and mail id and medical history( which was missed out to capture in initial submitted version). On 21-Oct-2021: Follow-up information received on 21-Oct-2021 included about outcome of event chest pain updated.

Other Meds: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; ASPIRIN (E.C.); BENLYSTA

Current Illness: Cholesterol; Drug allergy (Erythromycin); Hypertension; Shellfish allergy

ID: 1820434
Sex: M
Age: 83
State: DC

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/27/2021
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: unknown

Allergies: unknown

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

Symptoms: In vaccination clinic, patient presented for two vaccination, Fluzone-HD and Covid-19 booster, shots. While in preparation to give the vaccinations, I had patient to repeat what vaccines he was going to received that day. He said that he wanted the Flu and Covid-19 booster. Then, I processed to vaccinate. When processing, I saw that he had previously received this shots.

Other Meds: unknown

Current Illness: unknown

ID: 1820435
Sex: F
Age: 83
State: DC

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: unknown

Allergies: unknown

Symptom List: Injection site pain, Pain

Symptoms: In a local clinic, patient presented for Fluzone-HD vaccination. While in preparation to give her the vaccination, I had patient to repeat what vaccines she was going to received that day. She said that she wanted the Flu vaccine. Then, I processed to vaccinate her. When processing her content form, that when I realize that she had a previous Fluzone-HD several days ago... When trying to contact the patient, I finally reach their daughter (name unknown). She said that her parents can appear to be very lucid. But, their are not.

Other Meds: unknown

Current Illness: unknown

ID: 1820436
Sex: F
Age: 65
State: AZ

Vax Date: 09/15/2021
Onset Date: 09/16/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data:

Allergies: Amoxicillin/Augmentin

Symptom List: Injection site pain, Menorrhagia

Symptoms: Within 24 hours I got tinnitus. It is gradually getting worse. Some nights I get <3 hours of sleep because it's so loud. Some days it's difficult to think clearly or concentrate because it's so loud. Some days/nights are better/worse than others. Contacted my PCP who said she never heard of that as being related to the vaccine. Told to contact my employer's employee health. Contacted them and they also said they never heard of that as being related to the vaccine and to contact my PCP. Contacted my PCP again and she wrote for an ENT referral, which I still haven't heard from.

Other Meds: Cholesterol Thyroid Depression

Current Illness:

ID: 1820437
Sex: F
Age: 39
State: MI

Vax Date: 10/25/2021
Onset Date: 10/26/2021
Rec V Date: 10/27/2021
Hospital:

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

Lab Data: None

Allergies: None

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

Symptoms: Sore swollen lymph nodes on injection side, fever (101), lethargy, sore muscles, headache

Other Meds: Hydrclorathorazide Losartan

Current Illness: None

ID: 1820438
Sex: F
Age: 35
State: MA

Vax Date: 12/28/2020
Onset Date: 01/25/2021
Rec V Date: 10/27/2021
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: 20210730; Test Name: Pregnancy test; Test Result: Positive; Result Unstructured Data: Positive.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Fatigued; Fever; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued), PYREXIA (Fever) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 immunisation. The patient's past medical history included Alcohol use (1 drink/week) on 04-Jul-2021. Concurrent medical conditions included Drug allergy (Allergy to sulfa drugs) and Migraine with aura (occasional frequency (1 every few months) has not changed.) since 01-Jan-1998. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2019 to an unknown date for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Apr-2022. On 25-Jan-2021, the patient experienced FATIGUE (Fatigued), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Fever and Headache, at an unspecified dose and frequency. On 25-Jan-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 26-Jan-2021, FATIGUE (Fatigued) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Pregnancy test: positive (Positive) Positive. Last menstrual period of patient was 30-JUN-2021 The patient did not have any complications or acute illnesses during the pregnancy till date and prenatal care had been established to the patient. The patient did not seek any medical care for the events. CC: This case concerns a 36 year old with relevant medical history of migraine and alcohol use, who experienced non-serious expected events of fatigue, headache and pyrexia and unexpected event of Maternal exposure before pregnancy , which occurred on the same day after vaccination with the 2nd dose of mRNA-1273 (Moderna) . The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report. This patient got pregnant approximately 5 to 6 months after vaccination with the 2nd dose of mRNA - 1273 Currently there are no complication or illnesses noted during her present pregnancy and patient is to be followed up. This case was linked to MOD-2021-337813 (Patient Link).; Sender's Comments: This case concerns a 36 year old with relevant medical history of migraine and alcohol use, who experienced non-serious expected events of fatigue, headache and pyrexia and unexpected event of Maternal exposure before pregnancy , which occurred on the same day after vaccination with the 2nd dose of mRNA-1273 (Moderna) . The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report. This patient got pregnant approximately 5 to 6 months after vaccination with the 2nd dose of mRNA - 1273 Currently there are no complication or illnesses noted during her present pregnancy and patient is to be followed up.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness: Drug allergy (Allergy to sulfa drugs); Migraine with aura (occasional frequency (1 every few months) has not changed).

ID: 1820439
Sex: F
Age: 39
State: NC

Vax Date: 08/11/2021
Onset Date: 08/11/2021
Rec V Date: 10/27/2021
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: Inappropriate schedule of product administration; I'm 6 weeks pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) and MATERNAL EXPOSURE DURING PREGNANCY (I'm 6 weeks pregnant) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Last menstrual period and estimated date of delivery were not provided. On 11-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I'm 6 weeks pregnant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration). On 11-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (I'm 6 weeks pregnant) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of product administration) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided HCP did not remember whether the patient got first dose of Moderna vaccine on February or March. CC: This is a case of Inappropriate schedule of vaccine administration of this 39-year-old, female patient with no disclosed medical history, who experienced the non-serious, unexpected event of Maternal exposure during pregnancy. The patient received the second dose of vaccine at 6 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.; Sender's Comments: This is a case of Inappropriate schedule of vaccine administration of this 39-year-old, female patient with no disclosed medical history, who experienced the non-serious, unexpected event of Maternal exposure during pregnancy. The patient received the second dose of vaccine at 6 weeks of gestation. The benefit-risk relationship of Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1820440
Sex: F
Age: 29
State: OH

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/27/2021
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: Injection site is warm to the touch; Injection site is raised; Maternal exposure during pregnancy; Rash at the injection site; Lethargic; Fever; Chills; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is warm to the touch), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE RASH (Rash at the injection site) in a 29-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 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Last menstrual period and estimated date of delivery were not provided. On 11-Oct-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 12-Oct-2021, the patient experienced LETHARGY (Lethargic). On 13-Oct-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE SWELLING (Injection site is raised) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, LETHARGY (Lethargic), VACCINATION SITE WARMTH (Injection site is warm to the touch), PYREXIA (Fever), CHILLS (Chills), VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE SWELLING (Injection site is raised) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. Relevant concomitant medications were not reported. Treatment information was not provided. CC: This case concerns a 29 year old female , with no reported medical history , who experienced the non-serious , unexpected event of Maternal exposure during pregnancy( the AOG of the pregnancy during the time of vaccination with the 2nd dose is unknown) and expected events of fever and chills which occurred on the same day after vaccination with the 2nd dose of mRNA -1273(Moderna). The day after vaccination the patient experienced non-serious unexpected event of lethargy and the 2 days after expected event of vaccination site rash and on unknown date vaccination site swelling and unexpected event of vaccination site warmth . The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.; Sender's Comments: This case concerns a 29 year old female , with no reported medical history , who experienced the non-serious , unexpected event of Maternal exposure during pregnancy( the AOG of the pregnancy during the time of vaccination with the 2nd dose is unknown) and expected events of fever and chills which occurred on the same day after vaccination with the 2nd dose of mRNA -1273(Moderna). The day after vaccination the patient experienced non-serious unexpected event of lethargy and the 2 days after expected event of vaccination site rash and on unknown date vaccination site swelling and unexpected event of vaccination site warmth . The re-challenge for this case is not applicable. The benefit-risk relationship of mRNA-1273 (Moderna) is not affected by this report.

Other Meds:

Current Illness:

ID: 1820441
Sex: F
Age: 17
State: FL

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/27/2021
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: administered to a patient 17 years of age; Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Mar-2022. On 14-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 14-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) 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 product use was not provided by the reporter. ? No treatment information was provided. No underlying medical conditions identified. CC:This case concerns a 17 year old pregnant female with unknown LMP, EDC and weeks gestation and no reported history who experienced the non-serious unlisted events of Maternal exposure during pregnancy and Product administered to patient of inappropriate age the day of dose 1 of mRNA-1273. Re-challenge is not applicable as dose 2 not scheduled yet. Benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 17 year old pregnant female with unknown LMP, EDC and weeks gestation and no reported history who experienced the non-serious unlisted events of Maternal exposure during pregnancy and Product administered to patient of inappropriate age the day of dose 1 of mRNA-1273. Re-challenge is not applicable as dose 2 not scheduled yet. Benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1820442
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: dose administered past the 30-day use by date was the first or second shot; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use by date was the first or second shot) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1820443
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/27/2021
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: Palpations of the Heart; Sleepy; Headache until to date; Nausea, no vomiting; Chills; Soreness of Upper Left Arm where the Shot was given; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), NAUSEA (Nausea, no vomiting) and CHILLS (Chills) in a 73-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. Concurrent medical conditions included Heart disorder. 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 PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), HEADACHE (Headache until to date), NAUSEA (Nausea, no vomiting), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given). At the time of the report, PALPITATIONS (Palpations of the Heart), SOMNOLENCE (Sleepy), NAUSEA (Nausea, no vomiting), CHILLS (Chills) and VACCINATION SITE PAIN (Soreness of Upper Left Arm where the Shot was given) outcome was unknown and HEADACHE (Headache until to date) had not resolved. No concomitant medication was reported No treatment medication was reported. The patient had two shots of the Moderna Vaccine of which during the same night and awoke to reaction. This case was linked to MOD-2021-354427 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: FU Received on 19 Oct 2021, its contain no new information

Other Meds:

Current Illness: Heart disorder

ID: 1820444
Sex: U
Age:
State: SD

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/27/2021
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: Administered with an expired vaccine; 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 (administered with an expired vaccine) 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 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) 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. Reporter reported that expired (expiration date 13 Oct 2021) Moderna Covid-19 vaccine was given to 4 patients on 15 Oct 2021 between 8:00-10:00am. Reporter had no adverse drug reaction to report on four patients that received Moderna vaccine 36 hours post vial expiration. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Non Significant Follow Up received and updated contact information of reporter. On 19-Oct-2021: Non-Significant follow up received. Email failure notification received. On 20-Oct-2021: Source Document contains no new information.

Other Meds:

Current Illness:

ID: 1820445
Sex: M
Age:
State:

Vax Date: 11/02/2020
Onset Date: 09/12/2021
Rec V Date: 10/27/2021
Hospital: Y

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

Lab Data: Test Date: 20210913; Test Name: Body temperature; Result Unstructured Data: 37.9 degree Celsius

Allergies:

Symptom List: Tremor

Symptoms: Nausea; Vomiting; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and Prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ALKS 4230 injection for Neoplasm and PEMBROLIZUMAB (KEYTRUDA) injection for Neoplasm. Previously administered products included for Metastatic malignant melanoma: Pegylated interferon ALFA- 2A (Stage IV) from September 2012 to 07-Jun-2017, Nivolumab (Stage IV) from 21-Jul-2017 to 28-Sep-2017, IPILIMUMAB (Stage IV) from 21-Jul-2017 to 28-Sep-2017, CISPLATIN (Stage IV) from 27-Jun-2020 to 09-Sep-2020, DACARBAZINE (Stage IV) from 27-Jun-2020 to 09-Sep-2020 and CARMUSTINE (Stage IV) on 17-Aug-2020. Past adverse reactions to the above products included No adverse event with CARMUSTINE, CISPLATIN, DACARBAZINE, IPILIMUMAB, Nivolumab and Pegylated interferon ALFA- 2A. Concurrent medical conditions included Neoplasm, Metastatic malignant melanoma (Stage IV) since June 2012, Nausea (with previous chemotherapy or even before on current treatment) and Vomiting (with previous chemotherapy or even before on current treatment). On 02-Nov-2020, the patient ALKS 4230 (Intravenous) dosage was changed to 3 microgram/kilogram every three weeks. On 08-Feb-2021, PEMBROLIZUMAB (KEYTRUDA) (Intravenous) dosage was changed to 200 milligram every three weeks. On 12-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, ALKS 4230 (Intravenous) dosage was changed to 3 microgram/kilogram every three weeks and PEMBROLIZUMAB (KEYTRUDA) (Intravenous) dosage was changed to 200 milligram every three weeks. On an unknown date, the patient started ALKS 4230 (Intravenous) 3 microgram/kilogram every three weeks and PEMBROLIZUMAB (KEYTRUDA) (Intravenous) 200 milligram every three weeks. On 12-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criteria hospitalization and medically significant). 12-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criteria hospitalization and medically significant). On 13-Sep-2021, the patient experienced PYREXIA (fever). The patient was hospitalized on 13-Sep-2021 due to NAUSEA and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea and Vomiting, at an unspecified dose and frequency; METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) for Nausea and Vomiting, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for Nausea and Vomiting, at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had resolved with sequelae and PYREXIA (fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, Body temperature: 37.9 (High) 37.9 degree Celsius. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NAUSEA (Nausea) and VOMITING (Vomiting) to be possibly related. No further causality assessment was provided for PYREXIA (fever). Concomitant product use was not provided by the reporter. Additional treatment medications included was IV fluids and anti-nausea medications. Patient's wife reported that he had nausea and vomiting since around midnight after the COVID-19 vaccination. Adverse events was not resolved and the subject remain hospitalized at the time of reporting. Follow-up information received on 30 Sep 2021, the nausea and vomiting were considered as recovered with sequalae on an unknown date. Company Comment: This case concerns a 61-year-old, male patient with medical history of Metastatic malignant melanoma receiving immunotherapy (ALKS 4230 and pembrolizumab), who experienced the serious unexpected events of nausea and vomiting. The events occurred approximately on the same day after the most recent dose of Spikevax (Moderna COVID-19 vaccine) received as a booster dose. The rechallenge was not applicable since the events occurred after the booster dose without information regarding previous doses. The event was considered related to the vaccine per the reporter's assessment. The medical history of immunotherapy as treatment for metastatic malignant melanoma receiving remain a confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Reporter's Comments: Subject experienced events Nausea and Vomiting leading to hospitalized 10 months 11 days after initiating treatment with study drug. The underlying malignancy, melanoma is a confounding factor. Alternate causality was attributed to Covid-19 vaccine booster. There is no indication in this case that the events were attributable to study drugs, Hence, sponsor concurs with the investigator and considers the events as not related to ALK4230 and Keytruda.; Sender's Comments: This case concerns a 61-year-old, male patient with medical history of Metastatic malignant melanoma receiving immunotherapy (ALKS 4230 and pembrolizumab), who experienced the serious unexpected events of nausea and vomiting. The events occurred approximately on the same day after the most recent dose of Spikevax (Moderna COVID-19 vaccine) received as a booster dose. The rechallenge was not applicable since the events occurred after the booster dose without information regarding previous doses. The event was considered related to the vaccine per the reporter's assessment. The medical history of immunotherapy as treatment for metastatic malignant melanoma receiving remain a confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.

Other Meds:

Current Illness: Metastatic malignant melanoma (Stage IV); Nausea (with previous chemotherapy or even before on current treatment); Neoplasm; Vomiting (with previous chemotherapy or even before on current treatment)

ID: 1820446
Sex: F
Age: 12
State: CO

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/27/2021
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: 12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today; 12 yo given moderna vaccine and not Pfizer vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today) and PRODUCT SELECTION ERROR (12 yo given moderna vaccine and not Pfizer vaccine) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Oct-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced PRODUCT SELECTION ERROR (12 yo given moderna vaccine and not Pfizer vaccine). On 15-Oct-2021 at 5:00 PM, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today). On 15-Oct-2021, PRODUCT SELECTION ERROR (12 yo given moderna vaccine and not Pfizer vaccine) had resolved. On 15-Oct-2021 at 5:00 PM, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 yo given moderna vaccine and not Pfizer vaccine/1st dose of Moderna vaccine on accident today) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not reported. 12 yo given 1st dose of Moderna vaccine on accident on 15-Oct-2021 instead of Pfizer and stayed for 15 minutes after vaccination and did not have any side effects or reaction as per doctor. Also patient was asymptomatic. Medical test or laboratory test result related to the event was reported as none. The patient did not received any other vaccines within one month or prior to moderna vaccine. It was unknown if prescription, over the counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and other illnesses at the time of vaccination and up to one month prior. It was unknown if the patient had allergies to medications, food or other products and chronic or long standing health conditions. Other illnesses at the time of vaccination and up to one month prior. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Follow-up received on 19-Oct-2021. Added patient information and Vaccination information.

Other Meds:

Current Illness:

ID: 1820447
Sex: F
Age: 60
State: AR

Vax Date: 08/18/2021
Onset Date:
Rec V Date: 10/27/2021
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: mental block; can't spell/my speech goes in and out/I can't complete sentences and I get confused/I will start a sentence and the front part is in the back and back part is in the front, My speech goes in and out; cant see; can't move/Stiffness muscle/could not bend my knees/My body is not working; confused; When I am writing something I will write a couple of the words twice; My eyes everything is blurry (not necessarily blurry but will come in and out of focus, like you are looking through a kaleidoscope. The corner of something will move over there, and come close and go back. Whatever it is if I turn my head a certain; My bones and my muscles are so stiff and cant move, bend over/I'm like pillar of stone sometimes then it will let up then it will get hard again; My memory goes in and out; Severe headache/migraine; hurts and extremely, extremely painful; Arm soreness/pain in my arm came back and like I just go the shot; low fever; nauseas; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL DISORDER (mental block), APHASIA (can't spell/my speech goes in and out/I can't complete sentences and I get confused/I will start a sentence and the front part is in the back and back part is in the front, My speech goes in and out), VISUAL IMPAIRMENT (cant see), MOBILITY DECREASED (can't move/Stiffness muscle/could not bend my knees/My body is not working) and CONFUSIONAL STATE (confused) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MENTAL DISORDER (mental block), APHASIA (can't spell/my speech goes in and out/I can't complete sentences and I get confused/I will start a sentence and the front part is in the back and back part is in the front, My speech goes in and out), VISUAL IMPAIRMENT (cant see), MOBILITY DECREASED (can't move/Stiffness muscle/could not bend my knees/My body is not working), CONFUSIONAL STATE (confused), DYSGRAPHIA (When I am writing something I will write a couple of the words twice), VISION BLURRED (My eyes everything is blurry (not necessarily blurry but will come in and out of focus, like you are looking through a kaleidoscope. The corner of something will move over there, and come close and go back. Whatever it is if I turn my head a certain), MUSCULOSKELETAL STIFFNESS (My bones and my muscles are so stiff and cant move, bend over/I'm like pillar of stone sometimes then it will let up then it will get hard again), AMNESIA (My memory goes in and out), MIGRAINE (Severe headache/migraine), PAIN (hurts and extremely, extremely painful), VACCINATION SITE PAIN (Arm soreness/pain in my arm came back and like I just go the shot), PYREXIA (low fever), NAUSEA (nauseas) and VOMITING (vomiting). The patient was treated with TOPIRAMATE (oral) for Migraine, at a dose of 25 mg 1tab 2/day. At the time of the report, MENTAL DISORDER (mental block), APHASIA (can't spell/my speech goes in and out/I can't complete sentences and I get confused/I will start a sentence and the front part is in the back and back part is in the front, My speech goes in and out), VISUAL IMPAIRMENT (cant see), MOBILITY DECREASED (can't move/Stiffness muscle/could not bend my knees/My body is not working), CONFUSIONAL STATE (confused), DYSGRAPHIA (When I am writing something I will write a couple of the words twice), VISION BLURRED (My eyes everything is blurry (not necessarily blurry but will come in and out of focus, like you are looking through a kaleidoscope. The corner of something will move over there, and come close and go back. Whatever it is if I turn my head a certain), MUSCULOSKELETAL STIFFNESS (My bones and my muscles are so stiff and cant move, bend over/I'm like pillar of stone sometimes then it will let up then it will get hard again), AMNESIA (My memory goes in and out), MIGRAINE (Severe headache/migraine), PAIN (hurts and extremely, extremely painful), VACCINATION SITE PAIN (Arm soreness/pain in my arm came back and like I just go the shot), PYREXIA (low fever), NAUSEA (nauseas) and VOMITING (vomiting) 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. Patient stated she went to the hospital and received an X-ray, MRI without contrast -they were both clear.

Other Meds:

Current Illness:

ID: 1820448
Sex: F
Age: 0
State: FL

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 10/27/2021
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: body ache; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and FATIGUE (mild fatigue) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: PFIZER (LOT- EN6201) on 24-Jan-2021 and PFIZER (LOT-EN5318) on 13-Feb-2021. Concurrent medical conditions included Immunocompromised. Concomitant products included METFORMIN, GABAPENTIN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), LISINOPRIL, TRAZODONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM OXALATE (LEXAPRO), ATORVASTATIN and CERTOLIZUMAB PEGOL (CIMZIA) for an unknown indication. On 13-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 an unknown date, the patient experienced MYALGIA (body ache) and FATIGUE (mild fatigue). At the time of the report, MYALGIA (body ache) and FATIGUE (mild fatigue) had resolved. No treatment reported. It was reported that patient also received 2 doses of COVID-19 vaccines from Pfizer and experienced localized tenderness around the area of the shot. This case was linked to MOD-2021-355779 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: The follow up includes no new information.

Other Meds: Metformin; Gabapentin; Zyrtec Allergy; Lisinopril; Trazodone; Baby Aspirin; Lexapro; Atorvastatin; Cimzia

Current Illness: Immunocompromised

ID: 1820449
Sex: F
Age: 68
State: CA

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 10/27/2021
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: Received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-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 third 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 (Received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received a dose past 30-day use by date) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided by the reporter No treatment medications were provided by the reporter. This case was linked to MOD-2021-355943, MOD-2021-356165, MOD-2021-355963, MOD-2021-355936, MOD-2021-355901, MOD-2021-355936, MOD-2021-355911, MOD-2021-355963, MOD-2021-356222, MOD-2021-356295 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up information included no new information

Other Meds:

Current Illness:

ID: 1820450
Sex: F
Age: 71
State: IL

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/27/2021
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: lump where shot was given; lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.; now is reddish-brown like a bruise; stayed in bed all day; became sick for 3 days; back of her neck was hurting; got hot and cold; had chills; top of her head was hurting/headache; injection site pain under left arm; Accidental overdose; Off label use; got nervous; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (got nervous), ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold) and BEDRIDDEN (stayed in bed all day) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Latex allergy (medication sensitivities including latex). On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Oct-2021, the patient experienced NERVOUSNESS (got nervous), ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use). On 15-Oct-2021, the patient experienced ILLNESS (became sick for 3 days), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm). On 16-Oct-2021, the patient experienced BEDRIDDEN (stayed in bed all day). On 18-Oct-2021, the patient experienced VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.) and CONTUSION (now is reddish-brown like a bruise). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of UNK, qid. On 14-Oct-2021, ACCIDENTAL OVERDOSE (Accidental overdose) and OFF LABEL USE (Off label use) had resolved. In October 2021, ILLNESS (became sick for 3 days) had resolved. On 18-Oct-2021, BEDRIDDEN (stayed in bed all day) was resolving. At the time of the report, NERVOUSNESS (got nervous), NECK PAIN (back of her neck was hurting), FEELING OF BODY TEMPERATURE CHANGE (got hot and cold), VACCINATION SITE MASS (lump where shot was given), VACCINATION SITE DISCOLOURATION (lump is discolored/initially was reddishpurple but now is reddish-brown like a bruise.), CONTUSION (now is reddish-brown like a bruise), CHILLS (had chills), HEADACHE (top of her head was hurting/headache) and VACCINATION SITE PAIN (injection site pain under left arm) outcome was unknown. Concomitant medications were not reported. Patient lump was about the size of a dime. The patient has gained 25 lbs. This case was linked to MOD-2021-355953 (Patient Link).

Other Meds:

Current Illness: Latex allergy (medication sensitivities including latex)

ID: 1820451
Sex: M
Age: 80
State: PA

Vax Date: 02/28/2021
Onset Date: 02/28/2021
Rec V Date: 10/27/2021
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: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm). At the time of the report, PAIN IN EXTREMITY (Sore left arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was provided. This case was linked to MOD-2021-356211 (Patient Link).

Other Meds:

Current Illness:

ID: 1820452
Sex: M
Age: 57
State: WI

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 10/27/2021
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: Rash in his armpit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash in his armpit) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (DECONGESTANT II) for an unknown indication. On 12-Mar-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 RASH (rash in his armpit). The patient was treated with PREDNISONE for Allergy, at an unspecified dose and frequency. At the time of the report, RASH (rash in his armpit) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-356213 (Patient Link).

Other Meds: DECONGESTANT II

Current Illness:

ID: 1820453
Sex: M
Age: 49
State: CA

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 10/27/2021
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: face a little warm; a little red; after a week, I noticed a lump on my neck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (face a little warm), ERYTHEMA (a little red) and NECK MASS (after a week, I noticed a lump on my neck) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 04-Feb-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 FEELING HOT (face a little warm), ERYTHEMA (a little red) and NECK MASS (after a week, I noticed a lump on my neck). At the time of the report, FEELING HOT (face a little warm) and ERYTHEMA (a little red) outcome was unknown and NECK MASS (after a week, I noticed a lump on my neck) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient went to his doctor to do an ultrasound, but it wasn't anything. This case was linked to MOD-2021-356657, MOD-2021-356658 (Patient Link).

Other Meds:

Current Illness: Asthma

ID: 1820454
Sex: U
Age:
State: MI

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/27/2021
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: Patient administered vaccine that has possibly expired; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine that has possibly expired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The vial was initially stored in the refrigerator- 02-OCT-2021 The vial doesn't undergo any temperature excursions Concomitant medication were not reported. Treatment information were not reported. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow-up received and had no significant information. A query has been raised about expiration date extension of vaccine LOT#033B21A

Other Meds:

Current Illness:

ID: 1820455
Sex: F
Age: 76
State: PA

Vax Date: 03/29/2021
Onset Date: 02/28/2021
Rec V Date: 10/27/2021
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: sore left arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore left arm) in a 75-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 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore left arm). At the time of the report, PAIN IN EXTREMITY (sore left arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and Treatment was not specified. Case is crosslinked to MOD21-153943 This case was linked to MOD-2021-356211 (Patient Link).

Other Meds:

Current Illness:

ID: 1820456
Sex: F
Age: 14
State: PA

Vax Date: 09/16/2021
Onset Date: 09/16/2021
Rec V Date: 10/27/2021
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: Gave 14 years old 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave 14 years old 1st dose) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) from 16-Sep-2021 to an unknown date, MAGNESIUM OXIDE from 16-Sep-2021 to an unknown date and TRETINOIN (RETIN-A) for an unknown indication. On 16-Sep-2021 at 5:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave 14 years old 1st dose). On 16-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave 14 years old 1st dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug details was received. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow-up document received on 21-Oct-21 : patient height, weight ,race, ethinicity, second dose information, concomitant medications were updated.

Other Meds: KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]; MAGNESIUM OXIDE; RETIN-A

Current Illness:

ID: 1820457
Sex: M
Age: 49
State: CA

Vax Date: 02/04/2021
Onset Date: 09/08/2021
Rec V Date: 10/27/2021
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: he had pain in his arm at the injection site; lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there; he didn't feel anything right away/everything came down right away; tired; very low-grade fever; a little weak; really sick; joints and legs below the knees/ he couldn't walk for 7 hours; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/ he couldn't walk for 7 hours), NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there) and FEELING ABNORMAL (he didn't feel anything right away/everything came down right away ) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 88D21A, 015M20H and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, the patient experienced ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/ he couldn't walk for 7 hours), FEELING ABNORMAL (he didn't feel anything right away/everything came down right away ), FATIGUE (tired) and PYREXIA (very low-grade fever ). On 15-Oct-2021, the patient experienced NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there). On an unknown date, the patient experienced VACCINATION SITE PAIN (he had pain in his arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL A) on 08-Sep-2021 at a dose of 1 dosage form. At the time of the report, ASTHENIA (a little weak), ILLNESS (really sick), GAIT DISTURBANCE (joints and legs below the knees/ he couldn't walk for 7 hours), NEOPLASM (lymph nodes on the groin area were huge/ tumor/lumps in my groin area are still there), FEELING ABNORMAL (he didn't feel anything right away/everything came down right away ), FATIGUE (tired), PYREXIA (very low-grade fever ) and VACCINATION SITE PAIN (he had pain in his arm at the injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported Patient felt really sick. He had a very low-grade fever. His joints and legs below the knees he couldn't walk for 7 hours. He was just laying down and had a bottle of Tylenol and water. The patient adds that after the second and third dose, he had pain in his arm at the injection site. It was worse after the third dose This case was linked to MOD-2021-356190, MOD-2021-356657 (Patient Link).

Other Meds:

Current Illness: Asthma

ID: 1820458
Sex: U
Age: 64
State: PA

Vax Date: 09/20/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) 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. This case was linked to MOD-2021-356818 (Patient Link).

Other Meds:

Current Illness:

ID: 1820459
Sex: U
Age: 64
State: PA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment drugs were reported.

Other Meds:

Current Illness:

ID: 1820460
Sex: U
Age: 52
State: PA

Vax Date: 02/15/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness: Immunocompromised

ID: 1820461
Sex: U
Age: 74
State: PA

Vax Date: 02/25/2021
Onset Date: 10/18/2021
Rec V Date: 10/27/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment medications provided.

Other Meds:

Current Illness: Immunocompromised

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am