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: 1644945
Sex: F
Age: 32
State: KY

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: 1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E121A) for COVID-19 vaccination. No medical history was reported. Concomitant products included BUDESONIDE for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose). On 11-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose of moderna covid vaccine on 19Jan2021 at a hospital. The patient came to the pharmacy yesterday, 11Aug2021 for their second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided by the reporter.

Other Meds: BUDESONIDE

Current Illness:

ID: 1644946
Sex: F
Age: 33
State: AR

Vax Date: 06/01/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210728; Test Name: blood pressure; Result Unstructured Data: 150/90 mmHg

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: her body was on fire; foggy brain; she was so numb; could not walk; she threw up and it lasted for probably 7 hours; her neurological function went down; Her blood pressure was really high 150/90; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), HYPERTENSION (Her blood pressure was really high 150/90) and NERVOUS SYSTEM DISORDER (her neurological function went down) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced HYPERTENSION (Her blood pressure was really high 150/90). On 01-Aug-2021, the patient experienced NERVOUS SYSTEM DISORDER (her neurological function went down). On an unknown date, the patient experienced FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), GAIT INABILITY (could not walk) and VOMITING (she threw up and it lasted for probably 7 hours). At the time of the report, FEELING HOT (her body was on fire), FEELING ABNORMAL (foggy brain), HYPOAESTHESIA (she was so numb), HYPERTENSION (Her blood pressure was really high 150/90), NERVOUS SYSTEM DISORDER (her neurological function went down) and GAIT INABILITY (could not walk) outcome was unknown and VOMITING (she threw up and it lasted for probably 7 hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Blood pressure measurement: 150/90 mmhg (High) 150/90 mmHg. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. This case was linked to MOD-2021-285548 (Patient Link).

Other Meds:

Current Illness:

ID: 1644947
Sex: M
Age: 45
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication product use was not provided by the reporter. Vial may had been move from the freezer to the refrigerator on 02-Aug-2021. Vial did not undergo any previous temperature excursions. Total amount of time the vial was exposed to room temperature range (46? to 77? F). No treatment information was provided. This case was linked to MOD-2021-285140, MOD-2021-285144, MOD-2021-285214, MOD-2021-285623, MOD-2021-285659 (E2B Linked Report).; Sender's Comments: MOD-2021-285140:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285144:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285214:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285623:6 patients received expired Moderna COVID-19 vaccine MOD-2021-285659:6 patients received expired Moderna COVID-19 vaccine

Other Meds:

Current Illness:

ID: 1644948
Sex: M
Age: 62
State: IN

Vax Date: 12/29/2020
Onset Date: 08/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210805; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive took 3 minute; Test Date: 20210805; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive took 4 minute

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Lack of efficacy; congested in his sinus area; a little fatigue; contracted asymptomatic COVID; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (contracted asymptomatic COVID), DRUG INEFFECTIVE (Lack of efficacy), SINUS CONGESTION (congested in his sinus area) and FATIGUE (a little fatigue) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included VIT D [VITAMIN D NOS], ASCORBIC ACID (VIT C) and ZINC for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced ASYMPTOMATIC COVID-19 (contracted asymptomatic COVID). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of efficacy), SINUS CONGESTION (congested in his sinus area) and FATIGUE (a little fatigue). The patient was treated with GUAIFENESIN (MUCINEX) for Adverse event, at an unspecified dose and frequency. At the time of the report, ASYMPTOMATIC COVID-19 (contracted asymptomatic COVID), DRUG INEFFECTIVE (Lack of efficacy), SINUS CONGESTION (congested in his sinus area) and FATIGUE (a little fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive took 3 minute and positive (Positive) Positive took 4 minute.

Other Meds: VIT D [VITAMIN D NOS]; VIT C; ZINC

Current Illness:

ID: 1644949
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
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: Erythema multiforme; glomerulonephritis or kidney inflammation; nephrotic syndrome; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA MULTIFORME (Erythema multiforme), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) and NEPHROTIC SYNDROME (nephrotic syndrome) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (Erythema multiforme) (seriousness criterion medically significant), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) (seriousness criterion medically significant) and NEPHROTIC SYNDROME (nephrotic syndrome) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Erythema multiforme), GLOMERULONEPHRITIS (glomerulonephritis or kidney inflammation) and NEPHROTIC SYNDROME (nephrotic syndrome) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided and no treatment information was provided. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1644950
Sex: M
Age: 37
State: CA

Vax Date: 04/13/2021
Onset Date: 05/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Given vaccine after sitting out punctured for a day.; Given another dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Given vaccine after sitting out punctured for a day.) and EXTRA DOSE ADMINISTERED (Given another dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. It was reported that vaccine had been punctured on 10-May-2021 and left on the counter overnight before 3 doses were administered and the vaccine given to the patient was expired. Reporter also stated that concerning dose of vaccine had not experienced any previous temperature excursions. Patient did not experience any known symptoms on receiving 3 doses of the vaccine.

Other Meds:

Current Illness:

ID: 1644951
Sex: M
Age: 45
State: MO

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not reported. This case was linked to MOD21-129698, MOD21-129760, MOD21-129760, MOD21-129763, MOD21-129764, MOD-2021-285598 (Patient Link).

Other Meds:

Current Illness:

ID: 1644952
Sex: F
Age: 51
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: she won't be getting the second dose of the vaccine; chills; headaches; side effects that she is not comfortable with; "Everything it's sticking to me and I don't like it at all" ? to her arm and forehead.; she laid down on her phone and it got stuck to her arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all" ? to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all" ? to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), CHILLS (chills) and HEADACHE (headaches). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine). At the time of the report, DISCOMFORT (side effects that she is not comfortable with), VACCINATION COMPLICATION ("Everything it's sticking to me and I don't like it at all" ? to her arm and forehead.), LIMB DISCOMFORT (she laid down on her phone and it got stuck to her arm), INTENTIONAL DOSE OMISSION (she won't be getting the second dose of the vaccine), CHILLS (chills) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1644953
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: 5 months since first dose; Made my heart race and flutter for 3 weeks on and off; Made my heart race and flutter for 3 weeks on and off; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off) (seriousness criterion medically significant), PALPITATIONS (Made my heart race and flutter for 3 weeks on and off) and PRODUCT DOSE OMISSION ISSUE (5 months since first dose). At the time of the report, CARDIAC FLUTTER (Made my heart race and flutter for 3 weeks on and off), PALPITATIONS (Made my heart race and flutter for 3 weeks on and off) and PRODUCT DOSE OMISSION ISSUE (5 months since first dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment information was provided. The patient did not get the second dose because of the adverse events. Company Comment: Very limited information regarding the events has been provided at this time insufficient for causality assessment.; Sender's Comments: Very limited information regarding the events has been provided at this time insufficient for causality assessment.

Other Meds:

Current Illness:

ID: 1644954
Sex: F
Age: 62
State: SD

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Rash; Painful arm and arm hurting a lot; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Mastectomy (In Right hand side) and Migraine. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN MIGRAINE) for Migraine. On 15-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), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, RASH (Rash), VACCINATION SITE PAIN (Painful arm and arm hurting a lot), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. This case was linked to MOD-2021-285649 (Patient Link).

Other Meds: EXCEDRIN MIGRAINE

Current Illness: Mastectomy (In Right hand side); Migraine

ID: 1644955
Sex: F
Age: 51
State: NY

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20201223; Test Name: Blood pressure; Result Unstructured Data: blood pressure was "through the roof

Allergies:

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

Symptoms: Did not want to receive the second dose; Horrible Headache; Hypokalemia; Chest Pain; Chest Pressure; Felt like I was hit by a train; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOKALAEMIA (Hypokalemia) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced HYPOKALAEMIA (Hypokalemia) (seriousness criterion medically significant), CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Pressure), FEELING ABNORMAL (Felt like I was hit by a train) and HEADACHE (Horrible Headache). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not want to receive the second dose). The patient was treated with POTASSIUM (intravenous) for Hypokalemia, at an unspecified dose and frequency. On 26-Dec-2020, FEELING ABNORMAL (Felt like I was hit by a train) had resolved. At the time of the report, HYPOKALAEMIA (Hypokalemia), CHEST PAIN (Chest Pain), CHEST DISCOMFORT (Chest Pressure) and HEADACHE (Horrible Headache) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not want to receive the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Blood pressure measurement: high (High) blood pressure was "through the roof. 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. Additional treatment medications included intravenous fluids.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644956
Sex: F
Age:
State: CA

Vax Date: 05/07/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Beyond 42 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Beyond 42 days for 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644957
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
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: Dizziness; Chest pains; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and CHEST PAIN (Chest pains) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and CHEST PAIN (Chest pains). At the time of the report, DIZZINESS (Dizziness) and CHEST PAIN (Chest pains) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Medications details were provided. No Treatment Medications details were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1644958
Sex: F
Age: 63
State: NC

Vax Date: 08/10/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rashes itch; rashes on her stomach and back,rash sting; This spontaneous case was reported by a consumer and describes the occurrence of in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy and Drug allergy. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. NO Treatment drug reported. Patient reported she stayed in the observation room for 30 minutes & she did not experience any reaction that time. Patient is allergic to a lot of over the counter drugs, penicillin, sulfur.

Other Meds:

Current Illness: Drug allergy; Penicillin allergy

ID: 1644959
Sex: F
Age: 55
State: MO

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

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

Lab Data:

Allergies:

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

Symptoms: Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On 12-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided No treatment information was provided This case was linked to MOD-2021-285598 (Patient Link).

Other Meds:

Current Illness:

ID: 1644960
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Lump under arm; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump under arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MASS (Lump under arm). At the time of the report, MASS (Lump under arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1644961
Sex: M
Age: 57
State:

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

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

Lab Data:

Allergies:

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

Symptoms: sore injection site left arm; Headache; Fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (Headache), PYREXIA (Fever) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. No treatment details were reported. This case was linked to MOD-2021-285675 (Patient Link).

Other Meds:

Current Illness:

ID: 1644962
Sex: M
Age: 67
State:

Vax Date: 03/16/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Tremors in both hands and jaw; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremors in both hands and jaw) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 048A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced TREMOR (Tremors in both hands and jaw). At the time of the report, TREMOR (Tremors in both hands and jaw) had not resolved. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1644963
Sex: M
Age: 57
State:

Vax Date: 04/17/2021
Onset Date: 05/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: sore injection site left arm; headache; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown. No concomitant medication information was provided. No treatment medication information was provided. This case was linked to MOD-2021-285667 (Patient Link).

Other Meds:

Current Illness:

ID: 1644964
Sex: F
Age: 69
State: TX

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pain at the injection site but not on the muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site but not on the muscle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site but not on the muscle). At the time of the report, VACCINATION SITE PAIN (pain at the injection site but not on the muscle) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-285693.

Other Meds:

Current Illness:

ID: 1644965
Sex: F
Age: 69
State: AR

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: couldn't lift both arms and both legs; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (couldn't lift both arms and both legs) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) for COVID-19 vaccination. Concomitant products included GABAPENTIN for Neuropathy, Blood pressure and Thyroid therapy. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSKINESIA (couldn't lift both arms and both legs) (seriousness criterion hospitalization). The patient was hospitalized from sometime in March 2021 to 06-Apr-2021 due to DYSKINESIA. The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) at an unspecified dose and frequency. At the time of the report, DYSKINESIA (couldn't lift both arms and both legs) outcome was unknown. Patient was having physical therapy due to too much of antibodies (unspecified) were damaging patient's muscle. The patient was hospitalized for 12 days. Also patient was taking 2 infusions with rituxan caller does not know how to spell Rituxan, actual medicine could not be confirmed. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: GABAPENTIN

Current Illness:

ID: 1644966
Sex: M
Age: 64
State: SD

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a sore arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood disorder. On 22-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 VACCINATION SITE PAIN (a sore arm). At the time of the report, VACCINATION SITE PAIN (a sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication include chemotherapy for a blood disorder. No Treatment information was reported. This case was linked to MOD-2021-285685 (Patient Link).

Other Meds:

Current Illness: Blood disorder

ID: 1644967
Sex: M
Age: 64
State: SD

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: slept all day after the second dose; feeling bad; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 024M20A) for COVID-19 vaccination. The patient's past medical history included Chemotherapy (chemotherapy for a blood disorder.). On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-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 HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills). At the time of the report, HYPERSOMNIA (slept all day after the second dose), FEELING ABNORMAL (feeling bad), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Concomitant medications were not provided by the reporter. This case was linked to MOD-2021-285683 (Patient Link).

Other Meds:

Current Illness:

ID: 1644968
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning). At the time of the report, VACCINATION COMPLICATION (she went to the hospital and told them it was from the vaccine they told her it was probably food poisoning) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment and concomitant medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1644969
Sex: F
Age: 69
State: TX

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: lose strength/without strength/the muscle on the "rabbit" there is where lost strength; tried to lift the arm and the pain was strong; muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt; where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle; tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired). At the time of the report, ASTHENIA (lose strength/without strength/the muscle on the "rabbit" there is where lost strength), PAIN IN EXTREMITY (tried to lift the arm and the pain was strong), MYALGIA (muscle pain/after being out under the sun for a long time the muscle on the arms started to hurt), VACCINATION SITE PAIN (where the vaccine was injected the arm hurt a lot/pain at the injection site but not on the muscle) and FATIGUE (tired) outcome was unknown. Concomitant product information was not provided. Treatment information was not provided by the reporter. This case was linked to MOD-2021-285679 (Patient Link).

Other Meds:

Current Illness:

ID: 1644970
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: Achy for the day after first dose; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy for the day after first dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medication history information was reported. Concomitant products included APIXABAN (ELIQUIS) and CLONIDINE for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Achy for the day after first dose). At the time of the report, MYALGIA (Achy for the day after first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment medication were provided. This case was linked to MOD-2021-285702 (Patient Link).

Other Meds: ELIQUIS; CLONIDINE

Current Illness:

ID: 1644971
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Shortness of breath; Felt like a sinus infection; right eyelid is twitching; sometimes can't open eyelids in the morning /eyes feel heavy and sandy /heavy sandy feeling in both eyes; can't raise his left arm sometimes; Achy; the Injection site was aching; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning /eyes feel heavy and sandy /heavy sandy feeling in both eyes) and MOBILITY DECREASED (can't raise his left arm sometimes) in a 68-year-old male 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 Retinal hole (Patient has hole in the retina in his left eye so he sees eye doctor for that, was diagnosed three years ago.). Concomitant products included APIXABAN (ELIQUIS) and CLONIDINE for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection), BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning /eyes feel heavy and sandy /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes), MYALGIA (Achy) and INJECTION SITE PAIN (the Injection site was aching). At the time of the report, DYSPNOEA (Shortness of breath), SINUSITIS (Felt like a sinus infection) and MYALGIA (Achy) had resolved and BLEPHAROSPASM (right eyelid is twitching), EYELID FUNCTION DISORDER (sometimes can't open eyelids in the morning /eyes feel heavy and sandy /heavy sandy feeling in both eyes), MOBILITY DECREASED (can't raise his left arm sometimes) and INJECTION SITE PAIN (the Injection site was aching) had not resolved. No treatment medicine was provided. This case was linked to MOD-2021-285694 (Patient Link).

Other Meds: ELIQUIS; CLONIDINE

Current Illness: Retinal hole (Patient has hole in the retina in his left eye so he sees eye doctor for that, was diagnosed three years ago.)

ID: 1644972
Sex: F
Age: 72
State: FL

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Auto immune disease in inner right ear; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) and VERTIGO (Vertigo) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. Concurrent medical conditions included Meniere's disease (In left ear) since 2019. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) for Autoimmune inner ear disease, PREDNISONE, METOPROLOL TARTRATE (METOPROLOL XL), ROSUVASTATIN CALCIUM (CRESTOR), FAMOTIDINE (PEPCID [FAMOTIDINE]), LEVOTHYROXINE and DENOSUMAB (PROLIA) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) (seriousness criterion medically significant) and VERTIGO (Vertigo) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE INNER EAR DISEASE (Auto immune disease in inner right ear) and VERTIGO (Vertigo) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The treatment with Imuran for autoimmune ear disease was discontinued due to high liver enzymes. The patient received both of vaccinations in left arm shoulder deltoid muscle. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However patients' past history of Meniere's disease could be a confounding factor in the occurrence of events. This case was linked to MOD-2021-285741 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However patients' past history of Meniere's disease could be a confounding factor in the occurrence of events.

Other Meds: PREDNISONE; METOPROLOL XL; CRESTOR; PEPCID [FAMOTIDINE]; IMURAN [AZATHIOPRINE]; CELLCEPT [MYCOPHENOLATE MOFETIL]; LEVOTHYROXINE; PROLIA

Current Illness: Meniere's disease (In left ear)

ID: 1644973
Sex: F
Age: 72
State: FL

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 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: Auto immuneinner Ear Disease in her right ear.; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (Auto immuneinner Ear Disease in her right ear.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Meniere's disease (Left ear) in 2019. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]), DENOSUMAB (PROLIA), PREDNISONE, LEVOTHYROXINE, METOPROLOL TARTRATE (METOPROLOL XL) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE INNER EAR DISEASE (Auto immuneinner Ear Disease in her right ear.) (seriousness criterion medically significant) and VERTIGO (Vertigo). The patient was treated with AZATHIOPRINE (IMURAN [AZATHIOPRINE]) at an unspecified dose and frequency and MYCOPHENOLATE MOFETIL (CELLCEPT [MYCOPHENOLATE MOFETIL]) at an unspecified dose and frequency. At the time of the report, AUTOIMMUNE INNER EAR DISEASE (Auto immuneinner Ear Disease in her right ear.) and VERTIGO (Vertigo) outcome was unknown. Patient was treated with Imuran and was discontinued due to high Liver Enzymes and then patient was placed on Cellcept . This case was linked to MOD-2021-285739 (Patient Link).; Sender's Comments: This case concerns a 72-year-old female, with a history of Meniere's disease (left ear), who developed serious unexpected events of autoimmune inner ear disease (right ear) with associated vertigo. Event latency 2 weeks after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: PEPCID [FAMOTIDINE]; PROLIA; PREDNISONE; LEVOTHYROXINE; METOPROLOL XL; CRESTOR

Current Illness:

ID: 1644974
Sex: U
Age:
State:

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

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

Lab Data: Test Date: 20210803; Test Name: Heart rate; Result Unstructured Data: increased

Allergies:

Symptom List: Nausea

Symptoms: pneumonia; chest hurt; asthma; and fever since the end of May.; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a patient of an unknown age and gender 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 03-Apr-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. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant), CHEST PAIN (chest hurt), ASTHMA (asthma) and PYREXIA (and fever since the end of May.). At the time of the report, PNEUMONIA (pneumonia), CHEST PAIN (chest hurt), ASTHMA (asthma) and PYREXIA (and fever since the end of May.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: high (High) increased. No concomitant medication information was provided No treatment product information was provided Company comment: Very limited information regarding these events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.

Other Meds:

Current Illness:

ID: 1644975
Sex: F
Age: 69
State: PA

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: rash on both legs and arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on both legs and arms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included MELOXICAM from 18-Feb-2021 to an unknown date for Pain. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (rash on both legs and arms). At the time of the report, RASH (rash on both legs and arms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication were not provided. treatment medications included steroid cream for rash. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-286241 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MELOXICAM

Current Illness:

ID: 1644976
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: broke out with bumps everywhere; bumps from the tip of the shoulder to the injection site; rash; red bumps from the tip of the shoulder to the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (broke out with bumps everywhere), VACCINATION SITE MASS (bumps from the tip of the shoulder to the injection site), RASH (rash) and VACCINATION SITE ERYTHEMA (red bumps from the tip of the shoulder to the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder (it was reported as not clear whether hyperthyroidism or hypothyroidism, also mentioned Hajimoto's disease.), Heart attack (Reported as twice almost has a heart attack.), Allergy multiple (reported as allergic to everything), Adhesive tape allergy (reported as allergic to band-aids), Eczema and Hashimoto's disease. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (broke out with bumps everywhere), VACCINATION SITE MASS (bumps from the tip of the shoulder to the injection site), RASH (rash) and VACCINATION SITE ERYTHEMA (red bumps from the tip of the shoulder to the injection site). At the time of the report, SKIN MASS (broke out with bumps everywhere), VACCINATION SITE MASS (bumps from the tip of the shoulder to the injection site), RASH (rash) and VACCINATION SITE ERYTHEMA (red bumps from the tip of the shoulder to the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. This case was linked to MOD-2021-286389 (Patient Link).

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Adhesive tape allergy (reported as allergic to band-aids); Allergy multiple (reported as allergic to everything); Eczema; Hashimoto's disease; Heart attack (Reported as twice almost has a heart attack.); Thyroid disorder (it was reported as not clear whether hyperthyroidism or hypothyroidism, also mentioned Hajimoto's disease.)

ID: 1644977
Sex: F
Age: 45
State: CT

Vax Date: 03/24/2021
Onset Date: 08/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 1st dose 24Mar2021; no 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose). On 13-Aug-2021, PRODUCT DOSE OMISSION ISSUE (1st dose 24Mar2021; no 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had had an antibody test in end of Jun2021 or beginning of Jul2021 with a result of 20 (no units). No concomitant medications were reported. No treatment information were reported.

Other Meds:

Current Illness:

ID: 1644978
Sex: M
Age: 73
State: FL

Vax Date: 01/09/2021
Onset Date: 08/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: Tested positive for Covid-19

Allergies:

Symptom List: Tremor

Symptoms: feeling feverish fever reached 101F; Chills; Tested positive for Covid-19/tested positive after 6 months; tested positive after 6 months; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid-19/tested positive after 6 months), DRUG INEFFECTIVE (tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid-19/tested positive after 6 months) and DRUG INEFFECTIVE (tested positive after 6 months). On an unknown date, the patient experienced PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills). At the time of the report, COVID-19 (Tested positive for Covid-19/tested positive after 6 months), PYREXIA (feeling feverish fever reached 101F) and CHILLS (Chills) had resolved and DRUG INEFFECTIVE (tested positive after 6 months) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19. Treatment medication was not provided. Concomitant medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Live Follow up received on 13-Aug-2021, event information updated

Other Meds:

Current Illness:

ID: 1644979
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Was sick all night; Abdominal burning; Shaking; Fever; Muscle pain; Joint pain; severe headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever) and MYALGIA (Muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills). At the time of the report, ILLNESS (Was sick all night), ABDOMINAL DISCOMFORT (Abdominal burning), TREMOR (Shaking), PYREXIA (Fever), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), HEADACHE (severe headache) and CHILLS (Chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drugs were provided No treatment drugs were provided

Other Meds:

Current Illness:

ID: 1644980
Sex: M
Age: 30
State: NJ

Vax Date: 08/09/2021
Onset Date: 08/10/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: can't sleep; he's not even resting because of the pain irradiating from the neck and back, to ribs and chest; chest pain; pain went to the ribs; Neck pain; Shoulder pain; pain was from the injection site/the pain was excrutiating; This spontaneous case was reported by a non-health professional and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest) and NECK PAIN (Neck pain) in a 30-year-old male 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 was provided. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating). On 12-Aug-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (pain went to the ribs). On 13-Aug-2021, the patient experienced CHEST PAIN (chest pain). On an unknown date, the patient experienced INSOMNIA (can't sleep) and RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL CHEST PAIN (pain went to the ribs), CHEST PAIN (chest pain), INSOMNIA (can't sleep), RESTLESSNESS (he's not even resting because of the pain irradiating from the neck and back, to ribs and chest), NECK PAIN (Neck pain), ARTHRALGIA (Shoulder pain) and VACCINATION SITE PAIN (pain was from the injection site/the pain was excrutiating) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644981
Sex: M
Age: 13
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: 13 year old was given the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C1A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine) 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.

Other Meds:

Current Illness:

ID: 1644982
Sex: F
Age: 74
State: OH

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: headache/horrendous headache; I couldn't do anything I was lying down the whole time; she reported she is now sneezing occasionally; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache/horrendous headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I couldn't do anything I was lying down the whole time) and SNEEZING (she reported she is now sneezing occasionally) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concomitant products included CALCIUM, VITAMIN C [ASCORBIC ACID] and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache/horrendous headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I couldn't do anything I was lying down the whole time) and SNEEZING (she reported she is now sneezing occasionally). At the time of the report, HEADACHE (headache/horrendous headache), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I couldn't do anything I was lying down the whole time) and SNEEZING (she reported she is now sneezing occasionally) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: CALCIUM; VITAMIN C [ASCORBIC ACID]; VITAMIN D3

Current Illness:

ID: 1644983
Sex: U
Age: 48
State: MI

Vax Date: 07/14/2021
Onset Date: 07/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patients who received a vaccine which was more than 30 days in the refrigerator/For this patient, the number of days that have passed were 11) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644984
Sex: F
Age: 69
State: PA

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: WBC; Result Unstructured Data: increased

Allergies:

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

Symptoms: pain spread to her wrist; could barely move her hands; pain now moving up both arms; pain is now spreading to her neck; patient is not able to drive as a result of these conditions; Infection or inflammation; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) and INFECTION (Infection or inflammation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. Concomitant products included PREDNISONE for Pain. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain spread to her wrist) (seriousness criterion medically significant), MOBILITY DECREASED (could barely move her hands) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain now moving up both arms) (seriousness criterion medically significant), NECK PAIN (pain is now spreading to her neck) (seriousness criterion medically significant), IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) (seriousness criterion medically significant) and INFECTION (Infection or inflammation) (seriousness criterion medically significant). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency and ACETAMINOPHEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (pain spread to her wrist), MOBILITY DECREASED (could barely move her hands), PAIN IN EXTREMITY (pain now moving up both arms), NECK PAIN (pain is now spreading to her neck) and IMPAIRED DRIVING ABILITY (patient is not able to drive as a result of these conditions) outcome was unknown and INFECTION (Infection or inflammation) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: increased (High) increased. The patient had appointments with accupuncture , rheumatology and a chiropractor The patient was tested for Lupus, Leukemia, Carpal Tunnel and all were ruled out. Treatment medications include steroid injection and steroid cream for pain. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-286198 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds: PREDNISONE

Current Illness:

ID: 1644985
Sex: F
Age: 48
State: PA

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Immediately after the injection she felt a hot flash; Then an hour later she had a rapid heart rate; Then an hour later she had a rapid heart rate and heartburn; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008021A) for COVID-19 vaccination. No Medical History information was reported. On 29-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 HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn). On 29-Jul-2021, HOT FLUSH (Immediately after the injection she felt a hot flash), HEART RATE INCREASED (Then an hour later she had a rapid heart rate) and DYSPEPSIA (Then an hour later she had a rapid heart rate and heartburn) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1644986
Sex: M
Age: 65
State: TX

Vax Date: 02/11/2021
Onset Date: 02/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210811; Test Name: COVID-19 antibody test; Test Result: Negative ; Result Unstructured Data: COVID-19 antibody test negative.

Allergies:

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

Symptoms: He could die from it; jaw swelled up again; received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment; swollen jaw; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (He could die from it) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: FLU VACCINE VII (he gets the Flu vaccine every year.). Concurrent medical conditions included Blood pressure high, Diabetic and High cholesterol. Concomitant products included LISINOPRIL for Blood pressure high, INSULIN for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SWELLING FACE (swollen jaw). On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (He could die from it) (seriousness criterion medically significant) and SWELLING FACE (jaw swelled up again). At the time of the report, NEAR DEATH EXPERIENCE (He could die from it) and SWELLING FACE (jaw swelled up again) outcome was unknown and SWELLING FACE (swollen jaw) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna COVID-19 dose, skipped his second Moderna dose appointment) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 antibody test: negative (Negative) COVID-19 antibody test negative.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: INSULIN; LISINOPRIL

Current Illness: Blood pressure high; Diabetic; High cholesterol

ID: 1644987
Sex: U
Age:
State: SC

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

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

Lab Data:

Allergies:

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

Symptoms: Administering an expired vaccine to a patient; 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 (Administering an expired vaccine to a patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administering an expired vaccine to a patient) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. The vaccine vial was punctured and moved from the refrigerator to room temperature at 11:25 A.M in previous day, 12-Aug-2021, and this vial has been stored in room temperature since then.

Other Meds:

Current Illness:

ID: 1644988
Sex: U
Age:
State: LA

Vax Date: 08/05/2021
Onset Date: 08/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210812; Test Name: Tested positive for Covid; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Runny nose; Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) and RHINORRHOEA (Runny nose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 05-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, COVID-19 (Tested positive for Covid) and RHINORRHOEA (Runny nose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, COVID-19: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company Comment: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event RHINORRHOEA, causality is assessed as possible, however this event could be due COVID-19.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.For the event RHINORRHOEA, causality is assessed as possible, however this event could be due COVID-19.

Other Meds:

Current Illness:

ID: 1644989
Sex: F
Age: 57
State: SC

Vax Date: 07/31/2021
Onset Date: 08/08/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210808; Test Name: Blood pressure; Result Unstructured Data: 224/113.

Allergies:

Symptom List: Vomiting

Symptoms: Diagnosed with having a non-STEMI heart attack; Patient woke up and room was spinning (Vertigo); Dizzy; Nauseous; Throwing up; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack), VERTIGO (Patient woke up and room was spinning (Vertigo)), DIZZINESS (Dizzy), NAUSEA (Nauseous), VOMITING (Throwing up) and CHEST PAIN (Chest pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizzy) (seriousness criterion hospitalization), NAUSEA (Nauseous) (seriousness criterion hospitalization), VOMITING (Throwing up) (seriousness criterion hospitalization prolonged) and CHEST PAIN (Chest pain) (seriousness criterion hospitalization). 08-Aug-2021, the patient experienced VERTIGO (Patient woke up and room was spinning (Vertigo)) (seriousness criterion hospitalization). The patient was hospitalized from 08-Aug-2021 to 12-Aug-2021 due to ACUTE MYOCARDIAL INFARCTION, CHEST PAIN, DIZZINESS, NAUSEA, VERTIGO and VOMITING. At the time of the report, ACUTE MYOCARDIAL INFARCTION (Diagnosed with having a non-STEMI heart attack), VERTIGO (Patient woke up and room was spinning (Vertigo)), DIZZINESS (Dizzy), NAUSEA (Nauseous), VOMITING (Throwing up) and CHEST PAIN (Chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Blood pressure measurement: 224/113 (High) 224/113. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included heart medicine, cholesterol and high blood pressure medicine. Treatment information was not provided. Company comment: Very limited information regarding the events of acute myocardial infarction and chest pain has been provided at this time, additional information required. A causal relationship cannot be excluded for the events of vomiting, nausea, vertigo and dizziness; Sender's Comments: Very limited information regarding the events of acute myocardial infarction and chest pain has been provided at this time, additional information required. A causal relationship cannot be excluded for the events of vomiting, nausea, vertigo and dizziness.

Other Meds:

Current Illness:

ID: 1644990
Sex: U
Age: 41
State: MI

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644991
Sex: U
Age: 60
State: MI

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant information was provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1644992
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: chest pain; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, CHEST PAIN (chest pain), CHILLS (chills) and MYALGIA (muscle pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided. No concomitant medication was provided. Patient received vaccination a week ago but as of 3 days ago.

Other Meds:

Current Illness:

ID: 1644993
Sex: U
Age: 60
State: MI

Vax Date: 07/08/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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. Patient received vaccine which was more than 30 days in the refrigerator (30 days were on 03-JUL-2021). For this patient, the number of days that have passed were 5.

Other Meds:

Current Illness:

ID: 1644994
Sex: U
Age:
State:

Vax Date: 08/12/2021
Onset Date: 08/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bone pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination. No Medical History information was reported. On 12-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. On 13-Aug-2021, the patient experienced BONE PAIN (Bone pain) and FATIGUE (Fatigue). At the time of the report, BONE PAIN (Bone pain) and FATIGUE (Fatigue) outcome was unknown. No concomitant medication was provided. No treatment medication was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am