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: 1711160
Sex: M
Age:
State:

Vax Date: 08/01/2021
Onset Date: 09/08/2021
Rec V Date: 09/18/2021
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: Swelling about 1 inch high at injection site / diameter of a baseball at injection site; 1st dose maybe 1Aug20212nd dose yesterday 8Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site). On 08-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose maybe 1Aug20212nd dose yesterday 8Sep2021) outcome was unknown. At the time of the report, VACCINATION SITE SWELLING (Swelling about 1 inch high at injection site / diameter of a baseball at injection site) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-314674 (Patient Link).

Other Meds:

Current Illness:

ID: 1711161
Sex: F
Age: 55
State: AR

Vax Date: 08/21/2021
Onset Date: 08/22/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: She passed out after she got home from church; so sick; could not feel my left arm, it felt like somebody else's arm; dizzy; incoherent; wheezing; trouble breathing; thought I was dying; nauseous; 103 fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (She passed out after she got home from church) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Aug-2021, the patient experienced ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (She passed out after she got home from church) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (She passed out after she got home from church), ILLNESS (so sick), HYPOAESTHESIA (could not feel my left arm, it felt like somebody else's arm), DIZZINESS (dizzy), INCOHERENT (incoherent), WHEEZING (wheezing), DYSPNOEA (trouble breathing), FEELING ABNORMAL (thought I was dying), NAUSEA (nauseous) and PYREXIA (103 fever) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 55 year-old, female subject with no known medical history who experienced the unexpected events of Loss of consciousness, Illness, Hypoaesthesia, dizziness, Incoherent and expected events of Pyrexia and Nausea 1 day after receiving the first dose of the vaccine. The rechallenge is not applicable as patient only received first dose. The event pyrexia and nausea is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna covid 19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1711162
Sex: F
Age: 53
State: LA

Vax Date: 09/07/2021
Onset Date: 09/07/2021
Rec V Date: 09/18/2021
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: She was in bed/ not doing so hot/ knocked down in bed for two days; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (She was in bed/ not doing so hot/ knocked down in bed for two days) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced BEDRIDDEN (She was in bed/ not doing so hot/ knocked down in bed for two days). At the time of the report, BEDRIDDEN (She was in bed/ not doing so hot/ knocked down in bed for two days) outcome was unknown. No concomitant was reported. No treatment was reported. This case was linked to MOD-2021-314558 (Patient Link).

Other Meds:

Current Illness:

ID: 1711163
Sex: F
Age: 28
State: UT

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: feeling a little sick after her second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling a little sick after her second vaccination) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 VACCINATION COMPLICATION (feeling a little sick after her second vaccination). At the time of the report, VACCINATION COMPLICATION (feeling a little sick after her second vaccination) had not resolved. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1711164
Sex: F
Age: 70
State: MT

Vax Date: 03/19/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
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: arm hurts; felt poorly more than the first time; chill, bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. Previously administered products included for Flu: Flu shot (Seemed to have trouble breathing and didn't reported anything like that. Like congested.). Past adverse reactions to the above products included Unwell with Flu shot. On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills). At the time of the report, PAIN IN EXTREMITY (arm hurts), MALAISE (felt poorly more than the first time) and CHILLS (chill, bad chills) had resolved. No concomitant medications reported No treatment medications reported. This case was linked to MOD-2021-314548 (Patient Link).

Other Meds:

Current Illness:

ID: 1711165
Sex: F
Age: 29
State: MD

Vax Date: 09/07/2021
Onset Date: 09/08/2021
Rec V Date: 09/18/2021
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: I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest; I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat; Diarrhea; Nausea; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) and OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis (Has body aches from that) and Chest pain - cardiac (Cardiac history: Has chest pains sometimes (1-2x/month, or every 3 months).). On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, CHEST DISCOMFORT (I felt like I had something is sitting on my chest, Feels like I have something sitting on my chest) and OROPHARYNGEAL PAIN (I felt like I had something is sitting on my throat, Feels like I have something sitting on my throat) had not resolved and DIARRHOEA (Diarrhea) and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported. Company comment: This case refers to a 29-year-old female patient with a medical history of rheumatoid arthritis and cardiac chest pain who experienced the unexpected events of Chest Discomfort and Oropharyngeal Pain approximately 1 day after the first dose of Spikevax. No causality assessment was provided by the reporter. The past medical history of chest pain remains a confounder.The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case refers to a 29-year-old female patient with a medical history of rheumatoid arthritis and cardiac chest pain who experienced the unexpected events of Chest Discomfort and Oropharyngeal Pain approximately 1 day after the first dose of Spikevax. No causality assessment was provided by the reporter. The past medical history of chest pain remains a confounder.The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness: Chest pain - cardiac (Cardiac history: Has chest pains sometimes (1-2x/month, or every 3 months).); Rheumatoid arthritis (Has body aches from that)

ID: 1711166
Sex: F
Age: 50
State: FL

Vax Date: 04/08/2021
Onset Date:
Rec V Date: 09/18/2021
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: red circle in the injection site (second dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)). At the time of the report, VACCINATION SITE ERYTHEMA (red circle in the injection site (second dose)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication included steroids. Treatment information was not provided. This case was linked to MOD-2021-314562, MOD-2021-314599 (Patient Link).

Other Meds:

Current Illness:

ID: 1711167
Sex: M
Age:
State: CA

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 09/18/2021
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: Patient received a vaccine that had Expiration date Mar 06, 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. No Medical History information was reported. On 10-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 EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine that had Expiration date Mar 06, 2021) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1711168
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now). In 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Maternal exposure before pregnancy. The event occurred at the time of the first dose of Moderna COVID-19 vaccine. The patient received the first dose of vaccine before the gestation period, at the time of the report patient was 2 weeks pregnant and vaccination occurred one month prior, no exact date provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Maternal exposure before pregnancy. The event occurred at the time of the first dose of Moderna COVID-19 vaccine. The patient received the first dose of vaccine before the gestation period, at the time of the report patient was 2 weeks pregnant and vaccination occurred one month prior, no exact date provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1711169
Sex: M
Age: 44
State: MO

Vax Date: 08/24/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Increased

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Rash behind my ear, now its spreading; Eyes start to close and shut a little bit; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The medical history was not reported by reporter. Concomitant products included PROBIOTICS NOS, LAMOTRIGINE (LAMICTAL), CLOPIDOGREL, CARVEDILOL, DULOXETINE, METOCLOPRAMIDE HYDROCHLORIDE (REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]), ATORVASTATIN CALCIUM (LIPITOR), DIAZEPAM (VALIUM), CEFIXIME (FLEXERIL [CEFIXIME]), OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rash behind my ear, now its spreading) and OCULAR DISCOMFORT (Eyes start to close and shut a little bit) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications include emgality shot.

Other Meds: PROBIOTICS NOS; LAMICTAL; CLOPIDOGREL; CARVEDILOL; DULOXETINE; REGLAN [METOCLOPRAMIDE HYDROCHLORIDE]; LIPITOR; VALIUM; FLEXERIL [CEFIXIME]; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]; ADDERALL

Current Illness:

ID: 1711170
Sex: F
Age:
State: GA

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

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

Lab Data:

Allergies:

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

Symptoms: numbness in face, neck and cheeks; tingling in face,neck and cheeks; Sick; Injection site swollen; achiness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in face, neck and cheeks), PARAESTHESIA (tingling in face,neck and cheeks), ILLNESS (Sick), MYALGIA (achiness) and INJECTION SITE SWELLING (Injection site swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in face, neck and cheeks), PARAESTHESIA (tingling in face,neck and cheeks), ILLNESS (Sick), MYALGIA (achiness) and INJECTION SITE SWELLING (Injection site swollen). At the time of the report, HYPOAESTHESIA (numbness in face, neck and cheeks), PARAESTHESIA (tingling in face,neck and cheeks), ILLNESS (Sick), MYALGIA (achiness) and INJECTION SITE SWELLING (Injection site swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication reported. This case was linked to MOD-2021-314649 (Patient Link).

Other Meds:

Current Illness:

ID: 1711171
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Numbness in face; Sickness; injection site got swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. 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 HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash). At the time of the report, HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-314553, MOD-2021-314553 (Patient Link).

Other Meds:

Current Illness:

ID: 1711172
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: 2 red blotches in my right armpit; swollen lymph nodes; Itchy; rash; This last week it has been really bad; everything irritates it; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash) and MALAISE (This last week it has been really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it). At the time of the report, RASH MACULAR (2 red blotches in my right armpit), LYMPHADENOPATHY (swollen lymph nodes), PRURITUS (Itchy), RASH (rash), MALAISE (This last week it has been really bad) and SKIN IRRITATION (everything irritates it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1711173
Sex: F
Age:
State: IL

Vax Date: 01/22/2021
Onset Date: 02/18/2021
Rec V Date: 09/18/2021
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: Sick after second vaccine/ Out of it, after second vaccine; Chills after second vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Sick after second vaccine/ Out of it, after second vaccine) and CHILLS (Chills after second vaccine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced ILLNESS (Sick after second vaccine/ Out of it, after second vaccine) and CHILLS (Chills after second vaccine). On 19-Feb-2021, ILLNESS (Sick after second vaccine/ Out of it, after second vaccine) and CHILLS (Chills after second vaccine) had resolved. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1711174
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: tender sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (tender sore arm). At the time of the report, TENDERNESS (tender sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was provided. No Treatment medication was provided. This case was linked to MOD-2021-314581 (Patient Link).

Other Meds:

Current Illness:

ID: 1711175
Sex: M
Age: 29
State: IL

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 09/18/2021
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: Myocarditis; Pericarditis; Could not think; Anxiety related symptoms; Panic attack; Heart palpitations/ Felt rapid powerful palpitations/ Experienced immediately strong palpitations; Chest pain/ Atypical chest pain; Tightness; Along with palpitations and labored breathing; Could not move; Could not walk/ Had to crawl to the bathroom; left lung was closing/ Felt right lung was opening up slowly; Pain; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis), PERICARDITIS (Pericarditis) and MENTAL IMPAIRMENT (Could not think) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-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 MYOCARDITIS (Myocarditis) (seriousness criterion medically significant), PERICARDITIS (Pericarditis) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Could not think) (seriousness criterion medically significant), ANXIETY (Anxiety related symptoms), PANIC ATTACK (Panic attack), PALPITATIONS (Heart palpitations/ Felt rapid powerful palpitations/ Experienced immediately strong palpitations), CHEST PAIN (Chest pain/ Atypical chest pain), CHEST DISCOMFORT (Tightness), DYSPNOEA (Along with palpitations and labored breathing), MOVEMENT DISORDER (Could not move), GAIT DISTURBANCE (Could not walk/ Had to crawl to the bathroom), LUNG DISORDER (left lung was closing/ Felt right lung was opening up slowly), PAIN (Pain) and FATIGUE (Fatigued). At the time of the report, MYOCARDITIS (Myocarditis), PERICARDITIS (Pericarditis), MENTAL IMPAIRMENT (Could not think), ANXIETY (Anxiety related symptoms), PANIC ATTACK (Panic attack), PALPITATIONS (Heart palpitations/ Felt rapid powerful palpitations/ Experienced immediately strong palpitations), CHEST PAIN (Chest pain/ Atypical chest pain), CHEST DISCOMFORT (Tightness), DYSPNOEA (Along with palpitations and labored breathing), MOVEMENT DISORDER (Could not move), GAIT DISTURBANCE (Could not walk/ Had to crawl to the bathroom), LUNG DISORDER (left lung was closing/ Felt right lung was opening up slowly), PAIN (Pain) and FATIGUE (Fatigued) had not resolved. The patient mentioned that the doctor ordered an echocardiogram and Holter monitor for patient to wear on the chest along with blood tests and waiting for on imaging tests done with doctor. Before taking the appointment of doctor the patient needs to obtain the lab data of Cardiac lab values (Electrocardiogram, cardiac test, cardiac enzymes. No history of COVID-19 infection. Patient stated that his family had a history of high blood pressure in his grandmother and high cholesterol in his dad and also history of knee problems in his family. No concomitant medications was reported. No treatment drug details was reported. Company comment: This case concerns a 29 year-old, male with a history of anxiety, who experienced the expected events of myocarditis and pericarditis, and the unexepcted event of mental impairement. The events occurred after the second dose of mRNA-1273 Moderna vaccine (exact onset date of events was not recorded). The event was considered related to the product per the reporter?s assessment. The medical history of anxiety could be a potentially confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Sender's Comments: This case concerns a 29 year-old, male with a history of anxiety, who experienced the expected events of myocarditis and pericarditis, and the unexepcted event of mental impairement. The events occurred after the second dose of mRNA-1273 Moderna vaccine (exact onset date of events was not recorded). The event was considered related to the product per the reporter?s assessment. The medical history of anxiety could be a potentially confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds:

Current Illness: Anxiety

ID: 1711176
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Covid arm small area; Sore ankle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle). At the time of the report, VACCINATION SITE REACTION (Covid arm small area) and ARTHRALGIA (Sore ankle) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. With side effects (slight)

Other Meds:

Current Illness:

ID: 1711177
Sex: F
Age: 51
State:

Vax Date: 09/03/2021
Onset Date: 09/03/2021
Rec V Date: 09/18/2021
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: Tingling in feet and legs; twitching legs and abdomen; brain fog; pretty bad chills; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Rocephin). On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling in feet and legs), MUSCLE TWITCHING (twitching legs and abdomen), FEELING ABNORMAL (brain fog) and CHILLS (pretty bad chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported.

Other Meds:

Current Illness: Drug allergy (Rocephin)

ID: 1711178
Sex: M
Age: 75
State: UT

Vax Date: 01/26/2021
Onset Date: 09/09/2021
Rec V Date: 09/18/2021
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: very high temperatures/101.6; shakes; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (very high temperatures/101.6) and TREMOR (shakes) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 042220A and 031220A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced PYREXIA (very high temperatures/101.6) and TREMOR (shakes). At the time of the report, PYREXIA (very high temperatures/101.6) and TREMOR (shakes) outcome was unknown. Concomitant product usage were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1711179
Sex: F
Age: 36
State: TX

Vax Date: 12/29/2020
Onset Date: 08/31/2021
Rec V Date: 09/18/2021
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: Administered past the 30 day refrigeration time; Fever; Achiness; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time), PYREXIA (Fever) and MYALGIA (Achiness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A, 025L20A and 043L20A) for COVID-19 vaccination. Concurrent medical conditions included Immunosuppressant drug therapy (immunosuppressant medication). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Achiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved. At the time of the report, PYREXIA (Fever) and MYALGIA (Achiness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product reported by reporter. She received the 3rd dose because she is on immunosuppressant medication This case was linked to MOD-2021-314740, MOD-2021-314678 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up information received and added Reporter and Information added for dose 1 and dose 2.

Other Meds:

Current Illness: Immunosuppressant drug therapy (immunosuppressant medication)

ID: 1711180
Sex: F
Age: 38
State: NC

Vax Date: 04/09/2021
Onset Date: 04/10/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210804; Test Name: Ultrasound; Result Unstructured Data: 1 cm node with non-pathological results.

Allergies:

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

Symptoms: very concerned and anxious about her future prognosis with symptoms lasting now 5 months; left ear pain, fluid, and fullness; left ear pain, fluid, and fullness; left ear pain, fluid, and fullness; very enlarged, firm, and painful lymph nodes; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes), EAR PAIN (left ear pain, fluid, and fullness), ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes). On 15-Jun-2021, the patient experienced EAR PAIN (left ear pain, fluid, and fullness), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness). On an unknown date, the patient experienced ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months). At the time of the report, LYMPHADENOPATHY (very enlarged, firm, and painful lymph nodes), EAR PAIN (left ear pain, fluid, and fullness), ANXIETY (very concerned and anxious about her future prognosis with symptoms lasting now 5 months), OTORRHOEA (left ear pain, fluid, and fullness) and EAR DISCOMFORT (left ear pain, fluid, and fullness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Aug-2021, Ultrasound Doppler: abnormal (abnormal) 1 cm node with non-pathological results.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Symptoms: It was reported that on 10-Apr-2021, the patient started experienced a cluster of swollen lymph nodes in supraclavicular fossa on the left side, became enlarged, firm & painful, she had an appointment with ENT for the symptoms as the adenopathy was not completely resolved, pain was resolved but she had non painful nodes in that region. She was prescribed a TMJ regimen. After she was undergone an ultrasound which showed that left ear pain was resolved with minimal fullness, her follow up was schedule for Feb 2022. No concomitant medications were reported No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1711181
Sex: F
Age: 60
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/18/2021
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: relapse of Multiple Sclerosis; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple sclerosis, Blood pressure high, Strength loss of, Walker user and Bladder incontinence. Concomitant products included OCRELIZUMAB (OCREVUS), FUROSEMIDE (LASIX [FUROSEMIDE]), CARVEDILOL, POTASSIUM, OXYBUTYNIN, OLMESARTAN and FAMPRIDINE (AMPYRA) for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (relapse of Multiple Sclerosis) had resolved. Treatment information was not provided by reporter. It was reported that events occurred 1.5 days after patient received the vaccination and resolved after 1.5 days after started. This case refers to a 61-year-old female patient with a medical history of Multiple sclerosis, Blood pressure high and Bladder incontinence, who experienced the unexpected event of Multiple Sclerosis Relapse at an unspecified time after exposure to Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. Rechallenge was reported as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a 61-year-old female patient with a medical history of Multiple sclerosis, Blood pressure high and Bladder incontinence, who experienced the unexpected event of Multiple Sclerosis Relapse at an unspecified time after exposure to Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. Rechallenge was reported as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds: OCREVUS; LASIX [FUROSEMIDE]; CARVEDILOL; POTASSIUM; OXYBUTYNIN; OLMESARTAN; AMPYRA

Current Illness: Bladder incontinence; Blood pressure high; Multiple sclerosis; Strength loss of; Walker user

ID: 1711182
Sex: M
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: most horrible heartburn he's ever had in his life overnight; felt like his whole throat was going to be burned out; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) and THROAT IRRITATION (felt like his whole throat was going to be burned out) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) and THROAT IRRITATION (felt like his whole throat was going to be burned out). At the time of the report, DYSPEPSIA (most horrible heartburn he's ever had in his life overnight) had resolved and THROAT IRRITATION (felt like his whole throat was going to be burned out) outcome was unknown. No Concomitant medications were provided by the reporter. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1711183
Sex: F
Age: 67
State: CA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 09/18/2021
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: Vaccination site pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concurrent medical conditions included Lupus erythematosus and Immunocompromised. Concomitant products included HYDROXYCHLOROQUINE, METHOTREXATE, FOLIC ACID, OMEPRAZOLE, CALCIUM FOLINATE (LEUCOVORIN CALCIUM), DICYCLOVERINE, VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown. No treatment medications were reported. This case was linked to MOD-2021-314852, MOD-2021-314862 (Patient Link).

Other Meds: HYDROXYCHLOROQUINE; METHOTREXATE; FOLIC ACID; OMEPRAZOLE; LEUCOVORIN CALCIUM; DICYCLOVERINE; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS

Current Illness: Immunocompromised; Lupus erythematosus

ID: 1711184
Sex: F
Age: 50
State: WI

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 09/18/2021
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: It damaged my brain in sort of a concussion would damage the brain; They believe there was so much inflammation in my body due to the vaccine that it damaged my brain; Couldn't look at screens or computer screens, because would make me very nauseous and make my headache even worst; Never received the second dose; Headache/worsening headaches/headaches so severe I couldn't work; Muscle aches/body aches; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BRAIN INJURY (It damaged my brain in sort of a concussion would damage the brain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache/worsening headaches/headaches so severe I couldn't work), MYALGIA (Muscle aches/body aches) and FATIGUE (Fatigue). On an unknown date, the patient experienced BRAIN INJURY (It damaged my brain in sort of a concussion would damage the brain) (seriousness criterion medically significant), INFLAMMATION (They believe there was so much inflammation in my body due to the vaccine that it damaged my brain), NAUSEA (Couldn't look at screens or computer screens, because would make me very nauseous and make my headache even worst) and PRODUCT DOSE OMISSION ISSUE (Never received the second dose). At the time of the report, BRAIN INJURY (It damaged my brain in sort of a concussion would damage the brain), INFLAMMATION (They believe there was so much inflammation in my body due to the vaccine that it damaged my brain), MYALGIA (Muscle aches/body aches), FATIGUE (Fatigue) and NAUSEA (Couldn't look at screens or computer screens, because would make me very nauseous and make my headache even worst) outcome was unknown, HEADACHE (Headache/worsening headaches/headaches so severe I couldn't work) had not resolved and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication listed. No treatment information provided. The patient said the symptoms started about 6 hours after getting the vaccine and had the normal side effects, muscle aches, body aches, head ache, and fatigue. Then the patient said that had worsening headaches, headaches so severe I couldn't work and had to take pain medicines. Then the patient reported concussion like symptom's, couldn't look at screens or computer screens, because would make me very nauseous and make my headache even worst. The patient said that talked to a Neurologist and a Physical therapist ( and to the primary care doctor) which said that those are symptoms of concussions but the patient said that nothing happened besides getting the vaccine. The patient states that still have daily head aches twice a day and that it's been 5 months. The patient said they believe there was so much inflammation in my body due to the vaccine that it damaged my brain in sort of a concussion would damage the brain. The patient never received the second dose because of the severe reaction to the first. Company Comment - This case concerns a 50-year-old, female patient with no relevant medical history, who experienced the unexpected event of brain damage and product dose omission was considered as an additional event. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable. The patient had severe headaches and reported concussion like symptom's, couldn't look at screens or computer screens, because it would make him very nauseous and make his headache worst. The patient said patient's neurologist and physical therapist believe there was so much inflammation in my body due to the vaccine that it damaged patient's brain in sort of a way a concussion would damage the brain. The patient never received the second dose because of the severe reaction to the first. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 50-year-old, female patient with no relevant medical history, who experienced the unexpected event of brain damage and product dose omission was considered as an additional event. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable. The patient had severe headaches and reported concussion like symptom's, couldn't look at screens or computer screens, because it would make him very nauseous and make his headache worst. The patient said patient's neurologist and physical therapist believe there was so much inflammation in my body due to the vaccine that it damaged patient's brain in sort of a way a concussion would damage the brain. The patient never received the second dose because of the severe reaction to the first. The benefit-risk relationship of Spikevax in not affected by this report.

Other Meds:

Current Illness:

ID: 1711185
Sex: U
Age:
State:

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

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: low

Allergies:

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

Symptoms: hard to explain sensation in the middle of my chest; chest tighten and pressure mostly concentrated around the middle and left side of my chest but mostly the left side; blood pressure is low; feeling strange; noticed dry liquid on my shoulder as well as some blood; feel occasional sharp jabs in my left shoulder and back shoulder blade; pressure down the leg in artery and in neck artery; pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (pericarditis) 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. In 2021, 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 (hard to explain sensation in the middle of my chest), CHEST DISCOMFORT (chest tighten and pressure mostly concentrated around the middle and left side of my chest but mostly the left side), HYPOTENSION (blood pressure is low), FEELING ABNORMAL (feeling strange), VACCINATION SITE HAEMORRHAGE (noticed dry liquid on my shoulder as well as some blood), ARTHRALGIA (feel occasional sharp jabs in my left shoulder and back shoulder blade), DISCOMFORT (pressure down the leg in artery and in neck artery) and PERICARDITIS (pericarditis) (seriousness criterion medically significant). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN 1000) for Adverse reaction, at a dose of 1000 milligram three times a day. At the time of the report, CHEST PAIN (hard to explain sensation in the middle of my chest), CHEST DISCOMFORT (chest tighten and pressure mostly concentrated around the middle and left side of my chest but mostly the left side), HYPOTENSION (blood pressure is low), FEELING ABNORMAL (feeling strange), VACCINATION SITE HAEMORRHAGE (noticed dry liquid on my shoulder as well as some blood), ARTHRALGIA (feel occasional sharp jabs in my left shoulder and back shoulder blade), DISCOMFORT (pressure down the leg in artery and in neck artery) and PERICARDITIS (pericarditis) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. The patient experienced a feeling of chest tightening and chest pressure a few hour after vaccination. Since than the patient exhibited most symptoms of pericarditis, based on patient's research and conclusion. The patient also felt occasional sharp jabs in left shoulder and shoulder blade. The chest tightness tends to be worse when patient lays down. The patient cannot under any circumstances go to any clinic or hospital as these are epicentres of infection. Company Comment: This case concerns a patient with no relevant medical history reported, who experienced the expected event of pericarditis. The patient started experiencing tightening and pressure in chest on the same day after dose of Spikevax. The patient stated that symptoms of pericarditis were experienced based on patient's research and conclusion, however, the diagnosis was not confirmed by the HCP as the patient did not go to hospital or clinic. The rechallenge was unknown not applicable. The reporter assessed the event as related to the product. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a patient with no relevant medical history reported, who experienced the expected event of pericarditis. The patient started experiencing tightening and pressure in chest on the same day after dose of Spikevax. The patient stated that symptoms of pericarditis were experienced based on patient's research and conclusion, however, the diagnosis was not confirmed by the HCP as the patient did not go to hospital or clinic. The rechallenge was unknown not applicable. The reporter assessed the event as related to the product. The benefit-risk relationship of Spikevax in not affected by this report.

Other Meds:

Current Illness:

ID: 1711186
Sex: F
Age:
State: NY

Vax Date: 02/08/2021
Onset Date:
Rec V Date: 09/18/2021
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: Groggy/ They were falling down and falling asleep while standing/ slept for around 20 hours; They were falling down and falling asleep while standing; vertigo kicked in; At one point they fell through the baby chair they use because their vertigo kicked in, and they cut their chest open on the chair edge; Cut their chest open on the chair edge; , it hurt a lot/ major pain on the injection site; injection site was swollen red/red,lymph node red, patch 4-6 inches long in a circle underneath the injection site; fatigue; injection site was swollen red; caller' sibling got the third dose of the vaccine, not sure if immunocompromised; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of vertigo kicked in in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. notprovided) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (caller' sibling got the third dose of the vaccine, not sure if immunocompromised), VACCINATION SITE PAIN (, it hurt a lot/ major pain on the injection site), VACCINATION SITE ERYTHEMA (injection site was swollen red/red,lymph node red, patch 4-6 inches long in a circle underneath the injection site), FATIGUE (fatigue), SOMNOLENCE (Groggy/ They were falling down and falling asleep while standing/ slept for around 20 hours), BALANCE DISORDER (They were falling down and falling asleep while standing), vertigo kicked in (seriousness criterion medically significant), FALL (At one point they fell through the baby chair they use because their vertigo kicked in, and they cut their chest open on the chair edge), VACCINATION SITE SWELLING (injection site was swollen red) and SKIN LACERATION (Cut their chest open on the chair edge). At the time of the report, OFF LABEL USE (caller' sibling got the third dose of the vaccine, not sure if immunocompromised), VACCINATION SITE PAIN (, it hurt a lot/ major pain on the injection site), VACCINATION SITE ERYTHEMA (injection site was swollen red/red,lymph node red, patch 4-6 inches long in a circle underneath the injection site), FATIGUE (fatigue), SOMNOLENCE (Groggy/ They were falling down and falling asleep while standing/ slept for around 20 hours), BALANCE DISORDER (They were falling down and falling asleep while standing), vertigo kicked in, FALL (At one point they fell through the baby chair they use because their vertigo kicked in, and they cut their chest open on the chair edge), VACCINATION SITE SWELLING (injection site was swollen red) and SKIN LACERATION (Cut their chest open on the chair edge) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was reported No Treatment Drug was reported This case was linked to MOD-2021-314905 (Patient Link).; Sender's Comments: This is a case of Off Label Use for mRNA-1273 (lot #022C21A) (given third dose of vaccine to patient who is not immunocompromised) with associated AEs. Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1711187
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: severe abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (severe abdominal pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (severe abdominal pain). At the time of the report, ABDOMINAL PAIN (severe abdominal pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant and Treatment medication were reported.

Other Meds:

Current Illness:

ID: 1711188
Sex: F
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: bruise at left arm got very large; left under arm was swollen under armpit; big red spot at left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site). At the time of the report, CONTUSION (bruise at left arm got very large), LYMPHADENOPATHY (left under arm was swollen under armpit) and VACCINATION SITE ERYTHEMA (big red spot at left arm injection site) 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.

Other Meds:

Current Illness:

ID: 1711190
Sex: F
Age: 47
State: GA

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone; I found a lump between my left armpit & left breast & it's swollen; soreness in left shoulder at the injection site; I was feeling pain in the middle of my chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (I was feeling pain in the middle of my chest), SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone), SWELLING (I found a lump between my left armpit & left breast & it's swollen) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The patient's past medical history included Heart murmur. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced CHEST PAIN (I was feeling pain in the middle of my chest) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site). On 07-Sep-2021, the patient experienced SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone) and SWELLING (I found a lump between my left armpit & left breast & it's swollen). At the time of the report, CHEST PAIN (I was feeling pain in the middle of my chest), SKIN MASS (I found a lump between my left armpit & left breast & it's swollen/I found a lump on my left collarbone), SWELLING (I found a lump between my left armpit & left breast & it's swollen) and VACCINATION SITE PAIN (soreness in left shoulder at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1711191
Sex: M
Age:
State: NY

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: low electrolytes.

Allergies:

Symptom List: Injection site pain

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of electrolyte imbalance (low electrolytes) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 022C21A) for COVID-19 immunization. Concurrent medical conditions included eczema (demographic skin) and multiple allergies. On Mar 8, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced electrolyte imbalance (low electrolytes). At the time of the report, electrolyte imbalance (low electrolytes) outcome unknown/not provided. Diagnostic results: On an unknown date, blood test: low electrolytes. No concomitant medications or treatment information reported. This case linked to MOD-2021-314919 (patient link).

Other Meds:

Current Illness: Eczema (demographic skin); multiple allergies

ID: 1711192
Sex: F
Age: 36
State: WA

Vax Date: 08/31/2021
Onset Date: 09/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210907; Test Name: COVID-19 Virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: COVID-19 pneumonia; too sick; pneumonia-related cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criterion medically significant). In September 2021, the patient experienced ILLNESS (too sick) and COUGH (pneumonia-related cough). The patient was treated with CODEINE for Cough, at an unspecified dose and frequency. At the time of the report, COVID-19 PNEUMONIA (COVID-19 pneumonia), ILLNESS (too sick) and COUGH (pneumonia-related cough) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was treated with unspecified steroid medications for pneumonia related cough. No concomitant medications were reported. The patient was concerned about the possibility of the vaccine being the cause of testing positive for COVID19 Company comment: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected events of COVID-19 pneumonia. The event occurred approximately 8 days after the second dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The event was downgrade to non-serious due the patient was not hospitalized or meet the criteria for seriousness. The benefit-risk relationship of S mRNA-1273 in not affected by this report.; Sender's Comments: This case concerns a 36-year-old female patient with no relevant medical history, who experienced the unexpected events of COVID-19 pneumonia. The event occurred approximately 8 days after the second dose of mRNA-1273. The rechallenge was not applicable, as the event happened after the first dose. The event was downgrade to non-serious due the patient was not hospitalized or meet the criteria for seriousness. The benefit-risk relationship of S mRNA-1273 in not affected by this report.

Other Meds:

Current Illness:

ID: 1711193
Sex: M
Age:
State: FL

Vax Date: 02/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
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: I had a sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore arm at the injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy (Allergy to shrimp). On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (I had a sore arm at the injection site). At the time of the report, VACCINATION SITE PAIN (I had a sore arm at the injection site) outcome was unknown. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-314922 (Patient Link).

Other Meds:

Current Illness: Shellfish allergy (Allergy to shrimp)

ID: 1711194
Sex: F
Age: 59
State: CA

Vax Date: 07/29/2021
Onset Date: 07/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: she has not gotten 2nd dose yet; left arm soreness; Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow; Bell's Palsy and it has been awful; Earache in her right ear; Face was swollen; Left arm and under that arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy and it has been awful) and OPHTHALMOPLEGIA (Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced AXILLARY PAIN (Left arm and under that arm soreness). On 25-Aug-2021, the patient experienced EAR PAIN (Earache in her right ear) and SWELLING FACE (Face was swollen). On 26-Aug-2021, the patient experienced BELL'S PALSY (Bell's Palsy and it has been awful) (seriousness criterion medically significant) and OPHTHALMOPLEGIA (Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she has not gotten 2nd dose yet) and VACCINATION SITE PAIN (left arm soreness). The patient was treated with PARACETAMOL (TYLENOL) on 25-Aug-2021 for Earache, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy and it has been awful), EAR PAIN (Earache in her right ear), SWELLING FACE (Face was swollen), OPHTHALMOPLEGIA (Couldn't wink her right eye/has a hard time seeing out of her right eye/couldn't lift her right eyebrow), AXILLARY PAIN (Left arm and under that arm soreness) and VACCINATION SITE PAIN (left arm soreness) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she has not gotten 2nd dose yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Patient stated that she had a hard time seeing out of her right eye and did not receive the second dose. Company Comment: This case concerns a 59 year-old, female patient with no relevant medical history, who experienced the unexpected events of ear pain, swelling face, ophthalmoplegia, product dose omission and expected events of Bell's Palsy, axillary pain and vaccination site pain. The events ear pain and swelling face occurred approximately 27 days after the first dose while events ophthalmoplegia and Bell's palsy occurred 28 days after first dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 59 year-old, female patient with no relevant medical history, who experienced the unexpected events of ear pain, swelling face, ophthalmoplegia, product dose omission and expected events of Bell's Palsy, axillary pain and vaccination site pain. The events ear pain and swelling face occurred approximately 27 days after the first dose while events ophthalmoplegia and Bell's palsy occurred 28 days after first dose of Spikevax. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1711195
Sex: F
Age: 47
State: NY

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/18/2021
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 Name: Blood Pressure; Result Unstructured Data: High blood pressure 151/138

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Smell is off; Nostrils feel of; Felt disconnected to her body and mind; Taste is off; She is very cold; Blood pressure increased; Wasn't feeling good or well; Left arm became really sore; Feel vey tired; Nausea; Difficulty swallowing; Tongue was swelling; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Difficulty swallowing) and SWOLLEN TONGUE (Tongue was swelling) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gastrointestinal discomfort. Concurrent medical conditions included Vasovagal symptoms and Raynaud's disease. Concomitant products included MULTIVITAMINS [VITAMINS NOS], FISH OIL, VITAMIN D NOS, ESTROVEN and AMMONIUM CHLORIDE, BETAINE HYDROCHLORIDE, PANCREAS EXTRACT, PANCREATIN, PEPSIN, SPLEEN, STEARIC ACID (ZYPAN) for an unknown indication. On 10-Sep-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021 at 6:30 PM, the patient experienced DYSPHAGIA (Difficulty swallowing) (seriousness criterion medically significant) and SWOLLEN TONGUE (Tongue was swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced PAROSMIA (Smell is off), NASAL CONGESTION (Nostrils feel of), FEELING ABNORMAL (Felt disconnected to her body and mind), TASTE DISORDER (Taste is off), FEELING COLD (She is very cold), BLOOD PRESSURE INCREASED (Blood pressure increased), MALAISE (Wasn't feeling good or well), VACCINATION SITE PAIN (Left arm became really sore), FATIGUE (Feel vey tired) and NAUSEA (Nausea). The patient was treated with FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Difficulty swallowing), PAROSMIA (Smell is off), NASAL CONGESTION (Nostrils feel of), FEELING ABNORMAL (Felt disconnected to her body and mind), TASTE DISORDER (Taste is off), FEELING COLD (She is very cold), BLOOD PRESSURE INCREASED (Blood pressure increased), MALAISE (Wasn't feeling good or well), VACCINATION SITE PAIN (Left arm became really sore), FATIGUE (Feel vey tired) and NAUSEA (Nausea) outcome was unknown and SWOLLEN TONGUE (Tongue was swelling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 151/138 (High) High blood pressure 151/138. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient has stated that she called to hospital and assessed and they thought she is having vagovagal and patient notified her doctor. The patient was in emergency room for 4 hours. Laboratory investigations performed on 10 Sep 2021 included EKG (Electrocardiography) and vital signs whose results were not provided. Treatment for the event included steroids. Company comment: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious events of dysphagia and swollen tongue; unexpected non-serious events of parosmia, nasal congestion, feeling abnormal, taste disorder, feeling cold, blood pressure increased, malaise; expected non-serious events of vaccination site pain, fatigue and nausea. The events occurred on the same day after the first dose of mRNA1273. The rechallenge is not applicable since the second dose is not due at the time of report. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Additional information received as live follow up included patient demographics, relevant history details, concomitant medication details, adverse event details, laboratory investigation details and treatment medication details. The case was upgraded to serious.; Sender's Comments: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the unexpected serious events of dysphagia and swollen tongue; unexpected non-serious events of parosmia, nasal congestion, feeling abnormal, taste disorder, feeling cold, blood pressure increased, malaise; expected non-serious events of vaccination site pain, fatigue and nausea. The events occurred on the same day after the first dose of mRNA1273. The rechallenge is not applicable since the second dose is not due at the time of report. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA1273 in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; FISH OIL; VITAMIN D NOS; ESTROVEN; ZYPAN

Current Illness: Raynaud's disease; Vasovagal symptoms

ID: 1711196
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Test Name: blood tests; Result Unstructured Data: had an antiphospholipid antibody syndrome; Test Name: Protein S; Result Unstructured Data: very low protein S

Allergies:

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

Symptoms: I recently had some blood tests and had an antiphospholipid antibody syndrome; Maybe a bit of lethargy/ very mild; This spontaneous case was reported by a consumer and describes the occurrence of ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) (seriousness criterion medically significant) and LETHARGY (Maybe a bit of lethargy/ very mild). At the time of the report, ANTIPHOSPHOLIPID SYNDROME (I recently had some blood tests and had an antiphospholipid antibody syndrome) and LETHARGY (Maybe a bit of lethargy/ very mild) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: had an antiphospholipid antibody syndrome (abnormal) had an antiphospholipid antibody syndrome. On an unknown date, Protein S: very low protein s (Low) very low protein S. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a patient with no previous relevant medical history, who experienced the unexpected event of antiphospholipid syndrome and lethargy. The rechallenge was not applicable since no information about the dates available. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a patient with no previous relevant medical history, who experienced the unexpected event of antiphospholipid syndrome and lethargy. The rechallenge was not applicable since no information about the dates available. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1711197
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Vaccinated twice with Moderna. Both times I had an allergic reaction; Metallic taste in mouth; My lips and right check were tingling; Nausea; First shot: headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Vaccinated twice with Moderna. Both times I had an allergic reaction), DYSGEUSIA (Metallic taste in mouth), PARAESTHESIA (My lips and right check were tingling), NAUSEA (Nausea) and HEADACHE (First shot: headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Vaccinated twice with Moderna. Both times I had an allergic reaction), DYSGEUSIA (Metallic taste in mouth), PARAESTHESIA (My lips and right check were tingling), NAUSEA (Nausea) and HEADACHE (First shot: headache). At the time of the report, HYPERSENSITIVITY (Vaccinated twice with Moderna. Both times I had an allergic reaction) and PARAESTHESIA (My lips and right check were tingling) outcome was unknown and DYSGEUSIA (Metallic taste in mouth), NAUSEA (Nausea) and HEADACHE (First shot: headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported This case was linked to MOD-2021-315328 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1711198
Sex: F
Age: 33
State: MS

Vax Date: 07/27/2021
Onset Date: 07/30/2021
Rec V Date: 09/18/2021
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: More than 35 days from first dose/ second shot has not been given yet; Wart on right wrist; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PAPILLOMA (Wart on right wrist) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. Concurrent medical conditions included Clotting disorder. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Clotting disorder. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced SKIN PAPILLOMA (Wart on right wrist). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet). At the time of the report, SKIN PAPILLOMA (Wart on right wrist) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The historical vaccine Flu shot was reported and adverse event experienced was Wart. No Treatment information was reported.

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Clotting disorder

ID: 1711199
Sex: F
Age: 67
State: KS

Vax Date: 02/10/2021
Onset Date: 03/11/2021
Rec V Date: 09/18/2021
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: Trouble swallowing; Trouble sleeping; When she looks at or focus on an object it goes into her mouth; Hurting all over / Aching all over; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (Trouble swallowing), INSOMNIA (Trouble sleeping), FEELING ABNORMAL (When she looks at or focus on an object it goes into her mouth) and MYALGIA (Hurting all over / Aching all over) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medial history information provided. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced MYALGIA (Hurting all over / Aching all over). On 12-Mar-2021, the patient experienced DYSPHAGIA (Trouble swallowing), INSOMNIA (Trouble sleeping) and FEELING ABNORMAL (When she looks at or focus on an object it goes into her mouth). The patient was treated with ALPRAZOLAM (XANAX) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (Trouble swallowing) and INSOMNIA (Trouble sleeping) had not resolved and FEELING ABNORMAL (When she looks at or focus on an object it goes into her mouth) and MYALGIA (Hurting all over / Aching all over) outcome was unknown. Patient called to report that she received her 1st dose of the Moderna vaccine 10FEB2021 and her 2nd dose 10MAR2021. On 11MAR2021 patient stated that she was hurting and aching all over. On 12MAR2021 she was having hallucinations. The patient said she had razor blades, screws and pots and pans in her mouth. The patient also had shoe laces in her gums and a gun in top of her mouth. Patient further stated that when she looks at or focus on an object it seems to go into her mouth and still had trouble swallowing or sleeping. Patient further stated she was taking Lexapro before she took the Moderna vaccine and Xanax after she took the vaccine. This case concerns a 68-year-old, female with not reported medical history, who experienced the unexpected events of Hallucinations, insomnia, dysphagia and the expected event of myalgia . The event occurred approximately between 29 and 30 days after the first dose and between 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since no information regarding adverse events after the first dose were reported. The use of concomitant medication escitalopram could be a potentially co-suspect for the event hallucinations. Event hallucinations was automatically upgraded as a serious event as per IME list. However, based on the information available and as per medical judgment it is classified as Non-serious. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.; Sender's Comments: This case concerns a 68-year-old, female with not reported medical history, who experienced the unexpected events of Hallucinations, insomnia, dysphagia and the expected event of myalgia . The event occurred approximately between 29 and 30 days after the first dose and between 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable since no information regarding adverse events after the first dose were reported. The use of concomitant medication escitalopram could be a potentially co-suspect for the event hallucinations. Event hallucinations was automatically upgraded as a serious event as per Regulatory authority list. However, based on the information available and as per medical judgment it is classified as Non-serious. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.

Other Meds: LEXAPRO

Current Illness:

ID: 1711200
Sex: F
Age:
State: TX

Vax Date: 09/04/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Stroke after third dose; On 06Sep2021, patient started to feel poorly; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke after third dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced FEELING ABNORMAL (On 06Sep2021, patient started to feel poorly). On 08-Sep-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke after third dose) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 08-Sep-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke after third dose) had not resolved and FEELING ABNORMAL (On 06Sep2021, patient started to feel poorly) outcome was unknown. The patient reported to be suffering from a stroke after receiving the third dose of the Moderna COVID-19 vaccine on 04-SEP-2021. On 06-SEP-2021, the patient reportedly started to feel poorly. On 07-SEP-2021, the patient said she went into work and had to leave early. On 08-SEP-2021, the patient was admitted to the hospital for stroke. Company Comment: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 4 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and patient was hospitalized at the same day. The rechallenge was not applicable, as the event happened after the third dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 73-year-old, female patient with no relevant medical history, who experienced the unexpected event of Cerebrovascular Accident. The event occurred approximately 4 days after the third dose of mRNA-1273 (Moderna COVID-19 Vaccine) and patient was hospitalized at the same day. The rechallenge was not applicable, as the event happened after the third dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1711201
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: My daughter was 17 and accidentally was administered the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose) in a 17-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (My daughter was 17 and accidentally was administered the first dose) had resolved. No concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1711202
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: had one shot and a week later had covid.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (had one shot and a week later had covid.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had one shot and a week later had covid.). At the time of the report, COVID-19 (had one shot and a week later had covid.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. No treatment medications were reported. Patient was asking should she get the second shot. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1711203
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Flu like symptoms after 2nd shot; 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 INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd shot). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms after 2nd shot) outcome was unknown. No concomitant medications were reported. No treatment information were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1711204
Sex: M
Age:
State: MN

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

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

Lab Data:

Allergies:

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

Symptoms: Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received a 1st dose of the Moderna COVID 19 vaccine that was beyond use date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported

Other Meds:

Current Illness:

ID: 1711205
Sex: M
Age:
State: TX

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: patient is having a starting dementia; Alzheimer; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (patient is having a starting dementia) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Family history included Alzheimer's disease. On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (patient is having a starting dementia) (seriousness criterion medically significant) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) (seriousness criterion medically significant). At the time of the report, DEMENTIA (patient is having a starting dementia) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment was reported. Company Comment: This case concerns a male subject with relevant family history of Alzheimer who experienced the unexpected events of Dementia and Alzheimer's disease. It does not remain clear if the events occured prior of after the first dose of Spikevax. The rechallenge was not applicable as there is only information of the first dose. The medical family history of Alzheimer could be a risk factor for the events. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a male subject with relevant family history of Alzheimer who experienced the unexpected events of Dementia and Alzheimer's disease. It does not remain clear if the events occured prior of after the first dose of Spikevax. The rechallenge was not applicable as there is only information of the first dose. The medical family history of Alzheimer could be a risk factor for the events. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1711206
Sex: M
Age: 22
State: UT

Vax Date: 08/26/2021
Onset Date: 08/26/2021
Rec V Date: 09/18/2021
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: Patient was feeling faint, fainted in chair; Despondent, cold to touch, weak and pale; Cold to touch; Weak; Pale; Difficulty in muscle control; This spontaneous case was reported by a pharmacist and describes the occurrence of SYNCOPE (Patient was feeling faint, fainted in chair), FEELING OF DESPAIR (Despondent, cold to touch, weak and pale), FEELING COLD (Cold to touch), ASTHENIA (Weak) and PALLOR (Pale) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced SYNCOPE (Patient was feeling faint, fainted in chair), FEELING OF DESPAIR (Despondent, cold to touch, weak and pale), FEELING COLD (Cold to touch), ASTHENIA (Weak), PALLOR (Pale) and MOTOR DYSFUNCTION (Difficulty in muscle control). At the time of the report, SYNCOPE (Patient was feeling faint, fainted in chair), FEELING OF DESPAIR (Despondent, cold to touch, weak and pale), FEELING COLD (Cold to touch), ASTHENIA (Weak), PALLOR (Pale) and MOTOR DYSFUNCTION (Difficulty in muscle control) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: This concerns a case of a 22 year old Male with no relevant medical history who experienced unexpected events of syncope, feeling of despair, feeling cold, asthenia, pallor, and motor dysfunction. The events happened 1 day after receiving the first dose of the vaccine. The event syncope was upgraded to serious , however it is downgraded to non serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2021-315343, US-MODERNATX, INC.-MOD-2021-141984, US-MODERNATX, INC.-MOD-2021-141984, US-MODERNATX, INC.-MOD-2021-141758, US-MODERNATX, INC.-MOD-2021-142081, US-MODERNATX, INC.-MOD-2021-142219 (E2B Linked Report).; Sender's Comments: This concerns a case of a 22 year old Male with no relevant medical history who experienced unexpected events of syncope, feeling of despair, feeling cold, asthenia, pallor, and motor dysfunction. The events happened 1 day after receiving the first dose of the vaccine. The event syncope was upgraded to serious , however it is downgraded to non serious due to the lack of evidence of seriousness from a regulatory or clinical standpoint. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2021-315343:Same report US-MODERNATX, INC.-MOD-2021-141984: US-MODERNATX, INC.-MOD-2021-141984: US-MODERNATX, INC.-MOD-2021-141758: US-MODERNATX, INC.-MOD-2021-142081: US-MODERNATX, INC.-MOD-2021-142219:

Other Meds:

Current Illness:

ID: 1711207
Sex: M
Age: 59
State: FL

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 09/18/2021
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: Pemphigus vulgari; "I have a real bad issue life long issue"; Blister is eating up skin and is getting worse started with 2 bumps and is now covering whole forehead face and chest; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGUS (Pemphigus vulgari) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036E21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PEMPHIGUS (Pemphigus vulgari) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have a real bad issue life long issue") and CONDITION AGGRAVATED (Blister is eating up skin and is getting worse started with 2 bumps and is now covering whole forehead face and chest). At the time of the report, PEMPHIGUS (Pemphigus vulgari), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES ("I have a real bad issue life long issue") and CONDITION AGGRAVATED (Blister is eating up skin and is getting worse started with 2 bumps and is now covering whole forehead face and chest) outcome was unknown. Patient had received both doses of the Moderna COVID 19 vaccine and was diagnosed with pemphigus vulgari. It took months to diagnosed him, he had to go to a dermatologist and an infectious disease doctor to get diagnosed. No concomitant medication information provided. No treatment medication information provided. Company Comment: This case concerns a 60-year-old, male patient with no relevant medical history, who experienced the unexpected event of Pemphigus Vulgaris. The event occurred on an unknown number of days after the second dose of Moderna COVID-19 Vaccine. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up received on 13 Sep 2021 contains updated information on reporter details, vaccine information and new event: Activities of daily living impaired. On 13-Sep-2021: Follow-up received on 13 Sep 2021 contains no new information. On 15-Sep-2021: Follow-up was received on 15 September 2021 and events were added.; Sender's Comments: This case concerns a 60-year-old, male patient with no relevant medical history, who experienced the unexpected event of Pemphigus Vulgaris. The event occurred on an unknown number of days after the second dose of Moderna COVID-19 Vaccine. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1711208
Sex: M
Age: 63
State: MN

Vax Date: 03/24/2021
Onset Date: 04/22/2021
Rec V Date: 09/18/2021
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: Slight stroke; Everything in the body shut down/ hit the floor if there hadn't been a chair there; Whole body went limp; Tongue was hanging; All muscles went down; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Slight stroke) and SYNCOPE (Everything in the body shut down/ hit the floor if there hadn't been a chair there) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high and Cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Slight stroke) (seriousness criterion medically significant), SYNCOPE (Everything in the body shut down/ hit the floor if there hadn't been a chair there) (seriousness criterion medically significant), GAIT DISTURBANCE (Whole body went limp), PARAESTHESIA ORAL (Tongue was hanging) and MUSCULAR DYSTROPHY (All muscles went down). At the time of the report, CEREBROVASCULAR ACCIDENT (Slight stroke), SYNCOPE (Everything in the body shut down/ hit the floor if there hadn't been a chair there), GAIT DISTURBANCE (Whole body went limp), PARAESTHESIA ORAL (Tongue was hanging) and MUSCULAR DYSTROPHY (All muscles went down) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medications included high blood pressure pills and blood thinner medications Lab data included EKG and BP with unknown results. This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and high cholesterol, who experienced the unexpected events of cerebrovascular accident, syncope, gait disturbance, paraesthesia oral and muscular dystrophy. The events occurred 30 days day after the second dose of mRNA-1273. The rechallenge was not applicable due the patient did not experienced side effects after the first dose. The reporter assessed the events as possible. The medical history of hypertension, high cholesterol and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. On 22-Apr-21 patient was in the ER for four hours, he was not treated with any medications and was discharged with no medications.; Sender's Comments: This case concerns a 63-year-old, male patient with previous relevant medical history of hypertension and high cholesterol, who experienced the unexpected events of cerebrovascular accident, syncope, gait disturbance, paraesthesia oral and muscular dystrophy. The events occurred 30 days day after the second dose of mRNA-1273. The rechallenge was not applicable due the patient did not experienced side effects after the first dose. The reporter assessed the events as possible. The medical history of hypertension, high cholesterol and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: CRESTOR

Current Illness: Blood pressure high; Cholesterol

ID: 1711209
Sex: F
Age:
State: OH

Vax Date: 09/04/2021
Onset Date: 09/05/2021
Rec V Date: 09/18/2021
Hospital: Y

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: nausea; very confused; seizure in her bed; Anaphylactic allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure in her bed), CONFUSIONAL STATE (very confused), NAUSEA (nausea) and ANAPHYLACTIC REACTION (Anaphylactic allergic reaction) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced SEIZURE (seizure in her bed) (seriousness criteria hospitalization and medically significant) and ANAPHYLACTIC REACTION (Anaphylactic allergic reaction) (seriousness criteria hospitalization and medically significant). On 06-Sep-2021, the patient experienced CONFUSIONAL STATE (very confused) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion hospitalization). The patient was hospitalized from 05-Sep-2021 to 07-Sep-2021 due to ANAPHYLACTIC REACTION, CONFUSIONAL STATE, NAUSEA and SEIZURE. At the time of the report, SEIZURE (seizure in her bed), CONFUSIONAL STATE (very confused), NAUSEA (nausea) and ANAPHYLACTIC REACTION (Anaphylactic allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. On Sunday, 05-Sep-2021, at 7 PM, patient experienced a seizure in her bed. She was taken to ER. The patient woke up after 24 hours in confused state and gradually became aware of her surroundings She was treated with anti seizure medications and fluids. She was discharged 48 hours later with seizure medications. Company Comment: This case concerns a 52-year-old, female patient with no relevant medical history , who experienced the expected event of Anaphylactic reaction, also experienced seizures, confusional state and nausea. The event occurred the next day after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up received on 13-sep-2021 includes dose description, events, vaccine facility information.; Sender's Comments: This case concerns a 52-year-old, female patient with no relevant medical history , who experienced the expected event of Anaphylactic reaction, also experienced seizures, confusional state and nausea. The event occurred the next day after the first dose of mRNA-1273. The rechallenge was not applicable since only information about the first dose was disclosed. The reporter assessed the events as possible. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1711210
Sex: M
Age: 65
State: NY

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 09/18/2021
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: his arm was sore; kinda tired for 3 days; Nosebleed; This spontaneous case was reported by a patient and describes the occurrence of EPISTAXIS (Nosebleed), VACCINATION SITE PAIN (his arm was sore) and FATIGUE (kinda tired for 3 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21-2A) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced EPISTAXIS (Nosebleed). On an unknown date, the patient experienced VACCINATION SITE PAIN (his arm was sore) and FATIGUE (kinda tired for 3 days). On 10-Apr-2021, EPISTAXIS (Nosebleed) had resolved. At the time of the report, VACCINATION SITE PAIN (his arm was sore) outcome was unknown and FATIGUE (kinda tired for 3 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had nosebleed that just started spontaneously, it lasted for 10 to 15 minutes . Patient did not receive any medication for nosebleed and patient just put pressure on his nose with a Kleenex and overtime it clotted. This case was linked to MOD-2021-297968 (Patient Link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am