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: 1721732
Sex: M
Age: 70
State: FL

Vax Date: 01/07/2021
Onset Date:
Rec V Date: 09/22/2021
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: injection arm was warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection arm was warm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection arm was warm). At the time of the report, VACCINATION SITE WARMTH (injection arm was warm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-318263 (Patient Link).

Other Meds:

Current Illness:

ID: 1721733
Sex: M
Age: 13
State: MA

Vax Date: 07/29/2021
Onset Date:
Rec V Date: 09/22/2021
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: sore arm; fatigue; 13 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old). At the time of the report, MYALGIA (sore arm), FATIGUE (fatigue) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On an unknown date,patient got second dose of the Moderna COVID-19 vaccine. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1721734
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: extreme weakness in my hands; hurts to grab things, or even to just close them; swell at the injection site; swell at my upper arm quite a lot; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULAR WEAKNESS (extreme weakness in my hands), PAIN IN EXTREMITY (hurts to grab things, or even to just close them), VACCINATION SITE SWELLING (swell at the injection site) and VACCINATION SITE SWELLING (swell at my upper arm quite a lot) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULAR WEAKNESS (extreme weakness in my hands), PAIN IN EXTREMITY (hurts to grab things, or even to just close them), VACCINATION SITE SWELLING (swell at the injection site) and VACCINATION SITE SWELLING (swell at my upper arm quite a lot). At the time of the report, MUSCULAR WEAKNESS (extreme weakness in my hands), PAIN IN EXTREMITY (hurts to grab things, or even to just close them), VACCINATION SITE SWELLING (swell at the injection site) and VACCINATION SITE SWELLING (swell at my upper arm quite a lot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1721735
Sex: F
Age:
State: KS

Vax Date: 08/10/2021
Onset Date: 09/09/2021
Rec V Date: 09/22/2021
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: She was due to get the second dose on 07SEP2021 and she was out of town and missed it.; So far asymptomatic for COVID-19 Disease; Exposed to COVID-19 infected person; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person), PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.) and ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person). On 13-Sep-2021, the patient experienced ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.). At the time of the report, EXPOSURE TO SARS-COV-2 (Exposed to COVID-19 infected person) and ASYMPTOMATIC COVID-19 (So far asymptomatic for COVID-19 Disease) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She was due to get the second dose on 07SEP2021 and she was out of town and missed it.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1721736
Sex: F
Age: 33
State:

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 09/22/2021
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: injection in her fat; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (injection in her fat) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (injection in her fat). At the time of the report, PRODUCT ADMINISTRATION ERROR (injection in her fat) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1721737
Sex: U
Age:
State:

Vax Date: 09/12/2021
Onset Date: 09/12/2021
Rec V Date: 09/22/2021
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 am tired from not sleeping; Body hurt; 101 degrees fever; Started to feel bad; Could not sleep that night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), FATIGUE (I am tired from not sleeping), MYALGIA (Body hurt) and PYREXIA (101 degrees fever) 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 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), MYALGIA (Body hurt) and PYREXIA (101 degrees fever). On 13-Sep-2021, the patient experienced FATIGUE (I am tired from not sleeping). At the time of the report, FEELING ABNORMAL (Started to feel bad), INSOMNIA (Could not sleep that night), FATIGUE (I am tired from not sleeping), MYALGIA (Body hurt) and PYREXIA (101 degrees fever) outcome was unknown. Not Provided Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Patient started to feel somewhat better after lunch on 13 Sep 2021. This case was linked to MOD-2021-311034 (Patient Link).

Other Meds:

Current Illness:

ID: 1721738
Sex: F
Age:
State:

Vax Date: 09/03/2021
Onset Date:
Rec V Date: 09/22/2021
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: had a procedure done and had anesthetics and IV; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (had a procedure done and had anesthetics and IV) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included Anesthesia on 09-Sep-2021 and IV flush on 09-Sep-2021. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SURGERY (had a procedure done and had anesthetics and IV). The patient was treated with PREDNISONE at a dose of 50 mg. At the time of the report, SURGERY (had a procedure done and had anesthetics and IV) outcome was unknown. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1721739
Sex: F
Age: 72
State: WV

Vax Date: 03/08/2021
Onset Date: 09/05/2021
Rec V Date: 09/22/2021
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: Constant pain after 3rd shot; Suffering with bad headache after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Constant pain after 3rd shot) and HEADACHE (Suffering with bad headache after 3rd shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Angioma. Concomitant products included PARACETAMOL (ACETAMINOPHEN), TRAMADOL and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Angioma. On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced PAIN (Constant pain after 3rd shot) and HEADACHE (Suffering with bad headache after 3rd shot). At the time of the report, PAIN (Constant pain after 3rd shot) outcome was unknown and HEADACHE (Suffering with bad headache after 3rd shot) had resolved. Patient experienced headache and constant pain it was so bad that she visited the emergency room on Sunday,12-SEP-2021. They gave her a Migraine cocktail by IV. She believes that there was Muscle relaxer and Benadryl in the cocktail. They released her to follow up with her doctor. re-challenge is positive This case was linked to MOD-2021-318514, MOD-2021-318486 (Patient Link).; Sender's Comments: This case concerns a 73 year-old, female subject with a history of Angioma for which she takes Acetaminophen, Tramadol, and Flexeril who experienced the expected event of headache and unexpected event of pain. The events occurred occurred on the same day after the third dose of Spikevax. The rechallenge was positive as the subject experienced headache after the first, second and reoccurred on third dose. The event is consistent with the current understanding of the mechanism of action of the study medication. The medical history of Angioma for which she takes Acetaminophen, Tramadol, and Flexeril remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Events were assesed as non-serious as emergency room visits that do not result in admission to the hospital would not qualify for hospitalazation and the events doesn?t seem to be serious by medical judgement and from a clinical or regulatory standpoint.

Other Meds: ACETAMINOPHEN; TRAMADOL; FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]

Current Illness: Angioma

ID: 1721740
Sex: F
Age:
State:

Vax Date: 08/10/2021
Onset Date:
Rec V Date: 09/22/2021
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: Injection site of arm is warm, hot; Dry heaving; Nauseous and dry heaving; Fever; Chills; Injection site of arm is warm, hot and red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 042C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported by the reporter. Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication. On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site of arm is warm, hot), RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site of arm is warm, hot) and VACCINATION SITE ERYTHEMA (Injection site of arm is warm, hot and red) had not resolved and RETCHING (Dry heaving), NAUSEA (Nauseous and dry heaving), PYREXIA (Fever) and CHILLS (Chills) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient continued using ice and Tylenol for ongoing symptoms after taking guidance from HCP and pharmacist.

Other Meds: DAILY VITAMINS

Current Illness:

ID: 1721741
Sex: F
Age: 49
State: PR

Vax Date: 09/12/2021
Onset Date: 09/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Dizzy; All my body was itchy; Rash all over my body; A lot of cough; migraine; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PRURITUS (All my body was itchy), COUGH (A lot of cough), MIGRAINE (migraine) and RASH (Rash all over my body) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication. On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced DIZZINESS (Dizzy), PRURITUS (All my body was itchy) and RASH (Rash all over my body). In September 2021, the patient experienced COUGH (A lot of cough) and MIGRAINE (migraine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizzy), PRURITUS (All my body was itchy), COUGH (A lot of cough), MIGRAINE (migraine) and RASH (Rash all over my body) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ZOLOFT

Current Illness: Iodine allergy; Penicillin allergy

ID: 1721742
Sex: F
Age: 70
State: CO

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 09/22/2021
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: Tingling in the left side of her neck and shoulder; Redness; Scratchy; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. 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 an unknown date, the patient experienced PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy). At the time of the report, PARAESTHESIA (Tingling in the left side of her neck and shoulder), ERYTHEMA (Redness) and PRURITUS (Scratchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided. The patient experienced redness and it was scratchy within a week. This case was linked to MOD-2021-318618 (Patient Link).

Other Meds:

Current Illness:

ID: 1721743
Sex: M
Age: 78
State: CA

Vax Date: 07/23/2021
Onset Date: 08/20/2021
Rec V Date: 09/22/2021
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: diarrhea; swollen arm; red arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Abdominal aortic aneurysm (triple A Abdominal aorta aneurysm), Gallbladder stones and Heart attack. Concurrent medical conditions included Memory loss, High cholesterol, Stiffness and Vitamin D deficiency. Concomitant products included BACLOFEN, METOPROLOL, TERAZOSIN HCL, OXYBUTYNIN CHLORIDE, ASPIRIN [ACETYLSALICYLIC ACID], OMEPRAZOLE, ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS, PAROXETINE HCL and SALINE [SODIUM CHLORIDE] for an unknown indication. On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm). At the time of the report, DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (swollen arm) and VACCINATION SITE ERYTHEMA (red arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications was provided by the reporter.

Other Meds: BACLOFEN; METOPROLOL; TERAZOSIN HCL; OXYBUTYNIN CHLORIDE; ASPIRIN [ACETYLSALICYLIC ACID]; OMEPRAZOLE; CRESTOR; VITAMIN D NOS; PAROXETINE HCL; SALINE [SODIUM CHLORIDE]

Current Illness: High cholesterol; Memory loss; Stiffness; Vitamin D deficiency

ID: 1721744
Sex: F
Age: 70
State: CO

Vax Date: 03/08/2021
Onset Date:
Rec V Date: 09/22/2021
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: After the second dose, the tingling went up to her shoulder to the back of her neck; She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After the second dose, the tingling went up to her shoulder to the back of her neck) and HYPOAESTHESIA (She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 029A21A) for COVID-19 vaccination. 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 PARAESTHESIA (After the second dose, the tingling went up to her shoulder to the back of her neck) and HYPOAESTHESIA (She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.). At the time of the report, PARAESTHESIA (After the second dose, the tingling went up to her shoulder to the back of her neck) and HYPOAESTHESIA (She has tingling and numbing that goes off and on all day and night in the left side of her neck and shoulder.) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. This case was linked to MOD-2021-318602 (Patient Link).

Other Meds:

Current Illness:

ID: 1721745
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Bruising; he started having bloody nose every day when eating; This spontaneous case was reported by a patient and describes the occurrence of CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091B21A) 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. In 2021, the patient experienced CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating). At the time of the report, CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1721746
Sex: F
Age: 74
State: FL

Vax Date: 01/07/2021
Onset Date: 09/05/2021
Rec V Date: 09/22/2021
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: experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.; Left arm was hot; had to much swelling on their left arm, it was very hot, lasting 2-3 days; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 029K20A and 039K20A) for COVID-19 vaccination. The patient's past medical history included Thyroidectomy (thyroid removed). Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, FOLIC ACID, CALCIUM and MELOXICAM for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches). The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK UNK, q4h. At the time of the report, DISCOMFORT (experienced body aches and discomfort for a whole day, more severe than after the second dose, and they had to lay down.), VACCINATION SITE WARMTH (Left arm was hot), VACCINATION SITE SWELLING (had to much swelling on their left arm, it was very hot, lasting 2-3 days) and MYALGIA (Body aches) outcome was unknown. Concomitant medications included medication to replace thyroid. Treatment for the events included ice. This case was linked to MOD-2021-318648, MOD-2021-318654, MOD-2021-318659 (Patient Link).

Other Meds: INSULIN; FOLIC ACID; CALCIUM; MELOXICAM

Current Illness: Diabetes

ID: 1721747
Sex: U
Age:
State: OH

Vax Date: 09/09/2021
Onset Date: 09/12/2021
Rec V Date: 09/22/2021
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: Her arm feels sore after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Her arm feels sore after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Multiple myeloma. On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced MYALGIA (Her arm feels sore after vaccination). At the time of the report, MYALGIA (Her arm feels sore after vaccination) outcome was unknown. Concomitant medication was not provided. no treatment medication was provided. patients sated that she was wanted to know if she could take Tylenol or apply heat to the site of the injection.

Other Meds:

Current Illness: Multiple myeloma

ID: 1721748
Sex: F
Age: 66
State: FL

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 20210907; Test Name: IgG SARS CoV 2 antibody; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210908; Test Name: SARS-CoV-2 test negative; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Dry cough; Throat irritation/throat felt raw; last month and a half I have gotten hoarse; Felt the heeby jeeby; Felt the heeby jeeby; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse), the second episode of NERVOUSNESS (Felt the heeby jeeby) and the first episode of NERVOUSNESS (Felt the heeby jeeby) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 03K20A) for COVID-19 vaccination. Concurrent medical conditions included GERD, Barrett's esophagus (Patient had irritation in her hroat) and Hypertension (on medication). Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), METFORMIN, COLECALCIFEROL (VITAMIN D3), PRAVASTATIN, MAGNESIUM, ZINC, CALCIUM and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of NERVOUSNESS (Felt the heeby jeeby). On 12-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of NERVOUSNESS (Felt the heeby jeeby). On an unknown date, the patient experienced COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw) and DYSPHONIA (last month and a half I have gotten hoarse). At the time of the report, COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse) and the last episode of NERVOUSNESS (Felt the heeby jeeby) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 08-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant also included OTC vitamins. Treatment medication was not provided by the reporter. Patient doesn't recall being sick with COVID or being infected previously. She stated that she had a history of GERD and Barrett's Esophagus, so she always had irritation in her throat. However, a month ago she started having dry cough which she said was new and her throat felt very irritated and raw. She also stated that her voice became hoarse in the last month. She said that she did not really have any side effects from both doses except that she felt the heeby jeeby.

Other Meds: PRILOSEC [OMEPRAZOLE MAGNESIUM]; METFORMIN; VITAMIN D3; AMLODIPINE; PRAVASTATIN; MAGNESIUM; ZINC; CALCIUM; NITROGLYCERIN

Current Illness: Barrett's esophagus (Patient had irritation in her hroat); GERD; Hypertension (on medication)

ID: 1721749
Sex: F
Age:
State: FL

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 09/22/2021
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: she passed out three times after recieving second dose of moderna vaccine; she reports that a "hell night" for her following her 2nd dose.; she fell two times after the second dose.; vomiting; she also experienced a "very strong headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Kidney disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and ESTRADIOL, NORETHISTERONE ACETATE (COMBIPATCH) for an unknown indication. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache). At the time of the report, LOSS OF CONSCIOUSNESS (she passed out three times after recieving second dose of moderna vaccine), FEELING ABNORMAL (she reports that a "hell night" for her following her 2nd dose.), FALL (she fell two times after the second dose.), VOMITING (vomiting) and HEADACHE (she also experienced a "very strong headache) outcome was unknown. Not Provided Concomitant medication was not provided. Treatment medication was not provided . Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow-up information included no new information.; Sender's Comments: This case concerns a female patient of unknown age, with relevant medical history of kidney disorder, who experienced the expected events of vomiting and headache and the unexpected events of Feeling abnormal, fall and Loss of consciousness. The events occurred on an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the second dose. The events were considered related to the vaccine per the reporter's assessment. The events vomiting and headache are consistent with the current understanding of the mechanism of action of the study medication. The medical history, of kidney disorder, use of concomitant medication levothyroxine and estradiol/norethindrone acetate, remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. Event Loss of consciousness was automatically upgraded as serious as per IME list. However, based on reporter?s assesment, information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious.

Other Meds: SYNTHROID; COMBIPATCH

Current Illness: Kidney disorder

ID: 1721750
Sex: F
Age: 60
State: IL

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: C reactive protein; Result Unstructured Data: C reactive protein test at the beginning of July (it shows if there is any kind of inflammation).

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Redness in the eyelids; Puffiness in the eyelids; Pain in my back; It was hard to do anything with my arms; Numbness in my hands/50% of numbness in my fingers of both hands/(numbness) was going to the whole finger/partial numbness only/the middle finger was the worst; Much more severe pain; similar symptoms to carpal tunnel/mild case of carpal tunnel on the left side/moderate case of carpal tunnel on the right side; Feel pressure in my neck, where the thyroid gland is; Pain went to my right knee, underneath the knee/pain in the right shoulder/pain is similar to rheumatoid arthritis; (Pain) went to my left calf on my leg/pain was also in both arms (in the triceps)/was not able to sleep on my right side/pain went to both thighs/pain in my hands; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA OF EYELID (Redness in the eyelids), PERIORBITAL SWELLING (Puffiness in the eyelids), BACK PAIN (Pain in my back), MOBILITY DECREASED (It was hard to do anything with my arms) and HYPOAESTHESIA (Numbness in my hands/50% of numbness in my fingers of both hands/(numbness) was going to the whole finger/partial numbness only/the middle finger was the worst) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 026B21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-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 ERYTHEMA OF EYELID (Redness in the eyelids), PERIORBITAL SWELLING (Puffiness in the eyelids), BACK PAIN (Pain in my back), MOBILITY DECREASED (It was hard to do anything with my arms), HYPOAESTHESIA (Numbness in my hands/50% of numbness in my fingers of both hands/(numbness) was going to the whole finger/partial numbness only/the middle finger was the worst), PAIN (Much more severe pain), CARPAL TUNNEL SYNDROME (similar symptoms to carpal tunnel/mild case of carpal tunnel on the left side/moderate case of carpal tunnel on the right side), MUSCLE TIGHTNESS (Feel pressure in my neck, where the thyroid gland is), ARTHRALGIA (Pain went to my right knee, underneath the knee/pain in the right shoulder/pain is similar to rheumatoid arthritis) and MYALGIA ((Pain) went to my left calf on my leg/pain was also in both arms (in the triceps)/was not able to sleep on my right side/pain went to both thighs/pain in my hands). The patient was treated with NAPROXEN at an unspecified dose and frequency; METHYLPREDNISOLONE on 18-Aug-2021 at an unspecified dose and frequency and DEXAMETHASONE SODIUM PHOSPHATE (CORTICOIDEX) at an unspecified dose and frequency. At the time of the report, ERYTHEMA OF EYELID (Redness in the eyelids), PERIORBITAL SWELLING (Puffiness in the eyelids), BACK PAIN (Pain in my back), MOBILITY DECREASED (It was hard to do anything with my arms), HYPOAESTHESIA (Numbness in my hands/50% of numbness in my fingers of both hands/(numbness) was going to the whole finger/partial numbness only/the middle finger was the worst), PAIN (Much more severe pain), CARPAL TUNNEL SYNDROME (similar symptoms to carpal tunnel/mild case of carpal tunnel on the left side/moderate case of carpal tunnel on the right side), MUSCLE TIGHTNESS (Feel pressure in my neck, where the thyroid gland is), ARTHRALGIA (Pain went to my right knee, underneath the knee/pain in the right shoulder/pain is similar to rheumatoid arthritis) and MYALGIA ((Pain) went to my left calf on my leg/pain was also in both arms (in the triceps)/was not able to sleep on my right side/pain went to both thighs/pain in my hands) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, C-reactive protein (0-4): 17 (High) C reactive protein test at the beginning of July (it shows if there is any kind of inflammation). Patient started to go to physical therapy (electrodes, and massage), patient was not feeling better with this therapy, so patient was prescribed with Methylprednisolone On 03Sep2021, patient had an EMG test. Neurologist checked her nerves, mild case on the left side of carpal tunnel, and moderate case on the right side of carpal tunnel. Treatment information included Pain killers, topical creams.

Other Meds: SYNTHROID; VITAMIN D 2000

Current Illness:

ID: 1721751
Sex: F
Age: 22
State: TX

Vax Date: 08/17/2021
Onset Date: 09/11/2021
Rec V Date: 09/22/2021
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: Arm was sore; arm where they injected the vaccine was still red; left arm puffy with baseball size lump; This morning she had bad sweats; body ache /arm was sore; woke up really sick the next day; migraine; feels really bad; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats) and PAIN (body ache /arm was sore) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FB8448 and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included MAGNESIUM GLYCINATE (MAGNESIUM GUMMIES) for an unknown indication. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), PAIN (body ache /arm was sore), CHILLS (chills) and PYREXIA (fever). On 12-Sep-2021, the patient experienced HYPERHIDROSIS (This morning she had bad sweats), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm puffy with baseball size lump). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats), PAIN (body ache /arm was sore), PAIN IN EXTREMITY (Arm was sore), CHILLS (chills), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm puffy with baseball size lump) outcome was unknown and PYREXIA (fever) had resolved. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.

Other Meds: MAGNESIUM GUMMIES

Current Illness:

ID: 1721752
Sex: F
Age:
State: TX

Vax Date: 09/11/2021
Onset Date: 09/11/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dizzines; Fever like simptoms; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms) 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 11-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided.

Other Meds:

Current Illness:

ID: 1721753
Sex: F
Age: 50
State: SC

Vax Date: 09/11/2021
Onset Date: 09/12/2021
Rec V Date: 09/22/2021
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: 20210912; Test Name: Body temperature; Result Unstructured Data: 101.3F

Allergies:

Symptom List: Unevaluable event

Symptoms: Drenched in sweat; Feels like there was an elephant sitting on her chest; Tremors; Head hurt; Every part of the body hurts; Fever at 101.6F at 3am - current temperature now is at 101.3F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt) and MYALGIA (Every part of the body hurts) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy (sulfa based drug). On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 2 tabs and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) ongoing since an unknown date for Adverse event, at a dose of 2 tabs. At the time of the report, HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Body temperature: 101.3f (High) 101.3F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported.

Other Meds:

Current Illness: Sulfonamide allergy (sulfa based drug)

ID: 1721754
Sex: M
Age:
State: TX

Vax Date: 09/10/2021
Onset Date: 09/10/2021
Rec V Date: 09/22/2021
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: Chills; Headache; expired vaccine used; received 2 doses on same day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses on same day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses on same day). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses on same day) had resolved. On 12-Sep-2021, CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Headache) had not resolved. No concomitant medication provided. No treatment information provided. The patient said that the first dose was an expired dose and therefore on the same day, another dose was injected.

Other Meds:

Current Illness:

ID: 1721755
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: High

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: heart rate still up; felt horrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt horrible) and HEART RATE INCREASED (heart rate still up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt horrible) and HEART RATE INCREASED (heart rate still up). At the time of the report, FEELING ABNORMAL (felt horrible) was resolving and HEART RATE INCREASED (heart rate still up) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1721756
Sex: F
Age: 71
State: CO

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 09/22/2021
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: strong reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strong reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 029L20A and 038C21A) for COVID-19 vaccination. The patient's past medical history included Breast cancer in 2008. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third 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 (strong reaction). At the time of the report, VACCINATION COMPLICATION (strong reaction) outcome was unknown. In 2008 patient had breast cancer for which she was performed a Mastectomy, though didn't receive Radiation nor Chemo This case was linked to MOD-2021-318449 (Patient Link).

Other Meds:

Current Illness:

ID: 1721757
Sex: F
Age: 62
State: IL

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: e had a bad reaction where she she had a whopping COVID arm; Purple arm that lasted for a week; Felt terrible; Flu-like symptoms; lethargy; mild upset stomach; Headache so bad that she could hardly lift her head off the pillow; Was a tad nauseous but not enough to vomit; Had a little fever but nothing crazy/101+ degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and LETHARGY (lethargy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included IBD, Migraine, Seizure since an unknown date, Myocardial infarction (Myocardial bridge), Tachycardia, Lymph node abscess (with lymph node dissection ) on 26-Jan-2021, St. Louis encephalitis (when she was 15 years old and had a high fever and was in a coma for 5 days. ) and Radiation therapy. Concurrent medical conditions included Blood pressure high and Cancer since December 2020. Concomitant products included PARACETAMOL (TYLENOL) for Pain, LETROZOLE for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-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 VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees). At the time of the report, VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received: Added new events.

Other Meds: LETROZOLE; TYLENOL

Current Illness: Blood pressure high; Cancer; Seizure

ID: 1721758
Sex: F
Age:
State: PA

Vax Date: 09/04/2021
Onset Date: 09/04/2021
Rec V Date: 09/22/2021
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: Injection arm was aching; Fever; Chest pain; Heart started racing; Fluttering in her chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest), VACCINATION SITE PAIN (Injection arm was aching), CHEST PAIN (Chest pain) and PYREXIA (Fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 04-Sep-2021, the patient experienced PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest) and CHEST PAIN (Chest pain). On 05-Sep-2021, the patient experienced VACCINATION SITE PAIN (Injection arm was aching) and PYREXIA (Fever). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart started racing), CHEST DISCOMFORT (Fluttering in her chest), VACCINATION SITE PAIN (Injection arm was aching), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter. Patient stated that she received her 1st dose of the Moderna COVID 19 vaccine on 4SEPT2021 at Rite Aid. 30 minutes after getting the vaccine, her heart started racing, she felt some fluttering in her chest, and she had a chest pain. The symptoms lasted for 2 minutes; she did not get an EKG done. The next day, she had fever, her injection arm was aching, and she had chest pain which was on and off through out the day; it was not persistent that she needed to call 911. She went to her doctor today; her doctor said the vaccine is safe, but she feels her doctor is bias. She took Motrin at the time she was having the symptoms. She was not having the symptoms at the time of the call. She gave a consent for safety to follow-up with her or her healthcare provider. Lot number and date of birth was provided by patient but the information was deleted when system crashed.

Other Meds:

Current Illness:

ID: 1721759
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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 itching at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (severe itching at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (severe itching at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (severe itching at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided.

Other Meds:

Current Illness:

ID: 1721760
Sex: M
Age: 59
State: AZ

Vax Date: 09/11/2021
Onset Date: 09/12/2021
Rec V Date: 09/22/2021
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: Stomach ulcer came back; Had been throwing up and was throwing up again; Back spasms; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC ULCER (Stomach ulcer came back) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stomach ulcer (he had been diagnosed with a stomach ulcer in March 2021) in 2021. On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced MUSCLE SPASMS (Back spasms). On 13-Sep-2021, the patient experienced GASTRIC ULCER (Stomach ulcer came back) (seriousness criterion medically significant) and VOMITING (Had been throwing up and was throwing up again). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Stomach ulcer, at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM HYDROXIDE, SIMETICONE (MYLANTA [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM HYDROXIDE;SIMETICONE]) for Stomach ulcer, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach ulcer, at an unspecified dose and frequency. At the time of the report, GASTRIC ULCER (Stomach ulcer came back), MUSCLE SPASMS (Back spasms) and VOMITING (Had been throwing up and was throwing up again) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitant drug details not provided. Company Comment: This case concerns a 59-year-old, male patient with relevant medical history of stomach ulcer, who experienced the unexpected event of stomach ulcer The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. However, the patient's medical history and concomitant use of Advil, remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 59-year-old, male patient with relevant medical history of stomach ulcer, who experienced the unexpected event of stomach ulcer The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. However, the patient's medical history and concomitant use of Advil, remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1721761
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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 missed my second dose. I had my first in April; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April) 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 PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April) had resolved. No concomitant medications were not reported. No treatment medications were not provided.

Other Meds:

Current Illness:

ID: 1721762
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Legs are bloody and stuff; Legs are bloody and stuff; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff). At the time of the report, SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff) outcome was unknown. The Concomitant medications and Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1721763
Sex: F
Age: 33
State: NJ

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: After about a week following the first shot the patient experienced eczema all over her body; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (After about a week following the first shot the patient experienced eczema all over her body) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (After about a week following the first shot the patient experienced eczema all over her body). At the time of the report, ECZEMA (After about a week following the first shot the patient experienced eczema all over her body) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant was reported by reporter. The patient stated that about 3 months ago , her dermatologist prescribed a steroid cream. This case was linked to MOD-2021-319068 (Patient Link).

Other Meds:

Current Illness:

ID: 1721764
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown. No concomitant medication reported. No treatment medication reported.

Other Meds:

Current Illness:

ID: 1721765
Sex: F
Age:
State:

Vax Date: 08/18/2021
Onset Date: 08/23/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Tremor

Symptoms: We tested positive We must have already had covid when we got the shot although we didn't know it; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it) 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 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it). At the time of the report, COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. The patient received anti-body on 26-Aug-2021. This case was linked to MOD-2021-319706 (Patient Link).

Other Meds:

Current Illness:

ID: 1721766
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Hives with no relief; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives with no relief) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives with no relief). At the time of the report, URTICARIA (Hives with no relief) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter Patient has been to several doctors with no relief

Other Meds:

Current Illness:

ID: 1721767
Sex: M
Age: 49
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: He states his shoulder pain started with the first shot.; His shoulder was sore, like a Charlie's horse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 017E21A) for COVID-19 vaccination. 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 04-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse). At the time of the report, ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse) outcome was unknown. No concomitant medications reported. No treatment medications reported. This case was linked to MOD-2021-319007 (Patient Link).

Other Meds:

Current Illness:

ID: 1721768
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effect). At the time of the report, ADVERSE EVENT (Side effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information provided. No treatment medication information provided

Other Meds:

Current Illness:

ID: 1721769
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date: 07/01/2021
Rec V Date: 09/22/2021
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: first dose > 35 days before second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose) 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. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose). In July 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose) had resolved. No concomitant medication were reported no treatement of medication were reported

Other Meds:

Current Illness:

ID: 1721770
Sex: U
Age:
State:

Vax Date:
Onset Date: 09/13/2021
Rec V Date: 09/22/2021
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: I lost my taste after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I lost my taste after getting the vaccine) 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 13-Sep-2021, the patient experienced AGEUSIA (I lost my taste after getting the vaccine). At the time of the report, AGEUSIA (I lost my taste after getting the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1721771
Sex: F
Age: 59
State: FL

Vax Date: 06/26/2021
Onset Date: 06/26/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Date: 20210627; Test Name: BODY TEMPERATURE; Result Unstructured Data: 100?F

Allergies:

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

Symptoms: not getting 2nd dose on time; her bottom whip was swollen; fever of 100?F; soreness on the left side of her face; increasing left side chest pain/ pain on her chest; swelling on the left side of her face; feeling really sick; heaviness on the left side of her face; arm pain / pain on her left arm within 1 hour of receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face) and SWELLING (her bottom whip was swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine). On 27-Jun-2021, the patient experienced CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), PYREXIA (fever of 100?F) and MYALGIA (soreness on the left side of her face). On 11-Jul-2021, the patient experienced SWELLING (her bottom whip was swollen). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time). At the time of the report, CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), SWELLING (her bottom whip was swollen), PYREXIA (fever of 100?F), VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine) and MYALGIA (soreness on the left side of her face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2021, Body temperature: 100 (High) 100?F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient has not taken second dose due to fear. She had pain in her chest and lower arm. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1721772
Sex: F
Age:
State: CO

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: had a bad reaction; swollen "giant" arm; redness; hives; when trying to touch the arm "it felt like my hands were knives", "it hurt really bad"; something moving towards her heart and down her back; Did not take second dose (over 6 months now); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, and PAIN IN EXTREMITY in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy (bananas) and Alcohol allergy (whisky). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, SENSORY DISTURBANCE, and PRODUCT DOSE OMISSION ISSUE. At the time of the report, VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, and SENSORY DISTURBANCE outcome was unknown and PRODUCT DOSE OMISSION ISSUE had resolved. No Concomitants and Treatment medication were reported.

Other Meds:

Current Illness: Alcohol allergy (whisky); Fruit allergy (bananas)

ID: 1721773
Sex: F
Age: 33
State: NJ

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 09/22/2021
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: reported that the eczema keeps getting worse; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse). At the time of the report, ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse) had not resolved. The patient stated that about 3 months ago , her dermatologist that she had been seeing her prescribing a steroid cream. Concomitant drug information does not provided. This case was linked to MOD-2021-318836 (Patient Link).

Other Meds:

Current Illness:

ID: 1721774
Sex: F
Age: 77
State: MA

Vax Date: 02/04/2021
Onset Date: 08/01/2021
Rec V Date: 09/22/2021
Hospital:

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

Lab Data: Test Name: MRI; Result Unstructured Data: spine MRI ruled out MS; Comments: spine MRI ruled out MS

Allergies:

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

Symptoms: Vestibular migraine; Dizziness; Lack of concentration; Irritability; Anxiety; Depression; Tearfulness; Nausea; Fatigue; Headache; Started to feel ill; Blurred vision in both eyes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness) and DISTURBANCE IN ATTENTION (Lack of concentration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028C20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LORAZEPAM, SERTRALINE and PARACETAMOL, TRAMADOL HYDROCHLORIDE (TRACEDOL). On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes) and HEADACHE (Headache). On an unknown date, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: ms spine MRI ruled out MS. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: LORAZEPAM; SERTRALINE; TRACEDOL

Current Illness:

ID: 1721775
Sex: U
Age:
State:

Vax Date: 02/18/2021
Onset Date: 02/22/2021
Rec V Date: 09/22/2021
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: did have mycarditis og the heart; 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 MYOCARDITIS (did have mycarditis og the heart) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MYOCARDITIS (did have mycarditis og the heart) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (did have mycarditis og the heart) outcome was unknown. No concomitant medication details was provided. No treatment medication details was provided. Action taken was not applicable. This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report

Other Meds:

Current Illness:

ID: 1721776
Sex: F
Age: 55
State: CA

Vax Date: 04/01/2021
Onset Date: 04/29/2021
Rec V Date: 09/22/2021
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: Watery stools every day since april and continues; Stomach was upset; Fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Watery stools every day since april and continues), ABDOMINAL DISCOMFORT (Stomach was upset) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 027B21A) for COVID-19 vaccination. The patient's past medical history included Stools watery (20 years ago). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIARRHOEA (Watery stools every day since april and continues), ABDOMINAL DISCOMFORT (Stomach was upset) and PYREXIA (Fever). On 29-Apr-2021, PYREXIA (Fever) had resolved. On 01-May-2021, ABDOMINAL DISCOMFORT (Stomach was upset) had resolved. At the time of the report, DIARRHOEA (Watery stools every day since april and continues) had not resolved. Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter This case was linked to MOD-2021-319094 (Patient Link).

Other Meds:

Current Illness:

ID: 1721777
Sex: F
Age: 60
State: SD

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 09/22/2021
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: sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LIOTHYRONINE SODIUM (T3) from an unknown date to 01-Mar-2021 for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore right injection site arm) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient had a sore right injection site arm which felt better in a few days. No treatment medication was reported. Company comment: This case concerns a 61-year-old mal subject who experienced the expected event of VACCINATION SITE PAIN. The event occurred the same date after the first dose of Spikevax and it had resolved. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of spikevax is not affected by this report. This case was linked to MOD-2021-319204 (Patient Link).; Sender's Comments: This case concerns a 61-year-old mal subject who experienced the expected event of VACCINATION SITE PAIN. The event occurred the same date after the first dose of Spikevax and it had resolved. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of spikevax is not affected by this report.

Other Meds: T3

Current Illness:

ID: 1721778
Sex: F
Age: 33
State: MI

Vax Date: 09/08/2021
Onset Date:
Rec V Date: 09/22/2021
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: Weird side effects; feels like she has a bad sinus infection; Now she is losing taste and smell.; Now she is losing taste and smell.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.) in a 33-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 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.). At the time of the report, FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No Treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow up received and additional event added.

Other Meds:

Current Illness:

ID: 1721779
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/22/2021
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: I been getting really bad cramps but I don't get my period; I don't get my period this has never happen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I been getting really bad cramps but I don't get my period) and AMENORRHOEA (I don't get my period this has never happen) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (I been getting really bad cramps but I don't get my period) and AMENORRHOEA (I don't get my period this has never happen). At the time of the report, MUSCLE SPASMS (I been getting really bad cramps but I don't get my period) and AMENORRHOEA (I don't get my period this has never happen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1721780
Sex: F
Age: 60
State: SD

Vax Date: 12/29/2020
Onset Date: 01/28/2021
Rec V Date: 09/22/2021
Hospital:

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

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

Allergies:

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

Symptoms: blood pressure fluctuation; severe headache; heart started racing; felt like my body was vibrating; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart started racing), FEELING ABNORMAL (felt like my body was vibrating), BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation), INFLUENZA LIKE ILLNESS (flu like symptoms) and HEADACHE (severe headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product LEVOTHYROXINE SODIUM for Adverse event. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient started LEVOTHYROXINE SODIUM (Oral) 130 mcg once a day. On 28-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 10-Feb-2021, the patient experienced PALPITATIONS (heart started racing) and FEELING ABNORMAL (felt like my body was vibrating). On 15-Feb-2021, the patient experienced HEADACHE (severe headache). On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation). On 31-Jan-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. At the time of the report, PALPITATIONS (heart started racing), FEELING ABNORMAL (felt like my body was vibrating), BLOOD PRESSURE FLUCTUATION (blood pressure fluctuation) and HEADACHE (severe headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (120-80 mmHg): 163/100 mmHg (High) Increased and 101/80 mmHg (Low) Decreased. No relevant concomitant medications were reported. No treatment information was reported. Patient initially administered 130 mcg of T 3, after taking it her heart started racing and her doctor suggested to drop the dose of drug to 5 mcg orally daily and then her blood pressure was dropped to 163/100 to 101/80 and later physician totally discontinued the T-3.; Sender's Comments: This report concerns a 61 year old female patient who experienced flu like symptoms (on the same day), palpitations, abnormal feeling (13 days), headache and blood pressure fluctuation (18 days) after vaccination with second dose of mRNA-1273. The patient was on concomitant daily oral levothyroxine therapy (T3) 130 mcg. In view of her symptoms, the physician decreased the dosage to 125 mcg daily, then to 110 mcg and finally discontinued the drug. The patient reported resolution of symptoms upon discontinuation of levothyroxine. Based on the available information, the concomitant therapy with levothyroxine remains a confounder for the reported events of palpitations, blood pressure fluctuation and abnormal feeling. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1721781
Sex: F
Age: 58
State: IL

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 09/22/2021
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: full bladder feeling/ feeling a need to urinate; having excessive urination; injection sites felt hard; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination) and VACCINATION SITE INDURATION (injection sites felt hard) in a 58-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 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination) and VACCINATION SITE INDURATION (injection sites felt hard). At the time of the report, POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination) and VACCINATION SITE INDURATION (injection sites felt hard) outcome was unknown. Patient was sensitive to sodium and suspects the sodium in vaccine. No concomitant medications were reported. No treatment medications were reported This case was linked to MOD-2021-319620, MOD-2021-319619 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am