VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1552085
Sex: F
Age:
State: OH

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
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: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included DIAZEPAM (VALIUM) and VITAMIN D NOS for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 30-Jan-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reported Concomitant medications including Blood pressure and Allergy pill. It was reported that, the diarrhea was not severe enough for the patient to report to physician. It lasted for only one day. She was not sure if it was from the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event description was updated.

Other Meds: VALIUM; VITAMIN D NOS

Current Illness: Hypertension

ID: 1552086
Sex: F
Age: 83
State: VA

Vax Date: 01/20/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
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: Injection site rash; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date, Rash and Hives. Concomitant products included POTASSIUM for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The Concomitant medications were reported as unknown medication for high blood pressure with diuretic. The treatment information was not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 05-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date, Rash and Hives. Concomitant products included POTASSIUM for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE RASH (Injection site rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The Concomitant medications were reported as unknown medication for high blood pressure with diuretic. The treatment information was not reported.

Other Meds: POTASSIUM

Current Illness: Hypertension

ID: 1552087
Sex: M
Age:
State: CA

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: cough; Achy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and MYALGIA (Achy) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COUGH (cough) and MYALGIA (Achy). At the time of the report, COUGH (cough) and MYALGIA (Achy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and MYALGIA (Achy) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced COUGH (cough) and MYALGIA (Achy). At the time of the report, COUGH (cough) and MYALGIA (Achy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1552088
Sex: F
Age: 74
State: SC

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/13/2021
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: below. The patient's past medical history included Breast cancer (Prior to vaccine, Breast cancer in the right breast was removed. No Longer on any cancer medications and hasn't taken any for 11 years.), COVID-19 and Bypass surgery (There is a leak the doctor can't stop.) since 2016. Concomitant products included METOPROLOL, BACLOFEN, DIGOXIN, PRAVASTATIN and TADALAFIL (CIALIS) for an unknown indication. On 03-Feb-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (Could not stand without holding on to something), MOVEMENT DISORDER (could not turn over in the bed), DECREASED APPETITE (no appetite), MALAISE (felt sick), SLEEP DISORDER (woke up in the middle of the night at 2am) and PYREXIA (low grade fever 101.8F). At the time of the report, DYSSTASIA (Could not stand without holding on to something), MOVEMENT DISORDER (could not turn over in the bed), DECREASED APPETITE (no appetite), MALAISE (felt sick), SLEEP DISORDER (woke up in the middle of the night at 2am) and PYREXIA (low grade fever 101.8F) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (Low) Fever of 101.8 F. On an unknown date, COVID-19: positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (Could not stand without holding on to something), MOVEMENT DISORDER (could not turn over in the bed), DECREASED APPETITE (no appetite), MALAISE (felt sick) and SLEEP DISORDER (woke up in the middle of the night at 2am) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (Prior to vaccine, Breast cancer in the right breast was removed. No Longer on any cancer medications and hasn't taken any for 11 years.), COVID-19 and Bypass surgery (There is a leak the doctor can't stop.) since 2016. Concomitant products included METOPROLOL, BACLOFEN, DIGOXIN, PRAVASTATIN and TADALAFIL (CIALIS) for an unknown indication. On 03-Feb-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (Could not stand without holding on to something), MOVEMENT DISORDER (could not turn over in the bed), DECREASED APPETITE (no appetite), MALAISE (felt sick), SLEEP DISORDER (woke up in the middle of the night at 2am) and PYREXIA (low grade fever 101.8F). At the time of the report, DYSSTASIA (Could not stand without holding on to something), MOVEMENT DISORDER (could not turn over in the bed), DECREASED APPETITE (no appetite), MALAISE (felt sick), SLEEP DISORDER (woke up in the middle of the night at 2am) and PYREXIA (low grade fever 101.8F) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 (Low) Fever of 101.8 F. On an unknown date, COVID-19: positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. No Treatment information for the event was provided.

Other Meds: METOPROLOL; BACLOFEN; DIGOXIN; PRAVASTATIN; CIALIS

Current Illness: Bypass surgery (There is a leak the doctor can't stop.)

ID: 1552089
Sex: F
Age: 74
State: VA

Vax Date: 01/20/2021
Onset Date: 02/17/2021
Rec V Date: 08/13/2021
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: got arm rash from both doses of the vaccine; Chills; Fever 101.9; Very tired and exhausted; Swollen covid arm; Night sweat; Red; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm) and RASH (got arm rash from both doses of the vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Colitis and Osteoporosis. Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis, BUDESONIDE, LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]), LOPERAMIDE HYDROCHLORIDE (IMODIUM), ESTRADIOL, COLECALCIFEROL (VITAMIN D3), VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), BIOTIN and LIFITEGRAST (XIIDRA) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen covid arm), NIGHT SWEATS (Night sweat), ERYTHEMA (Red), VACCINATION SITE REACTION (COVID arm), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted). On an unknown date, the patient experienced RASH (got arm rash from both doses of the vaccine). At the time of the report, PERIPHERAL SWELLING (Swollen covid arm), NIGHT SWEATS (Night sweat), VACCINATION SITE REACTION (COVID arm), RASH (got arm rash from both doses of the vaccine), CHILLS (Chills), PYREXIA (Fever 101.9) and FATIGUE (Very tired and exhausted) had resolved and ERYTHEMA (Red) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Pyrexia: 101.9 (High) 101.9. No treatment information for the event was provided. This case was linked to MOD-2021-021462 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Updated concomitant drugs and patient medical history.

Other Meds: BUDESONIDE; LOMOTIL [LOPERAMIDE HYDROCHLORIDE]; IMODIUM; PROLIA; ESTRADIOL; VITAMIN D3; VITAMIN B 12 [VITAMIN B12 NOS]; BIOTIN; XIIDRA

Current Illness: Colitis; Osteoporosis

ID: 1552090
Sex: F
Age: 39
State: FL

Vax Date: 01/18/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: injection site warm; Injection site itchy; injection site red,redness growing at injection site; Soreness at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site red,redness growing at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History Information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site red,redness growing at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site red,redness growing at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications taken by the patient were not provided. Treatment activities for the event were not provided. This case was linked to MOD-2021-023395 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site red,redness growing at injection site) and VACCINATION SITE PAIN (Soreness at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History Information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site red,redness growing at injection site) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, VACCINATION SITE WARMTH (injection site warm), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE ERYTHEMA (injection site red,redness growing at injection site) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications taken by the patient were not provided. Treatment activities for the event were not provided. This case was linked to MOD-2021-023395 (Patient Link).

Other Meds:

Current Illness:

ID: 1552091
Sex: F
Age: 78
State: NC

Vax Date: 02/15/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
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: nausea and vomiting; nausea and vomiting; having issues; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) had not resolved. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was reported. On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (nausea and vomiting), NAUSEA (nausea and vomiting), MALAISE (having issues) and DIARRHOEA (diarrhea) had not resolved. No relevant Concomitant medications were reported. No Treatment information for the event was provided.

Other Meds:

Current Illness:

ID: 1552092
Sex: F
Age: 54
State: VA

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/13/2021
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: red; Itching; hurting; like a sunburn /getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History Information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment details included ice on the injection site. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History Information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger). At the time of the report, VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (hurting) and RASH ERYTHEMATOUS (like a sunburn /getting bigger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment details included ice on the injection site. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021:

Other Meds:

Current Illness:

ID: 1552093
Sex: F
Age: 29
State: NY

Vax Date: 01/08/2021
Onset Date: 02/02/2021
Rec V Date: 08/13/2021
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: Minor cold; Mild congestion; A little bit of a sore throat; Diarrhea; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea). At the time of the report, NASOPHARYNGITIS (Minor cold), NASAL CONGESTION (Mild congestion), OROPHARYNGEAL PAIN (A little bit of a sore throat), DIARRHOEA (Diarrhea) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. On 05-Feb-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Non significant follow up received on 05-MAY-2021, no new information

Other Meds:

Current Illness:

ID: 1552094
Sex: M
Age:
State: CA

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/13/2021
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: Body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain) 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 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body pain). At the time of the report, PAIN (Body pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Feb-2021 and was forwarded to Moderna on 06-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain) 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 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body pain). At the time of the report, PAIN (Body pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1552095
Sex: M
Age: 78
State: AL

Vax Date: 01/18/2021
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
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: Tested positive for COVID-19 after being vaccinated; cough; Fever of 99F; Body aches; headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PYREXIA (Fever of 99F), PAIN (Body aches), HEADACHE (headaches) and COVID-19 (Tested positive for COVID-19 after being vaccinated) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Diabetic since an unknown date. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced COUGH (cough), PYREXIA (Fever of 99F), PAIN (Body aches) and HEADACHE (headaches). On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after being vaccinated). At the time of the report, COUGH (cough), PYREXIA (Fever of 99F), PAIN (Body aches), HEADACHE (headaches) and COVID-19 (Tested positive for COVID-19 after being vaccinated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99F. On 25-Jan-2021, SARS-CoV-2 test:. On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported was diabetic medication for drug use for unknown indication. Reported treatment medication including cough medicine. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 29-Jan-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COUGH (cough), PYREXIA (Fever of 99F), PAIN (Body aches), HEADACHE (headaches) and COVID-19 (Tested positive for COVID-19 after being vaccinated) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Diabetic since an unknown date. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced COUGH (cough), PYREXIA (Fever of 99F), PAIN (Body aches) and HEADACHE (headaches). On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after being vaccinated). At the time of the report, COUGH (cough), PYREXIA (Fever of 99F), PAIN (Body aches), HEADACHE (headaches) and COVID-19 (Tested positive for COVID-19 after being vaccinated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature: 99F. On 25-Jan-2021, SARS-CoV-2 test:. On 26-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported was diabetic medication for drug use for unknown indication. Reported treatment medication including cough medicine.

Other Meds:

Current Illness: Diabetic

ID: 1552096
Sex: F
Age: 29
State: IN

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/13/2021
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: rash on at the injection site; warm at the injection site; tender at the injection site; raised at the injection site; redness at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (rash on at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PAIN (tender at the injection site), VACCINATION SITE SWELLING (raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination. No Medical History Information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PAIN (tender at the injection site), VACCINATION SITE SWELLING (raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE RASH (rash on at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PAIN (tender at the injection site), VACCINATION SITE SWELLING (raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant Concomitant medications were reported. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE RASH (rash on at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PAIN (tender at the injection site), VACCINATION SITE SWELLING (raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination. No Medical History Information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PAIN (tender at the injection site), VACCINATION SITE SWELLING (raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE RASH (rash on at the injection site), VACCINATION SITE WARMTH (warm at the injection site), VACCINATION SITE PAIN (tender at the injection site), VACCINATION SITE SWELLING (raised at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant Concomitant medications were reported. No Treatment information for the event was provided.

Other Meds:

Current Illness:

ID: 1552097
Sex: F
Age: 40
State: NJ

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
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: Diarrhea; Bone pain; Muscle spasms; Arm soreness; Joint pain; Headache; Fatigue; Fever; Chills; Vomiting; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness) and ARTHRALGIA (Joint pain) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced NAUSEA (Nausea). On 03-Feb-2021 at 4:00 PM, the patient experienced DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea), BONE PAIN (Bone pain), MUSCLE SPASMS (Muscle spasms), PAIN IN EXTREMITY (Arm soreness), ARTHRALGIA (Joint pain), HEADACHE (Headache), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1552098
Sex: F
Age:
State: NJ

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 08/13/2021
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: Itchy around mouth and nose; Flush in the face; itchy around IS; Redness around IS; COVID Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. No Medical History Information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE REACTION (COVID Arm). On 17-Feb-2021, the patient experienced THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, THROAT IRRITATION (Itchy around mouth and nose), FLUSHING (Flush in the face), VACCINATION SITE PRURITUS (itchy around IS) and VACCINATION SITE ERYTHEMA (Redness around IS) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received included no new information.

Other Meds:

Current Illness:

ID: 1552099
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Asthma; Fever; Cough; Sore; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history 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 ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore). At the time of the report, ASTHMA (Asthma), PYREXIA (Fever), COUGH (Cough) and PAIN (Sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1552100
Sex: M
Age: 25
State: OR

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 08/13/2021
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: Body aches; Fever; Couldn't sleep; Arm soreness; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Sore arm), MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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) (Intramuscular) 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 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 05-Feb-2021, the patient experienced MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness). On 09-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved. At the time of the report, MYALGIA (Body aches), PYREXIA (Fever), INSOMNIA (Couldn't sleep) and VACCINATION SITE PAIN (Arm soreness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1552101
Sex: F
Age: 81
State: CA

Vax Date: 01/16/2021
Onset Date: 01/26/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm felt sore; Redness 2x3 inches size; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness 2x3 inches size). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm felt sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPROFLO [CIPROFLOXACIN HYDROCHLORIDE]) for Adverse event, at a dose of 250 mg twice a day. On 02-Feb-2021, PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. Received treatment including ice at vaccination site. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 05-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Redness 2x3 inches size). On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm felt sore). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and CIPROFLOXACIN HYDROCHLORIDE (CIPROFLO [CIPROFLOXACIN HYDROCHLORIDE]) for Adverse event, at a dose of 250 mg twice a day. On 02-Feb-2021, PAIN IN EXTREMITY (Arm felt sore) and INJECTION SITE ERYTHEMA (Redness 2x3 inches size) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. Received treatment including ice at vaccination site.

Other Meds:

Current Illness:

ID: 1552102
Sex: M
Age: 92
State: CA

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/13/2021
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: Urinary tract infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History Information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. Reported Treatment medication including antibiotics. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History Information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant Concomitant medications were reported. Reported Treatment medication including antibiotics.

Other Meds:

Current Illness:

ID: 1552103
Sex: F
Age: 36
State: CA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Pregnant patient received both dose of vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine) in a 36-year-old female patient (gravida 6) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 025L20A) for COVID-19 vaccination. The patient's past medical history included Miscarriage of pregnancy in January 2016, Miscarriage in July 2019 and Miscarriage in February 2020. Concurrent medical conditions included MS (Stable) since March 2016. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Jun-2020 and the estimated date of delivery was 27-Mar-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-first week of the pregnancy. On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both dose of vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal. The patient's date of positive pregnancy test was 15-Jul-2020 and estimated date of conception was 05-Jul-2020. No treatment information was provided by the reporter.; Reporter's Comments: This is a case of Vaccine exposure during pregnancy with no associated adverse events for this 36-year-old female. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy .

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FOLIC ACID; VITAMIN D [VITAMIN D NOS]

Current Illness: MS (Stable)

ID: 1552104
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/13/2021
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: diagnosed with COVID; fever; headache; fatigue; a little cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) and ANASTROZOLE for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced COUGH (a little cough), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue). On 15-Jan-2021, the patient experienced COVID-19 (diagnosed with COVID). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (a little cough), COVID-19 (diagnosed with COVID), PYREXIA (fever), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No laboratory details were provided. No treatment medications were reported.

Other Meds: LIPITOR; ANASTROZOLE

Current Illness:

ID: 1552105
Sex: U
Age: 28
State: PA

Vax Date: 01/21/2021
Onset Date: 01/24/2021
Rec V Date: 08/13/2021
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: On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Officially diagnosed with COVID-19). At the time of the report, COVID-19 (Officially diagnosed with COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1552106
Sex: M
Age: 70
State: VA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: A little bit of sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of sore arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of sore arm). In February 2021, PAIN IN EXTREMITY (A little bit of sore arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1552107
Sex: F
Age: 74
State: CA

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
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: Pain at injection site (like bruised); Pain at injection site (like bruised); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Pain at injection site (like bruised)) and VACCINATION SITE PAIN (Pain at injection site (like bruised)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. Concomitant products included ISOSORBIDE NITRATE, PREDNISONE, ESTRADIOL, FAMOTIDINE (PEPCID [FAMOTIDINE]), VITAMIN D NOS and besacare for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Pain at injection site (like bruised)) and VACCINATION SITE PAIN (Pain at injection site (like bruised)). At the time of the report, VACCINATION SITE BRUISING (Pain at injection site (like bruised)) and VACCINATION SITE PAIN (Pain at injection site (like bruised)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included besacare. Treatment information not provided.

Other Meds: ISOSORBIDE NITRATE; PREDNISONE; ESTRADIOL; PEPCID [FAMOTIDINE]; VITAMIN D NOS; besacare

Current Illness:

ID: 1552108
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccine reaction) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccine reaction). At the time of the report, VACCINATION SITE REACTION (Vaccine reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1552109
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to MOD-2021-021800 (Patient Link).

Other Meds:

Current Illness:

ID: 1552110
Sex: F
Age: 65
State: NJ

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
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: Discomfort at the injection site; Body aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 04-Feb-2021, the patient experienced VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches). At the time of the report, VACCINATION SITE DISCOMFORT (Discomfort at the injection site), MYALGIA (Body aches) and HEADACHE (Headaches) outcome was unknown. No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1552111
Sex: F
Age: 72
State: PA

Vax Date: 02/10/2021
Onset Date: 02/11/2021
Rec V Date: 08/13/2021
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: developed what she thinks its an UTI; lower back pain; chills; very sore arm (couldn't even lift her arm); low grade fever; body aches; feel very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain), PYREXIA (low grade fever) and MYALGIA (body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), PYREXIA (low grade fever), MYALGIA (body aches) and FATIGUE (feel very tired). On 20-Feb-2021, the patient experienced URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) (oral) on 20-Feb-2021 for UTI, at a dose of UNK dosage form. On 12-Feb-2021, PAIN IN EXTREMITY (very sore arm (couldn't even lift her arm)), MYALGIA (body aches) and FATIGUE (feel very tired) had resolved. At the time of the report, URINARY TRACT INFECTION (developed what she thinks its an UTI), BACK PAIN (lower back pain) and CHILLS (chills) outcome was unknown and PYREXIA (low grade fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1552112
Sex: F
Age: 69
State: NY

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
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: doctor told her it was her body's reaction to the vaccine; still warm; injection site looked swollen; felt uncomfortable; discomfort in arm; itchy; hot to the touch; Pain; soreness on arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy) and INJECTION SITE WARMTH (hot to the touch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diabetes and Cholesterol. Concurrent medical conditions included Seasonal allergy, Allergy to chemicals, Allergy to chemicals, Drug allergy, Drug allergy and Drug allergy. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Pain) and PAIN IN EXTREMITY (soreness on arm). On 08-Feb-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch) and FEELING ABNORMAL (felt uncomfortable). On 11-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection site looked swollen) and INJECTION SITE WARMTH (still warm). On an unknown date, the patient experienced ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) for Adverse event, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN (Pain), PAIN IN EXTREMITY (soreness on arm), LIMB DISCOMFORT (discomfort in arm), PRURITUS (itchy), INJECTION SITE WARMTH (hot to the touch), INJECTION SITE SWELLING (injection site looked swollen), INJECTION SITE WARMTH (still warm), ADVERSE REACTION (doctor told her it was her body's reaction to the vaccine) and FEELING ABNORMAL (felt uncomfortable) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information not provided.

Other Meds: PROTONIX [OMEPRAZOLE]; PLAVIX.

Current Illness:

ID: 1552113
Sex: F
Age: 72
State: WI

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/13/2021
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: oval sized pink area that is 2 1/2 inches long and is warm to the touch; pink area the size of a dime; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (pink area the size of a dime) and VACCINATION SITE WARMTH (oval sized pink area that is 2 1/2 inches long and is warm to the touch) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) for Pain in knee, ATENOLOL, ALOPURINOL, HCTZ, METFORMIN, OLMESARTAN and ATORVASTATIN. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 16-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (pink area the size of a dime). On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (oval sized pink area that is 2 1/2 inches long and is warm to the touch). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (pink area the size of a dime) and VACCINATION SITE WARMTH (oval sized pink area that is 2 1/2 inches long and is warm to the touch) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ATENOLOL; ALOPURINOL; HCTZ; METFORMIN; OLMESARTAN; ATORVASTATIN; TYLENOL

Current Illness:

ID: 1552114
Sex: F
Age: 79
State: NC

Vax Date: 02/13/2021
Onset Date: 02/14/2021
Rec V Date: 08/13/2021
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: Itching all over my body; Blisters; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BLISTER (Blisters) and PRURITUS (Itching all over my body) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included Hypertension since an unknown date. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Feb-2021, the patient experienced BLISTER (Blisters). On an unknown date, the patient experienced PRURITUS (Itching all over my body). The patient was treated with CORTISONE for Adverse event, at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Sore arm), BLISTER (Blisters) and PRURITUS (Itching all over my body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness: Hypertension

ID: 1552115
Sex: F
Age: 61
State: NC

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/13/2021
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: Left arm sore; joint pain; excruciating pain and stiffness on left side of neck (couldn't move head); excruciating pain and stiffness on left side of neck (couldn't move head); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm sore), ARTHRALGIA (joint pain), NECK PAIN (excruciating pain and stiffness on left side of neck (couldn't move head)) and MUSCULOSKELETAL STIFFNESS (excruciating pain and stiffness on left side of neck (couldn't move head)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018M20A) for COVID-19 vaccination. No Medical History Information was reported. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and CICLOSPORIN (RESTASIS) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm sore), ARTHRALGIA (joint pain), NECK PAIN (excruciating pain and stiffness on left side of neck (couldn't move head)) and MUSCULOSKELETAL STIFFNESS (excruciating pain and stiffness on left side of neck (couldn't move head)). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm sore), ARTHRALGIA (joint pain), NECK PAIN (excruciating pain and stiffness on left side of neck (couldn't move head)) and MUSCULOSKELETAL STIFFNESS (excruciating pain and stiffness on left side of neck (couldn't move head)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm sore), ARTHRALGIA (joint pain), NECK PAIN (excruciating pain and stiffness on left side of neck (couldn't move head)) and MUSCULOSKELETAL STIFFNESS (excruciating pain and stiffness on left side of neck (couldn't move head)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018M20A) for COVID-19 vaccination. No Medical History Information was reported. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and CICLOSPORIN (RESTASIS) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Left arm sore), ARTHRALGIA (joint pain), NECK PAIN (excruciating pain and stiffness on left side of neck (couldn't move head)) and MUSCULOSKELETAL STIFFNESS (excruciating pain and stiffness on left side of neck (couldn't move head)). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Left arm sore), ARTHRALGIA (joint pain), NECK PAIN (excruciating pain and stiffness on left side of neck (couldn't move head)) and MUSCULOSKELETAL STIFFNESS (excruciating pain and stiffness on left side of neck (couldn't move head)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information for the event was provided.

Other Meds: CRESTOR; RESTASIS

Current Illness:

ID: 1552116
Sex: F
Age: 44
State: PA

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 08/13/2021
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: High fever 101; chills; fatigue; body joint pain; This spontaneous case was reported by a physical therapist and describes the occurrence of PYREXIA (High fever 101), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (body joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced PYREXIA (High fever 101), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (body joint pain). At the time of the report, PYREXIA (High fever 101), CHILLS (chills), FATIGUE (fatigue) and ARTHRALGIA (body joint pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, Body temperature: 101. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided.

Other Meds:

Current Illness:

ID: 1552117
Sex: F
Age: 49
State: UT

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/13/2021
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: flu-like symptoms; temperature 101; body aches; tiredness; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (temperature 101), MYALGIA (body aches) and FATIGUE (tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 037K20A) for COVID-19 vaccination. No Medical History Information was reported. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (temperature 101), MYALGIA (body aches) and FATIGUE (tiredness). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (temperature 101), MYALGIA (body aches) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) 101. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-021512 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (temperature 101), MYALGIA (body aches) and FATIGUE (tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 037K20A) for COVID-19 vaccination. No Medical History Information was reported. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (temperature 101), MYALGIA (body aches) and FATIGUE (tiredness). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (temperature 101), MYALGIA (body aches) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: (High) 101. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-021512 (Patient Link).

Other Meds: MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1552118
Sex: F
Age: 77
State: FL

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Arm sore at injection site; Felt pain when moving injected arm forward or backward; Low grade cough; Feels like a tickle in the throat; A spontaneous report was received from a consumer concerning a 77-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat. The patient's medical history was not provided. Concomitant medications reported were Vitamin D, Vitamin B Complex, Calcium, Levothyroxine, Melatonin, Biotin for drug use for unknown indication. On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown)unknown route for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced the events arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat. Treatment details included Zinc, Steam. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, arm sore at injection site, felt pain when moving injected arm forward or backward, low grade cough, feels like a tickle in the throat was unknown.

Other Meds: VITAMIN D 2000; VITAMIN B COMPLEX; CALCIUM; LEVOTHYROXINE; MELATONIN; BIOTIN

Current Illness:

ID: 1552119
Sex: F
Age:
State: MI

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/13/2021
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: Pinky rash upper breast; Itchy rash upper breast; Tenderness in right arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20A) for COVID-19 vaccination. Concurrent medical conditions included Breast cancer, Hypertension, Diabetes and Alcohol allergy (Allergy: alcohol when drinking). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection). At the time of the report, RASH ERYTHEMATOUS (Pinky rash upper breast), RASH PRURITIC (Itchy rash upper breast) and VACCINATION SITE PAIN (Tenderness in right arm of injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. patient uses unspecified medication for breast cancer survivor, blood pressure, diabetes as concomitant medications.

Other Meds:

Current Illness: Alcohol allergy (Allergy: alcohol when drinking); Breast cancer; Diabetes; Hypertension

ID: 1552120
Sex: F
Age: 49
State: UT

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/13/2021
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: flu-like symptoms; temperature 101; body aches; tiredness; nausea; a really bad headache; a bruise of 5 inches diameter; it stayed there for a long time; she also got bruises in her legs; big; unexplained; one of 6-7 inches diameter; took a long time to resolve; A spontaneous report was received from a healthcare professional concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness. The patient's medical history was not provided. Concomitant medications reported were Multivitamins for drug use for unknown indication. On 30 Dec 2020, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained. One of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness. Treatment details included Ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), nausea, a really bad headache, a bruise of 5 inches diameter, it stayed there for a long time, she also got bruises in her legs, big, unexplained, one of 6-7 inches diameter, took a long time to resolve, flu-like symptoms, temperature 101, body aches, tiredness was unknown.

Other Meds: MULTIVITAMINS & MINERALS PLUS LUTEIN

Current Illness:

ID: 1552121
Sex: F
Age: 57
State: LA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/13/2021
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: She had a 100.5 F temperature for a couple of days; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (She had a 100.5 F temperature for a couple of days) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Body temperature: 100.5 (High) 100.5 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1552122
Sex: U
Age:
State:

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/13/2021
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: adverse event; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (adverse event) 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 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment drugs were reported

Other Meds:

Current Illness:

ID: 1552123
Sex: F
Age: 65
State: NC

Vax Date: 02/20/2021
Onset Date:
Rec V Date: 08/13/2021
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: Large rash around the injection site; Injection site tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Large rash around the injection site) and VACCINATION SITE PAIN (Injection site tender) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Large rash around the injection site) and VACCINATION SITE PAIN (Injection site tender). At the time of the report, VACCINATION SITE RASH (Large rash around the injection site) and VACCINATION SITE PAIN (Injection site tender) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1552124
Sex: F
Age: 36
State: NY

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Pregnant. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 07-Jul-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications was provided by the reporter. No Treatment medications was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: Internal review on 23-Jul-2021 resulted in updates to the pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy

Other Meds:

Current Illness: Pregnant

ID: 1552125
Sex: F
Age:
State: CA

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 08/13/2021
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: Red arm; Swollen arm; Swollen lymph nodes at the arm of the injection; Pain at the injection site; Fever; Chills; Headache; Joint pain; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site) and PYREXIA (Fever) in a female patient of an unknown age 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 Penicillin allergy, Drug allergy (Allergy Aspirin), Drug allergy (Toradol), Drug allergy (Maclodent), Drug allergy (Anaprox), Contrast media allergy (Contrast), Drug allergy (Ensids) and Drug allergy (Retromicin). On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red arm), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes at the arm of the injection), VACCINATION SITE PAIN (Pain at the injection site), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not reported. Treatment : Steroids This case was linked to MOD-2021-022482 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness: Drug allergy (Toradol); Drug allergy (Allergy Aspirin); Penicillin allergy

ID: 1552126
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Little red spots on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Little red spots on injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Little red spots on injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Little red spots on injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant medication and treatment provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1552127
Sex: F
Age:
State: GA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Uable to move due to fatigue; Aches all over; She woke up in the middle of the night with fever102.6; Head hurting; Joint pain that is really bad; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting) and ARTHRALGIA (Joint pain that is really bad). On 05-Feb-2021, the patient experienced FATIGUE (Uable to move due to fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Aches all over), PYREXIA (She woke up in the middle of the night with fever102.6), HEADACHE (Head hurting), ARTHRALGIA (Joint pain that is really bad) and FATIGUE (Uable to move due to fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: 102.6 (High) body temperature 102.6. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1552128
Sex: M
Age: 76
State: MN

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 08/13/2021
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: started having diarrhea; cold sore lip; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm), PYREXIA (fever), DIARRHOEA (started having diarrhea) and ORAL HERPES (cold sore lip) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced ARTHRALGIA (sore arm). On 20-Feb-2021, the patient experienced PYREXIA (fever). On 22-Feb-2021, the patient experienced DIARRHOEA (started having diarrhea) and ORAL HERPES (cold sore lip). On 21-Feb-2021, PYREXIA (fever) had resolved. On 22-Feb-2021, ARTHRALGIA (sore arm) had resolved. At the time of the report, DIARRHOEA (started having diarrhea) and ORAL HERPES (cold sore lip) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1552129
Sex: F
Age: 72
State: VT

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/13/2021
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: Sinus Congestion; Runny nose; Felt miserable; This spontaneous case was reported by a consumer and describes the occurrence of SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable). At the time of the report, SINUS CONGESTION (Sinus Congestion), RHINORRHOEA (Runny nose) and FEELING ABNORMAL (Felt miserable) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: THYROXINE

Current Illness: Thyroid disorder

ID: 1552130
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Adverse reaction; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). 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 (Adverse reaction). At the time of the report, VACCINATION COMPLICATION (Adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested

Other Meds:

Current Illness:

ID: 1552131
Sex: F
Age: 71
State: AZ

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/13/2021
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: Red ring surrounding the area; Bacterial skin infection; Slight pain for few hours after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BACTERIAL INFECTION (Bacterial skin infection), VACCINATION SITE ERYTHEMA (Red ring surrounding the area) and VACCINATION SITE PAIN (Slight pain for few hours after the vaccination) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CLOBETASOL for Vaginal irritation, CLONAZEPAM for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Slight pain for few hours after the vaccination). On 22-Feb-2021, the patient experienced SKIN BACTERIAL INFECTION (Bacterial skin infection). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red ring surrounding the area). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) on 23-Feb-2021 for Skin infection, at a dose of 500 mg twice a day. On 08-Feb-2021, VACCINATION SITE PAIN (Slight pain for few hours after the vaccination) had resolved. At the time of the report, SKIN BACTERIAL INFECTION (Bacterial skin infection) outcome was unknown and VACCINATION SITE ERYTHEMA (Red ring surrounding the area) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient stated that the doctor said her to take antibiotics for 5 days instead of 7 if she wishes to do so. This case was linked to MOD-2021-187387 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Added concomitant medication, Added event, added dosage information On 27-May-2021: NNI

Other Meds: CLONAZEPAM; CLOBETASOL

Current Illness:

ID: 1552132
Sex: F
Age: 30
State: TX

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/13/2021
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: received Moderna COVID-19 vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 27-Jul-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twelfth week of the pregnancy. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (received Moderna COVID-19 vaccine while pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 30-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy

Other Meds:

Current Illness:

ID: 1552133
Sex: F
Age:
State: NY

Vax Date: 12/29/2020
Onset Date: 01/01/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COVID-19 infection just after the first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19 infection just after the first dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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 01-Jan-2021, the patient experienced COVID-19 (COVID-19 infection just after the first dose). At the time of the report, COVID-19 (COVID-19 infection just after the first dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information, the mRNA-1723 does not contain a virus and with the occurrence of Covid-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1552134
Sex: F
Age: 83
State: GA

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 08/13/2021
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: Chills; headache; nausea; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023L20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Dyslipidemia. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, CHILLS (Chills), HEADACHE (headache), NAUSEA (nausea), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LIPITOR

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm