VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1557539
Sex: M
Age: 59
State: AZ

Vax Date: 01/08/2021
Onset Date: 01/15/2021
Rec V Date: 08/14/2021
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: tested positive for COVID; a little sluggish; lost his taste; felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID), SLUGGISHNESS (a little sluggish), AGEUSIA (lost his taste) and FATIGUE (felt fatigued) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. On 15-Jan-2021, the patient experienced SLUGGISHNESS (a little sluggish), AGEUSIA (lost his taste) and FATIGUE (felt fatigued). On 16-Jan-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID), SLUGGISHNESS (a little sluggish), AGEUSIA (lost his taste) and FATIGUE (felt fatigued) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Tested positive for COVID. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication was reported. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557540
Sex: F
Age: 67
State: FL

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: upper right arm developed red mark and became hard; upper right arm developed red mark and became hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (upper right arm developed red mark and became hard) and VACCINATION SITE ERYTHEMA (upper right arm developed red mark and became hard) in a 67-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) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (upper right arm developed red mark and became hard) and VACCINATION SITE ERYTHEMA (upper right arm developed red mark and became hard). The patient was treated with IBUPROFEN ongoing from February 2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (upper right arm developed red mark and became hard) and VACCINATION SITE ERYTHEMA (upper right arm developed red mark and became hard) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported.

Other Meds:

Current Illness:

ID: 1557541
Sex: F
Age: 73
State: DE

Vax Date: 01/18/2021
Onset Date: 01/31/2021
Rec V Date: 08/14/2021
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: Started breaking out; Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.; Arm soreness; Had a lot of itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included No adverse event (medical history not provided). Concomitant products included FLUTICASONE for Allergy NOS, ROSUVASTATIN for High cholesterol, MACROGOL 3350 (MIRALAX) for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Feb-2021, FEELING ABNORMAL (Started breaking out), ERYTHEMA (Arm to shoulder to elbow turned bright red/redness from elbow to shoulder.), PAIN IN EXTREMITY (Arm soreness) and VACCINATION SITE PRURITUS (Had a lot of itching at injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: initial additional. On 10-Jul-2021: Contains no new information.

Other Meds: ROSUVASTATIN; FLUTICASONE; MIRALAX

Current Illness:

ID: 1557542
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 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 (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown. Not Provided Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1557543
Sex: M
Age: 62
State: NC

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
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: A Little Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A Little Sore Arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE PAIN (A Little Sore Arm). At the time of the report, VACCINATION SITE PAIN (A Little Sore Arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1557544
Sex: F
Age: 67
State: DE

Vax Date: 01/27/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: Pinkish rash is now spreading down towards her elbow and the back of her arm; Rash on her arm at injection site; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm) and VACCINATION SITE RASH (Rash on her arm at injection site) in a 67-year-old female patient 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 05-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE RASH (Rash on her arm at injection site). On 11-Feb-2021, the patient experienced RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) on 09-Feb-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Pinkish rash is now spreading down towards her elbow and the back of her arm) and VACCINATION SITE RASH (Rash on her arm at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. The patient stated that although recommended by pharmacist she had not yet taken the Benadryl tablets. Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up received and added new event. On 22-Apr-2021: Follow up received and contains no new information. On 13-Jul-2021: Follow-Up received and updated primary reporter contact details.

Other Meds:

Current Illness:

ID: 1557545
Sex: M
Age: 88
State: LA

Vax Date: 01/19/2021
Onset Date: 02/24/2021
Rec V Date: 08/14/2021
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: Neck pain; Balance disorder; Asthenia; Fall; Arthralgia; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No specified medical history has been reported. Concomitant products included TERAZOSIN, VITAMIN D2, FENOFIBRATE, HYDROCHLOROTHIAZIDE, TRIAMTERENE (MAXZIDE), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia). At the time of the report, NECK PAIN (Neck pain), BALANCE DISORDER (Balance disorder), ASTHENIA (Asthenia), FALL (Fall) and ARTHRALGIA (Arthralgia) had resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: updated events outcome

Other Meds: TERAZOSIN; VITAMIN D2; FENOFIBRATE; MAXZIDE; PROTONIX [OMEPRAZOLE]; PRESERVISION

Current Illness:

ID: 1557546
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 01/01/2021
Rec V Date: 08/14/2021
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: classic hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (classic hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included BUPROPION from 12-Jan-2021 to an unknown date for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced URTICARIA (classic hives). The patient was treated with PREDNISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (classic hives) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: BUPROPION

Current Illness:

ID: 1557547
Sex: F
Age: 79
State: TN

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
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: when she tries to bend her right arm, it hurts; joint pain on her right arm; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No medical history reported by the reporter. Concomitant products included LOSARTAN, ATENOLOL, ATORVASTATIN, GLIPIZIDE, LEVOTHYROXINE, METFORMIN and FERROUS SULFATE for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (when she tries to bend her right arm, it hurts), ARTHRALGIA (joint pain on her right arm) and MYALGIA (muscle pain) 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. Treatment included ice pack. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow-up received on 22-Apr-2021 as no new information added email address for the reporter.

Other Meds: LOSARTAN; ATENOLOL; ATORVASTATIN; GLIPIZIDE; LEVOTHYROXINE; METFORMIN; FERROUS SULFATE

Current Illness:

ID: 1557548
Sex: M
Age: 60
State: PA

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/14/2021
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: He started breaking out with a rash, it was spreading; This spontaneous case was reported by a consumer and describes the occurrence of RASH (He started breaking out with a rash, it was spreading) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (He started breaking out with a rash, it was spreading). At the time of the report, RASH (He started breaking out with a rash, it was spreading) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment medication was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1557549
Sex: F
Age: 80
State: TX

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: sore back; sore went to her upper chest, no breathing problems; sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included blood pressure medication, cholesterol medication and anxiety medication for an unknown indication. On 02-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 PAIN IN EXTREMITY (sore right arm). On 07-Feb-2021, the patient experienced BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Feb-2021, PAIN IN EXTREMITY (sore right arm) had resolved. On 09-Feb-2021, BACK PAIN (sore back) and CHEST PAIN (sore went to her upper chest, no breathing problems) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: blood pressure medication; cholesterol medication; anxiety medication

Current Illness:

ID: 1557550
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: mild soreness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness in the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (mild soreness in the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (mild soreness in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: No specific follow-up information.

Other Meds:

Current Illness:

ID: 1557551
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Felt sick; High fever; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Felt sick) and PYREXIA (High fever) 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 COVID-19. Concurrent medical conditions included Heart disorder and COPD. 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 (Felt sick) and PYREXIA (High fever). At the time of the report, VACCINATION COMPLICATION (Felt sick) and PYREXIA (High fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. . No treatment related information has been reported. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Patient last name and email address updated

Other Meds:

Current Illness: Heart disorder

ID: 1557552
Sex: F
Age: 68
State: NC

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
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: A Little Sore Arm; A spontaneous report was received from a consumer concerning a 68- year old-female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a sore arm. The patient's medical history was not provided.No relevant concomitant medications were reported. On 06-Feb-2021,prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection. On 06-Feb-2021,the patient experienced a little sore arm. No laboratory data was provided.Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event pain in arm was considered as not resolved at the time of the report.

Other Meds:

Current Illness:

ID: 1557553
Sex: M
Age: 81
State: NY

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: very very dizzy a lot; has had sweats; shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (very very dizzy a lot), HYPERHIDROSIS (has had sweats) and TREMOR (shaking) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012MZ0A) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (very very dizzy a lot), HYPERHIDROSIS (has had sweats) and TREMOR (shaking). At the time of the report, DIZZINESS (very very dizzy a lot), HYPERHIDROSIS (has had sweats) and TREMOR (shaking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment medications were unknown.

Other Meds:

Current Illness:

ID: 1557554
Sex: F
Age: 81
State: FL

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (decreased Appetite), MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus, Breast cancer, Penicillin allergy and Allergy to antibiotic (Erythromycin). Concomitant products included OMEPRAZOLE for GERD, CHLORDIAZEPOXIDE;CLIDINIUM, METHYLCELLULOSE (CITRUCEL) and LACTOBACILLUS ACIDOPHILUS (FLORASTOR [LACTOBACILLUS ACIDOPHILUS]) for Irritable bowel syndrome, RALOXIFENE for Osteoporosis NOS, VITAMIN 15, PRAVASTATIN, PYRIDOXINE, VITAMIN D3, UBIDECARENONE (CO-Q10-CHLORELLA), MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced DECREASED APPETITE (decreased Appetite). On 17-Jan-2021, MYALGIA (sore arm, arm pain), CHILLS (severe chills), FATIGUE (fatigue) and NAUSEA (nausea) had resolved. At the time of the report, DECREASED APPETITE (decreased Appetite) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Blood glucose: high (High) high blood sugar. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications were not reported for mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment This case was linked to MOD-2021-252848 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Significant follow-up received and concomitant medications, Medical history was updated. Patient demographics was added. Recovery date of all the events was added. New event added.

Other Meds: VITAMIN 15; PRAVASTATIN; PYRIDOXINE; OMEPRAZOLE; CHLORDIAZEPOXIDE;CLIDINIUM; CITRUCEL; FLORASTOR [LACTOBACILLUS ACIDOPHILUS]; RALOXIFENE; VITAMIN D3; CO-Q10-CHLORELLA; SYSTANE; ASPIRIN [ACETYLSALICYLIC ACID.]

Current Illness: Allergy to antibiotic (Erythromycin); Penicillin allergy; Type 2 diabetes mellitus.

ID: 1557555
Sex: M
Age:
State: NV

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included Blood thinner and VITAMINS NOS for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were unknown.

Other Meds: Blood thinner; VITAMINS NOS

Current Illness:

ID: 1557556
Sex: F
Age: 68
State:

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/14/2021
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: Chills; Headache; Fever 101.3; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever 101.3) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concomitant products included PARACETAMOL (TYLENOL) and IBUPROFEN (MOTRIN [IBUPROFEN]) for an unknown indication. 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 MYALGIA (Sore arm). On 06-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever 101.3). On 08-Feb-2021, CHILLS (Chills) and PYREXIA (Fever 101.3) had resolved. At the time of the report, HEADACHE (Headache) and MYALGIA (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: TYLENOL; MOTRIN [IBUPROFEN]

Current Illness:

ID: 1557557
Sex: F
Age:
State: NY

Vax Date: 01/16/2021
Onset Date: 01/18/2021
Rec V Date: 08/14/2021
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: rash arm IS; Itch IS; Swollen IS; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash arm IS), VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (rash arm IS), VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS). At the time of the report, VACCINATION SITE RASH (rash arm IS) had resolved and VACCINATION SITE PRURITUS (Itch IS) and VACCINATION SITE SWELLING (Swollen IS) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment drugs 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.

Other Meds:

Current Illness:

ID: 1557558
Sex: F
Age: 92
State: PA

Vax Date: 01/27/2021
Onset Date: 01/30/2021
Rec V Date: 08/14/2021
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: Dizziness; Fell down; Red Freckles; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red Freckles), DIZZINESS (Dizziness) and FALL (Fell down) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) 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) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced RASH MACULAR (Red Freckles). On 31-Jan-2021, the patient experienced DIZZINESS (Dizziness) and FALL (Fell down). At the time of the report, RASH MACULAR (Red Freckles), DIZZINESS (Dizziness) and FALL (Fell down) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication include hydrocortisone of unknown dose and frequency. No concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1557559
Sex: F
Age: 83
State: NV

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/14/2021
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: Can't eat anything but Jell-O; Stomach pain; Headache; Convulsing vomiting; stomach was having trouble like nausea; fever; lost about 10 pounds; Stomach was having trouble like nausea; Lost about 10 pounds; Fever; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost about 10 pounds), DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (Fever) in an 84-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 25-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 WEIGHT DECREASED (Lost about 10 pounds) and PYREXIA (Fever). On 26-Jan-2021, the patient experienced NAUSEA (Stomach was having trouble like nausea). On 07-Jul-2021, the patient experienced WEIGHT DECREASED (lost about 10 pounds) and PYREXIA (fever). On an unknown date, the patient experienced DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), HEADACHE (Headache), VOMITING (Convulsing vomiting) and NAUSEA (stomach was having trouble like nausea). The patient was treated with ONDANSETRON for Nausea, at a dose of 1 dosage form. On 28-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, WEIGHT DECREASED (Lost about 10 pounds), WEIGHT DECREASED (lost about 10 pounds), PYREXIA (fever) and NAUSEA (stomach was having trouble like nausea) outcome was unknown and DECREASED APPETITE (Can't eat anything but Jell-O), ABDOMINAL PAIN UPPER (Stomach pain), NAUSEA (Stomach was having trouble like nausea), HEADACHE (Headache) and VOMITING (Convulsing vomiting) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. 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. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added information about that after discharging from hospital patient experienced with same events.; 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: 1557560
Sex: F
Age:
State: LA

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 08/14/2021
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: Colitis; pain in the stomach; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0MJ20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach). At the time of the report, COLITIS (Colitis) and ABDOMINAL PAIN UPPER (pain in the stomach) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the se events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1557561
Sex: F
Age:
State: OH

Vax Date: 01/22/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
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: shoulders, kneels, hands and neck flared up more that it normally does; A spontaneous report was received from a consumer concerning herself, who is a 63-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event shoulders, kneels, hands and neck flared up more that it normally does The patient's medical history was osteoarthritis and rheumatoid arthritis. No relevant concomitant medications were reported. On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, the patient experienced the event shoulders, kneels, hands and neck flared up more that it normally does. Treatment details included acetaminophen, tropical methyl salicylate extra Strength. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event shoulders, kneels, hands and neck flared up more that it normally does was unknown.

Other Meds:

Current Illness: Osteoarthritis; Rheumatoid arthritis

ID: 1557562
Sex: F
Age:
State: NH

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: COVID-19; A spontaneous report was received from a physician concerning a female patient (Unspecified age) who experienced COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date, prior to the onset of the symptoms, the patient received their first/second (not specified) of two planned doses of mRNA-1273 (Batch number: Unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient undergone COVID-19 test and was diagnosed with COVID-19. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event COVID-19 was unknown. Based on MSA comment, MAH causality updated to Not applicable

Other Meds:

Current Illness:

ID: 1557563
Sex: M
Age: 72
State:

Vax Date: 01/28/2021
Onset Date: 01/31/2021
Rec V Date: 08/14/2021
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: hot injection site; hard injection site; Vaccination site pruritus; Vaccination site rash; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash). The patient was treated with PARACETAMOL (TYLENOL) for Inflammation, at a dose of 1 dosage form and IBUPROFEN for Inflammation, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE WARMTH (hot injection site), VACCINATION SITE INDURATION (hard injection site), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE RASH (Vaccination site rash) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications include a blood pressure medication and statin. Treatment includes a topical anti-histamine for itching. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-significant follow up updated on 06-Jul-2021: updated contact information.

Other Meds:

Current Illness: Hypertension

ID: 1557564
Sex: M
Age: 73
State: TX

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: Diarrhea; A spontaneous report was received from a healthcare professional concerning a 73-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 8 Feb 2021, the patient experienced diarrhea. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event diarrhea was unknown.

Other Meds:

Current Illness:

ID: 1557565
Sex: F
Age: 91
State: IN

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 08/14/2021
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: Water blister on her left ankle and foot; A spontaneous report was received from a consumer concerning a 91-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events water blister on her left ankle and foot/blister. The patient's medical history was not provided. No relevant concomitant medications were reported. On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) water blister on her left ankle and foot. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), water blister on her left ankle and foot was unknown.

Other Meds:

Current Illness:

ID: 1557566
Sex: M
Age: 75
State: TX

Vax Date: 02/07/2021
Onset Date: 02/09/2021
Rec V Date: 08/14/2021
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: Also has some pain in arm; high fever 98.4F; has been urinating constantly; shortness of breath and is breathing heavily; oxygen level is in 91; A spontaneous report (United States) was received from a consumer concerning her spouse a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high fever 98.4f, has been urinating constantly, shortness of breath and is breathing heavily, oxygen level is in 91, also has some pain in arm. The patient's medical history was high blood pressure. Concomitant medications reported were insulin, metmorfin, lisinopril high blood pressure, glipiside, vitamin d for drug use for unknown indication. On 7 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) through unknown route in the left arm for prophylaxis of COVID-19 infection. On 09 Feb 2021, the patient experienced the event after midnight he has had high fever 98.4F, he has been urinating constantly, his oxygen level is in 91, he has shortness of breath and is breathing heavily. also has some pain in arm. Treatment details included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events high fever 98, 4f, has been urinating constantly, shortness of breath and is breathing heavily, oxygen level is in 91, also has some pain in arm was unknown.

Other Meds: INSULIN; Metmorfin; LISINOPRIL; glipiside; VITAMIN D NOS

Current Illness: Blood pressure high (No medical history reported)

ID: 1557567
Sex: F
Age: 66
State: WA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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: increased swelling of her fingers; pain in her left toe; big red blotches; hardness; redness was 2-3 inches below the injection site; pain on her shoulder/joint pain; flare up of her arthritis; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (flare up of her arthritis), PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches) and VACCINATION SITE INDURATION (hardness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-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 ARTHRITIS (flare up of her arthritis) and ARTHRALGIA (pain on her shoulder/joint pain). On 08-Feb-2021, the patient experienced PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches), VACCINATION SITE INDURATION (hardness) and VACCINATION SITE ERYTHEMA (redness was 2-3 inches below the injection site). At the time of the report, ARTHRITIS (flare up of her arthritis), PERIPHERAL SWELLING (increased swelling of her fingers), PAIN IN EXTREMITY (pain in her left toe), VACCINATION SITE RASH (big red blotches), VACCINATION SITE INDURATION (hardness), VACCINATION SITE ERYTHEMA (redness was 2-3 inches below the injection site) and ARTHRALGIA (pain on her shoulder/joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by reporter. Treatment medication not reported.

Other Meds:

Current Illness:

ID: 1557568
Sex: F
Age: 71
State:

Vax Date: 01/28/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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: Lump in throat comes and goes; Lump in the throat; Hot neck; throat was also red hot, I mean my neck; Severe chills; This spontaneous case was reported by a physician and describes the occurrence of SENSATION OF FOREIGN BODY (Lump in the throat), FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck), CHILLS (Severe chills) and SENSATION OF FOREIGN BODY (Lump in throat comes and goes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR), METOPROLOL, ATORVASTATIN and MELATONIN for an unknown indication. On 28-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 SENSATION OF FOREIGN BODY (Lump in the throat), FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck) and CHILLS (Severe chills). On an unknown date, the patient experienced SENSATION OF FOREIGN BODY (Lump in throat comes and goes). The patient was treated with ACETYLSALICYLIC ACID (ASPIRINE) at an unspecified dose and frequency. On 31-Jan-2021, SENSATION OF FOREIGN BODY (Lump in the throat) and CHILLS (Severe chills) had resolved. At the time of the report, FEELING HOT (Hot neck), ERYTHEMA (throat was also red hot, I mean my neck) and SENSATION OF FOREIGN BODY (Lump in throat comes and goes) 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. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Telephone contact report attached.

Other Meds: EFFEXOR; METOPROLOL; ATORVASTATIN; MELATONIN

Current Illness:

ID: 1557569
Sex: F
Age: 53
State: NJ

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 08/14/2021
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: chills; body aches; stomach issues; A Spontaneous case was received from consumer, concerning a female patient and age 53, who received Moderna's COVID-19 vaccine experienced Chills, Myalgia/ body aches, Abdominal discomfort/ stomach issues. The patient's medical history was not provided. The Patient's concomitant medications were singulair, Pepcid, Claritin, fish, oil, zinc, collagen. On 11Jan2021 , prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number : 012L20A) via unspecified route for COVID-19 infection prophylaxis. On 09Feb2021 , prior to the onset of events, the patient received her second of two planned doses of mRNA-1273 (Batch number : 029L20A) via unspecified route for COVID-19 infection prophylaxis. On an unknown date, she experienced severe chills, body aches, stomach issues and severe congestion. Since the patient had already taken both the scheduled doses of vaccine, the action taken in response to the events, Chills, Myalgia, Abdominal discomfort was not applicable. The outcome of the event, Chills, Myalgia, Abdominal discomfort Vaccination site rash was considered to be unknown. The treatment medications reported to be taken by the patient was Voltaren.

Other Meds: SINGULAIR; PEPCID AC; CLARITIN ALLERGIC; FISH OIL; ZINC; COLLAGEN

Current Illness:

ID: 1557570
Sex: F
Age: 57
State: IN

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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: arm puffy; arm red; arm itchy; arm hot; arm was sore; A spontaneous report was received from a consumer concerning a 57-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain (arm puffy), vaccination site erythema (arm red), peripheral swelling (arm was sore), vaccination site pruritus (arm itchy) and vaccination site warmth ( arm hot). The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient reported experiencing arm was sore. On 7 Feb 2021, the patient experienced the events of arm red, arm puffy, arm itchy and arm hot. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 30 Jan 2021 the outcome of event, arm was sore was resolved. The outcome of events, arm red, arm puffy, arm itchy, arm hot was unknown. Based on MSA comment, change listedness to listed and unlisted for monograph and factsheet

Other Meds:

Current Illness:

ID: 1557571
Sex: F
Age: 73
State: TX

Vax Date: 01/07/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: fever; chills; headache in her eyes; eyes feel glassy and watery; arm started hurting immensely; pain in arm, neck, small of back; pain in shoulders, knees; Knot under the skin; knot higher up on shoulder; Red rash in a circle under where he put the medicine in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever) and CHILLS (chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees). On 03-Feb-2021 at 9:00 PM, the patient experienced VACCINATION SITE PAIN (arm started hurting immensely). On 04-Feb-2021, the patient experienced EYE IRRITATION (eyes feel glassy and watery), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache in her eyes). At the time of the report, VACCINATION SITE MASS (Knot under the skin; knot higher up on shoulder), EYE IRRITATION (eyes feel glassy and watery), VACCINATION SITE RASH (Red rash in a circle under where he put the medicine in), PYREXIA (fever), CHILLS (chills), HEADACHE (headache in her eyes), VACCINATION SITE PAIN (arm started hurting immensely), MYALGIA (pain in arm, neck, small of back) and ARTHRALGIA (pain in shoulders, knees) had not resolved. Treatment for the events included paracetamol and ice on the affected arm. No concomitant medication were 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:

Current Illness:

ID: 1557572
Sex: M
Age: 56
State: TX

Vax Date: 02/07/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: mild fever; Tired; headaches; A spontaneous report was received from a consumer concerning himself, who is a 56-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mild fever, tired, headaches. The patient's medical history was not provided. Concomitant medications reported were insulin, gavapentin for drug use for unknown indication. On 07 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient experienced the events mild fever, tired, headaches. Treatment details included ibuprofen. Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable On 09 Feb 2021 the outcome of events mild fever, tired, headaches was resolved.

Other Meds: INSULIN; gavapentin

Current Illness:

ID: 1557573
Sex: F
Age: 76
State: AZ

Vax Date: 02/01/2021
Onset Date: 02/09/2021
Rec V Date: 08/14/2021
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: Itching Injection Site; Swollen Injection Site; Red Injection Site; A spontaneous report was received from a consumer concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching injection site, swollen injection site, red injection site. The patient's medical history was not provided. No relevant concomitant medications were reported. On 1 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 9 Feb 2021, the patient experienced the event(s) itching injection site, swollen injection site, red injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), itching injection site, swollen injection site, red injection site was unknown.

Other Meds:

Current Illness:

ID: 1557574
Sex: F
Age: 65
State: WA

Vax Date: 01/08/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: extreme swelling of lymph node; swelling on in the injection arm/swelling on left arm; swelling of neck; swelling on the face; pain; pain inside of left ear; swelling on in the injection arm/swelling on left arm; rash on lower extremity of both leg more towards upper calf and lower thigh side; lost sense of taste; dehydrate; lack of appetite; fatigue for 4 days; A spontaneous report was received from a consumer concerning herself, who is a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extreme swelling of lymph node, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, fatigue for 4 days. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) Intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 5 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) Intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the events in evening with extreme swelling of lymph node, swelling of neck, swelling on in the injection arm as well as swelling on left arm, swelling on the face, pain, pain inside of left ear, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite, and fatigue for 4 days. Treatment details included diphenhydramine: for 2 days, acetaminophen, dextromethorphan, and phenylephrine 1/ 2 recommended dose listed on the bottle for 3 days. Patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable On 9 Feb 2021 the outcome of event pain inside of left ear, fatigue for 4 days was resolved. The outcome of events extreme swelling of lymph node, swelling of neck, swelling on in the injection arm, swelling on left arm, swelling on the face, pain, soreness on the injection arm, rash on lower extremity of both leg more towards upper calf and lower thigh side, lost sense of taste, dehydrate, lack of appetite was resolving.

Other Meds:

Current Illness:

ID: 1557575
Sex: F
Age: 71
State: KY

Vax Date: 02/04/2021
Onset Date: 02/12/2021
Rec V Date: 08/14/2021
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: Hotness at the injection site; Redness at the injection site; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Hotness at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), MAGNESIUM OXIDE (MAGNESIUM OXIDE 400), ATORVASTATIN CALCIUM (LIPITOR), OMEPRAZOLE, Vitamin D and CETIRIZINE HYDROCHLORIDE (ZYRTEC) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced INJECTION SITE PRURITUS (Itching at the injection site). On 13-Feb-2021, the patient experienced INJECTION SITE WARMTH (Hotness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). At the time of the report, INJECTION SITE WARMTH (Hotness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) outcome was unknown and INJECTION SITE PRURITUS (Itching at the injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was provided by the reporter as allergy shots every 2 weeks. Treatment information was provided as Triamcinolone 0.1%.

Other Meds: SYNTHROID; MAGNESIUM OXIDE 400; LIPITOR; OMEPRAZOLE; Vitamin D; ZYRTEC

Current Illness:

ID: 1557576
Sex: F
Age: 74
State:

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Injection site redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart disease, unspecified. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN CALCIUM (LIPITOR) and METOPROLOL for an unknown indication. On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). At the time of the report, PAIN (Pain in the whole body), PAIN IN EXTREMITY (Pain in arm of injection), HEADACHE (Headaches), FATIGUE (Fatigue), VACCINATION SITE ERYTHEMA (Injection site redness), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-031240 (Patient Link).

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; LIPITOR; METOPROLOL

Current Illness:

ID: 1557577
Sex: F
Age: 71
State: IN

Vax Date: 01/15/2021
Onset Date: 01/24/2021
Rec V Date: 08/14/2021
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: skin rash; Nine days after first dose rash on arm; Nine days after first dose arm swollen; Erythema; A spontaneous report was, received from a nurse, concerning a female patient of 71 years old age, who received Moderna's Covid-19 vaccine and experienced skin rash, Nine days after first dose ash on arm, Nine days after first dose arm swollen, Erythema. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 15Jan2021, prior the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 013L20A) via unknown route for COVID-19 infection prophylaxis. On 24Jan2021, the patient experienced ongoing skin rash, Nine days after first dose ash on arm, Nine days after first dose arm swollen, Erythema. The treatment information was not reported. Action taken with mRNA-1273 in response to the events were unknown. The outcome of the events, skin rash, Nine days after first dose ash on arm, Nine days after first dose arm swollen, Erythema were considered to be unknown at the time of this report. Based on MSA comment, Erythema change listedness to Unlisted, Vaccination site swelling and Vaccination site rash change listedness to listed

Other Meds:

Current Illness:

ID: 1557578
Sex: M
Age:
State: ID

Vax Date:
Onset Date: 02/09/2021
Rec V Date: 08/14/2021
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: felt cold; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (felt cold) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced CHILLS (felt cold). At the time of the report, CHILLS (felt cold) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1557579
Sex: F
Age:
State: ND

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Covid-19; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid 19. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient Tested positive for COVID 19.No laboratory details was provided.Treatment details included, Bamlanivimab was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event covid 19 was unknown at the time of the report.

Other Meds:

Current Illness:

ID: 1557580
Sex: M
Age: 65
State: PA

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
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: mild nausea and weakness; mild nausea and weakness; body aches; arm of the injection site was warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm of the injection site was warm to touch), ASTHENIA (mild nausea and weakness), NAUSEA (mild nausea and weakness) and MYALGIA (body aches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (arm of the injection site was warm to touch). On 07-Feb-2021, the patient experienced MYALGIA (body aches). On 09-Feb-2021, the patient experienced ASTHENIA (mild nausea and weakness) and NAUSEA (mild nausea and weakness). On 06-Feb-2021, VACCINATION SITE WARMTH (arm of the injection site was warm to touch) had resolved. At the time of the report, ASTHENIA (mild nausea and weakness), NAUSEA (mild nausea and weakness) and MYALGIA (body aches) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant products were not provided. Treatment medication were not reported. This case was linked to MOD-2021-096674 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: updated event outcome to recovered.

Other Meds:

Current Illness:

ID: 1557581
Sex: M
Age: 79
State:

Vax Date: 02/04/2021
Onset Date: 02/10/2021
Rec V Date: 08/14/2021
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: Sore Arm; Chills; A spontaneous report was received from a consumer concerning a 78-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced the event(s) sore arm, chills. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), sore arm, chills was unknown.

Other Meds:

Current Illness:

ID: 1557582
Sex: F
Age: 77
State: FL

Vax Date: 01/29/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: Little anxious; Injection site is still inflamed; Injection site hurts; Diarrhea; Stuffy nose; Ache all over; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed), NASAL CONGESTION (Stuffy nose) and MYALGIA (Ache all over) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for an unknown indication. The occurrence of additional non-serious events is detailed below. Concomitant products included LABETALOL, HYDRALAZINE, TELMISARTAN, ROSUVASTATIN, LEVOTHYROXINE, FAMOTIDINE, MULTIVITAMINS & MINERALS PLUS LUTEIN, CALCIUM, PROBIOTIC 10, PARACETAMOL (TYLENOL), VITAMIN B12 [VITAMIN B12 NOS], SODIUM CHLORIDE, BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN 81) and DENOSUMAB. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), NASAL CONGESTION (Stuffy nose), MYALGIA (Ache all over), CHILLS (Chills) and PYREXIA (Low grade fever). On 09-Feb-2021, the patient experienced ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed) and VACCINATION SITE PAIN (Injection site hurts). On 09-Feb-2021, DIARRHOEA (Diarrhea), NASAL CONGESTION (Stuffy nose), MYALGIA (Ache all over), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved. At the time of the report, ANXIETY (Little anxious), VACCINATION SITE INFLAMMATION (Injection site is still inflamed) and VACCINATION SITE PAIN (Injection site hurts) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. . No treatment related information has been reported.

Other Meds: LABETALOL; HYDRALAZINE; TELMISARTAN; ROSUVASTATIN; LEVOTHYROXINE; FAMOTIDINE; MULTIVITAMINS & MINERALS PLUS LUTEIN; CALCIUM; PROBIOTIC 10; TYLENOL; VITAMIN B12 [VITAMIN B12 NOS]; SODIUM CHLORIDE; BIOTIN; ASPIRIN 81; DENOSUMAB

Current Illness:

ID: 1557583
Sex: F
Age:
State: PA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 08/14/2021
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: SORE ARM; A spontaneous report was received from a Consumer concerning a 43-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 4 Jan 2021, the patient experienced the event sore arm . No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, sore arm was unknown.

Other Meds:

Current Illness:

ID: 1557584
Sex: F
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
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: General Body pain; Hot injection site; Itchy injection site; Redness at injection site; Joint ache; Headache; Nausea; Fever (101.9); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and ARTHRALGIA (Joint ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)). On an unknown date, the patient experienced PAIN (General Body pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (General Body pain), VACCINATION SITE WARMTH (Hot injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE ERYTHEMA (Redness at injection site), ARTHRALGIA (Joint ache), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever (101.9)) outcome was unknown. No Concomitant medication 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.

Other Meds:

Current Illness:

ID: 1557585
Sex: M
Age: 67
State: FL

Vax Date: 01/31/2021
Onset Date: 02/02/2021
Rec V Date: 08/14/2021
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: the rash also began to spread on his arms and legs; rash on his back; rash on his head; A spontaneous report was received from a consumer concerning a 67- year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash on his head, rash on his back and rash on his arms and legs. The patient's medical history was not provided. Concomitant medications were reported as blood high pressure medicine. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) in the right arm for prophylaxis of COVID-19 infection. On 2 Feb 2021, the patient experienced the event rash on his head. On 8 Feb 2021, the patient experienced the event rash on his back. On 9 Feb 2021, the patient experienced the event rash on his arms and legs.Now it's more visible on her back. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), rash on his head, rash on his back, rash on his arms and legs were unknown. Based on comment, Rashes ( change listedness to listed and unlisted for monograph and factsheet)

Other Meds:

Current Illness:

ID: 1557586
Sex: F
Age:
State: PA

Vax Date: 02/03/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: tightness on left upper shoulder and left side of the neck; tightness on left upper shoulder and left side of the neck; felt like having the flu; WEAK; COLD; difficulty sleeping because of the pain; body aches; burning in the arm of injection; chills; A spontaneous report was received from a 43-years-old female patient concerning self who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 3 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the patient experienced the events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events chills, burning in the arm of injection, tightness on left upper shoulder and left side of the neck, body aches, felt like having the flu, weak, cold, difficulty sleeping because of the pain. was unknown. Based on regulatory authority comment, Myalgia and Chills (listed). Injection site pain coded Vaccination site pain

Other Meds:

Current Illness:

ID: 1557587
Sex: F
Age: 49
State: NJ

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: swelling on her arm; Chills,shivering; temp is 101; Headache; A spontaneous report was received from a consumer concerning a 49 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling in the arm got vaccine/Peripheral swelling, chills, headaches, fever temp is 101, shivering/chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 8 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On 8 Feb 2021, the patient experienced the event(s) swelling in the arm got vaccine, chills, headaches, fever temp is 101, shivering. Treatment details included Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), swelling in the arm got vaccine, chills, headaches, fever temp is 101, shivering was unknown.

Other Meds:

Current Illness:

ID: 1557588
Sex: M
Age:
State: SC

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: Flu like symptoms; Muscle cramps; Headache; A spontaneous report was received on 9 Feb 2021, from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, flu. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 1 Feb 2021, the patient experienced the event(s) headache, flu. Treatment details included Tylenol, Product Product Description Product Detail Category Topic. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), headache, flu was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm