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: 1553336
Sex: M
Age: 61
State: PA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
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: chills; fatigue; Arm soreness; lower back pain; loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), BACK PAIN (lower back pain), AGEUSIA (loss of taste), CHILLS (chills) and FATIGUE (fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The patient's past medical history included Stent placement. Concomitant products included ISOSORBIDE for Heart disease, unspecified, METOPROLOL for Hypertension, ATORVASTATIN for an unknown indication. On 02-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), BACK PAIN (lower back pain) and AGEUSIA (loss of taste). On 07-Feb-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 02-Feb-2021, AGEUSIA (loss of taste) had resolved. On 03-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and BACK PAIN (lower back pain) had resolved. At the time of the report, CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included atorvastatin for cholesterol and multivitamins. Treatment information included water.

Other Meds: ATORVASTATIN; ISOSORBIDE; METOPROLOL

Current Illness:

ID: 1553337
Sex: F
Age: 77
State: OH

Vax Date: 02/06/2021
Onset Date: 02/06/2021
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: Soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) 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) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness) 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 relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1553338
Sex: F
Age:
State: FL

Vax Date: 02/04/2021
Onset Date: 02/04/2021
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: Body ache; Chills; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MYALGIA (Body ache) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) 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 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm pain). On 05-Feb-2021, the patient experienced MYALGIA (Body ache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Arm pain), MYALGIA (Body ache) and CHILLS (Chills) had not resolved. Concomitant and treatment information not provided. No Treatment information was provided by the reporter Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non-significant follow up appended

Other Meds:

Current Illness:

ID: 1553339
Sex: F
Age: 44
State:

Vax Date: 02/04/2021
Onset Date: 02/05/2021
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: Chills; Nausea; Headache; Fever 101.4; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever 101.4) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016MZ0A) 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 05-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever 101.4). The patient was treated with PARACETAMOL (TYLENOL) for Adverse drug reaction, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever 101.4) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: 101.4 High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter

Other Meds:

Current Illness:

ID: 1553340
Sex: M
Age: 85
State:

Vax Date: 02/19/2021
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: 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: Red and warm-to-the-touch arm; Red and warm-to-the-touch arm; Migraine; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), VACCINATION SITE WARMTH (Red and warm-to-the-touch arm) and VACCINATION SITE ERYTHEMA (Red and warm-to-the-touch arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. Concomitant products included RIVAROXABAN (XARELTO) and STEROIDS for an unknown indication. On 19-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. In February 2021, the patient experienced MIGRAINE (Migraine). On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red and warm-to-the-touch arm) and VACCINATION SITE ERYTHEMA (Red and warm-to-the-touch arm). In February 2021, MIGRAINE (Migraine) had resolved. At the time of the report, VACCINATION SITE WARMTH (Red and warm-to-the-touch arm) and VACCINATION SITE ERYTHEMA (Red and warm-to-the-touch arm) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Concomitant product also included supplements. Treatment information was not provided.

Other Meds: XARELTO; STEROIDS

Current Illness:

ID: 1553341
Sex: F
Age: 72
State: TX

Vax Date: 01/18/2021
Onset Date: 02/22/2021
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: diarrhea; feel a little shaky and a little off; feel like post flu; very bad body aches; lots of sputum; nausea; vomiting; terrible headache; chills; really hit me hard; This spontaneous case was reported by a health care professional and describes the occurrence of DIARRHOEA (diarrhea), NERVOUSNESS (feel a little shaky and a little off), INFLUENZA LIKE ILLNESS (feel like post flu), PAIN (very bad body aches) and PRODUCTIVE COUGH (lots of sputum) in a 72-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. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced DIARRHOEA (diarrhea), NERVOUSNESS (feel a little shaky and a little off), INFLUENZA LIKE ILLNESS (feel like post flu), PAIN (very bad body aches), PRODUCTIVE COUGH (lots of sputum), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (terrible headache), CHILLS (chills) and MUSCULOSKELETAL DISCOMFORT (really hit me hard). At the time of the report, DIARRHOEA (diarrhea), NERVOUSNESS (feel a little shaky and a little off), INFLUENZA LIKE ILLNESS (feel like post flu), PAIN (very bad body aches), PRODUCTIVE COUGH (lots of sputum), NAUSEA (nausea), VOMITING (vomiting), HEADACHE (terrible headache), CHILLS (chills) and MUSCULOSKELETAL DISCOMFORT (really hit me hard) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: BABY ASPIRIN

Current Illness:

ID: 1553342
Sex: F
Age: 71
State: CA

Vax Date: 01/22/2021
Onset Date: 01/24/2021
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: red patch on her arm that itch a lot and redness is evident; Allergic reaction; pain all over the body; itchiness; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over the body), PRURITUS (itchiness), PAIN IN EXTREMITY (arm soreness), ERYTHEMA (red patch on her arm that itch a lot and redness is evident) and HYPERSENSITIVITY (Allergic reaction) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included Multivitamins supplement, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Probiotics supplement and Tagamet Antacid 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 24-Jan-2021, the patient experienced PAIN (pain all over the body), PRURITUS (itchiness) and PAIN IN EXTREMITY (arm soreness). On 02-Feb-2021, the patient experienced ERYTHEMA (red patch on her arm that itch a lot and redness is evident) and HYPERSENSITIVITY (Allergic reaction). On 25-Jan-2021, PAIN (pain all over the body) had resolved. At the time of the report, PRURITUS (itchiness), PAIN IN EXTREMITY (arm soreness), ERYTHEMA (red patch on her arm that itch a lot and redness is evident) and HYPERSENSITIVITY (Allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Applied Hyderocortisone cream 1%. Reporter did not allow further contact

Other Meds: Multivitamins supplement; VITAMIN D 2000; Probiotics supplement; Tagamet Antacid

Current Illness:

ID: 1553343
Sex: M
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: congestion; headache; chills; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of NASAL CONGESTION (congestion), HEADACHE (headache) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced NASAL CONGESTION (congestion), HEADACHE (headache) and CHILLS (chills). At the time of the report, NASAL CONGESTION (congestion), HEADACHE (headache) and CHILLS (chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1553344
Sex: F
Age: 59
State: PA

Vax Date: 01/23/2021
Onset Date: 01/23/2021
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: her tongue got tingly for several hours; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (her tongue got tingly for several hours) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PARAESTHESIA ORAL (her tongue got tingly for several hours). On 23-Jan-2021, PARAESTHESIA ORAL (her tongue got tingly for several hours) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were also not reported Treatment for the event was not reported.

Other Meds:

Current Illness:

ID: 1553345
Sex: M
Age: 80
State: PA

Vax Date: 02/06/2021
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: shoulder pain both side, but most prominent in the left side; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (shoulder pain both side, but most prominent in the left side) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN, CAFFEINE, CALCIUM CITRATE, CALCIUM GLUCONATE, VITAMINS NOS (BIOPLUS) and Hypochloride 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 an unknown date, the patient experienced ARTHRALGIA (shoulder pain both side, but most prominent in the left side). At the time of the report, ARTHRALGIA (shoulder pain both side, but most prominent in the left side) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details are not provided by reporter. Reporter did not allow further contact

Other Meds: ATORVASTATIN; BIOPLUS; Hypochloride

Current Illness:

ID: 1553346
Sex: F
Age: 49
State:

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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: weird tingling in her mouth.; Within 25 minutes, the numbness and tingling had spread to her face and behind her ear.; symptoms were on both sides of her face.; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA ORAL (weird tingling in her mouth.), HYPOAESTHESIA (Within 25 minutes, the numbness and tingling had spread to her face and behind her ear.) and VACCINATION COMPLICATION (symptoms were on both sides of her face.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) 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) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PARAESTHESIA ORAL (weird tingling in her mouth.), HYPOAESTHESIA (Within 25 minutes, the numbness and tingling had spread to her face and behind her ear.) and VACCINATION COMPLICATION (symptoms were on both sides of her face.). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (weird tingling in her mouth.), HYPOAESTHESIA (Within 25 minutes, the numbness and tingling had spread to her face and behind her ear.) and VACCINATION COMPLICATION (symptoms were on both sides of her face.) was resolving. 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 provided by the reporter.

Other Meds:

Current Illness:

ID: 1553347
Sex: F
Age: 76
State: TN

Vax Date: 01/29/2021
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: arm swollen; arm a little red; arm with a bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (arm a little red) and VACCINATION SITE INDURATION (arm with a bump) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included CALCIUM and VITAMINS NOS for an unknown indication. On 29-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 SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (arm a little red) and VACCINATION SITE INDURATION (arm with a bump). At the time of the report, VACCINATION SITE SWELLING (arm swollen), VACCINATION SITE ERYTHEMA (arm a little red) and VACCINATION SITE INDURATION (arm with a bump) outcome was unknown. Not Provided 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 medications were not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received and Contact information was updated.

Other Meds: CALCIUM; VITAMINS NOS

Current Illness:

ID: 1553348
Sex: F
Age:
State: CA

Vax Date: 01/04/2021
Onset Date: 01/19/2021
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: diagnosed with Shingles; This spontaneous case was reported by an other health care professional and describes the occurrence of HERPES ZOSTER (diagnosed with Shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 04-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 HERPES ZOSTER (diagnosed with Shingles). At the time of the report, HERPES ZOSTER (diagnosed with Shingles) 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 medication included Acyclovir from 20 Jan2021 to 29 Jan 2021. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1553349
Sex: F
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: Temperature; Body aches; Chills; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Temperature), MYALGIA (Body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-Jan-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) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BODY TEMPERATURE INCREASED (Temperature), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, BODY TEMPERATURE INCREASED (Temperature), MYALGIA (Body aches) and CHILLS (Chills) outcome 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 provided.

Other Meds:

Current Illness:

ID: 1553350
Sex: F
Age: 38
State: NJ

Vax Date: 02/06/2021
Onset Date: 02/06/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Fever; deep inflammation; redness; Swelling hand; headache; muscle pain; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), INFLAMMATION (deep inflammation), ERYTHEMA (redness), PERIPHERAL SWELLING (Swelling hand) and HEADACHE (headache) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-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 PYREXIA (Fever), INFLAMMATION (deep inflammation), ERYTHEMA (redness), PERIPHERAL SWELLING (Swelling hand), HEADACHE (headache) and MYALGIA (muscle pain). At the time of the report, PYREXIA (Fever), INFLAMMATION (deep inflammation), ERYTHEMA (redness), PERIPHERAL SWELLING (Swelling hand), HEADACHE (headache) and MYALGIA (muscle pain) had not resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided by reporter. No treatment was reported.

Other Meds:

Current Illness:

ID: 1553351
Sex: M
Age:
State: CA

Vax Date: 01/28/2021
Onset Date: 02/01/2021
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: diarrhea; Headache; muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (Headache), MYALGIA (muscle pain) and 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 28-Jan-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 DIARRHOEA (diarrhea), HEADACHE (Headache), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (Headache), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1553352
Sex: F
Age:
State:

Vax Date:
Onset Date:
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: Felt lousy after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy after the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt lousy after the second dose). At the time of the report, MALAISE (Felt lousy after the second dose) outcome was unknown. Not Provided No concomitant medications were provided by the reporter Treatment information was not provided by the reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1553353
Sex: F
Age: 83
State: FL

Vax Date: 02/04/2021
Onset Date: 02/04/2021
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: Tired; Cold; Had trouble sleeping last night; Had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold), INSOMNIA (Had trouble sleeping last night), FATIGUE (Tired) and VACCINATION SITE PAIN (Had a sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028120A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. 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 VACCINATION SITE PAIN (Had a sore arm). On 05-Feb-2021, the patient experienced FEELING COLD (Cold) and INSOMNIA (Had trouble sleeping last night). On 06-Feb-2021, the patient experienced FATIGUE (Tired). At the time of the report, FEELING COLD (Cold), INSOMNIA (Had trouble sleeping last night), FATIGUE (Tired) and VACCINATION SITE PAIN (Had a sore arm) 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.

Other Meds:

Current Illness: Hypertension

ID: 1553354
Sex: M
Age: 68
State: NC

Vax Date: 02/05/2021
Onset Date: 02/05/2021
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: Felt dizzy bending over; Lack of appetite.; Fell; Acting draggy; Fever 101 F; Difficulty urinating.; A spontaneous report was received from a consumer, concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events difficulty in urinating/dysuria, fever, felt dizzy bending over/dizziness postural, fall, acting draggy/lethargy and lack of appetite. The patient's medical history included polycythemia and hypertension. On an unspecified date in Oct 2020, the patient experienced COVID. No relevant concomitant medications were reported. On 05 Feb 2021, at 12:00 pm, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: 011M20A) on left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, the night of vaccination, the patient experienced the event difficulty in urinating (dysuria). On 06 Feb 2021 (early morning), the patient developed the events fever with a body temperature of 101 F, felt dizzy upon bending over and fell. The patient was acting draggy and had lack of appetite. Treatment details included Tylenol for fever. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, difficulty urinating, fever 101 F, felt dizzy bending over and fell was considered as resolved on 6 Feb 2021. On 07 Feb 2021 the outcome of events, acting draggy, lack of appetite was resolved.; Sender's Comments: MOD21-022987:

Other Meds:

Current Illness:

ID: 1553355
Sex: F
Age: 66
State: AZ

Vax Date: 01/27/2021
Onset Date: 02/03/2021
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: Swollen; Red; Body aches; Dry cough; Headache; Fatigue; Slight fever 99.9; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen), ERYTHEMA (Red), PAIN (Body aches), COUGH (Dry cough) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included VITAMINS NOS for an unknown indication. On 27-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 PAIN (Body aches), COUGH (Dry cough), HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Slight fever 99.9). On 04-Feb-2021, the patient experienced SWELLING (Swollen) and ERYTHEMA (Red). On 04-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, SWELLING (Swollen), ERYTHEMA (Red), PAIN (Body aches), COUGH (Dry cough), FATIGUE (Fatigue) and PYREXIA (Slight fever 99.9) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant description included high blood pressure, and cholesterol. Treatment medication was not provided.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1553356
Sex: F
Age:
State: NY

Vax Date: 02/21/2021
Onset Date: 02/21/2021
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: Rash; Achiness; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Achiness), PAIN IN EXTREMITY (Arm Pain) and RASH (Rash) 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 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PAIN IN EXTREMITY (Achiness) and PAIN IN EXTREMITY (Arm Pain). On 23-Feb-2021, the patient experienced RASH (Rash). On 21-Feb-2021, PAIN IN EXTREMITY (Achiness) and PAIN IN EXTREMITY (Arm Pain) had resolved. At the time of the report, RASH (Rash) was resolving. Concomitant medications was not provided Treatment for the events included Benadryl for rash. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1553357
Sex: F
Age:
State: OR

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: Unevaluable event

Symptoms: feeling a flush in my face; was tired most of the day; Severe aching pain in both legs; Call into worksick; Severe diarrhea; Felt cold; Nasty taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), NASOPHARYNGITIS (Felt cold), AGEUSIA (Nasty taste in mouth), PAIN IN EXTREMITY (Severe aching pain in both legs) and FLUSHING (feeling a flush in my face) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes since 2006 and Drug allergy (Sulfer , macrobid). Concomitant products included METFORMIN from 06-Jan-2006 to an unknown date for Diabetes, OMEPRAZOLE from 2006 to an unknown date 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-Mar-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 NASOPHARYNGITIS (Felt cold) and AGEUSIA (Nasty taste in mouth). On 04-Feb-2021, the patient experienced DIARRHOEA (Severe diarrhea), PAIN IN EXTREMITY (Severe aching pain in both legs) and MALAISE (Call into worksick). On an unknown date, the patient experienced FLUSHING (feeling a flush in my face) and FATIGUE (was tired most of the day). On 03-Feb-2021, NASOPHARYNGITIS (Felt cold) and AGEUSIA (Nasty taste in mouth) had resolved. On 04-Feb-2021, DIARRHOEA (Severe diarrhea) and PAIN IN EXTREMITY (Severe aching pain in both legs) had resolved. At the time of the report, FLUSHING (feeling a flush in my face), MALAISE (Call into worksick) and FATIGUE (was tired most of the day) outcome was unknown. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up was received on 26 April 2021. Informations on patient demographics ,new events ( flushed face , feeling sick and tired all the time), other relevant history , concomitant medications and second dose information were added.

Other Meds: METFORMIN; OMEPRAZOLE

Current Illness: Diabetes

ID: 1553358
Sex: F
Age: 70
State: CA

Vax Date: 01/22/2021
Onset Date:
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: Very bad reaction; terrible chills that lasted 30 minutes,Her teeth were clanking; Flu-like symptoms that lasted for 72 hours; Lost taste; Lost smell; Her cough was back; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Very bad reaction), CHILLS (terrible chills that lasted 30 minutes,Her teeth were clanking), INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted for 72 hours), AGEUSIA (Lost taste) and ANOSMIA (Lost smell) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE REACTION (Very bad reaction), CHILLS (terrible chills that lasted 30 minutes,Her teeth were clanking), INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted for 72 hours), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Her cough was back) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, ADVERSE REACTION (Very bad reaction), CHILLS (terrible chills that lasted 30 minutes,Her teeth were clanking), INFLUENZA LIKE ILLNESS (Flu-like symptoms that lasted for 72 hours), AGEUSIA (Lost taste), ANOSMIA (Lost smell), COUGH (Her cough was back) and PYREXIA (Fever) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided.

Other Meds:

Current Illness:

ID: 1553359
Sex: F
Age:
State:

Vax Date: 01/10/2021
Onset Date: 01/10/2021
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: serious itching in extremities; tongue starting to swell; upper palate starting to swell; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (serious itching in extremities), SWOLLEN TONGUE (tongue starting to swell) and MOUTH SWELLING (upper palate starting to swell) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced PRURITUS (serious itching in extremities), SWOLLEN TONGUE (tongue starting to swell) and MOUTH SWELLING (upper palate starting to swell). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, PRURITUS (serious itching in extremities), SWOLLEN TONGUE (tongue starting to swell) and MOUTH SWELLING (upper palate starting to swell) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter She spoke to doctor who advised her to take Benadryl first before resorting to EpiPen that she keeps for anaphylactic reaction to bee stings.

Other Meds:

Current Illness:

ID: 1553360
Sex: M
Age:
State: NY

Vax Date: 02/05/2021
Onset Date: 02/05/2021
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: Injection site pain, Menorrhagia

Symptoms: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) 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 05-Feb-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 PAIN IN EXTREMITY (Arm was sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 aspirin. At the time of the report, PAIN IN EXTREMITY (Arm was sore) 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. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: FU makes case valid. NNI. Event start date updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1553361
Sex: M
Age:
State: CA

Vax Date: 02/01/2021
Onset Date: 02/05/2021
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: serious lower stomach pain; soreness in injection arm.; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was Reported. On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.). At the time of the report, ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) 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 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 05-Feb-2021 and was forwarded to Moderna on 07-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History Information was Reported. On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.). At the time of the report, ABDOMINAL PAIN LOWER (serious lower stomach pain) and VACCINATION SITE PAIN (soreness in injection arm.) 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 for the event was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1553362
Sex: F
Age: 84
State: KS

Vax Date: 02/05/2021
Onset Date: 02/06/2021
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: No appetite; No energy; Wiped out; A spontaneous report was received from a consumer concerning, a 84-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events no appetite, wiped out and no energy. The patient's medical history included cholesterol and macular degeneration. Products known to have been used by the patient, within two weeks prior to the event, included simvastatin, multivitamin, vitamin D and vitamins for eye. On 5 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (batch number: 015M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 6 Feb 2021, the patient experienced the events no appetite, wiped out and no energy. Treatment for the events included paracetamol and acetaminophen Action taken with mRNA-1273 in response to the events was not provided. The outcome of events, no appetite, wiped out and no energy was unknown at the time of this report.; Sender's Comments: Very limited information regarding this events has been provided at this time.Company assessed the events to be unlikely related to company product.

Other Meds: SIMVASTATIN; MULTIVITAMINUM; VITAMIN D NOS; VITAMINS NOS

Current Illness: Cholesterol; Macular degeneration

ID: 1553363
Sex: F
Age:
State: FL

Vax Date: 02/05/2021
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: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: flu like symptoms; extremally dizzy; shaky; chills; body ache; nausea; fatigue; diminished smell; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (extremally dizzy), NERVOUSNESS (shaky), CHILLS (chills) and PAIN (body ache) 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. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (extremally dizzy), NERVOUSNESS (shaky), CHILLS (chills), PAIN (body ache), NAUSEA (nausea), FATIGUE (fatigue) and ANOSMIA (diminished smell). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (extremally dizzy), NERVOUSNESS (shaky), CHILLS (chills), PAIN (body ache), NAUSEA (nausea), FATIGUE (fatigue) and ANOSMIA (diminished smell) 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. No relevant concomitant medications were reported. Treatment details included Advil and Tylenol.. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1553364
Sex: M
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: moderate chills; body pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHILLS (moderate chills) and MYALGIA (body pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-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 20-Jan-2021, the patient experienced CHILLS (moderate chills) and MYALGIA (body pain). At the time of the report, CHILLS (moderate chills) and MYALGIA (body pain) outcome 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 was reported.

Other Meds:

Current Illness:

ID: 1553365
Sex: F
Age:
State: TN

Vax Date: 01/22/2021
Onset Date: 01/22/2021
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: cold sensation on my legs; shivers, feeling cold; rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee; rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee; rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee; fast heart beat 1st hour after vaccine; headache; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee), RASH MACULAR (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee), HEART RATE INCREASED (fast heart beat 1st hour after vaccine), LIMB DISCOMFORT (cold sensation on my legs) and CHILLS (shivers, feeling cold) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HEART RATE INCREASED (fast heart beat 1st hour after vaccine) and HEADACHE (headache). On 05-Feb-2021, the patient experienced MILIARIA (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee), RASH MACULAR (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee), CHILLS (shivers, feeling cold) and RASH (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee). On an unknown date, the patient experienced LIMB DISCOMFORT (cold sensation on my legs). At the time of the report, MILIARIA (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee), RASH MACULAR (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee), HEART RATE INCREASED (fast heart beat 1st hour after vaccine), LIMB DISCOMFORT (cold sensation on my legs), CHILLS (shivers, feeling cold), RASH (rash inside my legs, not itchy more like hives or prickly heat, tiny little red dots extended at the top of my knee) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication were not provided No treatment medications were not provided Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Followup received on 07-MAY-2021 and contains e-mail details.

Other Meds:

Current Illness:

ID: 1553366
Sex: F
Age: 79
State: NC

Vax Date: 01/15/2021
Onset Date: 01/15/2021
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: Injection site pain

Symptoms: Red became itchy; Saw colors like a Kaleidoscope and fell; Redness; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHROMATOPSIA (Saw colors like a Kaleidoscope and fell), PRURITUS (Red became itchy), ERYTHEMA (Redness) and PAIN IN EXTREMITY (Sore arm at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE and CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for an unknown indication. On 15-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 ERYTHEMA (Redness) and PAIN IN EXTREMITY (Sore arm at the injection site). On 20-Jan-2021, the patient experienced DYSCHROMATOPSIA (Saw colors like a Kaleidoscope and fell). On 22-Jan-2021, the patient experienced PRURITUS (Red became itchy). On 22-Jan-2021, PAIN IN EXTREMITY (Sore arm at the injection site) had resolved. On 29-Jan-2021, DYSCHROMATOPSIA (Saw colors like a Kaleidoscope and fell) had resolved. At the time of the report, PRURITUS (Red became itchy) outcome was unknown and ERYTHEMA (Redness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Poison ivy cream on the itch. Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: NNI

Other Meds: LEVOTHYROXINE; CELEXA [CITALOPRAM HYDROBROMIDE]

Current Illness:

ID: 1553367
Sex: M
Age: 57
State: NY

Vax Date: 02/06/2021
Onset Date: 02/07/2021
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: fever 103F; body ache; coughing; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever 103F), MYALGIA (body ache) and COUGH (coughing) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 from March 2020 to April 2020. Concomitant products included DIPHENHYDRAMINE for Allergy, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Antiplatelet therapy, ATORVASTATIN for Cholesterol, NIFEDIPINE and LOSARTAN for Hypertension. On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (fever 103F), MYALGIA (body ache) and COUGH (coughing). The patient was treated with PARACETAMOL on 07-Feb-2021 at an unspecified dose and frequency. At the time of the report, PYREXIA (fever 103F), MYALGIA (body ache) and COUGH (coughing) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: NIFEDIPINE; LOSARTAN; DIPHENHYDRAMINE; ATORVASTATIN; BABY ASPIRIN

Current Illness:

ID: 1553368
Sex: F
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/01/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Body ache; Headache; Chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 20-Jan-2021, the patient experienced PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), PAIN (Body ache), HEADACHE (Headache) and CHILLS (Chills) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1553369
Sex: F
Age: 75
State:

Vax Date: 01/30/2021
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: Tremor

Symptoms: Purple discoloration of the lower right leg; Loss of muscle control of legs; She could not walk for approximately 1 month; Rash under right thigh; Reporting a reaction to my COVID 19 injection; Mottling underneath the skin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Reporting a reaction to my COVID 19 injection), LIVEDO RETICULARIS (Mottling underneath the skin), SKIN DISCOLOURATION (Purple discoloration of the lower right leg), MYOPATHY (Loss of muscle control of legs) and GAIT INABILITY (She could not walk for approximately 1 month) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Surgery (Spinal surgery and had been undergoing physical therapy.) since 30-Jun-2020. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Reporting a reaction to my COVID 19 injection), LIVEDO RETICULARIS (Mottling underneath the skin), SKIN DISCOLOURATION (Purple discoloration of the lower right leg), MYOPATHY (Loss of muscle control of legs), GAIT INABILITY (She could not walk for approximately 1 month) and RASH (Rash under right thigh). At the time of the report, VACCINATION SITE REACTION (Reporting a reaction to my COVID 19 injection), LIVEDO RETICULARIS (Mottling underneath the skin), SKIN DISCOLOURATION (Purple discoloration of the lower right leg), MYOPATHY (Loss of muscle control of legs), GAIT INABILITY (She could not walk for approximately 1 month) and RASH (Rash under right thigh) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication and treatment provided Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant follow-up received on 27-MAY-2021: Added patient demographic details, medical history and events.

Other Meds:

Current Illness: Surgery (Spinal surgery and had been undergoing physical therapy.)

ID: 1553370
Sex: F
Age: 87
State: IL

Vax Date: 02/06/2021
Onset Date: 02/21/2021
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: Drowsiness; Heavy head; Ear stuffed up; Flu like symptoms; Whole body aches mostly when laying down in bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Drowsiness), HEAD DISCOMFORT (Heavy head), EAR DISCOMFORT (Ear stuffed up), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Whole body aches mostly when laying down in bed) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication. The patient's past medical history included COVID-19 in February 2020. On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) at an unspecified dose. On 21-Feb-2021, the patient experienced SOMNOLENCE (Drowsiness), HEAD DISCOMFORT (Heavy head), EAR DISCOMFORT (Ear stuffed up), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Whole body aches mostly when laying down in bed). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Drowsiness), HEAD DISCOMFORT (Heavy head), EAR DISCOMFORT (Ear stuffed up) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown and MYALGIA (Whole body aches mostly when laying down in bed) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. patient still had whole body aches when she laying on bed

Other Meds:

Current Illness:

ID: 1553371
Sex: F
Age:
State: MN

Vax Date: 01/29/2021
Onset Date: 02/05/2021
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: Achy; nauseous; pretty itchy; the injection site is swollen; warm; tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm), TENDERNESS (tender to touch), PAIN (Achy), INJECTION SITE PRURITUS (pretty itchy) and VACCINATION SITE SWELLING (the injection site is swollen) in a 45-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 No adverse event (No reported medical history). On 29-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 WARMTH (warm), TENDERNESS (tender to touch), INJECTION SITE PRURITUS (pretty itchy) and VACCINATION SITE SWELLING (the injection site is swollen). On 06-Feb-2021, the patient experienced PAIN (Achy) and NAUSEA (nauseous). At the time of the report, VACCINATION SITE WARMTH (warm), TENDERNESS (tender to touch) and INJECTION SITE PRURITUS (pretty itchy) outcome was unknown and PAIN (Achy), VACCINATION SITE SWELLING (the injection site is swollen) and NAUSEA (nauseous) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant medication and treatment provided

Other Meds:

Current Illness:

ID: 1553372
Sex: M
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: Body ache; pyrexia; chills; vaccination site pain; myalgia; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (Body ache), PYREXIA (pyrexia), CHILLS (chills), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (myalgia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history was reported.). On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN (Body ache), PYREXIA (pyrexia), CHILLS (chills), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (myalgia). At the time of the report, PAIN (Body ache), PYREXIA (pyrexia), CHILLS (chills), VACCINATION SITE PAIN (vaccination site pain) and MYALGIA (myalgia) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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.; Reporter'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.; 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: 1553373
Sex: M
Age:
State:

Vax Date: 02/22/2021
Onset Date: 02/22/2021
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: Asthenia, Chills, Headache, Myalgia

Symptoms: shakes; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes) and HEADACHE (Headache) 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 Viral infection. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced TREMOR (shakes) and HEADACHE (Headache). On 24-Feb-2021, HEADACHE (Headache) had resolved. At the time of the report, TREMOR (shakes) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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:

Current Illness:

ID: 1553374
Sex: M
Age: 74
State: FL

Vax Date: 02/07/2021
Onset Date: 02/24/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Positive COVID-19 TesT; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive COVID-19 TesT) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). Concomitant products included METFORMIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), FINASTERIDE and LOSARTAN for an unknown indication. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced COVID-19 (Positive COVID-19 TesT). At the time of the report, COVID-19 (Positive COVID-19 TesT) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Feb-2021, SARS-CoV-2 test positive: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This is a case of a 74 year old male who tested positive for COVID 19 and without any other symptoms after receiving the first dose of Moderna Vaccine. Based on the information available the event is considered unlikely related to the vaccine. Further information has been requested.

Other Meds: METFORMIN; ASPIRIN (E.C.); FINASTERIDE; LOSARTAN

Current Illness:

ID: 1553375
Sex: M
Age:
State: MI

Vax Date: 01/28/2021
Onset Date: 02/05/2021
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: itchy redness in the area of the injection; itchy redness in the area of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (itchy redness in the area of the injection) and VACCINATION SITE PRURITUS (itchy redness in the area of the injection) in a male patient of an unknown age 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 (no medical history provided). On 28-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 ERYTHEMA (itchy redness in the area of the injection) and VACCINATION SITE PRURITUS (itchy redness in the area of the injection). At the time of the report, VACCINATION SITE ERYTHEMA (itchy redness in the area of the injection) and VACCINATION SITE PRURITUS (itchy redness in the area of the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant medication and treatment provided This case was linked to MOD-2021-022839 (Patient Link).

Other Meds:

Current Illness:

ID: 1553376
Sex: U
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:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: had a rash about a week after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH (had a rash about a week after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (had a rash about a week after vaccination). At the time of the report, RASH (had a rash about a week after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter stated that she knew a few people (her cousin and her neighbor) who also experienced an adverse reaction after receiving the Moderna COVID19 Vaccine. She stated that both patients had a rash about a week after vaccination. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-086393 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Followup received on 21-APR-2021 and contains e-mail details.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-086393:Crosslink

Other Meds:

Current Illness:

ID: 1553377
Sex: M
Age:
State: MS

Vax Date: 01/20/2021
Onset Date: 01/20/2021
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: kidney pain; body ache; This spontaneous case was reported by a physician and describes the occurrence of RENAL PAIN (kidney pain) and MYALGIA (body ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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 20-Jan-2021, the patient experienced RENAL PAIN (kidney pain) and MYALGIA (body ache). At the time of the report, RENAL PAIN (kidney pain) and MYALGIA (body ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4 100.4. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1553378
Sex: F
Age: 75
State: CA

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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: shortness of breath; hard to walk up stairs; fast heartbeat; headache; exhaustion; muscle pain in back; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), GAIT DISTURBANCE (hard to walk up stairs), HEART RATE INCREASED (fast heartbeat), HEADACHE (headache) and FATIGUE (exhaustion) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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. In February 2021, the patient experienced DYSPNOEA (shortness of breath), GAIT DISTURBANCE (hard to walk up stairs), HEART RATE INCREASED (fast heartbeat), HEADACHE (headache), FATIGUE (exhaustion) and MYALGIA (muscle pain in back). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), GAIT DISTURBANCE (hard to walk up stairs), HEART RATE INCREASED (fast heartbeat), HEADACHE (headache), FATIGUE (exhaustion) and MYALGIA (muscle pain in back) 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 provided by the reporter

Other Meds:

Current Illness:

ID: 1553379
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: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Headache; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 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 HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) not higher than 100F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter Treatment information was not provided by the reporter Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Updated Reporter's address, patient demographics (age at the time of event, date of birth) and suspect drug batch no. and anatomical location

Other Meds:

Current Illness:

ID: 1553380
Sex: F
Age: 63
State: CA

Vax Date: 01/16/2021
Onset Date: 01/16/2021
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: Flu symptoms 2 weeks after vaccination for 3 days; bed rested; right breast was tender; right breast was hot to touch; joint hurt; body ache in other area; severe cold sore; something behind her eye and it was sensitive to light and sore while blinking; something behind her eye and it was sensitive to light and sore while blinking; fatigue; Lower back pain; sore arm; redness; Swelling; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness), SWELLING (Swelling), LETHARGY (lethargic) and PHOTOPHOBIA (something behind her eye and it was sensitive to light and sore while blinking) in a 63-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. The patient's past medical history included No adverse event. Concomitant products included IBUPROFEN, LEVOTHYROXINE SODIUM (SYNTHROID), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) and ESTROGEN NOS 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 PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness), SWELLING (Swelling) and LETHARGY (lethargic). On 29-Jan-2021, the patient experienced PHOTOPHOBIA (something behind her eye and it was sensitive to light and sore while blinking), EYE PAIN (something behind her eye and it was sensitive to light and sore while blinking), FATIGUE (fatigue) and BACK PAIN (Lower back pain). On 30-Jan-2021, the patient experienced PAIN (body ache in other area) and ORAL HERPES (severe cold sore). On 31-Jan-2021, the patient experienced ARTHRALGIA (joint hurt). On 02-Feb-2021, the patient experienced BREAST TENDERNESS (right breast was tender) and BREAST DISCOMFORT (right breast was hot to touch). On 03-Feb-2021, the patient experienced ASTHENIA (bed rested). On an unknown date, the patient experienced INFLUENZA (Flu symptoms 2 weeks after vaccination for 3 days). On 18-Jan-2021, PAIN IN EXTREMITY (sore arm), ERYTHEMA (redness), SWELLING (Swelling) and LETHARGY (lethargic) had resolved. At the time of the report, PHOTOPHOBIA (something behind her eye and it was sensitive to light and sore while blinking), EYE PAIN (something behind her eye and it was sensitive to light and sore while blinking), FATIGUE (fatigue), BACK PAIN (Lower back pain), PAIN (body ache in other area), ORAL HERPES (severe cold sore), ARTHRALGIA (joint hurt), BREAST TENDERNESS (right breast was tender), BREAST DISCOMFORT (right breast was hot to touch), ASTHENIA (bed rested) and INFLUENZA (Flu symptoms 2 weeks after vaccination for 3 days) 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.

Other Meds: IBUPROFEN; SYNTHROID; MACROBID [CLARITHROMYCIN]; ESTROGEN NOS

Current Illness:

ID: 1553381
Sex: F
Age: 70
State: FL

Vax Date: 01/02/2021
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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: felt a little bit uncomfortable; Fever of 103/temperature of 103 F; This spontaneous case was reported by a patient and describes the occurrence of DISCOMFORT (felt a little bit uncomfortable) and PYREXIA (Fever of 103/temperature of 103 F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history provided by reporter. Concomitant products included DIAZEPAM, GABAPENTIN, LEVOTHYROXINE, GLICLAZIDE (MICROZIDE [GLICLAZIDE]), MORPHINE SULFATE (MS CONTIN) and ATORVASTATIN for an unknown indication. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (felt a little bit uncomfortable) and PYREXIA (Fever of 103/temperature of 103 F). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (felt a little bit uncomfortable) and PYREXIA (Fever of 103/temperature of 103 F) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 103 (High) 103. Concomitant medication also included Promapar twice a day. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Event discomfort, concomitant medications, start date and anatomical location for the suspect vaccination, treatment medication for the event fever all were added.

Other Meds: DIAZEPAM; GABAPENTIN; LEVOTHYROXINE; MICROZIDE [GLICLAZIDE]; MS CONTIN; ATORVASTATIN

Current Illness:

ID: 1553382
Sex: U
Age:
State: PA

Vax Date: 01/21/2021
Onset Date: 02/06/2021
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: Mild malaise; Injection site very itchy; Arm inflammation; Arm swelling; Sore arm; Muscle ache/ Back muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Mild malaise), VACCINATION SITE INFLAMMATION (Arm inflammation), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Arm swelling) and INJECTION SITE PRURITUS (Injection site very itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-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 INFLAMMATION (Arm inflammation) and VACCINATION SITE SWELLING (Arm swelling). On an unknown date, the patient experienced MALAISE (Mild malaise), PAIN IN EXTREMITY (Sore arm), INJECTION SITE PRURITUS (Injection site very itchy) and MYALGIA (Muscle ache/ Back muscle aches). The patient was treated with HYDROCORTISONE (topical) for Adverse event, at a dose of 10% cream. At the time of the report, MALAISE (Mild malaise), VACCINATION SITE INFLAMMATION (Arm inflammation), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Arm swelling), INJECTION SITE PRURITUS (Injection site very itchy) and MYALGIA (Muscle ache/ Back muscle aches) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medication not provided. The patient reported the injection site swelling and inflammation resolved about 2 and a half weeks after the first shot. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Follow-up information received updated event outcome. On 28-Jun-2021: Follow-up received updated event and suspect dosage details.

Other Meds:

Current Illness:

ID: 1553383
Sex: M
Age:
State: MO

Vax Date: 01/05/2021
Onset Date: 02/05/2021
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: Body aches; Long sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) and SOMNOLENCE (Long sleep) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 026L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history provided). On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosae. On 05-Feb-2021, the patient experienced PAIN (Body aches) and SOMNOLENCE (Long sleep). At the time of the report, PAIN (Body aches) and SOMNOLENCE (Long sleep) outcome was unknown. no treatment provided no concomitant medication given Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1553384
Sex: F
Age: 76
State: MI

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:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Large pink spot 4 inches down on her arm; Arm swollen and Arm looked like a big bicep; Arm itching; Arm warm to the touch; Light muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Large pink spot 4 inches down on her arm), PERIPHERAL SWELLING (Arm swollen and Arm looked like a big bicep), PRURITUS (Arm itching), VACCINATION SITE WARMTH (Arm warm to the touch) and MYALGIA (Light muscle pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ZINC, CALCIUM, MAGNESIUM and ELWENDIA PERSICA OIL (BLACK SEED [ELWENDIA PERSICA OIL]) for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced RASH MACULAR (Large pink spot 4 inches down on her arm), PERIPHERAL SWELLING (Arm swollen and Arm looked like a big bicep), PRURITUS (Arm itching), VACCINATION SITE WARMTH (Arm warm to the touch) and MYALGIA (Light muscle pain). At the time of the report, RASH MACULAR (Large pink spot 4 inches down on her arm), PERIPHERAL SWELLING (Arm swollen and Arm looked like a big bicep), PRURITUS (Arm itching), VACCINATION SITE WARMTH (Arm warm to the touch) and MYALGIA (Light muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Relevant concomitant medications also included blood pressure medications, thyroid medications and vitamins.; 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: ZINC; CALCIUM; MAGNESIUM; BLACK SEED [ELWENDIA PERSICA OIL]

Current Illness:

ID: 1553385
Sex: M
Age: 35
State: SC

Vax Date: 08/08/2021
Onset Date: 08/09/2021
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: RA

Lab Data:

Allergies: none known

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

Symptoms: diaphoresis, chest pain, lightheadedness

Other Meds: zyprexa paxil hydroxyzine

Current Illness: bipolar

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm