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

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1542424
Sex: F
Age:
State: GA

Vax Date: 01/11/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator o No treatment medications 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542425
Sex: M
Age: 75
State: GA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information 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: 1542426
Sex: F
Age: 70
State: NJ

Vax Date: 01/08/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Body temperature increased: 102 (High) 102. On 13-Jan-2021, Body temperature increased: 103 (High) 103. On 15-Jan-2021, Body temperature increased: 103.1 (High) 103.1. 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.; 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: 1542427
Sex: F
Age: 69
State: GA

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: itch systemic; Swelling raised; Lump; Warm skin; Fatigue; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), PRURITUS (itch systemic), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump) and SKIN WARM (Warm skin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011T20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer and Mastectomy (Right breast). Concurrent medical conditions included Diabetes. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump), SKIN WARM (Warm skin) and FATIGUE (Fatigue). On 10-Jan-2021, the patient experienced PRURITUS (itch systemic). On 08-Jan-2021, FATIGUE (Fatigue) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (Sore left arm), PRURITUS (itch systemic), SWELLING (Swelling raised), VACCINATION SITE MASS (Lump) and SKIN WARM (Warm skin) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information provided included paracetamol. 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: Diabetes

ID: 1542428
Sex: F
Age: 73
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Itchiness all over her body; This spontaneous case was reported by an other health professional and describes the occurrence of PRURITUS (Itchiness all over her body) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PRURITUS (Itchiness all over her body). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchiness all over her body) 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.; 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: 1542429
Sex: F
Age: 28
State: NV

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: vaccination exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) in a 28-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02SJ20-2A and 042L20A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (2 drinks/week. Stopped drinking every time I've been pregnant.) on 12-Oct-2014 and Miscarriage (baby stopped growing at 7w1d, identified via ultrasound at 11w3d. Pathology report revealed baby girl had a fatal & severe chromosomal abnormality called Triploidy (3 full sets of chromosomes)) on 17-Jan-2019. Concurrent medical conditions included Hashimoto's thyroiditis (increased TSH levels due to pregnancy). Concomitant products included MAGNESIUM for Headache, IRON for Iron low, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Pregnancy, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 18-Sep-2020 and the estimated date of delivery was 25-Jun-2021. On 14-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixteenth week of the pregnancy. On 14-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (vaccination exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2020, Pregnancy test: positive (Positive) Positive. On 15-Dec-2020, Prenatal screening test: normal (normal) Results were negative for any chromosomal abnormalities.. On 04-Feb-2021, Ultrasound scan: normal (normal) growth normal.. On 12-Mar-2021, Glucose tolerance test: inconclusive (Inconclusive) passed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The pregnancy history of the patient included 2 prior pregnancy history with 1 live, full term birth on 15-FEB-2020 and one spontaneous abortion on 17 jan 2019. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Internal review on 19-Jul-2021 resulted in updates to the pregnancy details On 13-Apr-2021: Follow up received on 13-Apr-2021 lab data added.

Other Meds: SYNTHROID; MAGNESIUM; ALLEGRA; IRON; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness: Hashimoto's thyroiditis (increased TSH levels due to pregnancy)

ID: 1542430
Sex: F
Age: 29
State: TX

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Delayed allergic reaction; Itchy at injection site; Hard at injection site; Injection site is red; Vaccination site swelling; Pain at the injection site; Raised at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) in a 29-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. Previously administered products included for Granulomatosis with polyangiitis: rituximab (She takes Rituximab for an autoimmune disease: Granulomatosis with polyangiitis and an ANCA-Associated vasculitis. She receives Rituximab to reduce her B-cells.) until November 2019. Concurrent medical conditions included Granulomatosis with polyangiitis. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site). On 14-Jan-2021, the patient experienced HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 08-Jan-2021, VACCINATION SITE PAIN (Pain at the injection site) and VACCINATION SITE SWELLING (Raised at injection site) had resolved. At the time of the report, HYPERSENSITIVITY (Delayed allergic reaction), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE INDURATION (Hard at injection site), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Vaccination site swelling) 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. Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: Additional information added to case on 01FEB2021, contains significant information, about new 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: Granulomatosis with polyangiitis

ID: 1542431
Sex: F
Age: 61
State: IL

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Fever; Body aches; Chills; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The patient's past medical history included Broken wrist (Fell on ice and broke her wrist.) on 24-Dec-2020. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever), MYALGIA (Body aches) and CHILLS (Chills) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Pyrexia: 37.77-38.77 degree Celsius (Inconclusive) Fever of 100-101 degrees F. In January 2021, SARS-CoV-2 test: negative (Negative) Negative. 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 for the events included Acetaminophen and ibuprofen. 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: 1542432
Sex: F
Age: 74
State: FL

Vax Date: 01/14/2021
Onset Date: 01/04/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: looked more like a rash, eczema rash around her eye; eye itchy; This spontaneous case was reported by a consumer and describes the occurrence of EYE PRURITUS (eye itchy) and ECZEMA (looked more like a rash, eczema rash around her eye) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced EYE PRURITUS (eye itchy). On 15-Jan-2021, the patient experienced ECZEMA (looked more like a rash, eczema rash around her eye). At the time of the report, EYE PRURITUS (eye itchy) and ECZEMA (looked more like a rash, eczema rash around her eye) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1542433
Sex: F
Age: 52
State: FL

Vax Date: 12/30/2020
Onset Date: 01/06/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Got worse with a white blush and some late kind of allergic reaction to vaccine; soreness on trapezius and back of the shoulder on that side; Redness on injection site; Swelling on injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (Got worse with a white blush and some late kind of allergic reaction to vaccine), VACCINATION SITE ERYTHEMA (Redness on injection site), VACCINATION SITE SWELLING (Swelling on injection site) and MYALGIA (soreness on trapezius and back of the shoulder on that side) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on injection site) and VACCINATION SITE SWELLING (Swelling on injection site). On 13-Jan-2021, the patient experienced MYALGIA (soreness on trapezius and back of the shoulder on that side). On an unknown date, the patient experienced VACCINATION SITE REACTION (Got worse with a white blush and some late kind of allergic reaction to vaccine). At the time of the report, VACCINATION SITE REACTION (Got worse with a white blush and some late kind of allergic reaction to vaccine), VACCINATION SITE ERYTHEMA (Redness on injection site), VACCINATION SITE SWELLING (Swelling on injection site) and MYALGIA (soreness on trapezius and back of the shoulder on that side) 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.; 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: 1542434
Sex: M
Age: 80
State: CA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Chills/had chills all day/cold; Fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills/had chills all day/cold) and PYREXIA (Fever of 102) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The patient's past medical history included Pneumonia. Concurrent medical conditions included Cancer. Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication, HYDROCHLOROTHIAZIDE. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced CHILLS (Chills/had chills all day/cold) and PYREXIA (Fever of 102). At the time of the report, CHILLS (Chills/had chills all day/cold) and PYREXIA (Fever of 102) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: LOSARTAN; AMLODIPINE; HYDROCHLOROTHIAZIDE

Current Illness: Cancer

ID: 1542435
Sex: F
Age: 42
State: IL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Small rash on the chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on the chest) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No recorded medical history). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced RASH (Small rash on the chest). At the time of the report, RASH (Small rash on the chest) 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 event, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1542436
Sex: F
Age:
State: CA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The patient's past medical history included Polycystic ovarian syndrome since an unknown date. Concomitant products included MAGNESIUM and SPIRONOLACTONE for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was 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 event, a causal relationship cannot be excluded.

Other Meds: MAGNESIUM; SPIRONOLACTONE

Current Illness: Polycystic ovarian syndrome

ID: 1542437
Sex: F
Age:
State: NY

Vax Date: 01/01/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: rash around injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (rash around 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. In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (rash around injection site). At the time of the report, VACCINATION SITE RASH (rash around injection site) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.; 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: 1542438
Sex: F
Age: 32
State: FL

Vax Date: 01/07/2021
Onset Date: 01/08/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: No appetite; does not taste food very well; either really hot or really cold; headache; Nauseous; arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was very sore), NAUSEA (Nauseous), HEADACHE (headache), DECREASED APPETITE (No appetite) and TASTE DISORDER (does not taste food very well) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 08-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was very sore). On 09-Jan-2021, the patient experienced NAUSEA (Nauseous). On 12-Jan-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold). On 12-Jan-2021, NAUSEA (Nauseous) had resolved. At the time of the report, VACCINATION SITE PAIN (arm was very sore), HEADACHE (headache), DECREASED APPETITE (No appetite), TASTE DISORDER (does not taste food very well) and TEMPERATURE REGULATION DISORDER (either really hot or really cold) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: negative Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542439
Sex: M
Age: 75
State: MD

Vax Date: 01/09/2021
Onset Date: 01/10/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Vomiting; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 09-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 CHILLS (Chills). On 13-Jan-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (Nausea). On 11-Jan-2021, CHILLS (Chills) had resolved. On 14-Jan-2021, VOMITING (Vomiting) and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542440
Sex: M
Age: 74
State: OH

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Became hot; indurated (left) shoulder; Really swollen (left) shoulder; Fever; Chills/Rigors; This spontaneous case was reported by a physician and describes the occurrence of FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Jan-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Jan-2021, FEELING HOT (Became hot), VACCINATION SITE INDURATION (indurated (left) shoulder), VACCINATION SITE SWELLING (Really swollen (left) shoulder), PYREXIA (Fever) and CHILLS (Chills/Rigors) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other treatment medications include Motrin. All listed adverse events developed within 12 hours of vaccinations and had resolved within 12 hours of taking Motrin and Tylenol. No concomitant medications 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: 1542441
Sex: F
Age: 52
State: AZ

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Severe cramping in her left leg; Pain in arm occassionally; Sharp pain above the heart occassionally; Bad nightmares; This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Bad nightmares), MUSCLE SPASMS (Severe cramping in her left leg), PAIN IN EXTREMITY (Pain in arm occassionally) and CHEST PAIN (Sharp pain above the heart occassionally) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced NIGHTMARE (Bad nightmares). On an unknown date, the patient experienced MUSCLE SPASMS (Severe cramping in her left leg), PAIN IN EXTREMITY (Pain in arm occassionally) and CHEST PAIN (Sharp pain above the heart occassionally). At the time of the report, NIGHTMARE (Bad nightmares), MUSCLE SPASMS (Severe cramping in her left leg), PAIN IN EXTREMITY (Pain in arm occassionally) and CHEST PAIN (Sharp pain above the heart occassionally) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1542442
Sex: F
Age: 42
State: MA

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: 12 weeks and 2 days pregnant when administed the vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine). On 09-Jan-2021, EXPOSURE DURING PREGNANCY (12 weeks and 2 days pregnant when administed the vaccine) had resolved. 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. Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 42-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1542443
Sex: F
Age: 39
State: TN

Vax Date: 01/06/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Her arm is paining; Bad rash; Redness; Itchy at the site of injection on her left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is paining), VACCINATION SITE RASH (Bad rash), VACCINATION SITE ERYTHEMA (Redness) and INJECTION SITE PRURITUS (Itchy at the site of injection on her left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included Diabetes since an unknown date. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Her arm is paining), VACCINATION SITE RASH (Bad rash), VACCINATION SITE ERYTHEMA (Redness) and INJECTION SITE PRURITUS (Itchy at the site of injection on her left arm). At the time of the report, PAIN IN EXTREMITY (Her arm is paining), VACCINATION SITE RASH (Bad rash), VACCINATION SITE ERYTHEMA (Redness) and INJECTION SITE PRURITUS (Itchy at the site of injection on her left arm) 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.; 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: Diabetes

ID: 1542444
Sex: F
Age: 46
State: MD

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Headache; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25120A) for COVID-19 vaccination. No Medical History information was reported. On 14-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 HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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: 1542445
Sex: M
Age: 76
State: PA

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his arm). At the time of the report, PAIN IN EXTREMITY (Soreness in his arm) was resolving. 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542446
Sex: F
Age:
State: NY

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Clay/gray colored stool; Mild nausea; Headache; Mild fatigue; Eye is swollen; Itchy eyes; Diarrhea; Runny nose; Stomach ache; Itchy Skin; Hives upper body; Rashes over the body; Pain at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), FAECES DISCOLOURED (Clay/gray colored stool) and RHINORRHOEA (Runny nose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma (Improvement) since 06-Jan-1992, Hypothyroidism since 2001, Anxiety since 1992, Anemia (Improvement) since 1974, ADHD, Food allergy (Allergic to fresh fruit, tree nuts.) and Pollen allergy. Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (AMPHETAMINE MIXED SALTS) and AMPHETAMINE for ADHD, LORATADINE and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for Allergy, LEVOTHYROXINE for Hypothyroidism, IBUPROFEN for Pain. On 14-Jan-2021 at 10:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body) and INJECTION SITE PAIN (Pain at injection site). On 15-Jan-2021, the patient experienced FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea), HEADACHE (Headache) and FATIGUE (Mild fatigue). On 15-Jan-2021, EYE SWELLING (Eye is swollen), EYE PRURITUS (Itchy eyes), DIARRHOEA (Diarrhea), RHINORRHOEA (Runny nose), ABDOMINAL PAIN UPPER (Stomach ache), PRURITUS (Itchy Skin), URTICARIA (Hives upper body), RASH (Rashes over the body), INJECTION SITE PAIN (Pain at injection site) and HEADACHE (Headache) had resolved. On 17-Jan-2021, FAECES DISCOLOURED (Clay/gray colored stool), NAUSEA (Mild nausea) and FATIGUE (Mild fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included Loratadine-D and a dose of Flonase and ibuprofen were reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Patient demographic added. Patient relevant history and concomitant medications were added. The outcome of the events from recovering to recovered updated. New events (hives, injection site soreness, nausea, fatigue, headache) were added.

Other Meds: IBUPROFEN; LEVOTHYROXINE; AMPHETAMINE MIXED SALTS; AMPHETAMINE; LORATADINE; FLONASE ALLERGY RELIEF

Current Illness: ADHD; Anemia (Improvement); Anxiety; Asthma (Improvement); Food allergy (Allergic to fresh fruit, tree nuts.); Hypothyroidism; Pollen allergy

ID: 1542447
Sex: M
Age: 72
State: NJ

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Increased heart rate (100 beats per minute); Face was red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Face was red) and HEART RATE INCREASED (Increased heart rate (100 beats per minute)) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026190A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced ERYTHEMA (Face was red). On 15-Jan-2021, the patient experienced HEART RATE INCREASED (Increased heart rate (100 beats per minute)). On 14-Jan-2021, ERYTHEMA (Face was red) had resolved. On 15-Jan-2021, HEART RATE INCREASED (Increased heart rate (100 beats per minute)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant medications details not reported by the reporter. Treatment details not reported 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 events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542448
Sex: F
Age: 58
State: NY

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Chills; Fever at 102 F; Bad headache; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever at 102 F) and HEADACHE (Bad headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 102 degree Celsius (High) Body temperature-102 degree celsius. 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 medication details not reported by the reporter. Treatment included ibuprofen.; 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: 1542449
Sex: F
Age:
State:

Vax Date:
Onset Date: 01/11/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Light headed; Aches, extremely sore; No feeling in the soles of her feet; Fever of 104; Really bad chills; Pain in arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Light headed), PAIN (Aches, extremely sore), HYPOAESTHESIA (No feeling in the soles of her feet) and PYREXIA (Fever of 104) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pneumonia in April 2020 and COVID-19 in March 2020. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 12-Jan-2021, the patient experienced DIZZINESS (Light headed), PAIN (Aches, extremely sore), HYPOAESTHESIA (No feeling in the soles of her feet), PYREXIA (Fever of 104) and CHILLS (Really bad chills). On 14-Jan-2021, PAIN (Aches, extremely sore) outcome was unknown. On 15-Jan-2021, PAIN IN EXTREMITY (Pain in arm), DIZZINESS (Light headed), HYPOAESTHESIA (No feeling in the soles of her feet), PYREXIA (Fever of 104) and CHILLS (Really bad chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Blood pressure measurement: 155/90 mmHg (High) Blood pressure high. On 12-Jan-2021, Body temperature: 104 degree Celsius (High) body temperature increases. On 12-Jan-2021, Heart rate: 127 (High) Pulse rate increases. 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 medication details were not reported by the reporter. Treatment included Tylenol and Motril.; 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: COVID-19; Pneumonia

ID: 1542450
Sex: F
Age: 77
State: TX

Vax Date: 01/04/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: It felt like bumble bee or wasp bit and tingling; Rash on her right upper arm; Mild site injection soreness/ Injection site tender to the touch; Red rash on her upper right arm; Injection site was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen). At the time of the report, INJECTION SITE PARAESTHESIA (It felt like bumble bee or wasp bit and tingling), RASH (Rash on her right upper arm), VACCINATION SITE PAIN (Mild site injection soreness/ Injection site tender to the touch), VACCINATION SITE ERYTHEMA (Red rash on her upper right arm) and VACCINATION SITE SWELLING (Injection site was a little swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter. Treatment included compress.; 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: 1542451
Sex: F
Age: 39
State: PA

Vax Date: 01/11/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Got a rash on the left arm pit; Itchiness at injection site; Redness around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Got a rash on the left arm pit), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunization. Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE NA) for Thyroid disorder. On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced RASH (Got a rash on the left arm pit), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, RASH (Got a rash on the left arm pit) and VACCINATION SITE ERYTHEMA (Redness around the injection site) was resolving and VACCINATION SITE PRURITUS (Itchiness at injection site) 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 included Benadryl for itchiness.; 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: LEVOTHYROXINE NA

Current Illness: Thyroid disorder

ID: 1542452
Sex: F
Age: 40
State: AZ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/11/2021
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Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Blood pressure approx. 180/110 mmhg; Tachycardia up to 140 bpm; Arm soreness; Dizziness; Weakness; Tingling sensation of both hands and feet; A spontaneous report was received on 24 Jan 2021 via the call center regarding a 40-year-old female patient who reported receiving the Moderna COVID-19 Vaccine (mRNA-1273) and experienced tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness. The patient's medical history was not provided. The patient was allergic to Demerol. Concomitant medication included Vyvanse for (ADHD) attention deficit hyperactivity disorder. On 23 Jan 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient reported tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness (still evident). No treatment medication was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 was resolved on 23 Jan 2021. The outcome of the event was arm soreness unknown.; Reporter's Comments: This case concerns a 40-year-old female patient with no provided medical history who received her first of two planned doses of mRNA-1273, and on the same day experienced non-serious unlisted events of tachycardia up to 140 bpm, dizziness, weakness, tingling sensation of both hands and feet, hypertension approximately 180/110 and arm soreness. Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Other Meds: VYVANSE

Current Illness: Drug allergy

ID: 1542453
Sex: M
Age: 79
State: KY

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
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Symptom List: Nausea

Symptoms: Running back and forth to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Running back and forth to the restroom) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Jan-2021, the patient experienced DIARRHOEA (Running back and forth to the restroom). At the time of the report, DIARRHOEA (Running back and forth to the restroom) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-008233 (Patient Link).; 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: 1542454
Sex: F
Age: 31
State: CT

Vax Date: 01/13/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

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Allergies:

Symptom List: Injection site pain

Symptoms: Fever; Body aches; Tremors; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Tremors), PYREXIA (Fever) and MYALGIA (Body aches) in a 31-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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TREMOR (Tremors). On an unknown date, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). At the time of the report, TREMOR (Tremors), PYREXIA (Fever) and MYALGIA (Body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 101.9 (Inconclusive) 101.9. On 13-Jan-2021, SARS-CoV-2 test positive: (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant details were reported by the reporter. No treatment details were reported by the reporter.; Sender's Comments: Based on biological implausibility the event of COVID-19 test positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events of (Pyrexia, Myalgia, Tremor), a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1542455
Sex: F
Age: 77
State: NJ

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

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Allergies:

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

Symptoms: Hives on her back; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her back) and PYREXIA (Low grade fever) 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 14-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 URTICARIA (Hives on her back) and PYREXIA (Low grade fever). At the time of the report, URTICARIA (Hives on her back) and PYREXIA (Low grade fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter. Treatment included Benadryl.; 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: 1542456
Sex: F
Age:
State: PA

Vax Date: 01/08/2021
Onset Date: 01/11/2021
Rec V Date: 08/11/2021
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Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Developed hives on her arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (Developed hives on her arms and legs) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 11-Jan-2021, the patient experienced URTICARIA (Developed hives on her arms and legs). At the time of the report, URTICARIA (Developed hives on her arms and legs) had not resolved. 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. 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.; 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: 1542457
Sex: F
Age:
State:

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

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Symptom List: Tremor

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was also not provided. Treatment activities for event was unknown. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up received as no new information.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this unspecified age female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds:

Current Illness:

ID: 1542458
Sex: F
Age: 67
State: NV

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

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Symptom List: Erythema, Pruritus

Symptoms: Eyes were swollen; Heart rate increase; Eyes were burning; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (Eyes were burning), EYE SWELLING (Eyes were swollen) and HEART RATE INCREASED (Heart rate increase) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for an unreported indication: LIDOCAINE. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced EYE IRRITATION (Eyes were burning) and HEART RATE INCREASED (Heart rate increase). On 13-Jan-2021, the patient experienced EYE SWELLING (Eyes were swollen). On 12-Jan-2021, HEART RATE INCREASED (Heart rate increase) had resolved. At the time of the report, EYE IRRITATION (Eyes were burning) and EYE SWELLING (Eyes were swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Heart rate: (High) Rapid heart beat which subsided.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.; 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: 1542459
Sex: F
Age:
State: MD

Vax Date: 01/15/2021
Onset Date: 12/18/2020
Rec V Date: 08/11/2021
Hospital:

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Allergies:

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

Symptoms: Very large triangular shaped very red area on her arm, around the injection site.; Injection site slightly itchy; Muscle at injection site is somewhat painful; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful). At the time of the report, VACCINATION SITE ERYTHEMA (Very large triangular shaped very red area on her arm, around the injection site.), VACCINATION SITE PRURITUS (Injection site slightly itchy) and VACCINATION SITE PAIN (Muscle at injection site is somewhat painful) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant medication also included for thyroid disorder. Treatment details not reported by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Possible NNI

Other Meds: PROTONIX [OMEPRAZOLE]

Current Illness: Thyroid disorder

ID: 1542460
Sex: F
Age: 53
State: WI

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: body aches; headache; fatigue; nausea; runny nose; sneezing; 99.2 fever; wheezing in the chest; This spontaneous case was reported by a patient and describes the occurrence of RHINORRHOEA (runny nose), WHEEZING (wheezing in the chest), SNEEZING (sneezing), PYREXIA (99.2 fever) and NAUSEA (nausea) in a 53-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 Heart failure since 15-Jan-2021, Asthma since 15-Jan-2021 and Heart attack since 15-Jan-2021. Concurrent medical conditions included Diabetes since 15-Jan-2021, Cholesterol since 15-Jan-2021, Hypertension on 15-Jan-2021 and Heart disease, unspecified since 15-Jan-2021. Concomitant products included METFORMIN , GLIMEPIRIDE, DULAGLUTIDE (TRULICITY), CARVEDILOL, LISINOPRIL, FUROSEMIDE, PRAVASTATIN, FENOFIBRATE and ACETYLSALICYLIC ACID (BABY ASPIRIN). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced WHEEZING (wheezing in the chest). On 14-Jan-2021, the patient experienced RHINORRHOEA (runny nose), SNEEZING (sneezing) and PYREXIA (99.2 fever). On 15-Jan-2021, the patient experienced NAUSEA (nausea), HEADACHE (headache) and FATIGUE (fatigue). On an unknown date, the patient experienced MYALGIA (body aches). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 15-Jan-2021, WHEEZING (wheezing in the chest) had resolved. At the time of the report, RHINORRHOEA (runny nose), SNEEZING (sneezing), PYREXIA (99.2 fever), NAUSEA (nausea), MYALGIA (body aches), HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included aspirin and Tylenol.; 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: METFORMIN; GLIMEPIRIDE; TRULICITY; CARVEDILOL; LISINOPRIL; FUROSEMIDE; PRAVASTATIN; FENOFIBRATE; BABY ASPIRIN

Current Illness: Asthma; Cholesterol; Diabetes; Heart attack; Heart disease, unspecified; Heart failure

ID: 1542461
Sex: F
Age: 62
State: CA

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Sore arm at the injection site; Fatigue; Feel "funny"; Fever of 102 and next morning fever of 101; Severe shivering; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Feel "funny"), VACCINATION SITE PAIN (Sore arm at the injection site), PYREXIA (Fever of 102 and next morning fever of 101), CHILLS (Severe shivering) and FATIGUE (Fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. Concurrent medical conditions included Anemia (thalessemia trait) since 10-Dec-1958, Palpitations since 02-Jun-1970 and Dry eyes since 14-Aug-2018. Concomitant products included ESTRADIOL (ESTROGEN) from 01-Jul-2015 to an unknown date, PROGESTERONE from 01-Jul-2015 to an unknown date and TESTOSTERONE from 01-Jul-2015 to an unknown date for Menopause, MULTI VITAMIN ONE A DAY and FISH OIL for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (Fever of 102 and next morning fever of 101) and CHILLS (Severe shivering). On 11-Jan-2021 at 10:00 PM, the patient experienced FEELING ABNORMAL (Feel "funny"). On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm at the injection site) and FATIGUE (Fatigue). On 12-Jan-2021, FATIGUE (Fatigue) had resolved. At the time of the report, FEELING ABNORMAL (Feel "funny"), VACCINATION SITE PAIN (Sore arm at the injection site), PYREXIA (Fever of 102 and next morning fever of 101) and CHILLS (Severe shivering) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 102 (High) 102. On 12-Jan-2021, Body temperature: 101 (High) 101. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was on unspecified antibiotics before the first dose was administered. Patient reports self-treating with acetaminophen. This case was linked to MOD-2021-090019 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Updated concomitant medications, updated event details

Other Meds: ESTROGEN; PROGESTERONE; TESTOSTERONE; MULTI VITAMIN ONE A DAY; FISH OIL

Current Illness: Anemia (thalessemia trait); Dry eyes; Palpitations

ID: 1542462
Sex: F
Age: 70
State: GA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Vax Site:

Lab Data:

Allergies:

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

Symptoms: Can?t lift it up, can?t move hand; Extreme soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can?t lift it up, can?t move hand) and VACCINATION SITE PAIN (Extreme soreness in her arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal and Blood cholesterol abnormal. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Extreme soreness in her arm). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can?t lift it up, can?t move hand). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can?t lift it up, can?t move hand) and VACCINATION SITE PAIN (Extreme soreness in her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication includes cholesterol and blood pressure medication. Treatment information includes: Put ice, Tylenol.; 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: Blood cholesterol abnormal; Blood pressure abnormal

ID: 1542463
Sex: F
Age:
State: FL

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

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

Symptoms: Swelling; Itching; Redness; Pain at injection site; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (Swelling), PRURITUS (Itching), ERYTHEMA (Redness) and VACCINATION SITE PAIN (Pain at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No recorded medical history). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). On 13-Jan-2021, the patient experienced SWELLING (Swelling), PRURITUS (Itching) and ERYTHEMA (Redness). On 06-Jan-2021, VACCINATION SITE PAIN (Pain at injection site) had resolved. At the time of the report, SWELLING (Swelling), PRURITUS (Itching) and ERYTHEMA (Redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication details not reported by the reporter. Treatment details not reported by the 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: 1542464
Sex: F
Age: 75
State: TN

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Vax Site:

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: two hours later, her fillers were swollen; A spontaneous report (United States) was received from a (Consumer) concerning a ? 75 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced two hours later, her fillers were swollen/ Swelling face. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, approximately same prior to the onset of the events, the patient received their unknown of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route and left site for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient experienced Swelling face just two hours after the vaccination. Laboratory details not provided. Treatment details were reported as Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was reported to be Recovered/Resolved.; 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: 1542465
Sex: F
Age: 78
State: FL

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Itchy; Rash; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy) and RASH (Rash) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 Vaccination. No medical history was provided by the reporter. Concomitant products included CORTISONE 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 an unknown date, the patient experienced PRURITUS (Itchy) and RASH (Rash). At the time of the report, PRURITUS (Itchy) and RASH (Rash) 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: CORTISONE

Current Illness:

ID: 1542466
Sex: F
Age: 73
State: TX

Vax Date: 01/03/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

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

Symptoms: Injection site redness; It is very big like the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (It is very big like the size of a quarter) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination. Concomitant products included CORTISONE from 13-Jan-2021 to an unknown date for Knee pain, LOSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), THYROID (ARMOUR THYROID) and IBUPROFEN for an unknown indication. On 03-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (It is very big like the size of a quarter). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness) had not resolved and INJECTION SITE SWELLING (It is very big like the size of a quarter) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: CORTISONE; LOSARTAN; SYNTHROID; ARMOUR THYROID; IBUPROFEN

Current Illness:

ID: 1542467
Sex: M
Age: 76
State: AZ

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
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Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Experiencing soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Experiencing soreness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Experiencing soreness). At the time of the report, VACCINATION SITE PAIN (Experiencing soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Concomitant medications were not provided. Treatment information was not 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 event, a causal relationship cannot be excluded.

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ID: 1542468
Sex: M
Age: 66
State:

Vax Date: 01/14/2021
Onset Date: 01/15/2020
Rec V Date: 08/11/2021
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Symptom List: Vomiting

Symptoms: Like a cellulitis or poison ivy rash; Discomfort today on the left hip; Broken capillaries 4 inches long; Soreness at the point of injection; Rash at the waist; A spontaneous report was received from a physician concerning a 66-years-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced soreness at the point of injection, discomfort today on the left hip, broken capillaries four inches long, rash at waist and cellulitis or poison ivy rash. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included Tylenol. On 14 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 041I20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient had soreness at the injection site. On 15 Jan 2021, he noticed a rash on his waist, no blood on the skin and broken capillaries under the surface four inches long under the rash poison ivy or cellulitis, and discomfort on left hip. Treatment for the event included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The event soreness at the point of injection was considered recovered/resolved on 15 Jan 2021. The outcome of the events discomfort on left hip, broken capillary four inches long, rash at the waist without blood on skin and like a cellulitis or poison ivy rash was not reported.; Reporter's Comments: This case concerns a 66-year old, male patient, who experienced non-serious unexpected events of musculoskeletal discomfort (left hip), capillary disorder, and rash, a non-serious expected event of injection site pain. The event of injection site pain occurred 1 day after first dose of mRNA-1273, lot # 041l20a. The event of musculoskeletal discomfort (left hip), capillary disorder occurred 2 days after first dose of mRNA-1273, lot # 041l20a. The event of rash occurred on an unspecified date after first dose of mRNA-1273, lot # 041l20a. Treatment included Tylenol. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.

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Current Illness:

ID: 1542469
Sex: F
Age: 83
State: CA

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/11/2021
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Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Swollen; red; itching; Hot; hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard) and INJECTION SITE ERYTHEMA (red). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (itching), VACCINATION SITE WARMTH (Hot), VACCINATION SITE INDURATION (hard), VACCINATION SITE SWELLING (Swollen) and INJECTION SITE ERYTHEMA (red) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On an unknown date after the first vaccination, the patient put lotion Hempz to the injection site, washed it off, then developed all events. Concomitant medications were not provided. Treatment information was not 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.

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Current Illness:

ID: 1542470
Sex: F
Age: 58
State: MD

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
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Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: tingling like feeling in her foot; Numbness in her foot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot). At the time of the report, PARAESTHESIA (tingling like feeling in her foot) and HYPOAESTHESIA (Numbness in her foot) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not 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.

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Current Illness:

ID: 1542471
Sex: F
Age: 77
State: LA

Vax Date: 01/06/2021
Onset Date: 01/16/2021
Rec V Date: 08/11/2021
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Symptom List: Injection site swelling, Limb discomfort

Symptoms: This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment for the event included diphenhydramine, naproxen and warm compresses.

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Current Illness:

ID: 1542472
Sex: U
Age:
State: CA

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

Symptoms: foggy head; Nasal congestion; Fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue). At the time of the report, FEELING ABNORMAL (foggy head), NASAL CONGESTION (Nasal congestion) and FATIGUE (Fatigue) outcome was unknown. Event outcome reported as 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 medication information was provided. No treatment medication were provided. Reporter did not allow further contact

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Current Illness:

ID: 1542473
Sex: M
Age:
State: OK

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/11/2021
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Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: This spontaneous case was reported by a health care professional and describes the occurrence of ANTIBODY TEST NEGATIVE (Negative igG antibody test) and PAIN IN EXTREMITY (a little bit sore 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 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (a little bit sore arm). On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Negative igG antibody test). At the time of the report, ANTIBODY TEST NEGATIVE (Negative igG antibody test) and PAIN IN EXTREMITY (a little bit sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Antibody with IgG and the result was negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant products were provided. Treatment products were not provided. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded.

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Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am