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: 1570372
Sex: M
Age: 78
State: NY

Vax Date: 03/15/2021
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: cough; shortness of breath; runny nose; Neck pain; diarrhea; chills; headache; fever; Joint pain/ Twinge below my elbow; light headed; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), DYSPNOEA (shortness of breath), RHINORRHOEA (runny nose), NECK PAIN (Neck pain) and DIARRHOEA (diarrhea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced DIZZINESS (light headed). On 16-Mar-2021, the patient experienced COUGH (cough), DYSPNOEA (shortness of breath), RHINORRHOEA (runny nose), NECK PAIN (Neck pain), DIARRHOEA (diarrhea), CHILLS (chills), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (Joint pain/ Twinge below my elbow). At the time of the report, COUGH (cough), DYSPNOEA (shortness of breath), RHINORRHOEA (runny nose), NECK PAIN (Neck pain), DIARRHOEA (diarrhea), DIZZINESS (light headed), CHILLS (chills), HEADACHE (headache), PYREXIA (fever) and ARTHRALGIA (Joint pain/ Twinge below my elbow) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient did not receive treatment.

Other Meds:

Current Illness:

ID: 1570373
Sex: M
Age: 87
State: MD

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Can't even sleep; Weak; Tired; Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), SLEEP DISORDER (Can't even sleep), ASTHENIA (Weak), HEADACHE (Headache) and FATIGUE (Tired) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 01-Mar-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) 1 dosage form. On 01-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). On an unknown date, the patient experienced SLEEP DISORDER (Can't even sleep), ASTHENIA (Weak) and FATIGUE (Tired). At the time of the report, DIZZINESS (Dizziness), SLEEP DISORDER (Can't even sleep), ASTHENIA (Weak) and FATIGUE (Tired) outcome was unknown and HEADACHE (Headache) had not resolved. Not Provided Patient was taking diabetes medication. No treatment information was provided.

Other Meds:

Current Illness: Diabetes

ID: 1570374
Sex: F
Age: 32
State: MN

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 32 weeks pregnant;received 1st dose of Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (32 weeks pregnant;received 1st dose of Moderna vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination. Concomitant products included 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], LEVOTHYROXINE, VITAMIN D [VITAMIN D NOS] and MAGNESIUM for an unknown indication. On 22-Mar-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 01-Aug-2020 and the estimated date of delivery was 16-May-2021. On 22-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (32 weeks pregnant;received 1st dose of Moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the thirty-second week of the pregnancy. On 22-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (32 weeks pregnant;received 1st dose of Moderna vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2020, Pregnancy test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided by the reporter.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; LEVOTHYROXINE; VITAMIN D [VITAMIN D NOS]; MAGNESIUM

Current Illness:

ID: 1570375
Sex: F
Age:
State: NJ

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: A little soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little soreness in the injected arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Fever (A high fever of 102 F.) since March 2021. On 22-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 PAIN IN EXTREMITY (A little soreness in the injected arm). At the time of the report, PAIN IN EXTREMITY (A little soreness in the injected arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Additional information received on 09-May-2021 had an event added which is soreness in the injected arm.

Other Meds:

Current Illness: Fever (A high fever of 102 F.); Hypertension

ID: 1570376
Sex: F
Age: 85
State: MI

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 08/15/2021
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: Warm to the touch knot at the site of injection; Warm to the touch knot at the site of injection; Red knot at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch knot at the site of injection), VACCINATION SITE INDURATION (Warm to the touch knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch knot at the site of injection), VACCINATION SITE INDURATION (Warm to the touch knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch knot at the site of injection), VACCINATION SITE INDURATION (Warm to the touch knot at the site of injection) and VACCINATION SITE ERYTHEMA (Red knot at the site of injection) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1570377
Sex: F
Age: 66
State: PA

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/15/2021
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: first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose tomorrow, 23mar2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose tomorrow, 23mar2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ULUMZ(U/O)A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 03-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose tomorrow, 23mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID19 vaccine 03feb2021 and is scheduled for the second dose tomorrow, 23mar2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported. No relevant concomitant medications were reported.; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: ULUMZ(U/O)A) with no associated AEs.

Other Meds:

Current Illness:

ID: 1570378
Sex: F
Age: 83
State: WV

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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: This spontaneous case reported by a consumer, describes the occurrence of vaccination site nodule (hard knot in it as big as a 50 cent piece), nausea, vaccination site swelling (injection site arm is swollen), headache and pyrexia (mild temperature) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 18, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 19, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient experienced vaccination site swelling (injection site arm is swollen). On an unknown date, patient experienced vaccination site nodule (hard knot in it as big as a 50 cent piece), nausea, headache, pyrexia (mild temperature), vaccination site erythema (red) and vaccination site pain (sore). At the time of the report, vaccination site nodule (hard knot in it as big as a 50 cent piece), nausea, vaccination site swelling (injection site arm is swollen), headache, pyrexia (mild temperature), vaccination site erythema (red) and vaccination site pain (sore) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant product use or treatment information provided.

Other Meds:

Current Illness:

ID: 1570379
Sex: F
Age: 30
State: NJ

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Pregnant and vaccinated; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) in a 30-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (CETRAK) for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 28-Oct-2020 and the estimated date of delivery was 28-Jul-2021. On 22-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and vaccinated). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twentieth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and vaccinated) 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.

Other Meds: CETRAK

Current Illness:

ID: 1570380
Sex: F
Age: 64
State: IL

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: At night heart rate went up a little bit; Tenderness at the injection site; Nausea; Soreness in the arm at the injection site; Itching at the injection site; Red spot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (At night heart rate went up a little bit), INJECTION SITE PAIN (Tenderness at the injection site), NAUSEA (Nausea), INJECTION SITE PAIN (Soreness in the arm at the injection site) and INJECTION SITE PRURITUS (Itching at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEART RATE INCREASED (At night heart rate went up a little bit), INJECTION SITE PAIN (Tenderness at the injection site), NAUSEA (Nausea), INJECTION SITE PAIN (Soreness in the arm at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Red spot at the injection site). At the time of the report, HEART RATE INCREASED (At night heart rate went up a little bit), INJECTION SITE PAIN (Tenderness at the injection site), NAUSEA (Nausea), INJECTION SITE PAIN (Soreness in the arm at the injection site), INJECTION SITE PRURITUS (Itching at the injection site) and INJECTION SITE ERYTHEMA (Red spot at the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1570381
Sex: M
Age:
State: NC

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), BACK PAIN (back pain), ANOSMIA (loss of smell) and PAIN IN EXTREMITY (arm pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 21-Mar-2021, the patient experienced DIARRHOEA (diarrhea), BACK PAIN (back pain) and ANOSMIA (loss of smell). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 21-Mar-2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, DIARRHOEA (diarrhea), BACK PAIN (back pain) and ANOSMIA (loss of 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 assessment.

Other Meds: TRUVADA

Current Illness:

ID: 1570382
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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: Cant sleep at night; Dizziness; headache; weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cant sleep at night), DIZZINESS (Dizziness), HEADACHE (headache) and FATIGUE (weak and tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history 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 INSOMNIA (Cant sleep at night), DIZZINESS (Dizziness), HEADACHE (headache) and FATIGUE (weak and tired). At the time of the report, INSOMNIA (Cant sleep at night), DIZZINESS (Dizziness) and FATIGUE (weak and tired) outcome was unknown and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. relevant concomitant products usage were not reported by the reporter. Treatment details not included.

Other Meds:

Current Illness:

ID: 1570383
Sex: F
Age: 62
State: UT

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Joint pain; Tired; Redness about 50 cents piece round; lump; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness about 50 cents piece round), VACCINATION SITE PAIN (Soreness), VACCINATION SITE MASS (lump), ARTHRALGIA (Joint pain) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. Concomitant products included NAPROXEN SODIUM (ALEVE) for Knee pain. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness). On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness about 50 cents piece round) and VACCINATION SITE MASS (lump). On an unknown date, the patient experienced ARTHRALGIA (Joint pain) and FATIGUE (Tired). At the time of the report, VACCINATION SITE ERYTHEMA (Redness about 50 cents piece round), VACCINATION SITE PAIN (Soreness), VACCINATION SITE MASS (lump), ARTHRALGIA (Joint pain) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment included

Other Meds: ALEVE

Current Illness:

ID: 1570384
Sex: F
Age:
State: FL

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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: Crumps on her right ankle and foot; Arm was really sore; This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SPASMS (Crumps on her right ankle and foot) and PAIN IN EXTREMITY (Arm was really sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The patient's past medical history included Open heart surgery (Open heart surgery at 6 y/o for a congenital problem.) and Knee replacement (2 knee replacements.). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]), VITAMINS NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MUSCLE SPASMS (Crumps on her right ankle and foot) and PAIN IN EXTREMITY (Arm was really sore). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (Arm was really sore) had resolved. At the time of the report, MUSCLE SPASMS (Crumps on her right ankle and foot) 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. Concomitant medications included Stuff for her hair and Half of a 25 mg water pill. Treatment information included creams. Doesn't have blood pressure on left arm because she was born without a subclavian artery.

Other Meds: PROTONIX [OMEPRAZOLE]; CARDIZEM [DILTIAZEM HYDROCHLORIDE]; VITAMINS NOS; BABY ASPIRIN

Current Illness:

ID: 1570385
Sex: F
Age:
State: PA

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/15/2021
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: Alopecia; Painful arm; Chills; FEVER; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Alopecia), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), PYREXIA (FEVER) and HEADACHE (Headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-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 ALOPECIA (Alopecia), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), PYREXIA (FEVER) and HEADACHE (Headache). At the time of the report, ALOPECIA (Alopecia), PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), PYREXIA (FEVER) and HEADACHE (Headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. no concomitant medications were reported. No treatment for the events was provided.

Other Meds:

Current Illness:

ID: 1570386
Sex: F
Age:
State: NY

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/15/2021
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: a little headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (a little headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 015M20A) for COVID-19 vaccination. The patient's past medical history included Cancer. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2021, the patient experienced HEADACHE (a little headache). On 19-Jan-2021, HEADACHE (a little headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the event was not applicable. treatment information was not reported. This case was linked to MOD-2021-046018 (Patient Link).

Other Meds:

Current Illness:

ID: 1570387
Sex: F
Age:
State: VA

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
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: Hard to pick up things; warm at the injection site; itchy at the injection site; muscle aches on the whole side of the arm; sore at the injection site; red at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of GRIP STRENGTH (Hard to pick up things), INJECTION SITE WARMTH (warm at the injection site), INJECTION SITE PRURITUS (itchy at the injection site), MYALGIA (muscle aches on the whole side of the arm) and INJECTION SITE PAIN (sore at the injection site) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced GRIP STRENGTH (Hard to pick up things), INJECTION SITE WARMTH (warm at the injection site), INJECTION SITE PRURITUS (itchy at the injection site), MYALGIA (muscle aches on the whole side of the arm), INJECTION SITE PAIN (sore at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site). At the time of the report, GRIP STRENGTH (Hard to pick up things), INJECTION SITE WARMTH (warm at the injection site), INJECTION SITE PRURITUS (itchy at the injection site), MYALGIA (muscle aches on the whole side of the arm), INJECTION SITE PAIN (sore at the injection site) and INJECTION SITE ERYTHEMA (red at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1570388
Sex: M
Age:
State: CA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/15/2021
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: has been more than 6 weeks and he still has not received the second dose.; 17 year old patient received the vaccine; A spontaneous report was received from a nurse concerning a 17 year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had been more than 6 weeks and he still had not received the second dose.. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, was not reported. On 13 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection. It had been more than 6 weeks and he still had not received the second dose. Treatment for the events was not reported. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events were considered recovered.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (17-year-old) and product dose omission issue (second dose) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1570389
Sex: F
Age: 39
State: UT

Vax Date: 03/05/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Groin pain\ somewhat tender; Groin swelling\ groin area in the junction of my leg and torso on right side was swollen; Swelling arm; Unusal taste; Armpit pain; Itchy red circular rash where I received my shot; Vaccination site rash; Itchy red circular rash where I received my shot; lymph node swollen; swollen and sore to touch; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Groin pain\ somewhat tender), SWELLING (Groin swelling\ groin area in the junction of my leg and torso on right side was swollen), PERIPHERAL SWELLING (Swelling arm), TASTE DISORDER (Unusal taste) and AXILLARY PAIN (Armpit pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (Groin pain\ somewhat tender), SWELLING (Groin swelling\ groin area in the junction of my leg and torso on right side was swollen), PERIPHERAL SWELLING (Swelling arm), TASTE DISORDER (Unusal taste), AXILLARY PAIN (Armpit pain), VACCINATION SITE PRURITUS (Itchy red circular rash where I received my shot), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Itchy red circular rash where I received my shot), LYMPHADENOPATHY (lymph node swollen) and LYMPH NODE PAIN (swollen and sore to touch). At the time of the report, GROIN PAIN (Groin pain\ somewhat tender), SWELLING (Groin swelling\ groin area in the junction of my leg and torso on right side was swollen), PERIPHERAL SWELLING (Swelling arm), TASTE DISORDER (Unusal taste), AXILLARY PAIN (Armpit pain), VACCINATION SITE PRURITUS (Itchy red circular rash where I received my shot), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Itchy red circular rash where I received my shot), LYMPHADENOPATHY (lymph node swollen) and LYMPH NODE PAIN (swollen and sore to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information were not reported . Concomitant medication were not reported . This case was linked to MOD-2021-243638 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Contains no new information On 30-Jun-2021: targeted questionnaire

Other Meds:

Current Illness:

ID: 1570390
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 03/15/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Infection; Missed my second dose because he was taking antibiotics; A spontaneous report was received from a consumer concerning himself, a male patient who experienced an infection causing him to miss his second dose of mRNA-1273 because he was taking antibiotics (product dose omission issue). The patient's medical history was not provided. Concomitant product use was not provided/unknown. On an unknown date, this patient received his first of two planned doses of mRNA-1273 (Lot/Batch number: Not provided) intramuscularly for prophylaxis of COVID-19 infection. On 15-Mar-2021, the patient was scheduled for his second dose of the vaccine, but missed this dose because he was on antibiotics for an infection. Treatment information was not provided/unknown. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome for the events, infection and missed second dose because he was taking antibiotics, were not provided/unknown.

Other Meds:

Current Illness:

ID: 1570391
Sex: F
Age: 74
State: TX

Vax Date: 02/03/2021
Onset Date:
Rec V Date: 08/15/2021
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: I missed my scheduled 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my scheduled 2nd dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) mRNA-1273. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I missed my scheduled 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my scheduled 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1570392
Sex: F
Age:
State: NY

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
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: Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little sore arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (Little sore arm). At the time of the report, VACCINATION SITE PAIN (Little sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1570393
Sex: F
Age:
State: NY

Vax Date: 01/15/2021
Onset Date: 02/13/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: a really bad headache; diarrhea; soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm), DIARRHOEA (diarrhea) and HEADACHE (a really bad headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ESOMEPRAZOLE, CALCIUM, COLECALCIFEROL (VIT D3) and LEVOTHYROXINE 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 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 20-Feb-2021, the patient experienced DIARRHOEA (diarrhea). On 23-Feb-2021, the patient experienced HEADACHE (a really bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm and Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in the arm), DIARRHOEA (diarrhea) and HEADACHE (a really bad headache) outcome was unknown. The treatment medication was Tylenol. Action taken with mRNA-1273 in response to the events were not applicable. This case was linked to MOD-2021-024497 (Patient Link).

Other Meds: ESOMEPRAZOLE; CALCIUM; VIT D3; LEVOTHYROXINE

Current Illness:

ID: 1570394
Sex: F
Age: 16
State:

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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: 16 year old patient inadvertently received their 1st Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient inadvertently received their 1st Moderna vaccine) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient inadvertently received their 1st Moderna vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old patient inadvertently received their 1st Moderna 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.

Other Meds:

Current Illness:

ID: 1570395
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 05/07/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: 1st dose and tested positive for COVID afterwards; she already passed 42 days time frame; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (1st dose and tested positive for COVID afterwards) and PRODUCT DOSE OMISSION ISSUE (she already passed 42 days time frame) 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 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 SARS-COV-2 TEST POSITIVE (1st dose and tested positive for COVID afterwards) and PRODUCT DOSE OMISSION ISSUE (she already passed 42 days time frame). At the time of the report, SARS-COV-2 TEST POSITIVE (1st dose and tested positive for COVID afterwards) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1570396
Sex: M
Age: 65
State:

Vax Date: 03/10/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: full body rash; swelling on injection arm; This spontaneous case was reported by a nurse and describes the occurrence of RASH (full body rash) and VACCINATION SITE SWELLING (swelling on injection arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced RASH (full body rash) and VACCINATION SITE SWELLING (swelling on injection arm). At the time of the report, RASH (full body rash) and VACCINATION SITE SWELLING (swelling on injection arm) 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.

Other Meds:

Current Illness:

ID: 1570397
Sex: F
Age:
State:

Vax Date: 03/21/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
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: Pregnant patient got second dose of moderna; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient got second dose of moderna) 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 21-Mar-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. Last menstrual period and estimated date of delivery were not provided. On 21-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient got second dose of moderna). On 21-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient got second dose of moderna) had resolved. Action taken with mRNA-1273 in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1570398
Sex: F
Age: 72
State: NY

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: nauseous; dizzy; weak; General Malaise; vomited; tired; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (General Malaise), VOMITING (vomited) and FATIGUE (tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (General Malaise), VOMITING (vomited), FATIGUE (tired) and HEADACHE (bad headache). On 22-Mar-2021, the patient experienced NAUSEA (nauseous). At the time of the report, DIZZINESS (dizzy), ASTHENIA (weak), MALAISE (General Malaise), VOMITING (vomited), FATIGUE (tired), HEADACHE (bad headache) and NAUSEA (nauseous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. The patient fell off the toilet.Patient still felt nauseous on 22-Mar-2021.

Other Meds:

Current Illness:

ID: 1570399
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 03/22/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: difficulty breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing). At the time of the report, DYSPNOEA (difficulty breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1570400
Sex: M
Age:
State:

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: aching in the body; aching in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching in the body) and PAIN IN EXTREMITY (aching in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Rhinitis. On 18-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (aching in the body) and PAIN IN EXTREMITY (aching in the arm). At the time of the report, PAIN (aching in the body) and PAIN IN EXTREMITY (aching in the arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. As reported patient have rhinitis and normally use cetirizine. As reported patient wanted to know after getting the vaccine can they normally take their treatment. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness: Rhinitis

ID: 1570401
Sex: F
Age: 45
State: TX

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Dizzy; Had period again/period deep dark red; Period not normal, very heavy, heavy clotting; Foggy; 50 cents painful; Purple bruise on L arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (50 cents painful), CONTUSION (Purple bruise on L arm of injection), MENSTRUAL DISORDER (Had period again/period deep dark red), HEAVY MENSTRUAL BLEEDING (Period not normal, very heavy, heavy clotting) and FEELING ABNORMAL (Foggy) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Autoimmune disorder NOS (Immunosuppressed). Concomitant products included VITAMIN D [VITAMIN D NOS], HYDROXYCHLOROQUINE, PREGABALIN (LYRICA), TRAZODONE, CLONAZEPAM and METHOTREXATE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (50 cents painful) and CONTUSION (Purple bruise on L arm of injection). On 19-Mar-2021, the patient experienced MENSTRUAL DISORDER (Had period again/period deep dark red), HEAVY MENSTRUAL BLEEDING (Period not normal, very heavy, heavy clotting) and FEELING ABNORMAL (Foggy). On an unknown date, the patient experienced DIZZINESS (Dizzy). On 21-Mar-2021, PAIN (50 cents painful) and CONTUSION (Purple bruise on L arm of injection) had resolved. At the time of the report, MENSTRUAL DISORDER (Had period again/period deep dark red), HEAVY MENSTRUAL BLEEDING (Period not normal, very heavy, heavy clotting), FEELING ABNORMAL (Foggy) and DIZZINESS (Dizzy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment information was provided.

Other Meds: VITAMIN D [VITAMIN D NOS]; HYDROXYCHLOROQUINE; LYRICA; TRAZODONE; CLONAZEPAM; METHOTREXATE

Current Illness:

ID: 1570402
Sex: F
Age: 62
State:

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: tingling; swelling of the lips and tongue; swelling of the lips and tongue; vaccine provider refused to administer her with the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling), LIP SWELLING (swelling of the lips and tongue), SWOLLEN TONGUE (swelling of the lips and tongue) and PRODUCT DOSE OMISSION ISSUE (vaccine provider refused to administer her with the 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 22-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 PARAESTHESIA (tingling), LIP SWELLING (swelling of the lips and tongue), SWOLLEN TONGUE (swelling of the lips and tongue) and PRODUCT DOSE OMISSION ISSUE (vaccine provider refused to administer her with the 2nd dose). At the time of the report, PARAESTHESIA (tingling), LIP SWELLING (swelling of the lips and tongue), SWOLLEN TONGUE (swelling of the lips and tongue) and PRODUCT DOSE OMISSION ISSUE (vaccine provider refused to administer her with the 2nd dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1570403
Sex: F
Age: 53
State: NC

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN ASPART (NOVOLOG), LISINOPRIL, HYDROCHLOORTHIAZIDE, BUPROPION, LEVOTHYROXINE, ROSUVASTATIN, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: NOVOLOG; LISINOPRIL; HYDROCHLOORTHIAZIDE; BUPROPION; LEVOTHYROXINE; ROSUVASTATIN; ALLEGRA; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Type 1 diabetes mellitus

ID: 1570404
Sex: M
Age: 73
State: OK

Vax Date: 03/01/2021
Onset Date: 03/02/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: No appetite; felt draggy; ached all over; fever off & on; mild pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), MOBILITY DECREASED (felt draggy), MYALGIA (ached all over), PYREXIA (fever off & on) and VACCINATION SITE PAIN (mild pain at the injection site) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced DECREASED APPETITE (No appetite), MOBILITY DECREASED (felt draggy), MYALGIA (ached all over), PYREXIA (fever off & on) and VACCINATION SITE PAIN (mild pain at the injection site). At the time of the report, DECREASED APPETITE (No appetite), MOBILITY DECREASED (felt draggy), MYALGIA (ached all over), PYREXIA (fever off & on) and VACCINATION SITE PAIN (mild pain at the injection site) outcome was unknown. Not Provided 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.

Other Meds:

Current Illness:

ID: 1570405
Sex: M
Age: 21
State: TX

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: chest pain near the shoulder; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and CHEST PAIN (chest pain near the shoulder) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B212A) for COVID-19 immunisation. The patient's past medical history included No adverse event. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 21-Mar-2021, the patient experienced CHEST PAIN (chest pain near the shoulder). At the time of the report, PAIN IN EXTREMITY (arm pain) and CHEST PAIN (chest pain near the shoulder) outcome was unknown. Not Provided 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.

Other Meds:

Current Illness:

ID: 1570406
Sex: M
Age: 72
State: NC

Vax Date: 01/25/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Hard to turn neck from one side to other; Muscle ache; Knee Muscle Pain; This spontaneous case was reported by an other health care professional and describes the occurrence of NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain). At the time of the report, NECK PAIN (Hard to turn neck from one side to other), MYALGIA (Muscle ache) and ARTHRALGIA (Knee Muscle Pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-037537 (E2B Linked Report).; Sender's Comments: MOD-2021-037537:

Other Meds:

Current Illness:

ID: 1570407
Sex: U
Age:
State: SC

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he did not give the entire vial, and there was still something left in the syringe.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.) 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 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.). At the time of the report, ACCIDENTAL UNDERDOSE (he did not give the entire vial, and there was still something left in the syringe.) 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.; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.

Other Meds:

Current Illness:

ID: 1570408
Sex: F
Age: 26
State: NC

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: burning on her arm; Blurred Vision; headaches; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning on her arm), VISION BLURRED (Blurred Vision) and HEADACHE (headaches) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Bipolar disorder. Concomitant products included LITHIUM for COVID-19 vaccination, QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced BURNING SENSATION (burning on her arm), VISION BLURRED (Blurred Vision) and HEADACHE (headaches). At the time of the report, BURNING SENSATION (burning on her arm), VISION BLURRED (Blurred Vision) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Reporter did not allow further contact

Other Meds: SEROQUEL; LITHIUM

Current Illness:

ID: 1570409
Sex: F
Age: 75
State: NJ

Vax Date: 03/12/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: little itchy injection site; swelling injection site; "reddish near 8cm size " on injection site; rash began small and increased for approximately 12 days, then subsided; This spontaneous case was reported by an other caregiver and describes the occurrence of VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. Concurrent medical conditions included Adhesive plaster sensitivity (Area of adhesive bandage becomes red, swollen, itchy) since 02-Feb-2021 and Hypersensitivity reaction (NOS). Concomitant products included FISH OIL, ASCORBIC ACID, COPPER GLUCONATE, TOCOPHERYL ACID SUCCINATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (AREDS 2 VISUAL ADVANTAGE) and CALCIUM, COLECALCIFEROL (CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]) for an unknown indication. On 12-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided). On 11-Apr-2021, VACCINATION SITE PRURITUS (little itchy injection site), VACCINATION SITE SWELLING (swelling injection site), VACCINATION SITE ERYTHEMA ("reddish near 8cm size " on injection site) and VACCINATION SITE RASH (rash began small and increased for approximately 12 days, then subsided) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported. Concomitant medicines include Fish oil, AREDS-2, Calcium-D Action taken with mRNA-1273 in response to the event was unknown Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up information received on 17-may-2021. Added reporters middle name, phone number. Updated reporter's mail id, patient initials, height, weight, race. Added other relevant history. Added event ? vaccination site rash. Updated outcome of events and stop date of events, event assessment. Updated action taken in product tab and event product details tab.

Other Meds: FISH OIL; AREDS 2 VISUAL ADVANTAGE; CALCIUM & VITAMIN D [CALCIUM;COLECALCIFEROL]

Current Illness: Adhesive plaster sensitivity (Area of adhesive bandage becomes red, swollen, itchy); Hypersensitivity reaction (NOS)

ID: 1570410
Sex: F
Age: 51
State: LA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY; FELT ITCHY; RASH LIKE WELT AT THE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (FELT ITCHY), VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE) and VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Adverse event (No medical information provided). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (FELT ITCHY) and VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE). On 20-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY). At the time of the report, VACCINATION SITE PRURITUS (FELT ITCHY), VACCINATION SITE RASH (RASH LIKE WELT AT THE INJECTION SITE) and VACCINATION SITE URTICARIA (24 HOURS LATER SPOT RAISED AND EXTREMELY ITCHY) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. no concomitant medications were reported no treatment drugs were reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1570411
Sex: F
Age:
State: NJ

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: delay in second vaccine dose; feeling cold; "not feeling good"; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), MALAISE ("not feeling good"), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING COLD (feeling cold), MALAISE ("not feeling good") and HEADACHE (headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose). At the time of the report, FEELING COLD (feeling cold), MALAISE ("not feeling good"), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in second vaccine dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient called to ask questions about travelling to state and timing of second dose Patient is scheduled for second dose on 31Mar2021 but wants to travel to state on 29Mar2021. Patient asked Customer Care if it was ok to delay second dose until her return. Patient confirmed with Customer Care agent that her HCP at the vaccine facility already okayed her to delay her second dose. Patient hung up during transfer. Patient was called back and there was no answer; patient does not have voicemail set up. Consent was not obtained. This case was linked to MOD21-075365 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up- patient answered wanted to inquire at day 43 could she still get second dose added. Patient consented to be contacted if needed- updated; Sender's Comments: MOD21-075365:

Other Meds:

Current Illness:

ID: 1570412
Sex: F
Age: 61
State: CO

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: body discomforts; some soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. no medical history was provided by reporter. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm). At the time of the report, DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. concomitant medication included high blood pressure medication,cholesterol medication no treatment information provided.

Other Meds:

Current Illness:

ID: 1570413
Sex: F
Age: 77
State: PA

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itchy on her arm; red on her arm; rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Muscle atrophy. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm). At the time of the report, PRURITUS (itchy on her arm), ERYTHEMA (red on her arm) and RASH (rash on her arm) outcome was unknown. Not Provided Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator No treatment medications provided by the reporter.

Other Meds:

Current Illness: Muscle atrophy

ID: 1570414
Sex: M
Age: 77
State: NM

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
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: Viral Infection; left arm still has soreness; This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (Viral Infection) and VACCINATION SITE PAIN (left arm still has soreness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history information reported. Concomitant products included ACYCLOVIR [ACICLOVIR] from 17-Feb-2021 to 17-Feb-2021 for Viral infection. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced VIRAL INFECTION (Viral Infection) and VACCINATION SITE PAIN (left arm still has soreness). At the time of the report, VIRAL INFECTION (Viral Infection) outcome was unknown and VACCINATION SITE PAIN (left arm still has soreness) had not resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Patient reported he took acyclovir 800 mg three times a day five days after first dose of vaccine and one day after the second dose of vaccine for one day. No other concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-053267 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-053267:Crosslinked with dose 2

Other Meds: ACYCLOVIR [ACICLOVIR]

Current Illness:

ID: 1570415
Sex: F
Age:
State: MI

Vax Date: 03/18/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: On 20Mar2021, she had pain in left knees, left leg and left calf.; On 20Mar2021, she had pain in left knees, left leg and left calf.; On 20Mar2021, she had pain in left knees, left leg and left calf.; Patient started getting aches in her legs, and arms next day after receiving 2nd dose; Patient started getting aches in her legs, and arms next day after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose), the second episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose), the first episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.), the second episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.) and ARTHRALGIA (On 20Mar2021, she had pain in left knees, left leg and left calf.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Mar-2021, the patient experienced the first episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose) and the second episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose). On 20-Mar-2021, the patient experienced the first episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.), the second episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.) and ARTHRALGIA (On 20Mar2021, she had pain in left knees, left leg and left calf.). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, last episode of PAIN IN EXTREMITY (Patient started getting aches in her legs, and arms next day after receiving 2nd dose), the last episode of PAIN IN EXTREMITY (On 20Mar2021, she had pain in left knees, left leg and left calf.) and ARTHRALGIA (On 20Mar2021, she had pain in left knees, left leg and left calf.) outcome was unknown. Concomitant medications included DIABETIC medication (NOS) and CHEMOTHERAPY (NOS). Action taken with mRNA-1273 in response to the events was not Applicable. Patient consents to contact. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: email address added

Other Meds:

Current Illness:

ID: 1570416
Sex: F
Age: 50
State:

Vax Date: 02/17/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: bad pain in her left wrist like arthritis; ringing in both ears; dull pain in her neck on the right side; inflammation (in her ear); pains in her breasts; Right ear felt like it was clogged; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)) and BREAST PAIN (pains in her breasts) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In February 2021, ARTHRALGIA (bad pain in her left wrist like arthritis) and TINNITUS (ringing in both ears) had resolved. At the time of the report, NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported. She was prescribed steroids in which she decided not to take but took Advil instead hoping that would help.

Other Meds:

Current Illness:

ID: 1570417
Sex: F
Age: 88
State: MN

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size; Itchiness; injection site was tender initially; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), INJECTION SITE PAIN (injection site was tender initially) and VACCINATION SITE ERYTHEMA (an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced INJECTION SITE PAIN (injection site was tender initially). On 20-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness). On 21-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size). On 14-Mar-2021, INJECTION SITE PAIN (injection site was tender initially) outcome was unknown. At the time of the report, VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (an oval shape patch at the injection site that was very red and approximately 3 by 3 inches in size) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information included cold compress to relieve the itchiness.

Other Meds:

Current Illness:

ID: 1570418
Sex: F
Age: 67
State: MI

Vax Date: 02/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
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Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Severe pain; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (Severe pain), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Severe pain), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-053275 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10 May 2021 included reporter information

Other Meds:

Current Illness:

ID: 1570419
Sex: M
Age: 77
State: NM

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/15/2021
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Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Left arm still has soreness; Took acyclovir between two doses for viral infection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm still has soreness) and VIRAL INFECTION (Took acyclovir between two doses for viral infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ACYCLOVIR [ACICLOVIR] for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm still has soreness) and VIRAL INFECTION (Took acyclovir between two doses for viral infection). At the time of the report, PAIN IN EXTREMITY (Left arm still has soreness) and VIRAL INFECTION (Took acyclovir between two doses for viral infection) had not resolved. Not Provided Treatment information not provided.

Other Meds: ACYCLOVIR [ACICLOVIR]

Current Illness:

ID: 1570420
Sex: F
Age:
State: MI

Vax Date: 03/17/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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Allergies:

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

Symptoms: Chest pressure; Her stomach was squeezing; Shortness of breath; Racing heartbeats; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HEART RATE INCREASED (Racing heartbeats), CHEST DISCOMFORT (Chest pressure) and ABDOMINAL PAIN UPPER (Her stomach was squeezing) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath) and HEART RATE INCREASED (Racing heartbeats). On 19-Mar-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) and ABDOMINAL PAIN UPPER (Her stomach was squeezing). The patient was treated with LOSARTAN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (Shortness of breath), CHEST DISCOMFORT (Chest pressure) and ABDOMINAL PAIN UPPER (Her stomach was squeezing) outcome was unknown and HEART RATE INCREASED (Racing heartbeats) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure measurement: 111/59 (Inconclusive) 111/59. On 19-Mar-2021, Blood pressure measurement: 106/56 (Inconclusive) 106/56. On 20-Mar-2021, Blood pressure measurement: 83/48 (Inconclusive) 83/48. On 21-Mar-2021, Blood pressure measurement: 102/55 (Inconclusive) 102/55. No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Reporter details updated.

Other Meds:

Current Illness:

ID: 1570421
Sex: F
Age: 61
State:

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
Hospital:

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Allergies:

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

Symptoms: Broke out in a rash all over her neck down to her abdomen; This spontaneous case was reported by a nurse and describes the occurrence of RASH (Broke out in a rash all over her neck down to her abdomen) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B211A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced RASH (Broke out in a rash all over her neck down to her abdomen). The patient was treated with PARACETAMOL (TYLENOL) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Broke out in a rash all over her neck down to her abdomen) 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. After receiving 1st dose of vaccine patient had a broke out in a rash all over her neck down to her abdomen. Patient took Tylenol and it went away. Concomitant medications were not reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am