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
63,521
AK1,564
AL4,919
AR3,110
AS44
AZ12,737
CA54,930
CO10,467
CT7,356
DC1,569
DE1,561
FL33,556
FM3
GA12,514
GU74
HI2,079
IA4,133
ID2,361
IL18,121
IN22,027
KS4,061
KY6,279
LA4,400
MA13,126
MD11,280
ME2,858
MH8
MI16,708
MN10,694
MO8,362
MP30
MS2,489
MT2,035
NC14,445
ND1,185
NE2,562
NH2,718
NJ16,044
NM3,536
NV3,791
NY30,945
OH17,043
OK5,673
OR7,485
PA21,122
PR1,959
QM2
RI1,833
SC5,608
SD1,087
TN8,053
TX31,927
UT3,792
VA13,189
VI48
VT1,592
WA13,029
WI9,862
WV2,120
WY754
XB5
XL1
XV2

ID: 1570122
Sex: F
Age: 58
State: AZ

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

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Symptom List:

Symptoms: Her appetite was down; little red spot and itching to touch on injection site; little red spot and itching to touch on injection site; felt big boost of energy; This spontaneous case was reported by a consumer and describes the occurrence of ENERGY INCREASED (felt big boost of energy), DECREASED APPETITE (Her appetite was down), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. 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 18-Mar-2021, the patient experienced ENERGY INCREASED (felt big boost of energy), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site). On an unknown date, the patient experienced DECREASED APPETITE (Her appetite was down). At the time of the report, ENERGY INCREASED (felt big boost of energy), DECREASED APPETITE (Her appetite was down), VACCINATION SITE PRURITUS (little red spot and itching to touch on injection site) and VACCINATION SITE ERYTHEMA (little red spot and itching to touch on injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. The treatment information was unknown.

Other Meds:

Current Illness:

ID: 1570123
Sex: M
Age: 59
State: PR

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

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Symptoms: perceived odors; taste became more acute; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The patient's past medical history included Surgery (8-10 years ago, a patient lost his sense of smell because he had a surgery where some polyps in his nose had to be removed, and where the septum was straightened.). Concomitant products included MONTELUKAST, CANNABIS and ALBUTEROL SULFATE 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 ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute). At the time of the report, ANOSMIA (perceived odors) and TASTE DISORDER (taste became more acute) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds: MONTELUKAST; CANNABIS; ALBUTEROL SULFATE

Current Illness:

ID: 1570124
Sex: F
Age: 37
State: OR

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 08/15/2021
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Symptoms: This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. uu3A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 10-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 30-Nov-2020 and the estimated date of delivery was 06-Sep-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourteenth week of the pregnancy. On 10-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant patient) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Dec-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Genetic test: normal (normal) Normal. On an unknown date, Oestrogen receptor assay: normal (normal) Normal. On an unknown date, Ultrasound uterus: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included Pre-natal VIT. Treatment medications were unknown.

Other Meds: LEXAPRO; BABY ASPIRIN

Current Illness:

ID: 1570125
Sex: U
Age: 64
State: FL

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

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Symptoms: blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. 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 VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication were provided. No concomitant medication were provided.

Other Meds:

Current Illness:

ID: 1570126
Sex: F
Age: 45
State: TX

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

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Symptoms: strong reaction; very uncomfortable to sleep; past her due date for their second dose; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced strong reaction (Vaccination complication) and very uncomfortable to sleep (insomnia). The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: G12M20A) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, on an unspecified date, the patient experienced a strong reaction to it. The patient did not have to go to the doctor, but it was very uncomfortable to sleep. The patient was past her due date for her second dose (inappropriate schedule of vaccine administered). Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, strong reaction, very uncomfortable to sleep and past her due date for their second dose were unknown.

Other Meds:

Current Illness:

ID: 1570127
Sex: F
Age: 66
State: NV

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: Little fever with the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Little fever with the first vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Cataract. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Little fever with the first vaccine). At the time of the report, PYREXIA (Little fever with the first vaccine) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-024075 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Additional information received suspect onset date and reporter contact details updated.

Other Meds:

Current Illness: Cataract

ID: 1570128
Sex: M
Age: 59
State: MI

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

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Symptoms: Tingling feet/hands; Muscle strain; Vaccination site reaction; Vaccination site rash; Vaccination site erythema; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling feet/hands), MUSCLE STRAIN (Muscle strain), VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) 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) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PARAESTHESIA (Tingling feet/hands), MUSCLE STRAIN (Muscle strain), VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site erythema). At the time of the report, PARAESTHESIA (Tingling feet/hands) and MUSCLE STRAIN (Muscle strain) had resolved and VACCINATION SITE REACTION (Vaccination site reaction), VACCINATION SITE RASH (Vaccination site rash), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site erythema) 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 provided as antibiotic cream.

Other Meds:

Current Illness:

ID: 1570129
Sex: F
Age: 72
State: TN

Vax Date: 02/19/2021
Onset Date: 02/01/2021
Rec V Date: 08/15/2021
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Symptoms: Little soreness at the injection site; arm swelled at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little soreness at the injection site) and VACCINATION SITE SWELLING (arm swelled at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 19-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 VACCINATION SITE PAIN (Little soreness at the injection site) and VACCINATION SITE SWELLING (arm swelled at injection site). In February 2021, VACCINATION SITE PAIN (Little soreness at the injection site) and VACCINATION SITE SWELLING (arm swelled at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported.The patient applied baking soda with water which resolved the reaction. This case was linked to MOD-2021-077634 (Patient Link).

Other Meds:

Current Illness:

ID: 1570130
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and HEADACHE (headache) 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 Migraine aggravated. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and HEADACHE (headache). At the time of the report, CHILLS (chills) and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No relevant concomitant medications were reported. Treatment information included, ibuprofen was provided. This case was linked to MOD-2021-011727 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: No new information

Other Meds:

Current Illness:

ID: 1570131
Sex: F
Age:
State:

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

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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist). At the time of the report, SKIN BURNING SENSATION (Patient rash burns), RASH PRURITIC (Patient rash itches) and RASH (rash inside of her arm/rash has intensified and grown now to the point where it stretches from patient armpit to wrist) outcome was unknown. No treatment information reported. This case was linked to MOD-2021-049994 (Patient Link).

Other Meds:

Current Illness:

ID: 1570132
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 01/31/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: swollen palm; Red palm; rash around neck, behind ears and in the chest; tiredness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen palm), PALMAR ERYTHEMA (Red palm), RASH (rash around neck, behind ears and in the chest), FATIGUE (tiredness) and CHILLS (Chills) in a 62-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) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced FATIGUE (tiredness) and CHILLS (Chills). On 01-Feb-2021, the patient experienced RASH (rash around neck, behind ears and in the chest). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen palm) and PALMAR ERYTHEMA (Red palm). On 03-Feb-2021, RASH (rash around neck, behind ears and in the chest), FATIGUE (tiredness) and CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen palm) and PALMAR ERYTHEMA (Red palm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Live follow up received on 10-May-2021: No new information was received.

Other Meds:

Current Illness:

ID: 1570133
Sex: F
Age: 66
State: IL

Vax Date: 02/18/2021
Onset Date: 02/18/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Felt cold; headache; mild body aches; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever). At the time of the report, NASOPHARYNGITIS (Felt cold), HEADACHE (headache), PAIN (mild body aches) and PYREXIA (slight fever) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 101 degrees Farenheight. No relevant concomitant medication was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1570134
Sex: F
Age:
State: TX

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

Vax Type:
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Symptom List:

Symptoms: ER for headache; ER for dehydration; dizziness; rash; fever; chills; extreme headache; nausea.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache) and PYREXIA (fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Traumatic brain injury (Patient was involved in car accident in 2012) and Orthopedic procedure (Patient has multiple plates throughout her body). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced DIZZINESS (dizziness), RASH (rash), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.). On 10-Mar-2021, the patient experienced DEHYDRATION (ER for dehydration). On 15-Mar-2021, the patient experienced HEADACHE (ER for headache). At the time of the report, DEHYDRATION (ER for dehydration), DIZZINESS (dizziness), RASH (rash), HEADACHE (ER for headache), PYREXIA (fever), CHILLS (chills), HEADACHE (extreme headache) and NAUSEA (nausea.) 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: 1570135
Sex: M
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: weakness; fever; chills; a little sore in right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021 and was forwarded to the company on 22-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little sore in right arm), ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (a little sore in right arm). On 14-Mar-2021, the patient experienced ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills). On 19-Mar-2021, ASTHENIA (weakness), PYREXIA (fever) and CHILLS (chills) outcome was unknown. At the time of the report, PAIN IN EXTREMITY (a little sore in right arm) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Body temperature: 98.8 (High) 98.8 Degree Fahrenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. No treatment medication information was provided.

Other Meds:

Current Illness:

ID: 1570136
Sex: F
Age:
State: MI

Vax Date: 03/12/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Intramuscular) 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) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1570137
Sex: F
Age: 59
State:

Vax Date: 03/05/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

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Symptom List:

Symptoms: a red rash, around the injection area; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE RASH (a red rash, around the injection area) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Rheumatoid arthritis, Graves' disease and Arthritis. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (a red rash, around the injection area). At the time of the report, VACCINATION SITE RASH (a red rash, around the injection area) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness: Arthritis; Graves' disease; Rheumatoid arthritis

ID: 1570138
Sex: F
Age:
State: FL

Vax Date: 03/12/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Symptom List:

Symptoms: Nausea; Swelling; Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. Concomitant products included HYDROCHLOROTHIAZIDE, METOPROLOL, METFORMIN and LISINOPRIL for an unknown indication. On 12-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 VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE ERYTHEMA (Redness). On 21-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness) and NAUSEA (Nausea) outcome was unknown. Unknown The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: HYDROCHLOROTHIAZIDE; METOPROLOL; METFORMIN; LISINOPRIL

Current Illness:

ID: 1570139
Sex: F
Age: 64
State: FL

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
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Symptoms: lightheadedness; pain in arm; dizzy; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in arm), DIZZINESS (dizzy) and CHILLS (Chills) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced DIZZINESS (lightheadedness), PAIN IN EXTREMITY (pain in arm), DIZZINESS (dizzy) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form; PARACETAMOL (TYLENOL) at a dose of 1 dosage form and Manual therapy (hot and cold compress) for Pain in extremity. On 20-Mar-2021, DIZZINESS (lightheadedness), DIZZINESS (dizzy) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (pain in arm) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) decreased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided.

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Current Illness:

ID: 1570140
Sex: F
Age: 43
State: AR

Vax Date: 03/12/2021
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Rec V Date: 08/15/2021
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash that got bigger and bigger on the arm), VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE ERYTHEMA (A little red spot at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history ). Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication. On 12-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 RASH (A rash that got bigger and bigger on the arm), VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE ERYTHEMA (A little red spot at the injection site). At the time of the report, RASH (A rash that got bigger and bigger on the arm), VACCINATION COMPLICATION (Moderna arm) and VACCINATION SITE ERYTHEMA (A little red spot at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included topical hydrocortisone.

Other Meds: ATORVASTATIN; LEVOTHYROXINE

Current Illness:

ID: 1570141
Sex: F
Age: 81
State: CA

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 08/15/2021
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Symptoms: Rash look like a burn; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash look like a burn) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROID), GABAPENTIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Rash look like a burn). At the time of the report, RASH (Rash look like a burn) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. About 12 hours later the first dose patient developed a rash that now looks like a burn 10 days later 19 Mar 2021. Treatment information was not provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: No new information.

Other Meds: SYNTHYROID; GABAPENTIN; ZOLOFT

Current Illness:

ID: 1570142
Sex: M
Age:
State: TX

Vax Date: 03/11/2021
Onset Date: 03/13/2021
Rec V Date: 08/15/2021
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Symptoms: Fatigue; Headache; Muscle pain; Chills; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) 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.

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ID: 1570143
Sex: F
Age:
State: PA

Vax Date: 02/16/2021
Onset Date: 02/23/2021
Rec V Date: 08/15/2021
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Symptoms: Squeezy in the stomach"; Little nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061M20A) for COVID-19 vaccination. No Medical History information was reported. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea). On 09-Mar-2021, ABDOMINAL DISCOMFORT (Squeezy in the stomach") and NAUSEA (Little nausea) had resolved. On 17 Mar 2021 again the patient felt squeezy in the stomach and on 22 Mar 2021 the event got resolved. Concomitant medications was not provided by the reporter. Treatment for the events included Mepromazin

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Current Illness:

ID: 1570144
Sex: F
Age: 72
State: CA

Vax Date: 03/07/2021
Onset Date: 03/18/2021
Rec V Date: 08/15/2021
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Symptoms: cold; stiffness; light headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headedness), NASOPHARYNGITIS (cold) and MUSCULOSKELETAL STIFFNESS (stiffness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (light headedness). On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and MUSCULOSKELETAL STIFFNESS (stiffness). At the time of the report, DIZZINESS (light headedness) had not resolved and NASOPHARYNGITIS (cold) and MUSCULOSKELETAL STIFFNESS (stiffness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

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ID: 1570145
Sex: M
Age:
State:

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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Symptoms: Shortness of breath; Nausea; Fatigue; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) 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 16-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 DYSPNOEA (Shortness of breath), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches). On 18-Mar-2021, DYSPNOEA (Shortness of breath), NAUSEA (Nausea), FATIGUE (Fatigue) and MYALGIA (Muscle aches) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact

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ID: 1570146
Sex: F
Age:
State: NY

Vax Date: 01/06/2021
Onset Date: 01/31/2021
Rec V Date: 08/15/2021
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Symptoms: Received 2nd dose 25 days after 1st dose; Red swollen palms; Rash around neck, behind ears and in the chest; Chills; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose), PERIPHERAL SWELLING (Red swollen palms), RASH (Rash around neck, behind ears and in the chest), CHILLS (Chills) and FATIGUE (Tiredness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 0111J20A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis. Concomitant products included CALCIUM and VITAMIN D3 for Osteoporosis. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (Tiredness). On 01-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash around neck, behind ears and in the chest). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose) and PERIPHERAL SWELLING (Red swollen palms). On 03-Feb-2021, RASH (Rash around neck, behind ears and in the chest), CHILLS (Chills) and FATIGUE (Tiredness) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 25 days after 1st dose) had resolved and PERIPHERAL SWELLING (Red swollen palms) outcome 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 medicines were not provided. Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: No New Information On 16-Apr-2021: Updated Reporter Details, Patient medical history, Concomitant medicines, both Vaccines details, Updated outcome of the event from Unknown to Recovered On 10-May-2021: No NewInformation

Other Meds: CALCIUM; VITAMIN D3

Current Illness: Osteoporosis

ID: 1570147
Sex: F
Age: 75
State: SC

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/15/2021
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Symptoms: sore Throat; Difficulty Breathing; Coughing; Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M24A) for COVID-19 vaccination. Concurrent medical conditions included COPD, Thyroid disorder and Diabetes. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills). At the time of the report, OROPHARYNGEAL PAIN (sore Throat), DYSPNEA (Difficulty Breathing), COUGH (Coughing) and CHILLS (Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included medication for COPD, Diabetes and thyroid. The patient went to the Urgent Care and was treated for an upper respirator infection.

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Current Illness: COPD; Diabetes; Thyroid disorder

ID: 1570148
Sex: M
Age: 68
State: CA

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 08/15/2021
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Symptoms: Hard for him to sleep; Chills at night; A spontaneous report was received from a consumer concerning a 68-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills at night and hard for him to sleep/poor quality sleep. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 20 Mar 2021, prior to onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 20 Feb 2021, the patient experienced chills at night and it was hard for him to sleep. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcomes of the events chills at night and hard for him to sleep was not reported.

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Current Illness:

ID: 1570149
Sex: F
Age: 62
State: MI

Vax Date: 02/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 023M20A) for COVID-19 vaccination. Concomitant products included LISINOPRIL and BUDESONIDE (PULMICORT) for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches). At the time of the report, FATIGUE (Fatigue), ERYTHEMA (arm was red) and PAIN IN EXTREMITY (arm aches) outcome was unknown. Not Provided Treatment was unknown.

Other Meds: LISINOPRIL; PULMICORT

Current Illness:

ID: 1570150
Sex: F
Age:
State: NJ

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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Symptoms: diarrhea; stomach pains; vomiting; nausea; muscle ache/body ache; joints pains; chills; fatigue and tiredness; itching at the site of the injection,; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,) and NAUSEA (nausea) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diverticulitis. Concurrent medical conditions included COPD. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ALPRAZOLAM (XANAX) 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 VACCINATION SITE PRURITUS (itching at the site of the injection,). On 20-Mar-2021, the patient experienced DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness). At the time of the report, DIARRHOEA (diarrhea), ABDOMINAL PAIN UPPER (stomach pains), VOMITING (vomiting), VACCINATION SITE PRURITUS (itching at the site of the injection,), NAUSEA (nausea), MYALGIA (muscle ache/body ache), ARTHRALGIA (joints pains), CHILLS (chills) and FATIGUE (fatigue and tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included other psychotropic agents(not specified).The patient did not take any treatment medication.

Other Meds: SPIRIVA; ADVAIR; XANAX

Current Illness: COPD

ID: 1570151
Sex: F
Age: 42
State: OK

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/15/2021
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Symptoms: tenderness; swelling on both arm pit (left arm, right arm auxillary swelling) and very painful; swelling on both arm pit (left arm, right arm auxillary swelling) and very painful; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), LYMPHADENOPATHY (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) and AXILLARY PAIN (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced TENDERNESS (tenderness), LYMPHADENOPATHY (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) and AXILLARY PAIN (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TENDERNESS (tenderness) and AXILLARY PAIN (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) outcome was unknown and LYMPHADENOPATHY (swelling on both arm pit (left arm, right arm auxillary swelling) and very painful) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication was reported. This case was linked to MOD-2021-117053. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up information was received and event outcome was updated.

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Current Illness:

ID: 1570152
Sex: M
Age:
State: FL

Vax Date: 03/03/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Symptoms: fatigue; arm pain; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included PYRIDOSTIGMINE BROMIDE and SALBUTAMOL SULFATE (INHALERIN) for an unknown indication. 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 PAIN IN EXTREMITY (arm pain) and PAIN IN EXTREMITY (arm soreness). On 04-Mar-2021, the patient experienced FATIGUE (fatigue). On 05-Mar-2021, PAIN IN EXTREMITY (arm pain), PAIN IN EXTREMITY (arm soreness) and FATIGUE (fatigue) 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. The consumer reports to having underlying health conditions. The medical condition was unknown. the treatment medication was also unknown.

Other Meds: PYRIDOSTIGMINE BROMIDE; INHALERIN

Current Illness:

ID: 1570153
Sex: F
Age: 57
State: PR

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: adenopathy - swelling of nose, above the clavicle, near to shoulder; severe allergic reaction to food and drinks; A spontaneous report was received from a healthcare professional concerning his wife, a 57-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling of nose (swelling), adenopathy-swelling above the clavicle, swelling near to shoulder(vaccination site lymphadenopathy) and severe allergic reaction to food and drinks(food allergy). The patient's medical history was not provided. The relevant concomitant medications use was not reported. On 29 Dec 2020, prior to the onset of the events, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On unspecified date, after vaccination the patient experienced adenopathy-swelling of nose, swelling above the clavicle, swelling near to shoulder and had severe allergic reactions to food and drinks. The patient has been to the emergency room twice and has seen a local immunologist. Treatment for the event was provided included prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, swelling of nose (swelling), adenopathy-swelling above the clavicle, swelling near to shoulder(vaccination site lymphadenopathy) and severe allergic reaction to food and drinks(food allergy), were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1570154
Sex: F
Age: 76
State: NY

Vax Date: 02/24/2021
Onset Date: 03/03/2021
Rec V Date: 08/15/2021
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Symptoms: Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 008B212A) for COVID-19 vaccination. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown. Not Provided Concomitant product information was not provided. Treatment information was not provided. This case was linked to MOD-2021-260311 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Second dose details added.

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Current Illness:

ID: 1570155
Sex: M
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
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Symptoms: Sick; coughing up yellow balls of mucus; bad cough; Lousy; Vaccination adverse reaction; Fatigued; Sweats; Fever; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Mar-2021. The most recent information was received on 09-May-2021 and was forwarded to Moderna on 09-May-2021. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction), HYPERHIDROSIS (Sweats), ILLNESS (Sick), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (coughing up yellow balls of mucus) and COUGH (bad cough) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced HYPERHIDROSIS (Sweats) and PYREXIA (Fever). On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction), ILLNESS (Sick), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (coughing up yellow balls of mucus), COUGH (bad cough), MALAISE (Lousy) and FATIGUE (Fatigued). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction), HYPERHIDROSIS (Sweats), ILLNESS (Sick), INCREASED VISCOSITY OF UPPER RESPIRATORY SECRETION (coughing up yellow balls of mucus), COUGH (bad cough), MALAISE (Lousy) and PYREXIA (Fever) outcome was unknown and FATIGUE (Fatigued) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, SARS-CoV-2 test: negative (Negative) negative. No concomitant medication was reported . No treatment medication was reported . Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: Follow up received included dose number lab data e,vent outcome as recovered for fatigue and events such as cough and coughing up yellow balls of mucous

Other Meds:

Current Illness:

ID: 1570156
Sex: M
Age: 71
State: IN

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/15/2021
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Symptoms: pain is located between the heart and the left shoulder, not on the heart but it is above the heart around the chest bone/the pain is above the heart and it's not the heart; Feet swollen again; had a rash from knees to feet, it was dark red; Rash from knees to feet; swelling at injection site; Rash from shoulder to elbow; Fatigued/tired; Knees and neck hurt; Light-headed / Dizzy; Knees and neck hurt; Chest pains; This spontaneous case was reported by a consumer and describes the occurrence of NON-CARDIAC CHEST PAIN (pain is located between the heart and the left shoulder, not on the heart but it is above the heart around the chest bone/the pain is above the heart and it's not the heart), DIZZINESS (Light-headed / Dizzy), NECK PAIN (Knees and neck hurt), CHEST PAIN (Chest pains) and PERIPHERAL SWELLING (Feet swollen again) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Open heart surgery and Knee surgery NOS. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), AMLODIPINE, SIMVASTATIN, ALLOPURINOL, OXYBUTYNIN, METOPROLOL and CLOPIDOGREL for an unknown indication. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Light-headed / Dizzy). 26-Feb-2021, the patient experienced NECK PAIN (Knees and neck hurt), CHEST PAIN (Chest pains), ARTHRALGIA (Knees and neck hurt), FATIGUE (Fatigued/tired) and VACCINATION SITE RASH (Rash from shoulder to elbow). On 27-Feb-2021, the patient experienced ERYTHEMA (had a rash from knees to feet, it was dark red), RASH (Rash from knees to feet) and VACCINATION SITE SWELLING (swelling at injection site). On 21-Mar-2021, the patient experienced PERIPHERAL SWELLING (Feet swollen again). On an unknown date, the patient experienced NON-CARDIAC CHEST PAIN (pain is located between the heart and the left shoulder, not on the heart but it is above the heart around the chest bone/the pain is above the heart and it's not the heart). On 03-Mar-2021, ERYTHEMA (had a rash from knees to feet, it was dark red) and RASH (Rash from knees to feet) outcome was unknown, VACCINATION SITE SWELLING (swelling at injection site) was resolving. On 22-Mar-2021, PERIPHERAL SWELLING (Feet swollen again) was resolving. At the time of the report, NON-CARDIAC CHEST PAIN (pain is located between the heart and the left shoulder, not on the heart but it is above the heart around the chest bone/the pain is above the heart and it's not the heart), DIZZINESS (Light-headed / Dizzy), NECK PAIN (Knees and neck hurt), ARTHRALGIA (Knees and neck hurt), FATIGUE (Fatigued/tired) and VACCINATION SITE RASH (Rash from shoulder to elbow) outcome was unknown and CHEST PAIN (Chest pains) had not resolved. Treatment drug include water pills. Lab data; Ultrasound, EKG, and X-rays . The patient said that had to go to ER again due to severe chest pain. The patient said it's not the heart. The patient said the cardiologist gave it an angiogram, ultrasound and every test you can get and can't find what it is. The patient stated that the pain now happens more often and that the first time thought it was having a heart attack and it wasn't a heart attack. The patient said that the times it was on ER it was always the same thing but that the first times it used to last from 5 to 10 minutes and disappeared for a while. The patient said that then on march 23rd had another attack and lasted for an hour and that the last time it lasted for 3 hours and then lingered on for a while. the patient stated that is getting this attacks more often and they are staying longer. the patient said there is no kind of medication or anything to control the pain, but then said that on March 23rd the cardiologist gave it pain killers and with them the pain went away, on July third the patient had another attack and called the doctor on July 5th to ask for more pills (still haven't heard of it's doctor). The patient states that the pain is above the heart and it's not the heart, The patient said the heart beats like normal, blood pressure normal, and that it has nothing to do with the heart. The patient said that from 1 to 10 the pain is a 20 and that it bends from the pain cause it hurts so mu Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non-Significant F/U AE Updates Info. On 24-May-2021: Non-Significant follow up appended to AER On 08-Jun-2021: All laboratory test added. Lower level term updated from rash to Vaccination site rash. Peripheral swelling and heartbeats increased deleted as event. Vaccination site swelling added as new event. Outcome updated for Chest pain, Vaccination site swelling, Swelling of feet.Action taken updated to not applicable in product-event details. On 06-Jul-2021: Significant follow up

Other Meds: ASPIRIN 81; AMLODIPINE; SIMVASTATIN; ALLOPURINOL; OXYBUTYNIN; METOPROLOL; CLOPIDOGREL

Current Illness:

ID: 1570157
Sex: F
Age: 53
State: UT

Vax Date: 03/10/2021
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Rec V Date: 08/15/2021
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Symptoms: Nausea; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and FATIGUE (Tiredness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 10-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 NAUSEA (Nausea) and FATIGUE (Tiredness). At the time of the report, NAUSEA (Nausea) and FATIGUE (Tiredness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1570158
Sex: F
Age:
State: CA

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 08/15/2021
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Symptoms: inability to schedule a second Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inability to schedule a second Moderna dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Cancer surgery (two cancer surgeries in 2020.) since 2020. Concurrent medical conditions included Hypertension (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.), Hypercholesterolemia (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.) and Diabetes (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.). On 12-Feb-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 an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inability to schedule a second Moderna dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inability to schedule a second Moderna dose) had resolved. No concomitant medications were reported. Treatment medications were not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: The patient had received the second vaccine dose, action taken was updated to not applicable and patient denied consent for further follow up.

Other Meds:

Current Illness: Cancer surgery (two cancer surgeries in 2020.); Diabetes (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.); Hypercholesterolemia (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.); Hypertension (Patient reports PMH significant for hypertension, hypercholesterolemia, diabetes mellitus, and two cancer surgeries in 2020.)

ID: 1570159
Sex: F
Age: 66
State: VT

Vax Date: 03/06/2021
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Rec V Date: 08/15/2021
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Symptoms: Migraine headaches; Neck pain for eight days; Mouth sores; Felt lethargic; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine headaches), NECK PAIN (Neck pain for eight days), ORAL PAIN (Mouth sores) and LETHARGY (Felt lethargic) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-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 MIGRAINE (Migraine headaches), NECK PAIN (Neck pain for eight days), ORAL PAIN (Mouth sores) and LETHARGY (Felt lethargic). At the time of the report, MIGRAINE (Migraine headaches), NECK PAIN (Neck pain for eight days), ORAL PAIN (Mouth sores) and LETHARGY (Felt lethargic) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications taken by the patient were not provided. Treatment information was not provided.

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Current Illness:

ID: 1570160
Sex: M
Age: 54
State: NC

Vax Date: 01/27/2021
Onset Date: 03/11/2021
Rec V Date: 08/15/2021
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Symptoms: Its been more than 42 days since 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days since 1st dose) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days since 1st dose). On 11-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Its been more than 42 days since 1st dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications provided. Patient was advised not to take the second dose while on antibiotics. No treatment details reported.

Other Meds:

Current Illness:

ID: 1570161
Sex: M
Age: 83
State: VA

Vax Date: 03/15/2021
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Rec V Date: 08/15/2021
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Symptoms: Warm to the touch; Real hard; It itches real bad; Redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (Real hard), VACCINATION SITE PRURITUS (It itches real bad) and VACCINATION SITE ERYTHEMA (Redness around the injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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 an unknown date, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (Real hard), VACCINATION SITE PRURITUS (It itches real bad) and VACCINATION SITE ERYTHEMA (Redness around the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), VACCINATION SITE INDURATION (Real hard), VACCINATION SITE PRURITUS (It itches real bad) and VACCINATION SITE ERYTHEMA (Redness around the injection site) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment included cortisone cream.

Other Meds:

Current Illness:

ID: 1570162
Sex: M
Age: 66
State: NJ

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/15/2021
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Symptoms: Delayed second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Delayed second shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Concurrent medical conditions included Cancer (NOS) (Was hospitalized for cancer and had a blood infection) since 14-Mar-2021. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Delayed second shot). On 16-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Delayed second shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications taken by the patient were not provided. Treatment information was not provided.

Other Meds:

Current Illness: Cancer (NOS) (Was hospitalized for cancer and had a blood infection)

ID: 1570163
Sex: M
Age: 60
State: NY

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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Symptoms: Stomach ache; Wide noise/ ringing noise in left ear; Diarrhea; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), TINNITUS (Wide noise/ ringing noise in left ear), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) 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) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), TINNITUS (Wide noise/ ringing noise in left ear), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. On 18-Mar-2021, ABDOMINAL PAIN UPPER (Stomach ache), DIARRHOEA (Diarrhea), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, TINNITUS (Wide noise/ ringing noise in left ear) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up information included no new information.

Other Meds:

Current Illness:

ID: 1570164
Sex: M
Age: 94
State: CA

Vax Date: 03/16/2021
Onset Date: 03/16/2021
Rec V Date: 08/15/2021
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Symptoms: Dizzy spell; Cannot walk without a walker or else they would fall; Got cold, couldn't get warm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Got cold, couldn't get warm), DIZZINESS (Dizzy spell) and GAIT DISTURBANCE (Cannot walk without a walker or else they would fall) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-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 FEELING COLD (Got cold, couldn't get warm). On 22-Mar-2021, the patient experienced DIZZINESS (Dizzy spell) and GAIT DISTURBANCE (Cannot walk without a walker or else they would fall). At the time of the report, FEELING COLD (Got cold, couldn't get warm), DIZZINESS (Dizzy spell) and GAIT DISTURBANCE (Cannot walk without a walker or else they would fall) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Outcome of the event was updated from unknown to recovered

Other Meds:

Current Illness:

ID: 1570165
Sex: F
Age: 51
State: MS

Vax Date: 01/21/2021
Onset Date: 02/03/2021
Rec V Date: 08/15/2021
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Symptoms: Blister at Injection Site; Redness at Injection Site; Swelling at Injection Site; Itching at Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE VESICLES (Blister at Injection Site), VACCINATION SITE ERYTHEMA (Redness at Injection Site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE PRURITUS (Itching at Injection Site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE VESICLES (Blister at Injection Site), VACCINATION SITE ERYTHEMA (Redness at Injection Site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE PRURITUS (Itching at Injection Site). In February 2021, VACCINATION SITE VESICLES (Blister at Injection Site), VACCINATION SITE ERYTHEMA (Redness at Injection Site), VACCINATION SITE SWELLING (Swelling at Injection Site) and VACCINATION SITE PRURITUS (Itching at Injection Site) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-052966. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1570166
Sex: F
Age: 78
State: NY

Vax Date: 02/07/2021
Onset Date: 03/07/2021
Rec V Date: 08/15/2021
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Symptoms: Dry skin at injection arm; Itchiness at rash; Rash all over muscle of injection arm; Chills; Aches and pains; Aches and pains; High fever; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchiness at rash), DRY SKIN (Dry skin at injection arm), PAIN (Aches and pains), MYALGIA (Aches and pains) and PYREXIA (High fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes, Blood pressure high and Cholesterol. Concomitant products included VITAMINS NOS for an unknown indication. On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PAIN (Aches and pains), MYALGIA (Aches and pains), PYREXIA (High fever) and CHILLS (Chills). On 10-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash all over muscle of injection arm). On 11-Mar-2021, the patient experienced RASH PRURITIC (Itchiness at rash). On an unknown date, the patient experienced DRY SKIN (Dry skin at injection arm). The patient was treated with CEFALEXIN (KEFLEX [CEFALEXIN]) at a dose of 500 mg every six hours. On 09-Mar-2021, PAIN (Aches and pains), MYALGIA (Aches and pains), PYREXIA (High fever) and CHILLS (Chills) had resolved. At the time of the report, RASH PRURITIC (Itchiness at rash) and VACCINATION SITE RASH (Rash all over muscle of injection arm) had resolved and DRY SKIN (Dry skin at injection arm) had not resolved. Concomitant medications reported were blood pressure medicine, diabetes medicine and cholesterol medicine. This case was linked to MOD-2021-052974 (Patient Link).

Other Meds: VITAMINS NOS

Current Illness: Blood pressure high; Cholesterol; Diabetes

ID: 1570167
Sex: F
Age: 64
State: VA

Vax Date: 03/19/2021
Onset Date: 03/19/2021
Rec V Date: 08/15/2021
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Symptoms: IBS became much worse post vaccination; Caller doesnt want to do second dose of vaccine because of side effect; diarrhea; extreme gut pain; Had flu like symptoms; Fatigue; Headache; Nausea; Fever; light nausea; Loose stool; GI issues/ Digestive problems; Stomach cramps and pain; Depression; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS became much worse post vaccination), PRODUCT DOSE OMISSION ISSUE (Caller doesnt want to do second dose of vaccine because of side effect), INFLUENZA LIKE ILLNESS (Had flu like symptoms), GASTROINTESTINAL PAIN (extreme gut pain) and ABDOMINAL DISCOMFORT (GI issues/ Digestive problems) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to plants (Allergy to Dandelion greens), Mercury sensitivity (Allergy to Mercury), Food allergy (Allergy to gluten) and Irritable bowel syndrome (Became much worse post vaccination) since 2013. Concomitant products included THYROID (ARMOUR THYROID) from 1998 to an unknown date for Hypothyroidism, CHOLESTYRAMINE and VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication. On 19-Mar-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (GI issues/ Digestive problems), ABDOMINAL PAIN UPPER (Stomach cramps and pain), DEPRESSION (Depression), DIARRHOEA (Loose stool) and NAUSEA (light nausea). On 20-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Had flu like symptoms), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever). On 23-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (extreme gut pain) and DIARRHOEA (diarrhea). On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (IBS became much worse post vaccination) and PRODUCT DOSE OMISSION ISSUE (Caller doesnt want to do second dose of vaccine because of side effect). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL INSTACOOL) at an unspecified dose and frequency; TRAMADOL at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; LAMOTRIGINE (LAMICTAL) for Depression, at an unspecified dose and frequency and CALCIUM CARBONATE (ANTACID [CALCIUM CARBONATE]) at an unspecified dose and frequency. On 21-Mar-2021, INFLUENZA LIKE ILLNESS (Had flu like symptoms), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) had resolved. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS became much worse post vaccination), ABDOMINAL DISCOMFORT (GI issues/ Digestive problems), ABDOMINAL PAIN UPPER (Stomach cramps and pain), DEPRESSION (Depression), DIARRHOEA (Loose stool) and NAUSEA (light nausea) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (Caller doesnt want to do second dose of vaccine because of side effect) had resolved and GASTROINTESTINAL PAIN (extreme gut pain) and DIARRHOEA (diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: inconclusive (Inconclusive) No problems were seen other than some inflammation.. On an unknown date, Endoscopy: inconclusive (Inconclusive) No problems were seen other than some inflammation.. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up received on 13-Apr-2021, Added treatment drugs Pepto-Bismol , Tramadol and added newevents extreme gut pain, diarrhea. On 22-Jun-2021: Follow up received on 22-Jun-2021, Reporter address added, added laboratory details, added treatment drugs Lamictal, antacid, added new events. On 28-Jul-2021: Patient demographic details were updated. Medical history updated - Current condition and allergic information were added. Dosage information of the concomitant drug ARMOUR THYROID were updated. New event Irritable bowel syndrome aggravated added. Event outcome updated for the events Gastro intestinal pain and Diarrhea from Unknown to Not recovered/Not resolved.

Other Meds: ARMOUR THYROID; CHOLESTYRAMINE; VALTREX

Current Illness: Allergy to plants (Allergy to Dandelion greens); Food allergy (Allergy to gluten); Irritable bowel syndrome (Became much worse post vaccination); Mercury sensitivity (Allergy to Mercury)

ID: 1570168
Sex: F
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Rec V Date: 08/15/2021
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Symptoms: difficult to stand up; so fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (difficult to stand up) and FATIGUE (so fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (difficult to stand up) and FATIGUE (so fatigue). At the time of the report, DYSSTASIA (difficult to stand up) and FATIGUE (so fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided Action taken with mRNA-1273 in response to the event was unknown

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Current Illness:

ID: 1570169
Sex: F
Age: 75
State: DE

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/15/2021
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Symptoms: Chills; Muscle Ache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), MYALGIA (Muscle Ache) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced CHILLS (Chills), MYALGIA (Muscle Ache) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), MYALGIA (Muscle Ache) and PYREXIA (Fever) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided This case was linked to MOD-2021-053064 (Patient Link).

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Current Illness:

ID: 1570170
Sex: F
Age: 74
State: PA

Vax Date: 03/05/2021
Onset Date: 03/21/2021
Rec V Date: 08/15/2021
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Symptoms: redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No medical history information was reported. Concurrent medical conditions included Blood pressure and Thyroid disorder. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced ERYTHEMA (redness). At the time of the report, ERYTHEMA (redness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported were blood pressure meds and thyroid meds. No treatment medications were reported Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: event outcome updated and further consent denied

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Current Illness: Blood pressure; Thyroid disorder

ID: 1570171
Sex: F
Age: 69
State: FL

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 08/15/2021
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Symptoms: Warmth; diarrhea; lethargic; itchy hives from left neck to shoulder to elbow; itchy hives from left neck to shoulder to elbow; headaches; nauseous; difficulty sleeping, had to sleep with pillow under arm; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (injection arm soreness), INSOMNIA (difficulty sleeping, had to sleep with pillow under arm), VACCINATION SITE WARMTH (Warmth), DIARRHOEA (diarrhea) and LETHARGY (lethargic) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-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 PAIN IN EXTREMITY (injection arm soreness). On 13-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping, had to sleep with pillow under arm). On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth), DIARRHOEA (diarrhea), LETHARGY (lethargic), VACCINATION SITE PRURITUS (itchy hives from left neck to shoulder to elbow), VACCINATION SITE URTICARIA (itchy hives from left neck to shoulder to elbow), HEADACHE (headaches) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (injection arm soreness), INSOMNIA (difficulty sleeping, had to sleep with pillow under arm), VACCINATION SITE WARMTH (Warmth), DIARRHOEA (diarrhea), LETHARGY (lethargic), VACCINATION SITE PRURITUS (itchy hives from left neck to shoulder to elbow), VACCINATION SITE URTICARIA (itchy hives from left neck to shoulder to elbow), HEADACHE (headaches) and NAUSEA (nauseous) 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. No treatment information was provided.

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Total 2021 VAERS Injuries: 560,435

Page last modified: 03 October 2021 5:28pm