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: 1556658
Sex: F
Age: 78
State: FL

Vax Date: 01/29/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: broke out, 'looked scarier than what it was'; Hot feeling; redness; experienced adverse events; hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch), URTICARIA (broke out, 'looked scarier than what it was'), FEELING HOT (Hot feeling) and VACCINATION SITE ERYTHEMA (redness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE ERYTHEMA (redness). On an unknown date, the patient experienced URTICARIA (broke out, 'looked scarier than what it was') and FEELING HOT (Hot feeling). At the time of the report, VACCINATION COMPLICATION (experienced adverse events), VACCINATION SITE WARMTH (hot to touch), URTICARIA (broke out, 'looked scarier than what it was'), FEELING HOT (Hot feeling) and VACCINATION SITE ERYTHEMA (redness) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No Treatment details was included. Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Additional information was received on 21-May-2021, patient demographic details (sex) and event outcome updated.

Other Meds:

Current Illness:

ID: 1556659
Sex: F
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/22/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE DISCOLOURATION (spot has some discoloration), VACCINATION SITE INDURATION (the area is still a bit hard), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (spot has some discoloration), VACCINATION SITE INDURATION (the area is still a bit hard), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for Adverse event following immunisation, at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. In January 2021, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (spot has some discoloration) and VACCINATION SITE INDURATION (the area is still a bit hard) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556660
Sex: F
Age: 74
State: FL

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A spontaneous report was received from a consumer concerning a 74-year-old, female patient who experienced diarrhea and a little sore at injection site/vaccination site pain. The patient's medical history and concomitant medications were not provided. On 21-Jan-2021, approximately one day prior to the onset of the symptoms, the patient received their planned first dose of mRNA-1273 injection (Lot/Batch number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection to the upper left arm. On 22-Jan-2021, the day after injection, the patient was a little sore at the injection site and experienced diarrhea. The soreness at the injection site lasted four to five days and stopped on 27-Jan-2021. The diarrhea persisted until 27JAN2021. It had been 18 days since she first experienced diarrhea. She took loperamide hydrochloride and electrolytes NOS/glucose, but had recently stopped. She was not taking any other medications. On 03-Feb-2021, she was seen by her Gastroenterologist, who sent a fecal sample for testing. The test showed no viral infection. She visited her General Practitioner on 08-Feb-2021 for bloodwork. A colonoscopy is planned at some point soon to rule out colitis. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the event of diarrhea is not recovered/not resolved. The outcome for the event little sore at injection site is recovered.; 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: 1556661
Sex: F
Age: 65
State: MI

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Body ache; Fever spiked that night to 102.6; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), PYREXIA (Fever spiked that night to 102.6), CHILLS (Chills) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history was not reported . Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever spiked that night to 102.6), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN (Body ache), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever spiked that night to 102.6) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were provided as Methotryx (sp?) an arthritis medicine. Treatment medication also include Tylenol; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: TYLENOL

Current Illness:

ID: 1556662
Sex: M
Age: 65
State: SC

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: Fever; rigors; headache; feeling tired; stomach cramps; muscle cramps; Flu like symptoms; Aches all over body; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired) and ABDOMINAL PAIN UPPER (stomach cramps) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (muscle cramps), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Aches all over body) and DIARRHOEA (Diarrhoea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (rigors), HEADACHE (headache), FATIGUE (feeling tired), ABDOMINAL PAIN UPPER (stomach cramps), MUSCLE SPASMS (muscle cramps), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Aches all over body) and DIARRHOEA (Diarrhoea) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1556663
Sex: M
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
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: Upper right arm arm, around the shoulder is kinda to somewhat sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Upper right arm arm, around the shoulder is kinda to somewhat sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: Placebo (Got unblinded in Moderna trial.). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE PAIN (Upper right arm arm, around the shoulder is kinda to somewhat sore). At the time of the report, VACCINATION SITE PAIN (Upper right arm arm, around the shoulder is kinda to somewhat sore) had not resolved. 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.

Other Meds:

Current Illness:

ID: 1556664
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: tested positive for covid after getting first dose; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for covid after getting first dose) in a 60-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 an unknown date, the patient experienced COVID-19 (tested positive for covid after getting first dose). At the time of the report, COVID-19 (tested positive for covid after getting first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. This case concerns a 60-year-old female who NS unexpected events of COVID-19. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 60-year-old female who NS unexpected events of COVID-19. Event onset occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556665
Sex: F
Age: 54
State: NJ

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: injection site and jaw still sore; face swelling; immediate throat burning; immediate chest burning; My arm was killing me; injection arm hand turned purple/red; unbearable face pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me) and VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red) in a 54-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 Surgery (right jaw joint replacement). On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me), VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red) and FACIAL PAIN (unbearable face pain). On 08-Feb-2021, the patient experienced MYALGIA (injection site and jaw still sore). The patient was treated with FENTANYL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SWELLING FACE (face swelling), THROAT IRRITATION (immediate throat burning), CHEST PAIN (immediate chest burning), LIMB DISCOMFORT (My arm was killing me), VACCINATION SITE ERYTHEMA (injection arm hand turned purple/red), FACIAL PAIN (unbearable face pain) and MYALGIA (injection site and jaw still sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Treatment- Benadryl Concomitant medication information was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1556666
Sex: F
Age: 80
State: CA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: low grade fever; red patch around injection site; injection site sore; swollen at injection site; injection site feels hot; Injection site hard; itchy at injection site; hivish at injection site; Felt exhausted and fatigued; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt exhausted and fatigued). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (red patch around injection site), VACCINATION SITE PAIN (injection site sore) and VACCINATION SITE SWELLING (swollen at injection site). On an unknown date, the patient experienced PYREXIA (low grade fever). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) for Itchy rash, at a dose of 0.1 %; LAVENDER OIL at a dose of 1 dosage form and MELALEUCA ALTERNIFOLIA OIL (TEA TREE) for Itchy rash, at a dose of 1 dosage form. In February 2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site), FATIGUE (Felt exhausted and fatigued) and VACCINATION SITE ERYTHEMA (red patch around injection site) had resolved, VACCINATION SITE URTICARIA (hivish at injection site) and VACCINATION SITE PAIN (injection site sore) had not resolved. At the time of the report, PYREXIA (low grade fever) and VACCINATION SITE SWELLING (swollen at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Consumer stated the events subsided within a few days. This case was linked to MOD-2021-124421 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 Added new event.

Other Meds: VENTOLIN [SALBUTAMOL]

Current Illness:

ID: 1556667
Sex: F
Age: 66
State:

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Left arm in elbow area was sore and slightly swollen; Pain in left elbow started weeks after first shot; Sore injection site; Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth; minor numbness at the perimeter of her mouth; arm was still sore; This spontaneous case was reported by a physician assistant and describes the occurrence of PARAESTHESIA (Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth), HYPOAESTHESIA (minor numbness at the perimeter of her mouth), AXILLARY PAIN (arm was still sore), JOINT SWELLING (Left arm in elbow area was sore and slightly swollen) and VACCINATION SITE PAIN (Sore injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE and LOSARTAN POTASSIUM for Blood pressure, ROSUVASTATIN CALCIUM. On 22-Feb-2021 at 4:00 PM, 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 22-Feb-2021, the patient experienced PARAESTHESIA (Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth), HYPOAESTHESIA (minor numbness at the perimeter of her mouth) and VACCINATION SITE PAIN (Sore injection site). 22-Feb-2021, the patient experienced AXILLARY PAIN (arm was still sore). On an unknown date, the patient experienced JOINT SWELLING (Left arm in elbow area was sore and slightly swollen) and ARTHRALGIA (Pain in left elbow started weeks after first shot). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling sensation on the left side of the face, underneath eye to chin and the perimeter of the mouth), HYPOAESTHESIA (minor numbness at the perimeter of her mouth) and AXILLARY PAIN (arm was still sore) was resolving, JOINT SWELLING (Left arm in elbow area was sore and slightly swollen) and VACCINATION SITE PAIN (Sore injection site) outcome was unknown and ARTHRALGIA (Pain in left elbow started weeks after first shot) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It is reported that patient is currently consuming blood pressure pills. This case was linked. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-Jul-2021, new events arthralgia and joint swelling were added and concomitant details were updated.

Other Meds: HYDROCHLOROTHIAZIDE; ROSUVASTATIN CALCIUM; LOSARTAN POTASSIUM

Current Illness: Blood pressure; Cholesterol

ID: 1556668
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/14/2021
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: red mark at her injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark at her injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medial history was provided by the reporter. In January 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 ERYTHEMA (red mark at her injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red mark at her injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1556669
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Reaction to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Reaction to the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Drug allergy (Sulfa allergy) since an unknown date. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Reaction to the vaccine). At the time of the report, ADVERSE EVENT (Reaction to the vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness: Drug allergy (Sulfa allergy)

ID: 1556670
Sex: M
Age:
State: GA

Vax Date: 02/04/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HEADACHE (Headache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1556671
Sex: F
Age:
State:

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/14/2021
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: I am also allergic; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (I am also allergic) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ADRENALINE [EPINEPHRINE] for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (I am also allergic). At the time of the report, ALLERGY TO VACCINE (I am also allergic) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: ADRENALINE [EPINEPHRINE]

Current Illness:

ID: 1556672
Sex: F
Age:
State: MT

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 08/14/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved. The patient received second dose of vaccine and was all fine and do not have any further Adverse event to report.

Other Meds:

Current Illness:

ID: 1556673
Sex: U
Age: 120
State: NC

Vax Date: 01/01/2021
Onset Date: 01/02/2021
Rec V Date: 08/14/2021
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: Chills; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills) and MYALGIA (Body aches) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102M20A) for COVID-19 vaccination. The patient's past medical history included Convalescent plasma transfusion in December 2020. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). On 02-Jan-2021, CHILLS (Chills) and MYALGIA (Body aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1556674
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (INTENSE ITCHING 3 HOURS AFTER HIS FIRST MODERNA SHOT ALL OVER HIS BODY EVEN HIS EARS AND EYES ITCHED) had 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.

Other Meds:

Current Illness:

ID: 1556675
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Reaction; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Reaction). At the time of the report, UNEVALUABLE EVENT (Reaction) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1556676
Sex: F
Age: 41
State: WI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Itchy at injection site; Tender at vaccination site; Large circular blotch in the skin; Little swollen at vaccination site; Arm hurt; Redness at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Tender at vaccination site), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 41-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. Concomitant products included MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tender at vaccination site), VACCINATION SITE MACULE (Large circular blotch in the skin) and VACCINATION SITE SWELLING (Little swollen at vaccination site). On 23-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site). On 22-Jan-2021, PAIN IN EXTREMITY (Arm hurt) had resolved. At the time of the report, VACCINATION SITE PAIN (Tender at vaccination site) had resolved, VACCINATION SITE MACULE (Large circular blotch in the skin), VACCINATION SITE SWELLING (Little swollen at vaccination site) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itchy at injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included lotion application on the affected area.

Other Meds: MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYR

Current Illness:

ID: 1556677
Sex: F
Age: 68
State: IN

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
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: did not feel like herself; right arm itchiness; could not do anything; felt exhausted; sore right arm; had no energy; feel like she had acovid again; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm), ASTHENIA (had no energy), MALAISE (could not do anything), DEREALISATION (did not feel like herself) and PRURITUS (right arm itchiness) in a 68-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 COVID-19 in November 2020. Concurrent medical conditions included Blood pressure abnormal, Blood cholesterol abnormal and Thyroid activity decreased. Concomitant products included SERTRALINE and INSULIN for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore right arm), ASTHENIA (had no energy), FEELING ABNORMAL (feel like she had acovid again), PYREXIA (fever) and CHILLS (chills). On 06-Feb-2021, the patient experienced MALAISE (could not do anything) and FATIGUE (felt exhausted). On an unknown date, the patient experienced DEREALISATION (did not feel like herself) and PRURITUS (right arm itchiness). The patient was treated with PARACETAMOL (TYLENOL) 05-Feb-2021 at an unspecified dose and frequency. On 07-Feb-2021, FEELING ABNORMAL (feel like she had acovid again), CHILLS (chills) and FATIGUE (felt exhausted) had resolved. On 08-Feb-2021, ASTHENIA (had no energy) and MALAISE (could not do anything) had resolved. At the time of the report, PAIN IN EXTREMITY (sore right arm) and PRURITUS (right arm itchiness) had not resolved, DEREALISATION (did not feel like herself) outcome was unknown and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Body temperature: inconclusive (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: SERTRALINE; INSULIN

Current Illness: Blood cholesterol abnormal; Blood pressure abnormal; Thyroid activity decreased

ID: 1556678
Sex: F
Age: 26
State: PA

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). At the time of the report, VACCINATION SITE PAIN (pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556679
Sex: M
Age: 64
State: AZ

Vax Date: 02/05/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Tooth ache; Swollen face/swollen nose/swollen cheeks; one eye swolllen; started experiencing allergic side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concomitant products included KETOROLAC and MELOXICAM for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects). At the time of the report, TOOTHACHE (Tooth ache), SWELLING FACE (Swollen face/swollen nose/swollen cheeks), EYE SWELLING (one eye swolllen) and HYPERSENSITIVITY (started experiencing allergic side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included None for swelling, some pain medications and antibiotic. Concomitant medication also included clomaxin.

Other Meds: KETOROLAC; MELOXICAM

Current Illness:

ID: 1556680
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Fever like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever like symptoms). At the time of the report, PYREXIA (Fever like symptoms) had resolved. No treatment information was provided. No concomitant medication was provided. This case was linked to MOD-2021-025847, MOD-2021-025858 (Patient Link).

Other Meds:

Current Illness:

ID: 1556681
Sex: F
Age: 79
State: MD

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Swollen lymph nodes in her arm; There's also some in her neck and clavicle area; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in her arm) and LYMPHADENOPATHY (There's also some in her neck and clavicle area) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in her arm) and LYMPHADENOPATHY (There's also some in her neck and clavicle area). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in her arm) and LYMPHADENOPATHY (There's also some in her neck and clavicle area) 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. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556682
Sex: F
Age:
State: AL

Vax Date: 01/30/2021
Onset Date: 02/02/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: stuffy nose; ache; little queasy; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose), PAIN (ache) and NAUSEA (little queasy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced NASAL CONGESTION (stuffy nose), PAIN (ache) and NAUSEA (little queasy). At the time of the report, NASAL CONGESTION (stuffy nose), PAIN (ache) and NAUSEA (little queasy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, SARS-CoV-2 test positive: positive Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556683
Sex: F
Age: 77
State: TX

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/14/2021
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: the redness seems to be moving down my arm 4-5 inches from the injection; it's warm to the touch; injection site was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) 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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE PAIN (injection site was sore). On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch). At the time of the report, INJECTION SITE PAIN (injection site was sore), VACCINATION SITE ERYTHEMA (the redness seems to be moving down my arm 4-5 inches from the injection) and VACCINATION SITE WARMTH (it's warm to the touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The entire reddened area has moved down about 4-5 inches from the injection site. It's oblong in shape, but about the circumference of an orange and it's warm to the touch. Concomitant medication information not provided. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1556684
Sex: M
Age: 77
State: CA

Vax Date: 01/27/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: nausea; sore arm; fatigue; temperature going up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (temperature going up) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced NAUSEA (nausea), MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (temperature going up). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), MYALGIA (sore arm), FATIGUE (fatigue) and PYREXIA (temperature going up) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556685
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: dry mouth; joint pain; headaches; chills; very painful at the shot site; This spontaneous case was reported by an other and describes the occurrence of DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site). At the time of the report, DRY MOUTH (dry mouth), ARTHRALGIA (joint pain), HEADACHE (headaches), CHILLS (chills) and VACCINATION SITE PAIN (very painful at the shot site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1556686
Sex: F
Age:
State: OR

Vax Date: 01/31/2021
Onset Date: 02/08/2021
Rec V Date: 08/14/2021
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: Her upper arm was all red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Her upper arm was all red) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ERYTHEMA (Her upper arm was all red). At the time of the report, ERYTHEMA (Her upper arm was all red) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient's medical history was not provided. No relevant concomitant medications were reported. Treatment details included was not provided; 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: 1556687
Sex: F
Age: 67
State: CA

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: swollen lump and hardness around the injection; swollen lump and hardness around the injection; flu like symptoms; red around the injection site about the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE ERYTHEMA (red around the injection site about the size of a quarter), VACCINATION SITE INDURATION (swollen lump and hardness around the injection) and VACCINATION SITE SWELLING (swollen lump and hardness around the injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE ERYTHEMA (red around the injection site about the size of a quarter). On 21-Feb-2021, the patient experienced VACCINATION SITE INDURATION (swollen lump and hardness around the injection) and VACCINATION SITE SWELLING (swollen lump and hardness around the injection). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE ERYTHEMA (red around the injection site about the size of a quarter), VACCINATION SITE INDURATION (swollen lump and hardness around the injection) and VACCINATION SITE SWELLING (swollen lump and hardness around the injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and 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: 1556688
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: detailed below. The patient's past medical history included Flu vaccination in 2020. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 21-Jan-2021, the patient experienced VACCINATION SITE MASS (felt like it was lumpy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Arm in the area of the injection site became red/redness migrated toward my elbow) and VACCINATION SITE PAIN (painful). On an unknown date, the patient experienced FEELING ABNORMAL (feels slightly uncomfortable). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Itching, at an unspecified dose and frequency. On 16-Jan-2021, PAIN IN EXTREMITY (Arm was sore) had resolved. On 25-Jan-2021, VACCINATION SITE MASS (felt like it was lumpy), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Arm in the area of the injection site became red/redness migrated toward my elbow) and VACCINATION SITE PAIN (painful) had resolved. At the time of the report, FEELING ABNORMAL (feels slightly uncomfortable) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556689
Sex: F
Age:
State: NJ

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/14/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection). At the time of the report, EAR PAIN (Ear pain while laying down), VACCINATION SITE PAIN (Injection site pain) and EAR INFECTION (ear hurts believing it might be has ear infection) 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 reported. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up received on 26-APR-2021 updated contact information.

Other Meds:

Current Illness:

ID: 1556690
Sex: M
Age: 42
State: PA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Haven't been feeling great; pain in the eyes; feels kind of dizzy; pain in the joints; Headache; A terrible reaction, pain from the hair of their head to the bottom of their feet; fever 103.2 ?F, fever of 100.2 ?F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and PYREXIA (fever 103.2 ?F, fever of 100.2 ?F) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet) and PYREXIA (fever 103.2 ?F, fever of 100.2 ?F). On 29-Jan-2021, the patient experienced EYE PAIN (pain in the eyes), DIZZINESS (feels kind of dizzy), ARTHRALGIA (pain in the joints) and HEADACHE (Headache). On an unknown date, the patient experienced MALAISE (Haven't been feeling great). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (A terrible reaction, pain from the hair of their head to the bottom of their feet), EYE PAIN (pain in the eyes), PYREXIA (fever 103.2 ?F, fever of 100.2 ?F) and ARTHRALGIA (pain in the joints) had resolved and DIZZINESS (feels kind of dizzy), MALAISE (Haven't been feeling great) and HEADACHE (Headache) had not resolved.

Other Meds: SYNTHROID

Current Illness:

ID: 1556691
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: blood came out when it was punctured, for a few second, enough to stain the cotton ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (blood came out when it was punctured, for a few second, enough to stain the cotton ball) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (blood came out when it was punctured, for a few second, enough to stain the cotton ball). At the time of the report, VACCINATION SITE HAEMORRHAGE (blood came out when it was punctured, for a few second, enough to stain the cotton ball) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556692
Sex: M
Age: 74
State: MI

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: He experienced redness and soreness on his arm following vaccination; redness and soreness on his arm following vaccination; redness and soreness on his arm following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (redness and soreness on his arm following vaccination), ERYTHEMA (redness and soreness on his arm following vaccination) and PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20a) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (redness and soreness on his arm following vaccination) and ERYTHEMA (redness and soreness on his arm following vaccination). On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination). At the time of the report, PAIN (redness and soreness on his arm following vaccination), ERYTHEMA (redness and soreness on his arm following vaccination) and PAIN IN EXTREMITY (He experienced redness and soreness on his arm following vaccination) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: TCR attached NNI case.

Other Meds:

Current Illness:

ID: 1556693
Sex: F
Age: 74
State: MI

Vax Date: 02/02/2021
Onset Date: 02/03/2021
Rec V Date: 08/14/2021
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: lips swelled up; chewing on the inside of her cheeks; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks). At the time of the report, LIP SWELLING (lips swelled up) and BITE (chewing on the inside of her cheeks) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was provided. No concomitant medication was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556694
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: Fever like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever like symptoms). At the time of the report, PYREXIA (Fever like symptoms) had resolved. No relevant concomitant medications were reported. Treatment information was not provided. This case was linked to MOD-2021-025847, MOD-2021-025842 (Patient Link).

Other Meds:

Current Illness:

ID: 1556695
Sex: F
Age: 83
State: WA

Vax Date: 01/27/2021
Onset Date: 02/07/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Rash around the injection site; Warm around the injection site; Injection site itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches). At the time of the report, VACCINATION SITE RASH (Rash around the injection site), VACCINATION SITE WARMTH (Warm around the injection site) and VACCINATION SITE PRURITUS (Injection site itches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556696
Sex: M
Age: 47
State: VA

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 08/14/2021
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: pain in arm; chaffing armpit and feels uncomfortable; chaffing armpit and feels uncomfortable; rash under his armpit; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), SKIN IRRITATION (chaffing armpit and feels uncomfortable), DISCOMFORT (chaffing armpit and feels uncomfortable), RASH (rash under his armpit) and VACCINATION SITE PAIN (pain at injection site) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm), SKIN IRRITATION (chaffing armpit and feels uncomfortable), DISCOMFORT (chaffing armpit and feels uncomfortable), RASH (rash under his armpit) and VACCINATION SITE PAIN (pain at injection site). At the time of the report, PAIN IN EXTREMITY (pain in arm), SKIN IRRITATION (chaffing armpit and feels uncomfortable), DISCOMFORT (chaffing armpit and feels uncomfortable), RASH (rash under his armpit) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided. Treatment medication included a cream.

Other Meds:

Current Illness:

ID: 1556697
Sex: F
Age: 77
State: NY

Vax Date: 01/14/2021
Onset Date: 01/22/2021
Rec V Date: 08/14/2021
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: delayed cutaneous hypersensitivity; Woozy feeling; Bit short of breath; Unsteady; Hives; Site of inoculation on left upper arm was very itchy; Red hive at injection site; Rash devolved at injection site; It was raised (at injection site)/2x3 inch raised; Soreness at the injection site; Not feeling great; it was red (at injection site); Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady) and URTICARIA (Hives) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jan-2021 at 4:10 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy), VACCINATION SITE URTICARIA (Red hive at injection site), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea). On 26-Jan-2021, URTICARIA (Hives), VACCINATION SITE PRURITUS (Site of inoculation on left upper arm was very itchy) and VACCINATION SITE URTICARIA (Red hive at injection site) had resolved. At the time of the report, DERMATITIS ALLERGIC (delayed cutaneous hypersensitivity), DIZZINESS (Woozy feeling), DYSPNOEA (Bit short of breath), GAIT DISTURBANCE (Unsteady), VACCINATION SITE RASH (Rash devolved at injection site), VACCINATION SITE SWELLING (It was raised (at injection site)/2x3 inch raised), VACCINATION SITE PAIN (Soreness at the injection site), FATIGUE (Not feeling great), VACCINATION SITE ERYTHEMA (it was red (at injection site)), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Heart rate: 62-70 (Inconclusive) 62-70. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-235772, MOD-2021-025863. Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: received on 24-Jun-2021 contains significant information about AE details and outcome On 24-Jun-2021: Follow-up 2 received on 24-Jun-2021 contains non-significant information.

Other Meds:

Current Illness:

ID: 1556698
Sex: U
Age:
State:

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: the arm is very red; swollen; the arm is very red, swollen, and tender; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history reported. On 16-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 ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender). At the time of the report, ERYTHEMA (the arm is very red), SWELLING (swollen) and TENDERNESS (the arm is very red, swollen, and tender) had not resolved. Not Related The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1556699
Sex: F
Age:
State:

Vax Date: 02/18/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) 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 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556700
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/14/2021
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: 16 year old got the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot) in a 16-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 an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot) had resolved. 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. ? Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up document was received on 29-Jun-2021 and contains no new information.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.

Other Meds:

Current Illness:

ID: 1556701
Sex: U
Age:
State:

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/14/2021
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: Have been very sick; A spontaneous report was received from a consumer concerning a patient of unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced have been very sick. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (lot batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced have been very sick. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. On an unknown date the outcome of event have been very sick was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556702
Sex: F
Age: 62
State: GA

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

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Rash on abdomen; soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) and RASH (Rash on abdomen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). On 03-Feb-2021, the patient experienced RASH (Rash on abdomen). On 05-Feb-2021, PAIN IN EXTREMITY (soreness in arm) had resolved. At the time of the report, RASH (Rash on abdomen) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1556703
Sex: F
Age: 23
State: IL

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/14/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: itchy injection site; injection site got swollen (the size of a quarter) throughout the night the swelling extended; injection site got hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended), VACCINATION SITE MASS (injection site got hard) and VACCINATION SITE PRURITUS (itchy injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended) and VACCINATION SITE MASS (injection site got hard). On 08-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy injection site). At the time of the report, VACCINATION SITE SWELLING (injection site got swollen (the size of a quarter) throughout the night the swelling extended), VACCINATION SITE MASS (injection site got hard) and VACCINATION SITE PRURITUS (itchy injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included birth control. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1556704
Sex: M
Age:
State: MT

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

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

Lab Data:

Allergies:

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

Symptoms: feels very tired after vaccination.; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-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 FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm). At the time of the report, FATIGUE (feels very tired after vaccination.) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1556705
Sex: F
Age:
State: OH

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/14/2021
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Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history provided by Reporter. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 30-Dec-2020, 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) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-May-2020 and the estimated date of delivery was 03-Mar-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 27-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal, normal (normal) normal and normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1556706
Sex: F
Age: 41
State:

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/14/2021
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Allergies:

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

Symptoms: Vaccination site red; Vaccination site sore; Vaccination site itchy; Vaccination site red; Vaccination site pain; Vaccination site swelling; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE SWELLING (Vaccination site swelling), the second episode of VACCINATION SITE ERYTHEMA (Vaccination site red) and VACCINATION SITE PAIN (Vaccination site sore) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SERTRALINE and OMEPRAZOLE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced the first episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling). On 06-Feb-2021, the patient experienced the second episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site sore) and VACCINATION SITE PRURITUS (Vaccination site itchy). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE SWELLING (Vaccination site swelling) had resolved and last episode of VACCINATION SITE ERYTHEMA (Vaccination site red), VACCINATION SITE PAIN (Vaccination site sore) and VACCINATION SITE PRURITUS (Vaccination site itchy) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: SERTRALINE; OMEPRAZOLE

Current Illness:

ID: 1556707
Sex: F
Age: 62
State: MI

Vax Date: 02/22/2021
Onset Date: 02/01/2021
Rec V Date: 08/14/2021
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Allergies:

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

Symptoms: Pain at the injection site; 99.5? - 100.6? fever; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INJECTION SITE PAIN (Pain at the injection site) and PYREXIA (99.5? - 100.6? fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INJECTION SITE PAIN (Pain at the injection site) and PYREXIA (99.5? - 100.6? fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (Pain at the injection site) and PYREXIA (99.5? - 100.6? fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am