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: 1611690
Sex: F
Age: 23
State:

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Sore Arm After the First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Arm After the First Vaccine) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm After the First Vaccine). On 12-Mar-2021, VACCINATION SITE PAIN (Sore Arm After the First Vaccine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-090334, US-MODERNATX, INC.-MOD-2021-090629 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090334:Cross linked US-MODERNATX, INC.-MOD-2021-090629:cross linked dose 1

Other Meds:

Current Illness:

ID: 1611691
Sex: F
Age:
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: sore arms; Red swollen patch on the vaccination site; vacination site pain; Bleeding upon injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms), VACCINATION SITE HAEMORRHAGE (Bleeding upon injection), VACCINATION SITE SWELLING (Red swollen patch on the vaccination site) and VACCINATION SITE PAIN (vacination site pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding upon injection) and VACCINATION SITE PAIN (vacination site pain). On 24-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arms) and VACCINATION SITE SWELLING (Red swollen patch on the vaccination site). At the time of the report, PAIN IN EXTREMITY (sore arms), VACCINATION SITE HAEMORRHAGE (Bleeding upon injection), VACCINATION SITE SWELLING (Red swollen patch on the vaccination site) and VACCINATION SITE PAIN (vacination site pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1611692
Sex: M
Age: 30
State: NY

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fever; chills; fatigue; nausea; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache). At the time of the report, PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue), NAUSEA (nausea) and MYALGIA (Body ache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1611693
Sex: F
Age: 75
State: NJ

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: hair fall; little body aches; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 042B212A) for COVID-19 vaccination. No concomitant medication reported. Concurrent medical conditions included Hypertension and Cholesterol. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches). At the time of the report, ALOPECIA (hair fall) and PAIN IN EXTREMITY (little body aches) outcome was unknown.

Other Meds:

Current Illness: Cholesterol; Hypertension

ID: 1611694
Sex: M
Age: 63
State: AL

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 08/22/2021
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: accidentally administered 1ml of the vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ACCIDENTAL OVERDOSE (accidentally administered 1ml of the vaccine) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (accidentally administered 1ml of the vaccine). At the time of the report, ACCIDENTAL OVERDOSE (accidentally administered 1ml of the vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-090611, US-MODERNATX, INC.-MOD-2021-090426, US-MODERNATX, INC.-MOD-2021-090288 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090611: US-MODERNATX, INC.-MOD-2021-090426: US-MODERNATX, INC.-MOD-2021-090288:

Other Meds:

Current Illness:

ID: 1611695
Sex: F
Age: 37
State: TN

Vax Date: 03/15/2021
Onset Date: 04/19/2021
Rec V Date: 08/22/2021
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: hives on her face and neck / broke into hives this morning; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives on her face and neck / broke into hives this morning) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 031A21A) 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 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2021 at 8:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives on her face and neck / broke into hives this morning). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives on her face and neck / broke into hives this morning) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-090576 (Patient Link).

Other Meds:

Current Illness:

ID: 1611696
Sex: F
Age:
State: TN

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/22/2021
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: Body aches; Tongue turned white; Headaches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027T21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. On 17-Apr-2021, PAIN (Body aches), TONGUE DISCOLOURATION (Tongue turned white), HEADACHE (Headaches) and PYREXIA (Fever) had resolved. No concomitant information provided. Treatment details included extra Strength Tylenol

Other Meds:

Current Illness:

ID: 1611697
Sex: F
Age: 23
State:

Vax Date: 03/12/2021
Onset Date: 04/08/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Menstrual Period is Late Because of the Vaccine; Sore Arm After the Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine) and VACCINATION SITE PAIN (Sore Arm After the Second Shot) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 002A21A) 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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore Arm After the Second Shot). On 26-Apr-2021, the patient experienced MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine). On 08-Apr-2021, VACCINATION SITE PAIN (Sore Arm After the Second Shot) had resolved. At the time of the report, MENSTRUAL DISORDER (Menstrual Period is Late Because of the Vaccine) outcome was unknown. Concomitant medication was not provided. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-090334 (E2B Linked Report). This case was linked to MOD-2021-090621 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090334:Cross linked

Other Meds:

Current Illness:

ID: 1611698
Sex: F
Age: 38
State: FL

Vax Date: 04/08/2021
Onset Date: 04/08/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: pressure in her head; fever; nausea; chills; body aches and muscle pain; joint pain; bad intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills) and MYALGIA (body aches and muscle pain) 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. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches). On an unknown date, the patient experienced MYALGIA (body aches and muscle pain). At the time of the report, HEAD DISCOMFORT (pressure in her head), PYREXIA (fever), NAUSEA (nausea), CHILLS (chills), ARTHRALGIA (joint pain) and HEADACHE (bad intense headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to INC.-MOD-2021-090357 (E2B Linked Report).; Sender's Comments: INC.-MOD-2021-090357:

Other Meds:

Current Illness:

ID: 1611699
Sex: F
Age: 71
State: CT

Vax Date: 01/20/2021
Onset Date: 04/16/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Blodd pressure elevated upto 154/99; 1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 028L20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included HYDROCHLOROTHIAZIDE, LORAZEPAM, SERTRALINE HCL, ATORVASTATIN, ESZOPICLONE (LUNESTA), MULTIVITAMIN [VITAMINS NOS], FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL] and FISH OIL for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021). On 16-Apr-2021 at 10:00 AM, the patient experienced BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021) had resolved. On 17-Apr-2021, BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: 154/99 (High) 154/99. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Treatment information was not provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-033069 (E2B Linked Report). This case was linked to MOD-2021-033069 (Patient Link).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-033069:Dose 1

Other Meds: HYDROCHLOROTHIAZIDE; LORAZEPAM; SERTRALINE HCL; ATORVASTATIN; LUNESTA; MULTIVITAMIN [VITAMINS NOS]; FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL]; FISH OIL.

Current Illness:

ID: 1611700
Sex: F
Age: 73
State: SC

Vax Date: 01/26/2021
Onset Date: 02/23/2021
Rec V Date: 08/22/2021
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: Tired now; flu like symptoms; red splotches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), RASH MACULAR (red splotches) and FATIGUE (Tired now) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 641L20A and N4017294) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included No adverse event. Concomitant products included BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) for Blood pressure high, SERTRALINE HYDROCHLORIDE (SERTRALINE A) for Depression, TOPIRAMATE for Headache, CEFIXIME (FLEXERIL [CEFIXIME]) for Muscle relaxant and rest, TRAMADOL for Pain. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) and RASH MACULAR (red splotches). On 26-Apr-2021, the patient experienced FATIGUE (Tired now). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved, RASH MACULAR (red splotches) had not resolved and FATIGUE (Tired now) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. concomitants included thyroid and cholesterol medication, Treatment medication included Dermand cream.

Other Meds: ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]; TOPIRAMATE; TRAMADOL; SERTRALINE A; FLEXERIL [CEFIXIME]

Current Illness:

ID: 1611701
Sex: U
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Gave the first dose to 6 patients between the ages of 16 - 17 years old; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave the first dose to 6 patients between the ages of 16 - 17 years old) in an adolescent patient of an unknown 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave the first dose to 6 patients between the ages of 16 - 17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave the first dose to 6 patients between the ages of 16 - 17 years old) 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. No treatment medication was provided. The reporter was a Chief Clinical Officer (MD). No patient details available.

Other Meds:

Current Illness:

ID: 1611702
Sex: M
Age: 32
State: UT

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 08/22/2021
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: Thawed in refrigerator then placed in freezer; removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Thawed in refrigerator then placed in freezer ) and PRODUCT STORAGE ERROR (removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Thawed in refrigerator then placed in freezer ) and PRODUCT STORAGE ERROR (removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,). On 26-Apr-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Thawed in refrigerator then placed in freezer ) and PRODUCT STORAGE ERROR (removed from the foam freezer, placed in the refrigerator for 4 to 6 hours,) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by the Reporter. No Treatment medications were provided by the Reporter. Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non Significant follow up and It was contain no new information.

Other Meds:

Current Illness:

ID: 1611703
Sex: F
Age: 55
State: FL

Vax Date: 03/22/2021
Onset Date: 04/22/2021
Rec V Date: 08/22/2021
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: skin was itchy both arms, arms to waist, back, legs; like sting sunburn, kept on scratching; could not think clearly; rash over the trunk, under breasts; a lot of red dots on upper arms and upper legs; bad flu; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash over the trunk, under breasts), ERYTHEMA (a lot of red dots on upper arms and upper legs), PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly) in a 55-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 LEVOTHYROXINE for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (bad flu). On 24-Apr-2021, the patient experienced RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs). On 26-Apr-2021, the patient experienced PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching) and THINKING ABNORMAL (could not think clearly). On 25-Apr-2021, RASH (rash over the trunk, under breasts) and ERYTHEMA (a lot of red dots on upper arms and upper legs) had resolved. At the time of the report, PRURITUS (skin was itchy both arms, arms to waist, back, legs), RASH ERYTHEMATOUS (like sting sunburn, kept on scratching), THINKING ABNORMAL (could not think clearly) and INFLUENZA LIKE ILLNESS (bad flu) outcome was unknown. Other concomitant medications include Hormone Replacement gel from France and Hormone Replacement take daily. No treatment medications were provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-090646 (Patient Link).

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1611704
Sex: M
Age:
State: AL

Vax Date: 03/21/2021
Onset Date: 04/21/2021
Rec V Date: 08/22/2021
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: can not move; itchy arm; right testicle was swollen; painful testicle; red testicle; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle), ERYTHEMA (red testicle), GAIT INABILITY (can not move) and PRURITUS (itchy 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle) and ERYTHEMA (red testicle). On an unknown date, the patient experienced GAIT INABILITY (can not move) and PRURITUS (itchy arm). At the time of the report, TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle), ERYTHEMA (red testicle), GAIT INABILITY (can not move) and PRURITUS (itchy arm) outcome was unknown. Not Provided

Other Meds:

Current Illness:

ID: 1611705
Sex: F
Age:
State: CA

Vax Date: 01/09/2021
Onset Date: 01/09/2021
Rec V Date: 08/22/2021
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: was unable to raise my arm; itchiness; injection site swelling; This spontaneous case was reported by a pharmacist and describes the occurrence of LIMB DISCOMFORT (was unable to raise my arm), PRURITUS (itchiness) and VACCINATION SITE SWELLING (injection site swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 042L20A) for COVID-19 vaccination. Concomitant products included VITAMIN D3 and VITAMIN B12 NOS for an unknown indication. On 09-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE SWELLING (injection site swelling). On an unknown date, the patient experienced LIMB DISCOMFORT (was unable to raise my arm) and PRURITUS (itchiness). On 20-Feb-2021, VACCINATION SITE SWELLING (injection site swelling) had resolved. At the time of the report, LIMB DISCOMFORT (was unable to raise my arm) and PRURITUS (itchiness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-027305 (Patient Link).

Other Meds: VITAMIN D3; VITAMIN B12 NOS

Current Illness:

ID: 1611706
Sex: F
Age: 55
State: FL

Vax Date: 03/22/2021
Onset Date: 03/22/2021
Rec V Date: 08/22/2021
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: Red dots on upper arms and upper legs; Skin was itchy on both arms / waist / back / leg; Sting sunburn; Patient could not think / sharpness was gone; red dots on arm; Rash on trunk / under breast; Bad flu; Chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Bad flu), PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn), MEMORY IMPAIRMENT (Patient could not think / sharpness was gone) and ERYTHEMA (Red dots on upper arms and upper legs) in a 55-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. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 22-Apr-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 22-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (fatigue). On 22-Apr-2021, the patient experienced INFLUENZA (Bad flu). On 24-Apr-2021, the patient experienced RASH (Rash on trunk / under breast) and ALLERGY TO VACCINE (red dots on arm). On 26-Apr-2021, the patient experienced PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn) and MEMORY IMPAIRMENT (Patient could not think / sharpness was gone). On an unknown date, the patient experienced ERYTHEMA (Red dots on upper arms and upper legs). On 24-Mar-2021, CHILLS (Chills) outcome was unknown. On 29-Mar-2021, FATIGUE (fatigue) outcome was unknown. On 25-Apr-2021, ALLERGY TO VACCINE (red dots on arm) outcome was unknown. At the time of the report, INFLUENZA (Bad flu), PRURITUS (Skin was itchy on both arms / waist / back / leg), SUNBURN (Sting sunburn), MEMORY IMPAIRMENT (Patient could not think / sharpness was gone), ERYTHEMA (Red dots on upper arms and upper legs) and RASH (Rash on trunk / under breast) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1611707
Sex: F
Age:
State: NJ

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: being tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (being tired and fatigued) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOFLOXACIN, RIVAROXABAN (XARELTO), LISINOPRIL, HYDROCHLOROTHIAZIDE, OXYCODONE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (being tired and fatigued). On 14-Feb-2021, FATIGUE (being tired and fatigued) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication details was reported. This case was linked to MOD-2021-090660 (Patient Link).

Other Meds: LEVOFLOXACIN; XARELTO; LISINOPRIL; HYDROCHLOROTHIAZIDE; OXYCODONE; SYNTHROID

Current Illness:

ID: 1611708
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: facial redness; some tingling; numbing in the front of her face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face). At the time of the report, ERYTHEMA (facial redness), PARAESTHESIA (some tingling) and HYPOAESTHESIA (numbing in the front of her face) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details were provided. Benadryl was used as treatment medication.

Other Meds:

Current Illness:

ID: 1611709
Sex: F
Age:
State: CA

Vax Date: 02/25/2021
Onset Date: 03/11/2021
Rec V Date: 08/22/2021
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: lower back pain two weeks after; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain two weeks after) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), VITAMIN D NOS, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), POTASSIUM, MAGNESIUM, ESTRADIOL and PROGESTERONE for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (lower back pain two weeks after). The patient was treated with NAPROXEN for Pain, at a dose of UNK dosage form. At the time of the report, BACK PAIN (lower back pain two weeks after) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-090652 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021. Patient stated that two weeks after 1st shot, lower back pain not bad, she stated that she ignored became worse after 2nd shot with other events.

Other Meds: BYSTOLIC; SYNTHROID; CYTOMEL; VITAMIN D NOS; FLAX SEED OIL; POTASSIUM; MAGNESIUM; ESTRADIOL; PROGESTERONE

Current Illness:

ID: 1611710
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
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: some contractors at their site got second doses for an interval gap of 50+ days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (some contractors at their site got second doses for an interval gap of 50+ days) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to US-MODERNATX, INC.-MOD-2021-090613 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090613:Case for patient

Other Meds:

Current Illness:

ID: 1611711
Sex: F
Age:
State: CA

Vax Date: 03/25/2021
Onset Date: 03/11/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: brainf fog; The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders. Can't turn head all the way right and left; can hardly walk , can't get out of bed, has a hard time getting off the toilet.; fatigue; chills; fever; back pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN, FEELING ABNORMAL (brains fog), MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders. Can't turn head all the way right and left) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), Flax Seed Oil, POTASSIUM, MAGNESIUM, ESTRADIOL and PROGESTERONE for an unknown indication. On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (back pain). On 25-Mar-2021, the patient experienced FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders. Can't turn head all the way right and left). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. On 27-Mar-2021, FATIGUE (fatigue), CHILLS (chills) and PYREXIA (fever) had resolved. At the time of the report, GAIT DISTURBANCE (can hardly walk , can't get out of bed, has a hard time getting off the toilet.), BACK PAIN (back pain), FEELING ABNORMAL (brainf fog) and MYALGIA (The second shot the back pain was worse and traveled down to legs, hips, and calves. Also pain in neck that moved down to shoulders. Can't turn head all the way right and left) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-090649 (Patient Link).

Other Meds: BYSTOLIC; SYNTHROID; CYTOMEL; VITAMIN D 2000; Flax Seed Oil; POTASSIUM; MAGNESIUM; ESTRADIOL; PROGESTERONE

Current Illness:

ID: 1611712
Sex: F
Age: 59
State: KS

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 08/22/2021
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: Aches/ body aches; Lymph node is swollen; Fever of 101.5; Chills; Headaches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, MYALGIA (Aches/ body aches), LYMPHADENOPATHY (Lymph node is swollen), PYREXIA (Fever of 101.5), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment was provided by the reporter.

Other Meds:

Current Illness:

ID: 1611713
Sex: M
Age: 43
State: CA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Tiredness; Chills; sore arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included No adverse reaction (no medical history reported). Concomitant products included HCTZ and METFORMIN for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site). On 26-Mar-2021, FATIGUE (Tiredness), CHILLS (Chills) and PAIN IN EXTREMITY (sore arm at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: HCTZ; METFORMIN

Current Illness:

ID: 1611714
Sex: F
Age: 73
State: NY

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: swelling arm; Arm sore; Itching at vaccination site; soreness of the injection site; that it was like lyme disease and looked like a bull's-eye; fever; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site) and VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032220A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Lyme disease. 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 PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills). At the time of the report, PERIPHERAL SWELLING (swelling arm), PAIN IN EXTREMITY (Arm sore), VACCINATION SITE PRURITUS (Itching at vaccination site), VACCINATION SITE PAIN (soreness of the injection site), VACCINATION SITE RASH (that it was like lyme disease and looked like a bull's-eye), PYREXIA (fever), NAUSEA (nausea) and CHILLS (chills) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient stated that her symptoms were like Lyme disease and looked like a bull's eye. She did not take anything to treat her symptoms and she wasn't taking any other concomitant medications. patient said vaccine helped with her arthritis symptoms. This case was linked to MOD-2021-090348 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up received- Contact info and medical history updated.

Other Meds:

Current Illness: Arthritis; Lyme disease

ID: 1611715
Sex: M
Age: 58
State: OH

Vax Date: 04/02/2021
Onset Date: 04/20/2021
Rec V Date: 08/22/2021
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: Covid-19 positive; he started feeling ill; Started feeling ill as if stomach flue; Diarrhea; fatigue; body ache; This spontaneous case was reported by a consumer and describes the occurrence of GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and COVID-19 in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, and ILLNESS. On 23-Apr-2021, the patient experienced COVID-19 (Covid-19 positive). At the time of the report, GASTROENTERITIS VIRAL, DIARRHOEA, FATIGUE, MYALGIA, COVID-19 (positive), and ILLNESS outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, SARS-CoV-2 test: Positive Covid Test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. No concomitant medication reported. No treatment medication reported. Most recent FOLLOW-UP information incorporated above included, on 27-May-2021: Follow up report received on 27-MAY-2021 contains No New Information.

Other Meds:

Current Illness:

ID: 1611716
Sex: F
Age: 52
State: TX

Vax Date: 03/26/2021
Onset Date: 04/25/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: still sick; also got covid 19; COVID arm; feeling out of it; itching; fatigue / tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced FEELING ABNORMAL (feeling out of it), PRURITUS (itching) and FATIGUE (fatigue / tired). On 26-Apr-2021, the patient experienced VACCINATION SITE REACTION (COVID arm). On an unknown date, the patient experienced ILLNESS (still sick) and EXPOSURE TO SARS-COV-2 (also got covid 19). At the time of the report, VACCINATION SITE REACTION (COVID arm), FEELING ABNORMAL (feeling out of it), PRURITUS (itching), ILLNESS (still sick), EXPOSURE TO SARS-COV-2 (also got covid 19) and FATIGUE (fatigue / tired) had resolved. This case was linked to MODERNATX, INC.-MOD-2021-090448 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Significant Follow up appended; Sender's Comments: MODERNATX, INC.-MOD-2021-090448:Case of son

Other Meds:

Current Illness:

ID: 1611717
Sex: F
Age: 51
State: SC

Vax Date: 03/25/2021
Onset Date: 04/23/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: itchy; Big hives at the injection site; red; swollen; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B21-2A) for COVID-19 vaccination. Concurrent medical conditions included Behcet's disease, Ankylosing spondylitis, Addison's disease and Gastroesophageal reflux disease. Concomitant products included PREDNISONE, SARILUMAB (KEVZARA), METHOTREXATE, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), NORTRIPTYLINE and PARACETAMOL (TYLENOL) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itchy), INJECTION SITE URTICARIA (Big hives at the injection site), VACCINATION SITE ERYTHEMA (red) and VACCINATION SITE SWELLING (swollen) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked toMOD-2021-090191,MOD-2021-090148 (E2B Linked Report).; Sender's Comments: MOD-2021-090191:Same reporter MOD-2021-090148:Same reporter

Other Meds: PREDNISONE; KEVZARA; METHOTREXATE; CLARITIN ALLERGIC; NORTRIPTYLINE; TYLENOL

Current Illness: Addison's disease; Ankylosing spondylitis; Behcet's disease; Gastroesophageal reflux disease

ID: 1611718
Sex: F
Age: 52
State: KY

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/22/2021
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: Fever; Sick feeling; Covid arm; Lethargic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), MALAISE (Sick feeling), VACCINATION SITE REACTION (Covid arm) and LETHARGY (Lethargic) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Insomnia and Drug allergy. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN) from 01-Jan-2015 to an unknown date for Insomnia, VITAMINS NOS and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 20-Feb-2021 at 11:15 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (Fever) and LETHARGY (Lethargic). 20-Feb-2021, the patient experienced MALAISE (Sick feeling) and VACCINATION SITE REACTION (Covid arm). On 25-Feb-2021, PYREXIA (Fever), MALAISE (Sick feeling), VACCINATION SITE REACTION (Covid arm) and LETHARGY (Lethargic) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Specific treatment information was not reported. This case was linked to MOD-2021-018071 (Patient Link).

Other Meds: AMBIEN; VITAMINS NOS; ADVIL [IBUPROFEN]

Current Illness: Drug allergy; Insomnia

ID: 1611719
Sex: U
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: upset stomach; body aches; chills; 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 ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. 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 ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), MYALGIA (body aches) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications information was reported. No treatment medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness: Hypertension.

ID: 1611720
Sex: F
Age: 43
State: TX

Vax Date: 04/22/2021
Onset Date: 04/26/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Positive covid-19 test post 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No historical conditions were reported. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid-19 test post 1st dose) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. 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 medications were provided.

Other Meds: VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1611721
Sex: F
Age:
State: WA

Vax Date: 01/08/2021
Onset Date: 02/05/2021
Rec V Date: 08/22/2021
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: still don't feel 100% back to my prevaccine health; fatigue; bruised on both lower extremities; lower legs became extremely sore; fever went from 97.1 to 101.8; myalgia; arthralgia; headaches; chills; prodromal symptoms of HSV outbreak; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HERPES SIMPLEX (prodromal symptoms of HSV outbreak), CONTUSION (bruised on both lower extremities), LIMB DISCOMFORT (lower legs became extremely sore), MALAISE (still don't feel 100% back to my prevaccine health) and FATIGUE (fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included HSV infection and Bell's palsy (Experienced after the first dose of Moderna Vaccine) in January 2021. Concomitant products included CALCIUM for Bone disorder, VALACYCLOVIR [VALACICLOVIR] for HSV infection, VITAMIN D3 for Vitamin D low. On 08-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced HERPES SIMPLEX (prodromal symptoms of HSV outbreak). On 05-Feb-2021 at 10:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever went from 97.1 to 101.8), MYALGIA (myalgia), ARTHRALGIA (arthralgia), HEADACHE (headaches) and CHILLS (chills). On 14-Feb-2021, the patient experienced CONTUSION (bruised on both lower extremities) and LIMB DISCOMFORT (lower legs became extremely sore). On an unknown date, the patient experienced MALAISE (still don't feel 100% back to my prevaccine health) and FATIGUE (fatigue). At the time of the report, HERPES SIMPLEX (prodromal symptoms of HSV outbreak), CONTUSION (bruised on both lower extremities), LIMB DISCOMFORT (lower legs became extremely sore), PYREXIA (fever went from 97.1 to 101.8), MYALGIA (myalgia), ARTHRALGIA (arthralgia), HEADACHE (headaches) and CHILLS (chills) had resolved and MALAISE (still don't feel 100% back to my prevaccine health) and FATIGUE (fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Blood creatine phosphokinase: normal (normal) Around 3 pm, results were within normal limits.. On 06-Feb-2021, Body temperature: increased (High) At 1am fever went from 97.1 to 101.8. On 06-Feb-2021, Metabolic function test: normal (normal) Around 3 pm, results were within normal limits.. On 06-Feb-2021, Renal function test: zero (Low) kidney output dropped to zero. On 06-Feb-2021, Specific gravity urine: low (Low) low due to my hydration of 3L of fluid.. On an unknown date, Blood creatine phosphokinase: normal (normal) normal. On an unknown date, C-reactive protein: normal (normal) Normal. On an unknown date, Full blood count: normal (normal) normal limits. On an unknown date, International normalised ratio: normal (normal) normal. On an unknown date, Metabolic function test: normal (normal) Normal. On an unknown date, Prothrombin time: normal (normal) normal. On an unknown date, Red blood cell sedimentation rate: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to events was not applicable. Patient was discharged with stable vitals. The bruising resolved over the following week. The low-level fatigue remained. Patient experienced prodromal symptoms of HSV outbreak about 4 times (much more than usual) and had to take valacyclovir for a few days each time. This case was linked to MOD-2021-011418, MOD-2021-011418 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: CALCIUM; VITAMIN D3; VALACYCLOVIR [VALACICLOVIR]

Current Illness:

ID: 1611722
Sex: F
Age: 44
State: FL

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

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

Lab Data:

Allergies:

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

Symptoms: left arm became swollen; hand became numb for 6 hours; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 148A21A and 177A27A) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included Clot blood (blood clot in left arm 3 years ago) and Factor V Leiden thrombophilia. Concomitant products included APIXABAN (ELIQUIS) 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 31-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 PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours). On 04-Mar-2021, PERIPHERAL SWELLING (left arm became swollen) and HYPOAESTHESIA (hand became numb for 6 hours) had resolved. Not Provided This case was linked to MOD-2021-090687 (Patient Link).

Other Meds: ELIQUIS

Current Illness:

ID: 1611723
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Fever; Headache; severe chills; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills) in a 64-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 PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills). At the time of the report, PYREXIA (Fever), HEADACHE (Headache) and CHILLS (severe chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.

Other Meds:

Current Illness:

ID: 1611724
Sex: M
Age:
State: FL

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: pain in arm; had little rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm) and RASH (had little rash) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm) and RASH (had little rash). The patient was treated with IBUPROFEN at an unspecified dose and frequency and CLONAZEPAM (KLONOPIN) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in arm) and RASH (had little rash) outcome was unknown. Possible The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-090694 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090694:case for second dose

Other Meds:

Current Illness:

ID: 1611725
Sex: M
Age: 47
State: CA

Vax Date: 01/11/2021
Onset Date: 04/24/2021
Rec V Date: 08/22/2021
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: Patient received second dose on 24Apr2021, over 90 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 24Apr2021, over 90 days after 1st dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 24Apr2021, over 90 days after 1st dose). On 24-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 24Apr2021, over 90 days after 1st dose) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatments were provided.

Other Meds:

Current Illness:

ID: 1611726
Sex: F
Age: 73
State: NY

Vax Date: 02/09/2021
Onset Date:
Rec V Date: 08/22/2021
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; headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 09-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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PYREXIA (fever) and HEADACHE (headache) had resolved. No concomitant medications reported. No treatment information provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-018435 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1611727
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Large swollen rectangle with a lump in the middle at injection site; Large swollen rectangle with a lump in the middle at injection site; 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 VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site). At the time of the report, VACCINATION SITE MASS (Large swollen rectangle with a lump in the middle at injection site) and VACCINATION SITE SWELLING (Large swollen rectangle with a lump in the middle at injection site) had resolved. No treatment of events was reported. No concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1611728
Sex: F
Age: 78
State: GA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/22/2021
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: She had a soft patter sound in her ears that Happened when she burped and bent over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EN6200) for COVID-19 vaccination. The patient's past medical history included Breast cancer (She was considered cancer free 5 years past her diagnosis) in 2001, Shoulder replacement in 2020 and Cardiac ablation (She had Cardiac ablation about 3 years ago) in 2018. Previously administered products included for COVID-19 vaccination: Pfizer Covid-19 Vaccine (Pfizer Lot Number: EL3427 She reported she got her first Covid vaccine in her left arm) on 05-Feb-2021. Concurrent medical conditions included AFib (She was diagnosed with AFib in either 2015 or 2016) and Osteoporosis in 2020. Concomitant products included APIXABAN (ELIQUIS) for AFib, DENOSUMAB (PROLIA) from July 2020 to an unknown date for Osteoporosis. On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over). At the time of the report, TINNITUS (She had a soft patter sound in her ears that Happened when she burped and bent over) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Acoustic stimulation tests: normal (normal) Normal. She has been on Eliquis 5mg tablet for about 3 years. On 01-Mar-2021, her second Covid vaccine was between 1:00 to 1:30PM On 15-Mar-2021, her ear doctor cleaned and waxed out both ears, and checked her ears, nose, and throat. On 07-Apr-2021, her ear doctor dug out a skin flap in her right ear but that did not take care of the soft patter sound in her ears. This case was linked to INC.-MOD-2021-089491, MOD-2021-185552 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No significant information received; Sender's Comments: INC.-MOD-2021-185552:Dose 1 INC.-MOD-2021-089491:Same reporter

Other Meds: PROLIA; ELIQUIS

Current Illness: AFib (She was diagnosed with AFib in either 2015 or 2016)

ID: 1611729
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/22/2021
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: Palpitations; Increase in m yblood pressure; Had lymph nodes; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Increase in m yblood pressure), LYMPHADENOPATHY (Had lymph nodes) and MYALGIA (Muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Increase in m yblood pressure), LYMPHADENOPATHY (Had lymph nodes) and MYALGIA (Muscle pain). At the time of the report, PALPITATIONS (Palpitations), BLOOD PRESSURE INCREASED (Increase in m yblood pressure), LYMPHADENOPATHY (Had lymph nodes) and MYALGIA (Muscle pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1611730
Sex: M
Age:
State: ME

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/22/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Almost blacked out; Dizziness; Anxiety attacks; Vision was not all that well; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations). At the time of the report, PRESYNCOPE (Almost blacked out), DIZZINESS (Dizziness), ANXIETY (Anxiety attacks), VISUAL IMPAIRMENT (Vision was not all that well) and PALPITATIONS (Heart palpitations) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medicines were not reported.

Other Meds:

Current Illness:

ID: 1611731
Sex: F
Age: 44
State: FL

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 08/22/2021
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: body aches; 98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit; headache; hand was numb for 6 hours; migraine; dizzy; administered downward in her left arm; wrist felt like some one was squeezing it; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm) and ARTHRALGIA (wrist felt like some one was squeezing it) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 148A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Factor V Leiden thrombophilia (blood clot in left arm 3 years ago). Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it) and HEADACHE (headache). On 01-Apr-2021, the patient experienced MYALGIA (body aches) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 01-Apr-2021, HYPOAESTHESIA (hand was numb for 6 hours), MIGRAINE (migraine), DIZZINESS (dizzy), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (administered downward in her left arm), ARTHRALGIA (wrist felt like some one was squeezing it), MYALGIA (body aches), HEADACHE (headache) and PYREXIA (98 degree Fahrenheit fever for a day/fever of 99.5 degrees Fahrenheit) had resolved. Not Provided This case was linked to US-irms-MOD21-097869 (E2B Linked Report). This case was linked to MOD-2021-090673 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received; adverse events and vaccination facility details were added.; Sender's Comments: US-irms-MOD21-097869:irms

Other Meds: ELIQUIS

Current Illness:

ID: 1611732
Sex: M
Age:
State: SC

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

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Allergies:

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

Symptoms: bad sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (bad sweating) in a 41-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced HYPERHIDROSIS (bad sweating). At the time of the report, HYPERHIDROSIS (bad sweating) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1611733
Sex: M
Age: 34
State: CA

Vax Date: 03/05/2021
Onset Date: 03/05/2021
Rec V Date: 08/22/2021
Hospital:

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Allergies:

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

Symptoms: fever; headache; body aches; muscle pain; tremors; weak; bone pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain) and TREMOR (tremors) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. 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 PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain). On 06-Mar-2021, PYREXIA (fever), HEADACHE (headache), PAIN (body aches), MYALGIA (muscle pain), TREMOR (tremors), ASTHENIA (weak) and BONE PAIN (bone pain) 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. No concomitant medications taken. No treatment information provided. This case was linked to MOD-2021-090705 (Patient Link).

Other Meds:

Current Illness:

ID: 1611734
Sex: F
Age: 52
State: MI

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 08/22/2021
Hospital:

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Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Hot-flashes; Difficulty breathing; Arm swollen like a baseball; Arm tender; Hear rate 194; Headache; Fatigue; Joint pain; Muscle pain; Fever of 101.9; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender) and PALPITATIONS (Hear rate 194) in a 52-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. No medical history was provided by the reporter. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), MAGNESIUM and CALCIUM for an unknown indication. On 17-Apr-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Apr-2021, the patient experienced HOT FLUSH (Hot-flashes), DYSPNOEA (Difficulty breathing), PERIPHERAL SWELLING (Arm swollen like a baseball), TENDERNESS (Arm tender), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea). On 19-Apr-2021, DYSPNOEA (Difficulty breathing) outcome was unknown. On 22-Apr-2021, HOT FLUSH (Hot-flashes), PERIPHERAL SWELLING (Arm swollen like a baseball), PALPITATIONS (Hear rate 194), HEADACHE (Headache), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), PYREXIA (Fever of 101.9) and NAUSEA (Nausea) had resolved. At the time of the report, TENDERNESS (Arm tender) and MYALGIA (Muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 101.9 f (High) outcome was recovered/resolved. On 17-Apr-2021, Heart rate: 194 (High) outcome was recovered/resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported

Other Meds: VITAMIN D 2000; MAGNESIUM; CALCIUM

Current Illness:

ID: 1611735
Sex: M
Age:
State:

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

Vax Type:
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Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Slight fever; Headache; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Fatigue) in a 57-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Slight fever), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. Not Provided No concomitant information and no treatment medication were reported. Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: No additional information was provided.

Other Meds:

Current Illness:

ID: 1611736
Sex: F
Age: 83
State: PA

Vax Date: 03/24/2021
Onset Date: 03/31/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of Moderna COVID-19 vaccine on 24MAR2021 (Lot# 018B21A ) and the Second dose on 31MAR2021) 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. No concomitant drugs and treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-090246 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090246:

Other Meds:

Current Illness:

ID: 1611737
Sex: F
Age: 80
State: IL

Vax Date: 01/19/2021
Onset Date: 02/17/2021
Rec V Date: 08/22/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 026L20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder, Arthritis, GERD, Depression, Hyperglycemia, Drug allergy (Nexium), Drug allergy (Prilosec), Drug allergy (Zantac) and Drug allergy (PCN). Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) for Depression, PIOGLITAZONE HYDROCHLORIDE (ACTOS) for Hyperglycemia, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Thyroid disorder. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain in arm). On 18-Feb-2021, PAIN IN EXTREMITY (Pain in arm) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (Pain in arm) to be probably related. Treatment information was not provided by the reporter. This case was linked to MOD-2021-009888, MOD-2021-009888 (Patient Link).

Other Meds: LEVOTHYROXIN; ACTOS; PAXIL [PAROXETINE HYDROCHLORIDE]

Current Illness: Arthritis; Depression; Drug allergy (Zantac); Drug allergy (Prilosec); Drug allergy (PCN); Drug allergy (Nexium); GERD; Hyperglycemia; Thyroid disorder

ID: 1611738
Sex: M
Age: 49
State: PA

Vax Date: 03/27/2021
Onset Date:
Rec V Date: 08/22/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

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

Symptoms: allergies have intensified; Urticaria with itching, on exposed parts and after exposure to cold; itching on exposed parts and after exposure to cold; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy. On 27-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 HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold). At the time of the report, HYPERSENSITIVITY (allergies have intensified), COLD URTICARIA (Urticaria with itching, on exposed parts and after exposure to cold) and PRURITUS (itching on exposed parts and after exposure to cold) 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. Treatment information was not provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy

ID: 1611739
Sex: F
Age:
State: OR

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

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

Lab Data:

Allergies:

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

Symptoms: Little fatigued; Slight chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little fatigued) and CHILLS (Slight chills) in a 73-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 FATIGUE (Little fatigued) and CHILLS (Slight chills). At the time of the report, FATIGUE (Little fatigued) and CHILLS (Slight chills) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 26 October 2021 2:21am