chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Flu like symptoms; very hot to touch; Vaccination site itchy; Headache; Injection site was very red; Injection site rash; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Injection site was very red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) 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 INSULIN GLARGINE (LANTUS), METOPROLOL TARTRATE, AMLODIPINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash) had resolved.            Patient reported that the side effects healed after couple of days.  Treatment medications was not provided by the reporter   This case was linked to MOD-2021-030690 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Flu like symptoms; very hot to touch; Vaccination site itchy; Headache; Injection site was very red; Injection site rash; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Injection site was very red) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) 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 INSULIN GLARGINE (LANTUS), METOPROLOL TARTRATE, AMLODIPINE, OMEPRAZOLE, PIOGLITAZONE, HYDROCHLOROTHIAZIDE, GLIPIZIDE and TRAZODONE for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE WARMTH (very hot to touch), VACCINATION SITE PRURITUS (Vaccination site itchy), HEADACHE (Headache), VACCINATION SITE ERYTHEMA (Injection site was very red) and VACCINATION SITE RASH (Injection site rash) had resolved.            Patient reported that the side effects healed after couple of days.  Treatment medications was not provided by the reporter   This case was linked to MOD-2021-030690 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Groin pain
Clinical narrative: pain in groin; This spontaneous case was reported by a non-health professional and describes the occurrence of GROIN PAIN (pain in groin) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.    On 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (pain in groin). At the time of the report, GROIN PAIN (pain in groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This spontaneous case was reported by a  and describes the occurrence of GROIN PAIN (pain in groin) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced GROIN PAIN (pain in groin). At the time of the report, GROIN PAIN (pain in groin) outcome was unknown.       Patient take Amoxicillin and Prednisone as a Concomitant medication.     Reporter did not allow further contact
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Patient experienced headache 1 & 1/2 week after receiving 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (Patient experienced headache 1 & 1/2 week after receiving 1st dose) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Unspecified other surgery). Concomitant products included IBUPROFEN (ADVIL 12 HOUR) for Surgery.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, the patient experienced HEADACHE (Patient experienced headache 1 & 1/2 week after receiving 1st dose). At the time of the report, HEADACHE (Patient experienced headache 1 & 1/2 week after receiving 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take any treatment for the event
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Throat tightness
Clinical narrative: generalized itching; feeling of tightness of throat; shortness of breath; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (generalized itching), THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included FEXOFENADINE, ALPRAZOLAM, CARVEDILOL, VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES), Esterase, THIOPHENE and USTELL for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (generalized itching), THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath). On 15-Feb-2021, THROAT TIGHTNESS (feeling of tightness of throat) and DYSPNOEA (shortness of breath) had resolved. At the time of the report, PRURITUS (generalized itching) 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.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired; Fatigued; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired) and FATIGUE (Fatigued) 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) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (Tired) and FATIGUE (Fatigued). At the time of the report, FATIGUE (Tired) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: 2.5-3 inch hard spot on her arm (half the size of a tennis ball); Swelling and redness in the injection site; Swelling and redness in the injection site; More painful/soreness at the injection site post first dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)), INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) 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 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)). 01-Mar-2021, the patient experienced INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) on 28-Feb-2021 for Injection site reaction, at a dose of 1 dosage form. At the time of the report, INJECTION SITE REACTION (2.5-3 inch hard spot on her arm (half the size of a tennis ball)), INJECTION SITE SWELLING (Swelling and redness in the injection site), INJECTION SITE ERYTHEMA (Swelling and redness in the injection site) and INJECTION SITE PAIN (More painful/soreness at the injection site post first dose) had not resolved.            As treatment patient  also applied ice but with no relief   This case was linked to MOD-2021-030659 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Erythema, Pain in extremity, Throat tightness, Vaccination site erythema
Clinical narrative: arm was sore at the injection site; hot at the injection site; red at injection site; face got red & blotchy; neck got red & blotchy; mouth got very dry; throat tightened up; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry) and VACCINATION SITE WARMTH (hot at the injection site) in a 67-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.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DRY MOUTH (mouth got very dry) and THROAT TIGHTNESS (throat tightened up). On 25-Feb-2021 at 12:05 AM, the patient experienced ERYTHEMA (face got red & blotchy) and ERYTHEMA (neck got red & blotchy). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore at the injection site), VACCINATION SITE WARMTH (hot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry), VACCINATION SITE WARMTH (hot at the injection site), THROAT TIGHTNESS (throat tightened up) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm was sore at the injection site; hot at the injection site; red at injection site; face got red & blotchy; neck got red & blotchy; mouth got very dry; throat tightened up; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry) and VACCINATION SITE WARMTH (hot at the injection site) in a 67-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.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DRY MOUTH (mouth got very dry) and THROAT TIGHTNESS (throat tightened up). On 25-Feb-2021 at 12:05 AM, the patient experienced ERYTHEMA (face got red & blotchy) and ERYTHEMA (neck got red & blotchy). On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore at the injection site), VACCINATION SITE WARMTH (hot at the injection site) and VACCINATION SITE ERYTHEMA (red at injection site). At the time of the report, ERYTHEMA (face got red & blotchy), ERYTHEMA (neck got red & blotchy), PAIN IN EXTREMITY (arm was sore at the injection site), DRY MOUTH (mouth got very dry), VACCINATION SITE WARMTH (hot at the injection site), THROAT TIGHTNESS (throat tightened up) and VACCINATION SITE ERYTHEMA (red at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Fatigue, Headache, Malaise, Migraine
Clinical narrative: bad reaction to the second shot; friend is female and she had to lied in bed all day; Fatigue; headache; pain in arm; migraine; muscle pain; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache) and PAIN IN EXTREMITY (pain in arm) in a 19-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 No adverse event. Concomitant products included PROLIFE for Asthma, ASCORBIC ACID, VITAMIN D3, ZINC and VITAMIN B COMPLEX for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache), PAIN IN EXTREMITY (pain in arm), MIGRAINE (migraine), MYALGIA (muscle pain) and MALAISE (Malaise). At the time of the report, VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache), PAIN IN EXTREMITY (pain in arm), MIGRAINE (migraine), MYALGIA (muscle pain) and MALAISE (Malaise) outcome was unknown.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination complication
Clinical narrative: bad reaction to the second shot; friend is female and she had to lied in bed all day; Fatigue; headache; pain in arm; migraine; muscle pain; Malaise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache) and PAIN IN EXTREMITY (pain in arm) in a 19-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 No adverse event. Concomitant products included PROLIFE for Asthma, ASCORBIC ACID, VITAMIN D3, ZINC and VITAMIN B COMPLEX for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache), PAIN IN EXTREMITY (pain in arm), MIGRAINE (migraine), MYALGIA (muscle pain) and MALAISE (Malaise). At the time of the report, VACCINATION COMPLICATION (bad reaction to the second shot), BEDRIDDEN (friend is female and she had to lied in bed all day), FATIGUE (Fatigue), HEADACHE (headache), PAIN IN EXTREMITY (pain in arm), MIGRAINE (migraine), MYALGIA (muscle pain) and MALAISE (Malaise) outcome was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: COVID arm; Raised Bump; injection arm ache; Red circle; Injection arm ache; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), PAIN IN EXTREMITY (Injection arm ache) and INJECTION SITE PAIN (injection arm ache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle). At the time of the report, NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache) had not resolved, VACCINATION SITE REACTION (COVID arm) outcome was unknown and INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment of the events include, Ibuprofen and naproxen.   This case was linked to US-MODERNATX, INC.-MOD-2021-098624 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up information was received on 29 Apr 2021, include, contact details, date of second dose administration and events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098624:Case created for second dose
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: COVID arm; Raised Bump; injection arm ache; Red circle; Injection arm ache; neck ache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck ache), VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), PAIN IN EXTREMITY (Injection arm ache) and INJECTION SITE PAIN (injection arm ache) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle). At the time of the report, NECK PAIN (neck ache) and PAIN IN EXTREMITY (Injection arm ache) had not resolved, VACCINATION SITE REACTION (COVID arm) outcome was unknown and INJECTION SITE MASS (Raised Bump), INJECTION SITE PAIN (injection arm ache) and INJECTION SITE ERYTHEMA (Red circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment of the events include, Ibuprofen and naproxen.   This case was linked to US-MODERNATX, INC.-MOD-2021-098624 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up information was received on 29 Apr 2021, include, contact details, date of second dose administration and events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098624:Case created for second dose
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site rash, Pruritus, Rash
Clinical narrative: bad itching; Redness; rash; circle of rash 3 or 4 inches below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site). At the time of the report, PRURITUS (bad itching), ERYTHEMA (Redness), RASH (rash) and INJECTION SITE RASH (circle of rash 3 or 4 inches below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Muscle soreness; Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    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 PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever). At the time of the report, PAIN IN EXTREMITY (Arm pain), MYALGIA (Muscle soreness) and PYREXIA (Slight fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Hypertension, Nausea, Pain in extremity
Clinical narrative: not able to eat; light headed; high blood pressure; nauseous; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), DECREASED APPETITE (not able to eat), DIZZINESS (light headed), HYPERTENSION (high blood pressure) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included SEMAGLUTIDE (OZEMPIC) for Type 2 diabetes mellitus.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 28-Feb-2021, the patient experienced DECREASED APPETITE (not able to eat), DIZZINESS (light headed), HYPERTENSION (high blood pressure) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (arm was sore), DECREASED APPETITE (not able to eat), DIZZINESS (light headed), HYPERTENSION (high blood pressure) and NAUSEA (nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient got COVID after the first dose of the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine) 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 SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient got COVID after the first dose of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) got COVID after the first dose of the vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication and treatment drug were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in arm at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm at injection site). The patient was treated with NAPROXEN at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Pain in arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: The site of injection itching; the site of injection is swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling). At the time of the report, INJECTION SITE PRURITUS (The site of injection itching) and INJECTION SITE SWELLING (the site of injection is swelling) 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus, Pyrexia, Swelling
Clinical narrative: Fever; Redness; Swelling; Hotness; Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), ERYTHEMA (Redness), SWELLING (Swelling), FEELING HOT (Hotness) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Vomiting
Clinical narrative: Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had second shot outside of 42 day window; A spontaneous report was received from a consumer concerning a 69-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced second shot outside of 42 day window (Inappropriate schedule of vaccine administration).  The patient's medical history, was not reported. Concomitant medications reported included bupropion, lamotrigine, Librium, progesterone/ estrogen, magnesium glycinate, deplin and suboxone.  On 13 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly for prophylaxis of COVID-19 infection. Patient took second dose outside of 42 day window.  No laboratory details was provided.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, second shot outside of 42 day window, was considered as resolved on 27 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # 012A21A  with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of arm) 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 10-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness of arm). At the time of the report, MYALGIA (Soreness of arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Based on the available information and the temporal association between the use of the product and the event occurrence, a causal relationship cannot be excluded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound antenatal screen
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 33-year-old female patient (gravida 4, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage on 26-May-2017, Miscarriage on 15-Nov-2017, Depression, Anxiety, Degenerative disc disease in 2009, Stenosis in 2009, Spinal osteoarthritis in 2009, Alcohol use from 2003 to 2011 and Ex-smoker from 2006 to 2020. Concurrent medical conditions included Allergy to topical drugs (allergic to sulfa drugs) and Latex allergy. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) and VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores, MAGNESIUM for Headache and Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, ALCOHOL, NICOTINE and MARIJUANA.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Sep-2020 and the estimated date of delivery was 09-Jun-2021. On 25-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 25-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2020, Pregnancy test: positive (Positive) Positive. On 27-Sep-2020, Ultrasound antenatal screen: normal (normal) normal.     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.   On a unknown dates, the patient reports having an ultrasound, NIPP, and genetic screening that resulted in normal findings.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Palpitations
Clinical narrative: Difficulty Breathing; Heart Palpitation for two and half days; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 23-Feb-2021, the patient experienced DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness). At the time of the report, DYSPNOEA (Difficulty Breathing), PALPITATIONS (Heart Palpitation for two and half days) and DIZZINESS (Dizziness) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided. Patient treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Heart rate increased, Hypotension
Clinical narrative: Very Weak; Lightheaded; Low Blood Pressure 130/60 mmHg; High Resting Heart Rate 80 BPM.; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID- 19 Immunisation.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.). At the time of the report, ASTHENIA (Very Weak), DIZZINESS (Lightheaded), HYPOTENSION (Low Blood Pressure 130/60 mmHg) and HEART RATE INCREASED (High Resting Heart Rate 80 BPM.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 80 80 BPM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: sore arm; very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and SOMNOLENCE (very sleepy) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm) and SOMNOLENCE (very sleepy). At the time of the report, VACCINATION SITE PAIN (sore arm) and SOMNOLENCE (very sleepy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Nine days later she had a pruritic rash with urticaria lasting four days; Nine days later she had a pruritic rash with urticaria lasting four days; This spontaneous case was reported by a health care professional and describes the occurrence of RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days). At the time of the report, RASH PRURITIC (Nine days later she had a pruritic rash with urticaria lasting four days) and URTICARIA (Nine days later she had a pruritic rash with urticaria lasting four days) 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.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site pain
Clinical narrative: red ring around the injection site; soreness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red ring around the injection site) and VACCINATION SITE PAIN (soreness around the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RASH ERYTHEMATOUS (red ring around the injection site) and VACCINATION SITE PAIN (soreness around the injection site). At the time of the report, RASH ERYTHEMATOUS (red ring around the injection site) and VACCINATION SITE PAIN (soreness around the injection site) 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. Treatment medications were not provided by reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 041L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Muscle strain, Pain, Rash
Clinical narrative: shingles; rash on her ribs on her front right side; pulled muscle; pain in her right back shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles), PAIN (pain in her right back shoulder blade), RASH (rash on her ribs on her front right side) and MUSCLE STRAIN (pulled muscle) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN (pain in her right back shoulder blade) and MUSCLE STRAIN (pulled muscle). On 21-Feb-2021, the patient experienced RASH (rash on her ribs on her front right side). On 22-Feb-2021, the patient experienced HERPES ZOSTER (shingles). On 22-Feb-2021, MUSCLE STRAIN (pulled muscle) had resolved. At the time of the report, HERPES ZOSTER (shingles), PAIN (pain in her right back shoulder blade) and RASH (rash on her ribs on her front right side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: did not feel well; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel well) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (did not feel well) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 24-Feb-2021, MALAISE (did not feel well) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival pain, Hypoaesthesia, Injection site rash, Peripheral swelling
Clinical narrative: Left leg became really swollen to the point the skin was stretching; Leg was numb; Gums became very sensitive; Developed a rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm) in a 70-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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm). At the time of the report, PERIPHERAL SWELLING (Left leg became really swollen to the point the skin was stretching), HYPOAESTHESIA (Leg was numb), GINGIVAL PAIN (Gums became very sensitive) and INJECTION SITE RASH (Developed a rash on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment drugs include Steroid for 7 days for an unknown indication.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Sharp ringing noise in ear still going; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Sharp ringing noise in ear still going) and FATIGUE (Little tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy and Tinnitus.   On 28-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 01-Mar-2021, the patient experienced TINNITUS (Sharp ringing noise in ear still going) and FATIGUE (Little tired). At the time of the report, TINNITUS (Sharp ringing noise in ear still going) had not resolved and FATIGUE (Little tired) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.