chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Pain in extremity, Swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit), SWELLING (Some swelling), FATIGUE (Fatigue) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017CZIA) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LISINOPRIL and THYROID (ARMOUR THYROID) for an unknown indication. On 30-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 PAIN IN EXTREMITY (arm hurt a little bit), SWELLING (Some swelling), FATIGUE (Fatigue) and DIARRHOEA (Diarrhea). At the time of the report, PAIN IN EXTREMITY (arm hurt a little bit), SWELLING (Some swelling), FATIGUE (Fatigue) and DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Treatment information was reported. This case was linked to MOD-2021-207553 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: It contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the 2nd  dose of Modera vaccine; 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 PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Modera 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Modera vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 2nd  dose of Modera vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Myalgia
Clinical narrative: can breath to will; arm hurt; 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 DYSPNOEA (can breath to will) and MYALGIA (arm hurt) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (can breath to will) and MYALGIA (arm hurt). At the time of the report, DYSPNOEA (can breath to will) and MYALGIA (arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numb finger tips; 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 HYPOAESTHESIA (Numb finger tips) 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 HYPOAESTHESIA (Numb finger tips). At the time of the report, HYPOAESTHESIA (Numb finger tips) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: fever; nausea; 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 PYREXIA (fever) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PYREXIA (fever) and NAUSEA (nausea). At the time of the report, PYREXIA (fever) and NAUSEA (nausea) outcome was unknown.            Med Info. AE submitted.  patient has second moderna vaccine and is suffering from fever and nausea Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; 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 HEADACHE (headache) 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 HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not reported
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugars to be significantly higher than usual for about 3 weeks; 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 BLOOD GLUCOSE INCREASED (Blood sugars to be significantly higher than usual for about 3 weeks) 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 Diabetes.    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 BLOOD GLUCOSE INCREASED (Blood sugars to be significantly higher than usual for about 3 weeks). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugars to be significantly higher than usual for about 3 weeks) 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 product use was provided by the reporter.  No treatment medication was provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dysstasia, Feeling abnormal, Hypoaesthesia
Clinical narrative: swelling of the throat; knees look like water balloons; shaking like a jitterbug and twitching; stuffy nose; cough that is getting worse; feels over heated/ temperature of 103.7F; Squeezing the life out of her neck; both legs went numb; cant stand; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both legs went numb), PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching) and NASAL CONGESTION (stuffy nose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA (both legs went numb) and DYSSTASIA (cant stand). On 03-Jun-2021, the patient experienced FEELING ABNORMAL (Squeezing the life out of her neck). On an unknown date, the patient experienced PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching), NASAL CONGESTION (stuffy nose), COUGH (cough that is getting worse) and PYREXIA (feels over heated/ temperature of 103.7F). At the time of the report, HYPOAESTHESIA (both legs went numb), PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching), NASAL CONGESTION (stuffy nose), DYSSTASIA (cant stand), FEELING ABNORMAL (Squeezing the life out of her neck), COUGH (cough that is getting worse) and PYREXIA (feels over heated/ temperature of 103.7F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7 (Inconclusive) 103.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter and no concomitant medication reported.; 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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Nasal congestion, Pharyngeal swelling, Pyrexia, Tremor
Clinical narrative: swelling of the throat; knees look like water balloons; shaking like a jitterbug and twitching; stuffy nose; cough that is getting worse; feels over heated/ temperature of 103.7F; Squeezing the life out of her neck; both legs went numb; cant stand; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both legs went numb), PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching) and NASAL CONGESTION (stuffy nose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA (both legs went numb) and DYSSTASIA (cant stand). On 03-Jun-2021, the patient experienced FEELING ABNORMAL (Squeezing the life out of her neck). On an unknown date, the patient experienced PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching), NASAL CONGESTION (stuffy nose), COUGH (cough that is getting worse) and PYREXIA (feels over heated/ temperature of 103.7F). At the time of the report, HYPOAESTHESIA (both legs went numb), PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching), NASAL CONGESTION (stuffy nose), DYSSTASIA (cant stand), FEELING ABNORMAL (Squeezing the life out of her neck), COUGH (cough that is getting worse) and PYREXIA (feels over heated/ temperature of 103.7F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7 (Inconclusive) 103.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter and no concomitant medication reported.; 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.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a punctured vial after the 12 hour timeframe in the refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hour timeframe in the refrigerator) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hour timeframe in the refrigerator). On 19-Mar-2021, EXPIRED PRODUCT ADMINISTERED (received a dose from a punctured vial after the 12 hour timeframe in the refrigerator) 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 medications were reported. No Treatment information was reported.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Trouble breathing; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing) and PYREXIA (Fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 027C21A) for COVID-19 vaccination.     The patient's past medical history included Asthma (At age 15).   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced PYREXIA (Fever). On 28-May-2021, the patient experienced DYSPNOEA (Trouble breathing). At the time of the report, DYSPNOEA (Trouble breathing) and PYREXIA (Fever) had not resolved.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with respect to mRNA-1273 was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: just to make my next shot my first shoot was 4/28/21; 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 PRODUCT DOSE OMISSION ISSUE (just to make my next shot my first shoot was 4/28/21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-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 PRODUCT DOSE OMISSION ISSUE (just to make my next shot my first shoot was 4/28/21). At the time of the report, PRODUCT DOSE OMISSION ISSUE (just to make my next shot my first shoot was 4/28/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: Diarrhoea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and FATIGUE (Fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017CZIA) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included LISINOPRIL and THYROID (ARMOUR THYROID) for an unknown indication.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhoea) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Diarrhoea) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-207535 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up Information Received on 06-JUL-2021  contains No New Information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment details were provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, No adverse event, X-ray
Clinical narrative: severe pain in neck has not gone away at all; can't turn neck to the left or right very much; severe pain in neck / crook in my neck/came as a result of this second shot; first shot didn't affect me at all; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe pain in neck has not gone away at all), MUSCULOSKELETAL STIFFNESS (can't turn neck to the left or right very much), NECK PAIN (severe pain in neck / crook in my neck/came as a result of this second shot) and NO ADVERSE EVENT (first shot didn't affect me at all) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included METFORMIN, METOPROLOL, DILTIAZEM, BUMETANIDE, LISINOPRIL, PANTOPRAZOLE, LOVASTATIN, TAMSULOSIN, HYDRALAZINE, GLIPIZIDE, COLECALCIFEROL (VITAMIN D3), GLUCOSAMINE, FISH OIL, MULTIVITAMIN [VITAMINS NOS] and CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced NO ADVERSE EVENT (first shot didn't affect me at all). On 13-Mar-2021, the patient experienced NECK PAIN (severe pain in neck / crook in my neck/came as a result of this second shot). On 03-Jun-2021, the patient experienced NECK PAIN (severe pain in neck has not gone away at all) and MUSCULOSKELETAL STIFFNESS (can't turn neck to the left or right very much). The patient was treated with PREDNISONE for Pain, at an unspecified dose and frequency and CYCLOBENZAPRINE for Sleeplessness, at an unspecified dose and frequency. At the time of the report, NECK PAIN (severe pain in neck has not gone away at all) had not resolved and MUSCULOSKELETAL STIFFNESS (can't turn neck to the left or right very much), NECK PAIN (severe pain in neck / crook in my neck/came as a result of this second shot) and NO ADVERSE EVENT (first shot didn't affect me at all) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, X-ray: normal (normal) nothing wrong with it.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No known allergies were provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got my second dose too early; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second dose too early) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second dose too early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second dose too early) outcome was unknown.            No concomitant medications were reported.  No treatment medications were provided by the reporter.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (raised area at the injection site.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (raised area at the injection site.). On 15-Apr-2021, VACCINATION SITE PAIN (sore arm) and VACCINATION SITE SWELLING (raised area at the injection site.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. No treatment medications provided by the reporter.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 03-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose in allocated timeframe; 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 PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in allocated timeframe) 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.    In January 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 PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in allocated timeframe). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose in allocated timeframe) 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 concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Discharge
Clinical narrative: start to have some discharge and have been a month and still; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of DISCHARGE (start to have some discharge and have been a month and still) 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 01-May-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 DISCHARGE (start to have some discharge and have been a month and still). At the time of the report, DISCHARGE (start to have some discharge and have been a month and still) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided/unknown by the reporter Treatment information was not provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on body) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced RASH (Rash on body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency and CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash on body) had not resolved. Concomitant medication was not provided. Additional information was provided that Cortisone 10 cream was used for rash treatment.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever 102; 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 PYREXIA (Fever 102) 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 02-Jun-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 an unknown date, the patient experienced PYREXIA (Fever 102). At the time of the report, PYREXIA (Fever 102) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102F.         No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Everybody I know is getting the second shot and is like really sick, and a family members who got the second dose and they were really sick; 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 ILLNESS (Everybody I know is getting the second shot and is like really sick, and a family members who got the second dose and they were really sick) 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 08-Apr-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 ILLNESS (Everybody I know is getting the second shot and is like really sick, and a family members who got the second dose and they were really sick). At the time of the report, ILLNESS (Everybody I know is getting the second shot and is like really sick, and a family members who got the second dose and they were really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; 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 URTICARIA (hives) 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) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment details was not reported .
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna COVID-19 vaccine as SECOND dose today to a patient who had the **PFIZER** COVID-19 vaccine as FIRST dose; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna COVID-19 vaccine as SECOND dose today to a patient who had the **PFIZER** COVID-19 vaccine as FIRST dose) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 477C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.  Concomitant products included TRAZODONE, ATORVASTATIN, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), TIZANIDINE, DULOXETINE, GABAPENTIN, MELOXICAM, BUPROPION HYDROCHLORIDE (WELLBUTRIN), FUROSEMIDE, FINASTERIDE, POTASSIUM CHLORIDE, FOLIC ACID, ERGOCALCIFEROL (VITAMIN D2), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), SALBUTAMOL (PROVENTIL [SALBUTAMOL]), VITAMIN B3, MAGNESIUM, ZINC, CUPRUM and CALCIUM for an unknown indication.   On 04-May-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna COVID-19 vaccine as SECOND dose today to a patient who had the **PFIZER** COVID-19 vaccine as FIRST dose). On 03-Jun-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna COVID-19 vaccine as SECOND dose today to a patient who had the **PFIZER** COVID-19 vaccine as FIRST dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported. Patient  did not have any reaction after receiving the Moderna COVID-19 mRNA vaccine second dose.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Feeling unwell; sore arm; Myalgia; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell), VACCINATION SITE PAIN (sore arm), MYALGIA (Myalgia) and FATIGUE (Tiredness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell), VACCINATION SITE PAIN (sore arm), MYALGIA (Myalgia) and FATIGUE (Tiredness). At the time of the report, MALAISE (Feeling unwell), VACCINATION SITE PAIN (sore arm), MYALGIA (Myalgia) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not provided  Concomitant medication were not provided   This case was linked to MOD-2021-207560 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 39 days between first and second dose; Child 17 years old at time of second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child 17 years old at time of second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (39 days between first and second dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child 17 years old at time of second dose). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (39 days between first and second dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Child 17 years old at time of second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (39 days between first and second dose) had resolved. Not Provided          concomitant product used was not provided. treatment information was not provided. DOB of the consumer was incorrectly captured.   This case was linked to MOD-2021-078006 (Patient Link).
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered, Underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Pretty big amount of the liquid leaked while administering the vaccine), DEVICE CONNECTION ISSUE (It was because of the syringe) and INCORRECT DOSE ADMINISTERED (Administering another dose in the opposite arm) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced UNDERDOSE (Pretty big amount of the liquid leaked while administering the vaccine) and DEVICE CONNECTION ISSUE (It was because of the syringe). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Administering another dose in the opposite arm). On 03-Jun-2021, UNDERDOSE (Pretty big amount of the liquid leaked while administering the vaccine) and DEVICE CONNECTION ISSUE (It was because of the syringe) had resolved. At the time of the report, INCORRECT DOSE ADMINISTERED (Administering another dose in the opposite arm) 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. Concomitant product use was not provided by the reporter. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up telephone call response (TCR) received from  pharmacist. Added new event with outcome.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: I just started coughing; 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 COUGH (I just started coughing) 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 COUGH (I just started coughing). At the time of the report, COUGH (I just started coughing) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Excessive bleeding while it is not her regular periods; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Excessive bleeding while it is not her regular periods) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Excessive bleeding while it is not her regular periods). At the time of the report, HEAVY MENSTRUAL BLEEDING (Excessive bleeding while it is not her regular periods) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Amnesia
Clinical narrative: memory loss; 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 AMNESIA (memory loss) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 AMNESIA (memory loss). At the time of the report, AMNESIA (memory loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: fatigue; body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder. Concomitant products included CALCIUM, VITAMINS NOS and SIMVASTATIN (STATIN [SIMVASTATIN]) for an unknown indication.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced MYALGIA (body aches). On 18-May-2021, the patient experienced FATIGUE (fatigue). On 13-May-2021, MYALGIA (body aches) had resolved. At the time of the report, FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Product known to be used by the patient, within two week prior to the event, included thyroid medicine. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: redness in the arm; swelling in the arm; 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 ERYTHEMA (redness in the arm) and PERIPHERAL SWELLING (swelling in the 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 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 ERYTHEMA (redness in the arm) and PERIPHERAL SWELLING (swelling in the arm). At the time of the report, ERYTHEMA (redness in the arm) and PERIPHERAL SWELLING (swelling in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  No treatment information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Therapeutic response unexpected
Clinical narrative: improvement of Parkinson's symptoms after first dose; sore arm; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (improvement of Parkinson's symptoms after first dose), MYALGIA (sore arm) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Parkinson's disease since 2007. Concomitant products included GABAPENTIN for Neuropathic pain, CARBIDOPA, LEVODOPA (CARBIDOPA AND LEVODOPA) for Parkinson's disease.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (sore arm) and PYREXIA (Fever). On 27-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improvement of Parkinson's symptoms after first dose). On 26-Mar-2021, MYALGIA (sore arm) and PYREXIA (Fever) had resolved. On 28-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (improvement of Parkinson's symptoms after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Memory vitamins is known to have been used by the patient. No treatment information was provided by the reporter.   This case was linked to MOD-2021-207635 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness; Tingling; 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 HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) 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.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling). At the time of the report, HYPOAESTHESIA (Numbness) and PARAESTHESIA (Tingling) outcome was unknown.            Concomitant medication were not reported  Treatment medication information were not reported  Action taken with mRNA-1273 in response to the event was not applicable   Reporter did not allow further contact
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid 19; Unwell; Aches, pain; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid 19), MALAISE (Unwell) and MYALGIA (Aches, pain) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No medical history of patient was reported.  Concurrent medical conditions included Heart disorder.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid 19). On an unknown date, the patient experienced MALAISE (Unwell) and MYALGIA (Aches, pain). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid 19) had not resolved and MALAISE (Unwell) and MYALGIA (Aches, pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products included Heart medications. No laboratory data was provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: became infected with cover-19; time I may need to wait after getting cover 19; 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 COVID-19 (became infected with cover-19) and PRODUCT DOSE OMISSION ISSUE (time I may need to wait after getting cover 19) 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 28-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 COVID-19 (became infected with cover-19) and PRODUCT DOSE OMISSION ISSUE (time I may need to wait after getting cover 19). At the time of the report, COVID-19 (became infected with cover-19) and PRODUCT DOSE OMISSION ISSUE (time I may need to wait after getting cover 19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: A pulsing movement near our thumb; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (A pulsing movement near our thumb) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (A pulsing movement near our thumb). At the time of the report, MUSCLE TWITCHING (A pulsing movement near our thumb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.