chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Supraventricular tachycardia
Clinical narrative: Body ache; Super ventricular tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of SUPRAVENTRICULAR TACHYCARDIA (Super ventricular tachycardia) and MYALGIA (Body ache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced SUPRAVENTRICULAR TACHYCARDIA (Super ventricular tachycardia). On an unknown date, the patient experienced MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SUPRAVENTRICULAR TACHYCARDIA (Super ventricular tachycardia) and MYALGIA (Body ache) outcome was unknown.            No concomitant medicines were reported.  Action taken with the drug in response to events was not applicable.  About 2.5 months after vaccination (30May2021) patient went to the hospital and was diagnosed with super ventricular tachycardia (SVT) and at the hospital for a few hours until it resolved on its own.and now she is going back on  5Aug2021 for an ablation of the heart.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to  patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) 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 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to  patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned. The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Product dose omission issue
Clinical narrative: Has not received the second dose, 2 months after the first dose; Tingling on the tongue; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tingling on the tongue) and PRODUCT DOSE OMISSION ISSUE (Has not received the second dose, 2 months after the first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Bee sting hypersensitivity.    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced PARAESTHESIA ORAL (Tingling on the tongue). On 21-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose, 2 months after the first dose). On 21-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose, 2 months after the first dose) had resolved. At the time of the report, PARAESTHESIA ORAL (Tingling on the tongue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Patient always carries an EpiPen with her as she's allergic to Bee stings.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine that expired yesterday was inadvertently given today; 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 EXPIRED PRODUCT ADMINISTERED (vaccine that expired yesterday was inadvertently given today) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that expired yesterday was inadvertently given today). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine that expired yesterday was inadvertently given today) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter  Treatment information was not provided   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for 2 days). At the time of the report, ILLNESS (Sick for 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was reported. No treatment medications was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: ill for five days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill for five days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (ill for five days). The patient was treated with GLUCOSE, POTASSIUM CHLORIDE (INTRAVENOUS DEXTROSE AND POTASSIUM CHLORIDE) (parenteral) for Illness, at a dose of UNK dosage form. At the time of the report, ILLNESS (ill for five days) 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 event was not applicable. No relevant concomitant medications were reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Feeding disorder, Illness
Clinical narrative: getting sick and really weak; Hasn't been able to go back to work; Her stomach was hurting so bad at night that she went to ER; She's with diarrhea; Hasn't been able to eat anything; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea) and FEEDING DISORDER (Hasn't been able to eat anything) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) 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 LISINOPRIL for Blood pressure, INSULIN for Diabetes.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea), FEEDING DISORDER (Hasn't been able to eat anything) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea), FEEDING DISORDER (Hasn't been able to eat anything) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Body temperature: 100 (High) Fever of 100 every day.     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: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Nausea
Clinical narrative: getting sick and really weak; Hasn't been able to go back to work; Her stomach was hurting so bad at night that she went to ER; She's with diarrhea; Hasn't been able to eat anything; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea) and FEEDING DISORDER (Hasn't been able to eat anything) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) 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 LISINOPRIL for Blood pressure, INSULIN for Diabetes.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea), FEEDING DISORDER (Hasn't been able to eat anything) and NAUSEA (Nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, ILLNESS (getting sick and really weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Hasn't been able to go back to work), ABDOMINAL PAIN UPPER (Her stomach was hurting so bad at night that she went to ER), DIARRHOEA (She's with diarrhea), FEEDING DISORDER (Hasn't been able to eat anything) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Body temperature: 100 (High) Fever of 100 every day.     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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Menstruation irregular, Myalgia, Pain in extremity
Clinical narrative: Chills; Body aches; Menstrual period for 2 1/2 months straight; Pretty sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Menstrual period for 2 1/2 months straight), PAIN IN EXTREMITY (Pretty sore right arm), CHILLS (Chills) and MYALGIA (Body aches) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced MENSTRUATION IRREGULAR (Menstrual period for 2 1/2 months straight) and PAIN IN EXTREMITY (Pretty sore right arm). On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. On 18-May-2021, PAIN IN EXTREMITY (Pretty sore right arm) had resolved. At the time of the report, MENSTRUATION IRREGULAR (Menstrual period for 2 1/2 months straight) had not resolved and CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications reported.  Patient's menstrual period started before the first dose of the vaccine. Patient reported that she never had COVID before and wanted to stress that she firmly believes that the extended menstrual period was associated with the Moderna vaccine.   This case was linked to MOD-2021-262879 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary pain
Clinical narrative: lung to hurt some when taking a really deep breath; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (lung to hurt some when taking a really deep breath) 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 PULMONARY PAIN (lung to hurt some when taking a really deep breath). At the time of the report, PULMONARY PAIN (lung to hurt some when taking a really deep breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Menstruation irregular, Myalgia
Clinical narrative: Body aches; chills ( 1st & 2nd dose); menstrual period for 2 1/2 months straight; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (menstrual period for 2 1/2 months straight), MYALGIA (Body aches) and CHILLS (chills ( 1st & 2nd dose)) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced MENSTRUATION IRREGULAR (menstrual period for 2 1/2 months straight). On an unknown date, the patient experienced MYALGIA (Body aches) and CHILLS (chills ( 1st & 2nd dose)). At the time of the report, MENSTRUATION IRREGULAR (menstrual period for 2 1/2 months straight), MYALGIA (Body aches) and CHILLS (chills ( 1st & 2nd dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided.  Treatment information was not provided.   This case was linked to MOD-2021-262867 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Missed second dose (extended time between doses)/ It has been 5 months; This spontaneous case was reported by a nurse and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Missed second dose (extended time between doses)/ It has been 5 months) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Missed second dose (extended time between doses)/ It has been 5 months). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Missed second dose (extended time between doses)/ It has been 5 months) 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.   No concomitant medication was provided No treatment medication was provided
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and FATIGUE (Tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (Fever) and FATIGUE (Tired). On 25-Mar-2021, PYREXIA (Fever) and FATIGUE (Tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 101 (High) fever of 101 degrees Fahrenheit.         No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-033369 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Smooth muscle antibody, Smooth muscle antibody positive
Clinical narrative: Tested positive for Smooth Muscle AB; This spontaneous case was reported by a consumer and describes the occurrence of SMOOTH MUSCLE ANTIBODY POSITIVE (Tested positive for Smooth Muscle AB) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced SMOOTH MUSCLE ANTIBODY POSITIVE (Tested positive for Smooth Muscle AB). At the time of the report, SMOOTH MUSCLE ANTIBODY POSITIVE (Tested positive for Smooth Muscle AB) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Smooth muscle antibody: positive (Positive) Positive (Routine testing).         No concomitant medications were provided. The patient reported that he is a healthy person and the test was a routine test. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: A big knot at the site of the injection for 10 days; Very warm to the touch/warm to the touch/it was hot to the touch; Sore; Arm began to swell slightly/Swollen arm; Itch at the injection site/itchy; It is a red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A big knot at the site of the injection for 10 days), VACCINATION SITE WARMTH (Very warm to the touch/warm to the touch/it was hot to the touch), PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (Arm began to swell slightly/Swollen arm) and VACCINATION SITE PRURITUS (Itch at the injection site/itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Robitussin DM Allergy), Cholesterol and Hypothyroidism. Concomitant products included ROSUVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced VACCINATION SITE MASS (A big knot at the site of the injection for 10 days), VACCINATION SITE WARMTH (Very warm to the touch/warm to the touch/it was hot to the touch), PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (Arm began to swell slightly/Swollen arm), VACCINATION SITE PRURITUS (Itch at the injection site/itchy) and VACCINATION SITE ERYTHEMA (It is a red). On 23-Jul-2021, VACCINATION SITE WARMTH (Very warm to the touch/warm to the touch/it was hot to the touch), PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (Arm began to swell slightly/Swollen arm) and VACCINATION SITE PRURITUS (Itch at the injection site/itchy) had resolved. At the time of the report, VACCINATION SITE MASS (A big knot at the site of the injection for 10 days) and VACCINATION SITE ERYTHEMA (It is a red) 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.   Patient blood type was RH negative. Patient had a seasonal cold from time to time. Patient had a bad reaction to a cough medicine - Robitussin DM. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up information was received on 30-Jul-2021, reporter information was updated. Patient demographics and medical history was updated. Concomitant medications were added. Added new events-Swollen arm, pain in arm, Vaccination site warmth and itchy. Event outcome was updated for above events was updated from unknown to recovered/resolved.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: A big knot at the site of the injection for 10 days; Very warm to the touch/warm to the touch/it was hot to the touch; Sore; Arm began to swell slightly/Swollen arm; Itch at the injection site/itchy; It is a red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (A big knot at the site of the injection for 10 days), VACCINATION SITE WARMTH (Very warm to the touch/warm to the touch/it was hot to the touch), PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (Arm began to swell slightly/Swollen arm) and VACCINATION SITE PRURITUS (Itch at the injection site/itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Robitussin DM Allergy), Cholesterol and Hypothyroidism. Concomitant products included ROSUVASTATIN for Cholesterol, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced VACCINATION SITE MASS (A big knot at the site of the injection for 10 days), VACCINATION SITE WARMTH (Very warm to the touch/warm to the touch/it was hot to the touch), PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (Arm began to swell slightly/Swollen arm), VACCINATION SITE PRURITUS (Itch at the injection site/itchy) and VACCINATION SITE ERYTHEMA (It is a red). On 23-Jul-2021, VACCINATION SITE WARMTH (Very warm to the touch/warm to the touch/it was hot to the touch), PAIN IN EXTREMITY (Sore), PERIPHERAL SWELLING (Arm began to swell slightly/Swollen arm) and VACCINATION SITE PRURITUS (Itch at the injection site/itchy) had resolved. At the time of the report, VACCINATION SITE MASS (A big knot at the site of the injection for 10 days) and VACCINATION SITE ERYTHEMA (It is a red) 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.   Patient blood type was RH negative. Patient had a seasonal cold from time to time. Patient had a bad reaction to a cough medicine - Robitussin DM. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up information was received on 30-Jul-2021, reporter information was updated. Patient demographics and medical history was updated. Concomitant medications were added. Added new events-Swollen arm, pain in arm, Vaccination site warmth and itchy. Event outcome was updated for above events was updated from unknown to recovered/resolved.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: An expired dose was administered; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired dose was administered) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired dose was administered). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (An expired dose was administered) 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 relevant concomitant medications were reported. Treatment medication was not provided by the reporter  The vial was moved to the refrigerator on 18/Jun/2021 and did not undergo any temperature excursion. According to refrigerator conditions, the vial expired on 18/Jul/2021.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: primary reporter  demographics was updated. patient race and Ethnicity was updated Dose 1 info body site.was added
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It has been 6 months since first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 6 months since first shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 6 months since first shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 6 months since first shot) had resolved.            Concomitant medications were not reported . Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow up was received. Patient demographics- gender ad vaccine first dose date was added
Sex: U
Vaccine: COVID19
Symptoms: Adverse reaction, COVID-19, Product dose omission issue, SARS-CoV-2 antibody test positive
Clinical narrative: Full blown COVID/ Tested positive for covid antibodies; severe reaction; did not get second dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Full blown COVID/ Tested positive for covid antibodies), ADVERSE REACTION (severe reaction) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Full blown COVID/ Tested positive for covid antibodies), ADVERSE REACTION (severe reaction) and PRODUCT DOSE OMISSION ISSUE (did not get second dose). At the time of the report, COVID-19 (Full blown COVID/ Tested positive for covid antibodies), ADVERSE REACTION (severe reaction) and PRODUCT DOSE OMISSION ISSUE (did not get second dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Covid after receiving the first dose of covid19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of SUSPECTED COVID-19 (Covid after receiving the first dose of covid19 vaccine) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced SUSPECTED COVID-19 (Covid after receiving the first dose of covid19 vaccine). At the time of the report, SUSPECTED COVID-19 (Covid after receiving the first dose of covid19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that the patient's family got COVID-19. The patient had no symptoms and did not confirm it with a COVID-19 test.   No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received which does not contain any new information
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Dyspnoea, Neck pain
Clinical narrative: Bones hurt very much (where you want to cry), especially my neck; Shortness of breath; Bones hurt very much (where you want to cry), especially my neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Bones hurt very much (where you want to cry), especially my neck), DYSPNOEA (Shortness of breath) and BONE PAIN (Bones hurt very much (where you want to cry), especially my neck) 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 NECK PAIN (Bones hurt very much (where you want to cry), especially my neck), DYSPNOEA (Shortness of breath) and BONE PAIN (Bones hurt very much (where you want to cry), especially my neck). At the time of the report, NECK PAIN (Bones hurt very much (where you want to cry), especially my neck), DYSPNOEA (Shortness of breath) and BONE PAIN (Bones hurt very much (where you want to cry), especially my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: a patient received the 1st dose 3 months ago and didn't receive the 2nd on time; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (a patient received the 1st dose 3 months ago and didn't receive the 2nd on time) 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 June 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 (a patient received the 1st dose 3 months ago and didn't receive the 2nd on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (a patient received the 1st dose 3 months ago and didn't receive the 2nd on time) 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 treatment medications were provided.  No concomitant medications were provided.  Patient wants to know if the schedule should be restarted and no further information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Telephone contact report was attached which included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash that lasted 5 days; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash that lasted 5 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced RASH (Rash that lasted 5 days). At the time of the report, RASH (Rash that lasted 5 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-262976 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Rash
Clinical narrative: Rash; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired) and RASH (Rash) 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. In March 2021, the patient experienced RASH (Rash). In 2021, the patient experienced FATIGUE (feeling tired). At the time of the report, FATIGUE (feeling tired) and RASH (Rash) outcome was unknown.            This case was linked to MOD-2021-262966 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: pain to injection site; chills; dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered), INJECTION SITE PAIN (pain to injection site) and CHILLS (chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes since 09-Apr-2019 and Hypertension since 21-Jul-2021.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered). On 22-Jul-2021, the patient experienced INJECTION SITE PAIN (pain to injection site) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Injection site pain and Chills, at an unspecified dose and frequency. On 21-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (dministered Moderna Vaccine 2 weeks early/COVID Vaccine 2 administered) had resolved. At the time of the report, INJECTION SITE PAIN (pain to injection site) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information added -Medical History, Patient information,  Events Provided, Facility detail added
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red area on arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red area on arm at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Hives, treated with Benadryl and they went away.). Concomitant products included LOVASTATIN for an unknown indication.    On 23-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 ERYTHEMA (Red area on arm at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red area on arm at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment details were provided.   This case was linked to MOD-2021-263036 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats
Clinical narrative: Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Night sweats). At the time of the report, NIGHT SWEATS (Night sweats) had resolved.            Action taken with mRNA-1273 in response to the event were not applicable.  Treatment information was not provided Concomitant medication were not provided.   This case was linked to MOD-2021-056567 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nasopharyngitis
Clinical narrative: Had cold before 2nd shot; I have been not normal since; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Had cold before 2nd shot) and FEELING ABNORMAL (I have been not normal since) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Had cold before 2nd shot) and FEELING ABNORMAL (I have been not normal since). At the time of the report, NASOPHARYNGITIS (Had cold before 2nd shot) and FEELING ABNORMAL (I have been not normal since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.   This case was linked to MOD-2021-261628 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Additional event was added.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave dose to a pediatric patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave dose to a pediatric patient) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave dose to a pediatric patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (gave dose to a pediatric patient) 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.   Concomitant medications were not reported.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Mixed series; Past 36 days for second dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Mixed series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 36 days for second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 INTERCHANGE OF VACCINE PRODUCTS (Mixed series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 36 days for second dose). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Mixed series) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Past 36 days for second 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.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This report refers to a case of interchange of vaccine products and inappropriate schedule of product administration with no associated AEs.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Woke up the 17th with severe sore throat; Runny nose; Super drained and I'm not getting any bet; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Woke up the 17th with severe sore throat), RHINORRHOEA (Runny nose), FATIGUE (Super drained and I'm not getting any bet), MYALGIA (Body aches) and 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 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Woke up the 17th with severe sore throat), RHINORRHOEA (Runny nose), FATIGUE (Super drained and I'm not getting any bet), MYALGIA (Body aches) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Woke up the 17th with severe sore throat), RHINORRHOEA (Runny nose), FATIGUE (Super drained and I'm not getting any bet), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment provided include OTC medications and vitamins. Concomitant medication list was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, COVID-19, SARS-CoV-2 test
Clinical narrative: Developed symptoms; Positive test post immunization/ tested positive for covid today; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Developed symptoms) and COVID-19 (Positive test post immunization/ tested positive for covid today) 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 21-Jul-2021, the patient experienced ADVERSE EVENT (Developed symptoms) and COVID-19 (Positive test post immunization/ tested positive for covid today). At the time of the report, ADVERSE EVENT (Developed symptoms) had not resolved and COVID-19 (Positive test post immunization/ tested positive for covid today) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive post immunization.         Concomitant product use was not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Menstruation irregular, Oligomenorrhoea
Clinical narrative: Prolonged menstrual bleeding; Irregular menstrual bleeding; This spontaneous case was reported by a consumer and describes the occurrence of OLIGOMENORRHOEA (Prolonged menstrual bleeding) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding) 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 OLIGOMENORRHOEA (Prolonged menstrual bleeding) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding). At the time of the report, OLIGOMENORRHOEA (Prolonged menstrual bleeding) and MENSTRUATION IRREGULAR (Irregular menstrual bleeding) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.