chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Illness, Paraesthesia, Pyrexia, Rash
Clinical narrative: Rash is sore, achy, itchy; bubbling sunburn effect,dry-looking; has a numb feeling; tingling feeling; Rash is sore, achy, stings. dry looking; extremely bad vomiting; fever; After second dose patient had a "bad reaction"; Four to six hours after the shot became sick for 2 days, really sick.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.), RASH PRURITIC (Rash is sore, achy, itchy), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking) and HYPOAESTHESIA (has a numb feeling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Seizure.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.). On an unknown date, the patient experienced VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), RASH PRURITIC (Rash is sore, achy, itchy), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking), HYPOAESTHESIA (has a numb feeling), PARAESTHESIA (tingling feeling), RASH (Rash is sore, achy, stings. dry looking), VOMITING (extremely bad vomiting) and PYREXIA (fever). The patient was treated with CORTISONE (topical) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking), HYPOAESTHESIA (has a numb feeling), PARAESTHESIA (tingling feeling), VOMITING (extremely bad vomiting) and PYREXIA (fever) outcome was unknown, ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.) had resolved and RASH PRURITIC (Rash is sore, achy, itchy) and RASH (Rash is sore, achy, stings. dry looking) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Seizure medication.   This case was linked to MOD-2021-355992.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Vaccination complication, Vomiting
Clinical narrative: Rash is sore, achy, itchy; bubbling sunburn effect,dry-looking; has a numb feeling; tingling feeling; Rash is sore, achy, stings. dry looking; extremely bad vomiting; fever; After second dose patient had a "bad reaction"; Four to six hours after the shot became sick for 2 days, really sick.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.), RASH PRURITIC (Rash is sore, achy, itchy), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking) and HYPOAESTHESIA (has a numb feeling) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Seizure.   On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.). On an unknown date, the patient experienced VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), RASH PRURITIC (Rash is sore, achy, itchy), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking), HYPOAESTHESIA (has a numb feeling), PARAESTHESIA (tingling feeling), RASH (Rash is sore, achy, stings. dry looking), VOMITING (extremely bad vomiting) and PYREXIA (fever). The patient was treated with CORTISONE (topical) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (After second dose patient had a "bad reaction"), RASH ERYTHEMATOUS (bubbling sunburn effect,dry-looking), HYPOAESTHESIA (has a numb feeling), PARAESTHESIA (tingling feeling), VOMITING (extremely bad vomiting) and PYREXIA (fever) outcome was unknown, ILLNESS (Four to six hours after the shot became sick for 2 days, really sick.) had resolved and RASH PRURITIC (Rash is sore, achy, itchy) and RASH (Rash is sore, achy, stings. dry looking) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included Seizure medication.   This case was linked to MOD-2021-355992.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured) 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 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered the Moderna COVID-19 Vaccine to a patient more than 12 hours after the vial was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.; Tinnitus; Wind in the ear; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 011L20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypothyroidism and Hypertension. Concomitant products included RAMIPRIL, HYDROCHLOROTHIAZIDE, AMLODIPINE, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and LEVOTHYROXINE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear). At the time of the report, HYPOACUSIS (Feeling deaf in the left ear/First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%.), TINNITUS (Tinnitus) and EAR DISCOMFORT (Wind in the ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Acoustic stimulation tests: abnormal (abnormal) First audiology test 30% hearing loss, second audiology test after steroids hearing loss was at 50%..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received 4 doses of steroids in the ear and it had no significant improvement. ENT suggested taking steroids by mouth.  On 18OCT2021 the ringing in the ear has improved a little and she can hear a little better but the problem hearing still exists.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site warmth
Clinical narrative: patient had fatigue and a red hot injection site few hours after first dose; patient had fatigue and a red hot injection site few hours after first dose; patient had fatigue and a red hot injection site few hours after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE WARMTH (patient had fatigue and a red hot injection site few hours after first dose), FATIGUE (patient had fatigue and a red hot injection site few hours after first dose) and INJECTION SITE ERYTHEMA (patient had fatigue and a red hot injection site few hours after first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN and LAMOTRIGINE (LAMICTAL) for an unknown indication.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE WARMTH (patient had fatigue and a red hot injection site few hours after first dose), FATIGUE (patient had fatigue and a red hot injection site few hours after first dose) and INJECTION SITE ERYTHEMA (patient had fatigue and a red hot injection site few hours after first dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, INJECTION SITE WARMTH (patient had fatigue and a red hot injection site few hours after first dose), FATIGUE (patient had fatigue and a red hot injection site few hours after first dose) and INJECTION SITE ERYTHEMA (patient had fatigue and a red hot injection site few hours after first dose) was resolving.        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.   This case was linked to MOD-2021-356141, MOD-2021-356002 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vial that was punctured more than 12 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vial that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. No treatment information was provided by the reporter. No Concomitant medicines were reported.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021) 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 06-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021). On 06-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient states she received the Johnson and Johnson COVID19 vaccine 6Mar2021 and then she stated she "chose to get" the Moderna vaccine 6Oct2021) had resolved.            On 06-Mar-2021, patient had received the Johnson and Johnson COVID19 vaccine. In addition it was stated that the patient chose to get Moderna vaccine. No relevant concomitant and treatment medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient who received a dose past 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient who received a dose past 30-day use by date) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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 third 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 EXPIRED PRODUCT ADMINISTERED (Patient who received a dose past 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient who received a dose past 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No Treatment information was reported.   This case was linked to MOD-2021-355908 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Pretty pronounced fatigue; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and FATIGUE (Pretty pronounced fatigue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and FATIGUE (Pretty pronounced fatigue). At the time of the report, PYREXIA (Fever) outcome was unknown and FATIGUE (Pretty pronounced fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Blood pressure high, Acid reflux (esophageal) and MS. Concomitant products included COLECALCIFEROL (VITAMIN D3) and ASCORBIC ACID (VIT C) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine). On 17-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient got first dose of the Moderna vaccine and second dose of the Pfizer vaccine) had resolved.            Concomitant medications taken by the patient also included unspecified high blood pressure medication and acid reflux medication.  No treatment medications were reported.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore left arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced MYALGIA (Sore left arm). At the time of the report, MYALGIA (Sore left arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-356258, MOD-2021-356046 (Patient Link).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose past 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-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 third 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 EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-355908 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose past 30-day use by date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) 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 EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose past 30-day use by date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: sleep after second dose; feeling of wanting to go back into bed; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleep after second dose) and FATIGUE (feeling of wanting to go back into bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleep after second dose) and FATIGUE (feeling of wanting to go back into bed). At the time of the report, SOMNOLENCE (sleep after second dose) and FATIGUE (feeling of wanting to go back into bed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-355704 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Myalgia, Oedema, Pruritus
Clinical narrative: Pruritus; Severe Edema; Erythema at injection site extending to elbow; Fatigue; Temp; Generalized myalgia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue) and PYREXIA (Temp) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Mild hypertension-Treated). Concomitant products included SIMVASTATIN (ZOCOR), LANSOPRAZOLE (PREVACID), MELOXICAM and METOPROLOL for an unknown indication.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Sep-2021, PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia) 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.   Patient took bed rest and was observed and treated at home. The vaccine was taken on 21-Sep-2021 at 08:45 a.m.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received on 18-oct-2021, case contains No new information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Pruritus; Severe Edema; Erythema at injection site extending to elbow; Fatigue; Temp; Generalized myalgia; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue) and PYREXIA (Temp) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Mild hypertension-Treated). Concomitant products included SIMVASTATIN (ZOCOR), LANSOPRAZOLE (PREVACID), MELOXICAM and METOPROLOL for an unknown indication.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 28-Sep-2021, PRURITUS (Pruritus), OEDEMA (Severe Edema), INJECTION SITE ERYTHEMA (Erythema at injection site extending to elbow), FATIGUE (Fatigue), PYREXIA (Temp) and MYALGIA (Generalized myalgia) 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.   Patient took bed rest and was observed and treated at home. The vaccine was taken on 21-Sep-2021 at 08:45 a.m.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Follow-up received on 18-oct-2021, case contains No new information.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm hurt a little bit; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired). On 28-Mar-2021, PAIN IN EXTREMITY (arm hurt a little bit) and FATIGUE (felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-356505, MOD-2021-356638 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: Euphoria; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (Euphoria) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced EUPHORIC MOOD (Euphoria). On 25-Apr-2021, EUPHORIC MOOD (Euphoria) had resolved.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-356492, MOD-2021-356638 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Receiving a dose from an expired vaccine; 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 EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired 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 18-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Receiving a dose from an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  It was reported that 10 or 11 patients received a third dose of Moderna COVID-19  vaccine.  Treatment information was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Vaccination complication
Clinical narrative: Blood clot in his leg; really bad side effects; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in his leg) in a 5-decade-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 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 THROMBOSIS (Blood clot in his leg) (seriousness criterion medically significant) and VACCINATION COMPLICATION (really bad side effects). At the time of the report, THROMBOSIS (Blood clot in his leg) and VACCINATION COMPLICATION (really bad side effects) had resolved.            No relevant concomitant medication information provided.  Caller said that friend got really bad side effects from the Moderna vaccine. It was after the second shot. He was over 50. Within a very short time (days to a week), friend got a blood clot in his leg. He went to the hospital and doctors believed it was due to the Moderna vaccine. Doctors gave him blood thinners for three months and nowhe was doing fine. Caller did not want to provide any additional personal information. Caller said that friend probably got the first shot in February/March.  Treatment medication include blood thinners for blood clot provided.  Company Comment: This case concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of thrombosis. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the second dose and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of thrombosis. The event occurred unknown number of days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the event occurred after the second dose and no additional dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm was sore; A little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired). At the time of the report, PAIN IN EXTREMITY (Arm was sore) and FATIGUE (A little tired) 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 was reported. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion
Clinical narrative: Having COVID19 following vaccination; Congestion in her chest; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest) 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 COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest). At the time of the report, COVID-19 (Having COVID19 following vaccination) and NASAL CONGESTION (Congestion in her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a female patient of unknown age, with no medical history disclosed, who experienced the unexpected non-serious adverse event of special interest of COVID-19 with other non-serious unexpected event. The event of COVID-19 occurred on unknown date, after the most recent dose of Spikevax (Moderna COVID-19 vaccine). No information is provided regarding dates of events and vaccination, so assessment is very limited. The rechallenge was not applicable as dose number is not informed in the source document. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: fever; headache; achy arm/sore arm; felt tired /felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm/sore arm), FATIGUE (felt tired /felt really tired), PYREXIA (fever) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced PAIN IN EXTREMITY (achy arm/sore arm) and FATIGUE (felt tired /felt really tired). On 29-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (achy arm/sore arm), FATIGUE (felt tired /felt really tired), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-356645, MOD-2021-356492, MOD-2021-356505 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Erythema
Clinical narrative: shortness of breath/difficulty breathing; loss of energy; next day experienced redness; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 053E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Sep-2021, the patient experienced DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness). At the time of the report, DYSPNOEA (shortness of breath/difficulty breathing), ASTHENIA (loss of energy) and ERYTHEMA (next day experienced redness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient had no reactions after receiving first dose and after the second shot had no reactions in the beginning. Patient experienced the symptoms the next day after the second dose.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Gait disturbance, Illness, Neck mass, Pyrexia
Clinical narrative: [after second dose] pain in my arm at the injection site; felt really really, super sick; couldn't even walk from my room to the bathroom; almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever; Fifteen minutes after the second shot, the lump appeared even bigger; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20H and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger). On 04-Mar-2021, the patient experienced ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom) and PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever). On an unknown date, the patient experienced VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 104 (High) 104. On 05-Mar-2021, Body temperature: low (Low) low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.   This case was linked to MOD-2021-356190, MOD-2021-356658 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: [after second dose] pain in my arm at the injection site; felt really really, super sick; couldn't even walk from my room to the bathroom; almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever; Fifteen minutes after the second shot, the lump appeared even bigger; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20H and 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger). On 04-Mar-2021, the patient experienced ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom) and PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever). On an unknown date, the patient experienced VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, NECK MASS (Fifteen minutes after the second shot, the lump appeared even bigger), ILLNESS (felt really really, super sick), GAIT DISTURBANCE (couldn't even walk from my room to the bathroom), PYREXIA (almost-104 fever, which left after 2-3 hours, next day he had a low-grade fever) and VACCINATION SITE PAIN ([after second dose] pain in my arm at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 104 (High) 104. On 05-Mar-2021, Body temperature: low (Low) low grade fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported.   This case was linked to MOD-2021-356190, MOD-2021-356658 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) 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 EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The HCP had reported that the vaccine was administered to an unknown number of patients and it was not known whether that were the patients 1st or 2nd doses. It was unknown to him if the vaccines were stored in the freezer or refrigerator prior its use.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment); This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)). The patient was treated with LOPERAMIDE HYDROCHLORIDE (ANTI-DIARRHEAL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Chronic diarrhea/Diarrhea since 1st dose/He stated that 7 months later they are still taking medications (anti-diarrheal treatment)) was resolving.        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 details were not reported by the reporter. Reporter stated that 7 months later they are still taking medications (anti-diarrheal treatment). Before they had diarrheal episodes 6-7 times a day but now it is 2-3 times a day.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired vaccine; 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 EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) 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 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   07Oct2021: Removed from freezer & placed in the refrigerator. 14Oct2021: Administered to 21 patients/soldiers.  Concomitant medications was not provided by the reporter Treatment information was not provided