chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: the site of the vaccination (upper left arm) started to turn very red; itchy in big area of the arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (the site of the vaccination (upper left arm) started to turn very red) and VACCINATION SITE PRURITUS (itchy in big area of the arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION SITE ERYTHEMA (the site of the vaccination (upper left arm) started to turn very red) and VACCINATION SITE PRURITUS (itchy in big area of the arm). The patient was treated with TRIAMCINOLONE for Adverse event, at an unspecified dose and frequency; Manual therapy (Cold compress) for Vaccination site erythema and Manual therapy (Cold compress) for Vaccination site pruritus. At the time of the report, VACCINATION SITE ERYTHEMA (the site of the vaccination (upper left arm) started to turn very red) and VACCINATION SITE PRURITUS (itchy in big area of the arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.    This case was linked to MOD-2021-370411, MOD-2021-370412 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Extra dose administered, Off label use
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE and EXTRA DOSE ADMINISTERED in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902, 043L20A, and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus since 1999. Concomitant products included METFORMIN for Diabetes mellitus, CRESTOR, LOSARTAN, and METOPROLOL for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced OFF LABEL USE and EXTRA DOSE ADMINISTERED. On 11-Aug-2021, OFF LABEL USE and EXTRA DOSE ADMINISTERED had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 29-Sep-2021, Antibody test 216 (Low).          Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes on 03-Nov-2021 Medical history and concomitant medications updated.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza, Nausea
Clinical narrative: pretty sick from the last vaccine; like having a bad case of the flu for 24 hours; felt kind of queasy after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, INFLUENZA, and NAUSEA in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 089A21A and 095A21A) for COVID-19 vaccination. No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS, INFLUENZA, and NAUSEA. At the time of the report, ILLNESS and NAUSEA outcome was unknown and INFLUENZA had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-370422, MOD-2021-370441, MOD-2021-370435 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high.    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 VACCINATION COMPLICATION. The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION  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 medications reported.  It was reported that patient took cold compresses on an unspecified date.   This case was linked to MOD-2021-370398, MOD-2021-370412 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-370411, MOD-2021-370398 (Patient Link).
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Nausea, Vaccination site haemorrhage, Vomiting
Clinical narrative: Vomit; Feeling nauseated; When he received the booster shot they jabbed him quite bad that he had a bit of blood on the bandage they stuck on his arm.; Feeling very cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE, FEELING COLD, NAUSEA, and VOMITING in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939908) for COVID-19 vaccination.     No medical history was provided by the reporter. Concomitant products included MELOXICAM from 15-Oct-2021 to an unknown date for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced VACCINATION SITE HAEMORRHAGE and FEELING COLD. On 31-Oct-2021, the patient experienced NAUSEA. On 01-Nov-2021, the patient experienced VOMITING. At the time of the report, VACCINATION SITE HAEMORRHAGE, FEELING COLD, NAUSEA, and VOMITING outcome was unknown.            No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: pretty sick from the last vaccine; felt bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (pretty sick from the last vaccine) and FEELING ABNORMAL (felt bad) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 095A21A and 089A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (pretty sick from the last vaccine) and FEELING ABNORMAL (felt bad). At the time of the report, ILLNESS (pretty sick from the last vaccine) and FEELING ABNORMAL (felt bad) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-370441 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blister
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLISTER on the Face, Collar bone area, and the opposite arm in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced BLISTER on the Face, Collar bone area, and the opposite arm). At the time of the report, BLISTER on the Face, Collar bone area, and the opposite arm outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 20 days between 1st and 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 23-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION had resolved.            No concomitant product was provided by the reporter. On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular). No treatment medication was provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling in the injection site; Pain in the injection site; Redness in the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, and PYREXIA in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Oct-2021, the patient experienced VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA, and PYREXIA. The patient was treated with DAYQUIL for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING, VACCINATION SITE PAIN, VACCINATION SITE ERYTHEMA and PYREXIA outcome was unknown.            Concomitant medications details were not reported by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment to the events not reported.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: felt crummy; very tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Nov-2021 and was forwarded to Moderna on 01-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL and FATIGUE 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL and FATIGUE. At the time of the report, FEELING ABNORMAL and FATIGUE outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Erythema, Feeling abnormal, Feeling cold
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, and ERYTHEMA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced FEELING ABNORMAL, FEELING COLD, MYALGIA, and CHILLS. On 30-Oct-2021, the patient experienced SWELLING FACE, ERYTHEMA, RASH MACULAR, PRESYNCOPE, and NAUSEA. On an unknown date, the patient experienced VACCINATION COMPLICATION, PAIN, and DISCOMFORT. The patient was treated with CLONAZEPAM for Adverse event, at a dose of 1 and a half pills; ASPIRIN for Adverse event, at an unspecified dose and frequency and OSCILLOCOCCINUM for Aches & pains in legs, Headache, Fever, Chills, Fatigue, and Flu like symptoms, at an unspecified dose and frequency. On 30-Oct-2021, CHILLS had resolved. At the time of the report, FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, ERYTHEMA, RASH MACULAR, PAIN, PRESYNCOPE, DISCOMFORT, MYALGIA, and NAUSEA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. She used hemp oil sav on the arm and it took a lot of the pain and discomfort away. drank some Pepsi, because sometimes when she has gas she feels like fainting. She had three big burps afterwards and felt better.   This case was linked to MOD-2021-255333, MOD-2021-255328 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Presyncope, Rash macular
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, and ERYTHEMA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced FEELING ABNORMAL, FEELING COLD, MYALGIA, and CHILLS. On 30-Oct-2021, the patient experienced SWELLING FACE, ERYTHEMA, RASH MACULAR, PRESYNCOPE, and NAUSEA. On an unknown date, the patient experienced VACCINATION COMPLICATION, PAIN, and DISCOMFORT. The patient was treated with CLONAZEPAM for Adverse event, at a dose of 1 and a half pills; ASPIRIN for Adverse event, at an unspecified dose and frequency and OSCILLOCOCCINUM for Aches & pains in legs, Headache, Fever, Chills, Fatigue, and Flu like symptoms, at an unspecified dose and frequency. On 30-Oct-2021, CHILLS had resolved. At the time of the report, FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, ERYTHEMA, RASH MACULAR, PAIN, PRESYNCOPE, DISCOMFORT, MYALGIA, and NAUSEA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. She used hemp oil sav on the arm and it took a lot of the pain and discomfort away. drank some Pepsi, because sometimes when she has gas she feels like fainting. She had three big burps afterwards and felt better.   This case was linked to MOD-2021-255333, MOD-2021-255328 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, and ERYTHEMA in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 026B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced FEELING ABNORMAL, FEELING COLD, MYALGIA, and CHILLS. On 30-Oct-2021, the patient experienced SWELLING FACE, ERYTHEMA, RASH MACULAR, PRESYNCOPE, and NAUSEA. On an unknown date, the patient experienced VACCINATION COMPLICATION, PAIN, and DISCOMFORT. The patient was treated with CLONAZEPAM for Adverse event, at a dose of 1 and a half pills; ASPIRIN for Adverse event, at an unspecified dose and frequency and OSCILLOCOCCINUM for Aches & pains in legs, Headache, Fever, Chills, Fatigue, and Flu like symptoms, at an unspecified dose and frequency. On 30-Oct-2021, CHILLS had resolved. At the time of the report, FEELING ABNORMAL, FEELING COLD, VACCINATION COMPLICATION, SWELLING FACE, ERYTHEMA, RASH MACULAR, PAIN, PRESYNCOPE, DISCOMFORT, MYALGIA, and NAUSEA outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. She used hemp oil sav on the arm and it took a lot of the pain and discomfort away. drank some Pepsi, because sometimes when she has gas she feels like fainting. She had three big burps afterwards and felt better.   This case was linked to MOD-2021-255333, MOD-2021-255328 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastrointestinal disorder, Headache, Myalgia, Nausea
Clinical narrative: Gastro symptoms; Gastric pain; Pain in the arm; Nausea; Headache; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER, ABDOMINAL PAIN UPPER, PAIN IN EXTREMITY, NAUSEA, and HEADACHE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 012L20A) 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 ATACAND for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, 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 GASTROINTESTINAL DISORDER (Gastro symptoms), ABDOMINAL PAIN UPPER, PAIN IN EXTREMITY, NAUSEA, HEADACHE, MYALGIA, and PYREXIA. At the time of the report, GASTROINTESTINAL DISORDER, ABDOMINAL PAIN UPPER, PAIN IN EXTREMITY, NAUSEA, HEADACHE, MYALGIA, and PYREXIA outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-370262, MOD-2021-370458 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Gastro symptoms; Gastric pain; Pain in the arm; Nausea; Headache; Muscle aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER, ABDOMINAL PAIN UPPER, PAIN IN EXTREMITY, NAUSEA, and HEADACHE in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 012L20A) 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 ATACAND for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, 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 GASTROINTESTINAL DISORDER (Gastro symptoms), ABDOMINAL PAIN UPPER, PAIN IN EXTREMITY, NAUSEA, HEADACHE, MYALGIA, and PYREXIA. At the time of the report, GASTROINTESTINAL DISORDER, ABDOMINAL PAIN UPPER, PAIN IN EXTREMITY, NAUSEA, HEADACHE, MYALGIA, and PYREXIA outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-370262, MOD-2021-370458 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Fall, Sluggishness, Somnolence
Clinical narrative: found him the next morning on the floor; very difficult to wake; trouble talking or did not want to talk; legs were very weak and he could not hold himself up; still sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish) and FALL (found him the next morning on the floor) in a 74-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 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up) and SLUGGISHNESS (still sluggish). On 06-Mar-2021, the patient experienced FALL (found him the next morning on the floor). At the time of the report, SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish) and FALL (found him the next morning on the floor) was resolving.            No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-370478, MOD-2021-370485 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Aphasia, Asthenia, Fall, Head injury, Sluggishness
Clinical narrative: very difficult to wake; trouble talking or did not want to talk; legs were very weak and he could not hold himself up; still sluggish; Found him the next morning on the floor/ fell again; this time he scraped his head,; It looked like a carpet burn; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish) and FALL (Found him the next morning on the floor/ fell again) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AC21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish), FALL (Found him the next morning on the floor/ fell again), HEAD INJURY (this time he scraped his head,) and THERMAL BURN (It looked like a carpet burn). At the time of the report, SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish), FALL (Found him the next morning on the floor/ fell again), HEAD INJURY (this time he scraped his head,) and THERMAL BURN (It looked like a carpet burn) outcome was unknown.            The patient got the flu shot 2 weeks prior to the booster.  No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-370484, MOD-2021-370478 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Thermal burn
Clinical narrative: very difficult to wake; trouble talking or did not want to talk; legs were very weak and he could not hold himself up; still sluggish; Found him the next morning on the floor/ fell again; this time he scraped his head,; It looked like a carpet burn; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish) and FALL (Found him the next morning on the floor/ fell again) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04AC21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish), FALL (Found him the next morning on the floor/ fell again), HEAD INJURY (this time he scraped his head,) and THERMAL BURN (It looked like a carpet burn). At the time of the report, SOMNOLENCE (very difficult to wake), APHASIA (trouble talking or did not want to talk), ASTHENIA (legs were very weak and he could not hold himself up), SLUGGISHNESS (still sluggish), FALL (Found him the next morning on the floor/ fell again), HEAD INJURY (this time he scraped his head,) and THERMAL BURN (It looked like a carpet burn) outcome was unknown.            The patient got the flu shot 2 weeks prior to the booster.  No concomitant medication details were provided. No treatment medication details were provided.   This case was linked to MOD-2021-370484, MOD-2021-370478 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Pyrexia
Clinical narrative: Balance was off a little; A little fever of 101.5 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance was off a little) and PYREXIA (A little fever of 101.5 degrees Fahrenheit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 013L20Q and 013L20Q) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced BALANCE DISORDER (Balance was off a little) and PYREXIA (A little fever of 101.5 degrees Fahrenheit). At the time of the report, BALANCE DISORDER (Balance was off a little) and PYREXIA (A little fever of 101.5 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2021, Body temperature: 101.5 (High) little fever of 101.5 degrees Fahrenheit.         No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-370402, MOD-2021-374893 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his first Moderna Covid-19 vaccine on 11Jan2021, second dose on 5FEB2021) and FATIGUE in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his first Moderna Covid-19 vaccine on 11Jan2021, second dose on 5FEB2021) and FATIGUE. On 05-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his first Moderna Covid-19 vaccine on 11Jan2021, second dose on 5FEB2021) had resolved. At the time of the report, FATIGUE outcome 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.   This case was linked to MOD-2021-370274 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Alzheimer's disease.   On 26-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. The patient had sore arm from the first two Moderna COVID19 Vaccines, but otherwise had no other adverse reactions.   This case was linked to MOD-2021-369011, MOD-2021-373853 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pruritus
Clinical narrative: Redness; Itching; myalgia; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, PRURITUS, and ERYTHEMA in a 35-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced MYALGIA. On 28-Oct-2021, the patient experienced PRURITUS. On 30-Oct-2021, the patient experienced ERYTHEMA. On 20-Oct-2021, MYALGIA outcome was unknown. On 29-Oct-2021, PRURITUS had resolved. At the time of the report, ERYTHEMA outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication was not reported. Treatment information was not reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED 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 medications were reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: "covid arm"; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION ("covid arm") in a 36-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION ("covid arm"). At the time of the report, VACCINATION SITE REACTION ("covid arm") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was reported. No Treatment medications were provided.   This case was linked to MOD-2021-370414.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered the booster dose  (0.25ml) instead of the 3rd dose; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Patient has underlying malignant condition).    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED. At the time of the report, INCORRECT DOSE ADMINISTERED had resolved.        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.  Physician states that they had administered the Moderna Covid-19 booster dose (0.25ml) to a patient who was supposed to receive the 3rd dose.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache, Hypersensitivity, Vomiting
Clinical narrative: sore stomach; felt still tired; excruciating headache; She feels to have an allergic reaction to the Moderna Covid-19 vaccine.; vomiting for 6-7 hours; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (sore stomach), VOMITING (vomiting for 6-7 hours), FATIGUE (felt still tired), HEADACHE (excruciating headache) and HYPERSENSITIVITY (She feels to have an allergic reaction to the Moderna Covid-19 vaccine.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A-B) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (sore stomach), VOMITING (vomiting for 6-7 hours), FATIGUE (felt still tired), HEADACHE (excruciating headache) and HYPERSENSITIVITY (She feels to have an allergic reaction to the Moderna Covid-19 vaccine.). The patient was treated with PROMETHAZINE (PHENERGAN [PROMETHAZINE]) for No adverse event, at an unspecified dose and frequency and ONDANSETRON (ZOFRAN [ONDANSETRON]) for No adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (sore stomach), FATIGUE (felt still tired), HEADACHE (excruciating headache) and HYPERSENSITIVITY (She feels to have an allergic reaction to the Moderna Covid-19 vaccine.) outcome was unknown and VOMITING (vomiting for 6-7 hours) had resolved.        Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    No concomitant medication was provided   This case was linked to MOD-2021-371132.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: immunocompromised patient received 0.25ml dose of booster; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (immunocompromised patient received 0.25ml dose of booster) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Oct-2021, the patient experienced UNDERDOSE (immunocompromised patient received 0.25ml dose of booster). On 28-Oct-2021, UNDERDOSE (immunocompromised patient received 0.25ml dose of booster) 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 medication was reported.  The patient was immunocompromised, but she did not indicate it on her form, so she received 0.25 ml of Moderna booster instead of 0.50 ml third dose on 28-Oct-2021. Two days later, the patient  went back to get another dose of 0.25 ml. The patient received her first two doses of Moderna COVID19 Vaccine on unknown dates.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that 1 third dose was given to an immunocompromised patient out of 3 patient.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-370372, MOD-2021-371249, MOD-2021-371275, MOD-2021-371244, MOD-2021-371280, MOD-2021-371284 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine past its expiration date administered to 11 patients; 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 (vaccine past its expiration date administered to 11 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (vaccine past its expiration date administered to 11 patients) had resolved.        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.  Patient was administered with booster dose after 30-day Use By Date or after manufacturer date of expiry. Vaccine was expired on 27-OCT-2021.   This case was linked to MOD-2021-370372, MOD-2021-371236 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine past its expiration date administered to 11 patients; 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 in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant use were reported No Treatment were reported vial was initially stored in the refrigerator 4-OCT-2021
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine past its expiration date administered to 11 patients; 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 in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.    This case was linked to MOD-2021-371236 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine past its expiration date administered to 11 patients; 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 in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications are not provided.  On 04-Oct-2021, the vial was initially stored in the refrigerator. On 29-Oct-2021, 1 first dose given, 1 third dose given to an immunocompromised patient and 1 booster dose given for a total of 3 patients. On 29-Oct-2021, 1 first dose given, 5 third doses given to immunocompromised patients, total of 6 patients. On 30-Oct-2021, 1 first dose given. 1 third full dose to an immunocompromised patient given.   Treatment information does not provided.   This case was linked to MOD-2021-371236 (Patient Link).