chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: Feeling miserable all day; Headache; Nausea; Body ache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Body ache) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling miserable all day; Headache; Nausea; Body ache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Body ache) and FATIGUE (Fatigue) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Body ache), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Feeling miserable all day), HEADACHE (Headache), NAUSEA (Nausea), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Sciatica, Spinal stenosis
Clinical narrative: Sciatica pain; Chronic spinal stenosis; High blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of SCIATICA (Sciatica pain), SPINAL STENOSIS (Chronic spinal stenosis) and HYPERTENSION (High blood pressure) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included ATENOLOL for Blood pressure high.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SCIATICA (Sciatica pain), SPINAL STENOSIS (Chronic spinal stenosis) and HYPERTENSION (High blood pressure). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) (epidural) for Spinal stenosis, at a dose of 80 milligram. At the time of the report, SCIATICA (Sciatica pain), SPINAL STENOSIS (Chronic spinal stenosis) and HYPERTENSION (High blood pressure) outcome was unknown.            The Patient had stated that a week ago on 15Oct2021, she had a spinal epidural for sciatica pain. She received the Kenalog 80mg epidural which is a high dose steroid, 80mg, per the patient for her chronic spinal stenosis with frequent sciatica pain. The patient had stated that the epidural infusion with the steroid is every 6 months and was taking this even before the first dose of the moderna vaccine for last couple of years.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence
Clinical narrative: he developed diarrhea; alot of gas; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (he developed diarrhea) and FLATULENCE (alot of gas) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16767) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced DIARRHOEA (he developed diarrhea) and FLATULENCE (alot of gas). At the time of the report, DIARRHOEA (he developed diarrhea) and FLATULENCE (alot of gas) outcome was unknown.            Concomitant products included Statin for an unknown indication. No treatment details were reported.  Patient reported that he got the first shot as J&J on 09-Mar-2021. Age at time of onset of reaction/event were reported as 84 and weight were reported as 140 without units.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Chills, Headache, Somnolence
Clinical narrative: Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose; Stomach issues; Don't have a lot of energy; Slept all day; Head aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day) and HEADACHE (Head aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A or 012F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day), HEADACHE (Head aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day), HEADACHE (Head aches) and CHILLS (Chills) was resolving.      Concomitant medications include one day pill daily for asthma.  Patient reported that she had a stronger reaction to booster dose than with the second dose. She stated that the symptoms started three or four hours after the booster dose.   This case was linked to MOD-2021-362994, MOD-2021-363397, MOD-2021-363444 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose; Stomach issues; Don't have a lot of energy; Slept all day; Head aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day) and HEADACHE (Head aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A or 012F21A, 010M20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day), HEADACHE (Head aches) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Feeling funny/ feeling miserable/ not feeling myself/ had a strong reaction to the booster dose), ABDOMINAL DISCOMFORT (Stomach issues), ASTHENIA (Don't have a lot of energy), SOMNOLENCE (Slept all day), HEADACHE (Head aches) and CHILLS (Chills) was resolving.      Concomitant medications include one day pill daily for asthma.  Patient reported that she had a stronger reaction to booster dose than with the second dose. She stated that the symptoms started three or four hours after the booster dose.   This case was linked to MOD-2021-362994, MOD-2021-363397, MOD-2021-363444 (Patient Link).
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: received 3rd full dose instead of booster dose; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (received 3rd full dose instead of booster dose) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3rd full dose instead of booster dose). On 22-Oct-2021, EXTRA DOSE ADMINISTERED (received 3rd full dose instead of booster dose) had resolved.  No concomitant medication was reported.  No treatment medication use was reported. Reporter did not allow further contact
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: Received 0.5 mL instead of 0.25 mL for booster dose; THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 0.5 mL instead of 0.25 mL for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received 0.5 mL instead of 0.25 mL for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna). On 22-Oct-2021, INCORRECT DOSE ADMINISTERED (Received 0.5 mL instead of 0.25 mL for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (THe patient received a single dose of Johnson nad Johnson and then booster dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.  The patient received a single dose of Johnson and Johnson vaccine, and then received booster dose of Moderna COVID-19 Vaccine. The patient was not asked whether immunocompromised or not.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: lower back pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain) 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 December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 BACK PAIN (lower back pain). At the time of the report, BACK PAIN (lower back pain) outcome was unknown.            Patient reported that two weeks ago he had flu shot. He also reported that he is having cortisone shots for lower back pain. No concomitant medications were reported. No treatment medications were reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vomiting
Clinical narrative: Vomiting; Chills; Aches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Aches) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Aches). At the time of the report, VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Aches) outcome was unknown.            Concomitant medications were not reported.  The treatment information was nit provided.   This case was linked to MOD-2021-362105 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Depressed mood, Fatigue, Hyperhidrosis, Illness
Clinical narrative: Extremely sick; Severe reaction; Sweats; She was down for 5 days; All my joints were hurting like I've never hurt before; Body aches; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), DEPRESSED MOOD (She was down for 5 days) and ARTHRALGIA (All my joints were hurting like I've never hurt before) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), ARTHRALGIA (All my joints were hurting like I've never hurt before), MYALGIA (Body aches), FATIGUE (Fatigue) and PYREXIA (Fever). September 2021, the patient experienced DEPRESSED MOOD (She was down for 5 days). The patient was treated with IBUPROFEN in September 2021 for Adverse event, at an unspecified dose and frequency and HYDROCODONE in September 2021 for Adverse event, at an unspecified dose and frequency. In September 2021, DEPRESSED MOOD (She was down for 5 days) had resolved. At the time of the report, ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), ARTHRALGIA (All my joints were hurting like I've never hurt before), MYALGIA (Body aches), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-363473, MOD-2021-363475 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Extremely sick; Severe reaction; Sweats; She was down for 5 days; All my joints were hurting like I've never hurt before; Body aches; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), DEPRESSED MOOD (She was down for 5 days) and ARTHRALGIA (All my joints were hurting like I've never hurt before) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 026A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), ARTHRALGIA (All my joints were hurting like I've never hurt before), MYALGIA (Body aches), FATIGUE (Fatigue) and PYREXIA (Fever). September 2021, the patient experienced DEPRESSED MOOD (She was down for 5 days). The patient was treated with IBUPROFEN in September 2021 for Adverse event, at an unspecified dose and frequency and HYDROCODONE in September 2021 for Adverse event, at an unspecified dose and frequency. In September 2021, DEPRESSED MOOD (She was down for 5 days) had resolved. At the time of the report, ILLNESS (Extremely sick), VACCINATION COMPLICATION (Severe reaction), HYPERHIDROSIS (Sweats), ARTHRALGIA (All my joints were hurting like I've never hurt before), MYALGIA (Body aches), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-363473, MOD-2021-363475 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 expired doses given to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 expired doses given to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 expired doses given to patients). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (5 expired doses given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date moved to refrigeration: 12Oct2021   Concomitant medication was not reported.  Treatment information was not reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Feeding disorder, Nausea
Clinical narrative: Down for 3 days after 2nd dose; Could not  eat anything after 2nd dose; Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (Down for 3 days after 2nd dose), FEEDING DISORDER (Could not  eat anything after 2nd dose) and NAUSEA (Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced DEPRESSED MOOD (Down for 3 days after 2nd dose), FEEDING DISORDER (Could not  eat anything after 2nd dose) and NAUSEA (Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose). On 26-Mar-2021, DEPRESSED MOOD (Down for 3 days after 2nd dose), FEEDING DISORDER (Could not  eat anything after 2nd dose) and NAUSEA (Felt nauseous if we had a sip of water after 2nd dose/Could not drink water after 2nd dose) had resolved.            No concomitant and treatment information were reported by the reporter
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Myocarditis
Clinical narrative: Patient developed arrhythmias; Myocarditis; This spontaneous case was reported by a physician and describes the occurrence of ARRHYTHMIA (Patient developed arrhythmias) and MYOCARDITIS (Myocarditis) in a 30-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Patient developed arrhythmias) (seriousness criteria hospitalization and medically significant) and MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, ARRHYTHMIA (Patient developed arrhythmias) and MYOCARDITIS (Myocarditis) 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 product was provided. No treatment information was provided.  Company's comment: This case concerns a 30-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and myocarditis. The events occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 30-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected events of arrhythmia and myocarditis. The events occurred on an unknown number of days after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Coronary artery disease and Blood pressure abnormal.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products included medication for blood pressure and heart medication for an unknown indication. Treatment information was unknown.  Reporter stated that the event onset was 1-2 weeks after the dose.   This case was linked to MOD-2021-363353, MOD-2021-363354 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Illness, Myalgia, Somnolence
Clinical narrative: lost her appetite; slept a long time; sick; Aches; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lost her appetite), SOMNOLENCE (slept a long time), ILLNESS (sick) and MYALGIA (Aches) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-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 DECREASED APPETITE (lost her appetite), SOMNOLENCE (slept a long time), ILLNESS (sick) and MYALGIA (Aches). At the time of the report, DECREASED APPETITE (lost her appetite), SOMNOLENCE (slept a long time), ILLNESS (sick) and MYALGIA (Aches) outcome was unknown.            Concomitant medications were not reported.  No Treatment medications were reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose of Moderna COVID-19 vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose of Moderna COVID-19 vaccine). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose of Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  The vials were used 48 and 49 days after expiration which was administered to 2 patients. On 18-Oct-2021, 8 vials were moved from freezer to the refrigerator. 20 unpunctured vials were still in the Freezer and 8 unpunctured in the refrigerator and 1 punctured vial was discarded (used for 2 patients) after 12 hours. All these vials had the same Lot and Expiration date. Twenty vials werecbeing quarantined in the freezer and 8 unpunctured vials were quarantined in the refrigerator. Visual inspection noted no change in vaccine state. There was no previous excursion.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: After getting the 2nd shot they felt like they do after they get the flu shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (After getting the 2nd shot they felt like they do after they get the flu shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant. Concurrent medical conditions included Cancer (Former cancer patient).   In 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. In 2021, the patient experienced VACCINATION COMPLICATION (After getting the 2nd shot they felt like they do after they get the flu shot). At the time of the report, VACCINATION COMPLICATION (After getting the 2nd shot they felt like they do after they get the flu shot) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was not sure whether or not patient considered to be immunocompromised.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Myalgia, Pain, Pain in extremity
Clinical narrative: Bad cough; Awful fatigue; Muscle soreness; Pain came back; some soreness in the muscles throughout her body; It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes; pain from her arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough), THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes), PAIN IN EXTREMITY (pain from her arm), PAIN (Pain came back) and FATIGUE (Awful fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone marrow transplant (Bone marrow donor procedure) in 1990. Concurrent medical conditions included Asthma and Chronic pain (Experienced chronic pain in both her legs and her lower back like she was being stabbed every day since the bone marrow donor procedure in 1990. Her pain was in both legs, but mostly in her left and also in her lower back).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes), PAIN IN EXTREMITY (pain from her arm) and MYALGIA (some soreness in the muscles throughout her body). In August 2021, the patient experienced PAIN (Pain came back). In September 2021, the patient experienced COUGH (Bad cough), FATIGUE (Awful fatigue) and MYALGIA (Muscle soreness). On 18-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes) had resolved. In August 2021, PAIN (Pain came back) had resolved. At the time of the report, COUGH (Bad cough), FATIGUE (Awful fatigue) and MYALGIA (Muscle soreness) was resolving and PAIN IN EXTREMITY (pain from her arm) and MYALGIA (some soreness in the muscles throughout her body) had resolved.            No concomitant medication reported. No treatment medication reported. One day following the first dose of the Moderna vaccine her long term pain went away. Patient also had experienced some soreness in the muscles throughout her body and pain from her arm, but those have resolved later. Patient reported that in September 2021, she did not have a positive COVID-19 test but the symptoms were present. She stayed home for 15 days and her symptoms were improved.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Bad cough; Awful fatigue; Muscle soreness; Pain came back; some soreness in the muscles throughout her body; It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes; pain from her arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Bad cough), THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes), PAIN IN EXTREMITY (pain from her arm), PAIN (Pain came back) and FATIGUE (Awful fatigue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone marrow transplant (Bone marrow donor procedure) in 1990. Concurrent medical conditions included Asthma and Chronic pain (Experienced chronic pain in both her legs and her lower back like she was being stabbed every day since the bone marrow donor procedure in 1990. Her pain was in both legs, but mostly in her left and also in her lower back).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes), PAIN IN EXTREMITY (pain from her arm) and MYALGIA (some soreness in the muscles throughout her body). In August 2021, the patient experienced PAIN (Pain came back). In September 2021, the patient experienced COUGH (Bad cough), FATIGUE (Awful fatigue) and MYALGIA (Muscle soreness). On 18-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (It was a miracle/my pain went away/I had that pain for 30 years/filled the holes in my legs/filled my holes) had resolved. In August 2021, PAIN (Pain came back) had resolved. At the time of the report, COUGH (Bad cough), FATIGUE (Awful fatigue) and MYALGIA (Muscle soreness) was resolving and PAIN IN EXTREMITY (pain from her arm) and MYALGIA (some soreness in the muscles throughout her body) had resolved.            No concomitant medication reported. No treatment medication reported. One day following the first dose of the Moderna vaccine her long term pain went away. Patient also had experienced some soreness in the muscles throughout her body and pain from her arm, but those have resolved later. Patient reported that in September 2021, she did not have a positive COVID-19 test but the symptoms were present. She stayed home for 15 days and her symptoms were improved.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided. The vial was expired on 24-Oct-2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered from vial that had been in the refrigerator past the 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered from vial that had been in the refrigerator past the 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered from vial that had been in the refrigerator past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered from vial that had been in the refrigerator past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), 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-2021-364236, MOD-2021-364598, MOD-2021-364962, MOD-2021-364355, MOD-2021-364754, MOD-2021-364515, MOD-2021-364819, MOD-2021-364949, MOD-2021-365131, MOD-2021-364926, MOD-2021-365177 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness, Therapeutic response unexpected, Vaccination complication
Clinical narrative: After that I was brand new, cured. Moderna vaccine was a resolution tom my illness; Moderna vaccine attacked my body; I was like Covid-19, really sick; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After that I was brand new, cured. Moderna vaccine was a resolution tom my illness), VACCINATION COMPLICATION (Moderna vaccine attacked my body) and ILLNESS (I was like Covid-19, really sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sickness (Patient was really sick.).   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 THERAPEUTIC RESPONSE UNEXPECTED (After that I was brand new, cured. Moderna vaccine was a resolution tom my illness), VACCINATION COMPLICATION (Moderna vaccine attacked my body) and ILLNESS (I was like Covid-19, really sick). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After that I was brand new, cured. Moderna vaccine was a resolution tom my illness), VACCINATION COMPLICATION (Moderna vaccine attacked my body) and ILLNESS (I was like Covid-19, really sick) had resolved.            Concomitant information was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt a soreness in their arms, and there may have been a "mild effect."; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt a soreness in their arms, and there may have been a "mild effect.") in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Felt a soreness in their arms, and there may have been a "mild effect."). At the time of the report, PAIN IN EXTREMITY (Felt a soreness in their arms, and there may have been a "mild effect.") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-363252, MOD-2021-363423.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Regular sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Regular sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Postmenopausal bleeding in 2019 and Endometriosis (had an intervention to remove a "polyp or something" in her uterus that ended up being endometriosis) in 2019. Concomitant products included VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Regular sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 10-Mar-2021, VACCINATION SITE PAIN (Regular sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had pain in arm since 6 months.   This case was linked to MOD-2021-363265 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches). In March 2021, CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.  Patient experienced 2 days of chills, body aches, and headaches after the first vaccination.  Patient received his second Moderna COVID-19 vaccine on 2 APR 2021 lot number 019B21A.   This case was linked to MOD-2021-363368 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Off label use
Clinical narrative: body aches; horrible headache; joint aches; all tired; chills; 3rd dose given and not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced OFF LABEL USE (3rd dose given and not immunocompromised). On an unknown date, the patient experienced PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Oct-2021, OFF LABEL USE (3rd dose given and not immunocompromised) had resolved. At the time of the report, PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-268326, MOD-2021-364583 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches; horrible headache; joint aches; all tired; chills; 3rd dose given and not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced OFF LABEL USE (3rd dose given and not immunocompromised). On an unknown date, the patient experienced PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Oct-2021, OFF LABEL USE (3rd dose given and not immunocompromised) had resolved. At the time of the report, PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-268326, MOD-2021-364583 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine injected from a vial (storage more than 30 days); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine injected from a vial (storage more than 30 days)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine injected from a vial (storage more than 30 days)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine injected from a vial (storage more than 30 days)) 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.