chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).    Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported. No treatment details were reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that total 77 Monovalent doses were administered after the BUD to patients 12 and up. 37 doses from lot 059H21, 26 Doses from lot 065K21A and 12 doses from lot 058A22-2A.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medications were reported. 113 Bivalent doses administered after the BUD to patients 12 and up. 51 doses from Lot AS7140C and  60 doses from Lot AS7148B. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Patient reference ID was mentioned. No concomitant medications was reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that 113 Bivalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B. No treatment drug details was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).    Patient ID was reported.  Concomitant medication was not reported.  Reportedly, in this report the patient was eligible for COVID-19 vaccine.  Treatment medication was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7248B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022 at 9:15 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up).    The patient ID. The concomitant medication was not reported. The treatment medication was not reported. 113 bivalent doses administered after the BUD to patient of 12 and up. The information was unknown whether the patient received other vaccines in the 4 wees prior to COVID-19 vaccination.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    Concomitant medication was not reported.  Patient ID was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, in this report the patient was eligible for COVID-19 vaccine. Breakdown of doses were reported as 37 doses from lot 059H21, 26 doses from lot 065K21A, and 12 doses from lot 058A22-2A Treatment medication was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up).    Patient ID was reported. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication were reported.             No treatment information was provided by the reporter.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 42-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    No concomitant drug was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment drug was reported.   This case was linked to MOD-2022-690931 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Patient ID was reported as 7597754. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was reported. No treatment medications was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medications was provided. No treatment medications was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medication information was provided.  Total 113 Bivalent doses administered after the BUD to patients 12 and up. 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B.  It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medication was not provided.  It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 51 doses from Lot AS7140C were administered.   Treatment information was not provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    No concomitant medications were provided. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was repored that administered 113 Bivalent doses administered after the BUD to patients 12 and up. 60 doses from Lot AS7148B.  No treatment medication was provided.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported as Unknown. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).     Concomitant product use was not provided by the reporter. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant medications were reported. Total 77 Monovalent doses were administered after the BUD to patients 12 and up.37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    Patient ID was reported as Unknown No concomitant medications was reported. It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses is as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A. No treatment drug details was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).     Concomitant medication was not reported.  Reportedly, in this report the patient was eligible for COVID-19 vaccine.   Treatment medication was not reported.   This case was linked to MOD-2022-691012 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    No concomitant medication details was reported. No treatment medication details was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 41-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Concomitant medication was not reported.  Patient ID was reported as Unknown.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that breakdown of doses were reported as 51 doses from batch number AS7140C and 60 doses from Batch number AS7148B.  Treatment medication was not reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).     No concomitant drug was reported. No treatment drug was reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    It was reported as COVID19 Eligible. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication were reported.             No treatment information was provided by the reporter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).    No concomitant drug was reported. Patient ID was reported as Unknown It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reportedly, the patient was eligible for COVID-19 vaccine. No treatment drug was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Monovalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients).   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant drug was reported. No treatment drug was reported.