chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: Vaccine given to unknown amount of patient past 30-day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (normal) antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not report any adverse events.and That  the vaccine vials were never punched until use. No concomitant medications reported No Treatment medications reported   This case was linked to MOD-2021-415889 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Pharmacist reports that they administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home. Pharmacist stated that the beyond the use date was 09 Dec 2021 at 10:00 PM and they administered the vaccine from 10 Dec 2021 to 13 Dec 2021.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.  The caller stated that they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use and the doctor at the office wants to know if what else should be done. The office manager stated that they called ever patient the following day and no adverse events were noted, and they performed an antibody test on all of them and the patients antibody numbers were in the 800-900 range.   This case was linked to MOD-2021-415889 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Allergy NOS.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and CHILLS (chills). At the time of the report, MYALGIA (Body aches) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications reported included unspecified blood pressure medication and medication for allergies. No treatment medications provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over my body; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash all over my body) 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 RASH (Rash all over my body). At the time of the report, RASH (Rash all over my body) 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.   Concomitant medications were not reported Treatment medications were not reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM . These were all booster doses given at 0.25ml, intramuscularly. Lot number/Expiration date -067F21A; 31Dec2069.  No treatment details were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   The caller stated that they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use and the doctor at the office wants to know if what else should be done. The office manager stated that they called ever patient the following day and no adverse events were noted, and they performed an antibody test on all of them and the patients antibody numbers were in the 800-900 range.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and MYALGIA (Body aches) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-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 CHILLS (chills) and MYALGIA (Body aches). The patient was treated with AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (chills) and MYALGIA (Body aches) outcome was unknown.            The concomitant medications reported included blood pressure medication and medication for allergies.   This case was linked to MOD-2021-415972, MOD-2021-414551 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The beyond the use date was reported as 09-Dec-2021 at 10:00PM.  The vial was initially stored in the refrigerator on 28-Nov-2021 in the afternoon and the number of vials were 14.  No concomitant medications were reported.  No treatment information was reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). In December 2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient administered the vaccine from 10Dec2021-13Dec2021. Concomitant medication was not provided. Treatment information was not provided.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) antibody test was done on patient and antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date). In December 2021, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that they administered the Moderna COVID-19 vaccine which was beyond the use date which was 09-Dec-2021 at 10:00PM and expiration date was 31-Dec-2069.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: some chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (some chills) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021 at 11:45 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021 at 9:00 PM, the patient experienced CHILLS (some chills) and HEADACHE (Headache). On 16-Dec-2021, CHILLS (some chills) and HEADACHE (Headache) had resolved.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient went to bed and slept if off and felt pretty good on 16-Dec-2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist reports that they administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home.  Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM  No concomitant medication were provided No treatment details were provided Date the vial was initially stored in the refrigerator - 28Nov2021
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given to unknown amount of patient past 30-day BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD). On 02-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patients experienced no adverse events and patients antibody numbers were in the 800-900 range after vaccination. No relevant concomitant medications were reported. No treatment information was provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.  Reporter stated that on 24-May-2021 vaccines were received and immediately placed vaccines into refrigerated storage and they administered this vaccine to patients after this 30 day mark. That vaccine vials were never punched until use.  Reporter also stated that patient did not report any adverse events and symptoms. And also stated that they performed an antibody test on all of the patients and antibody numbers were in the 800-900 range.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered the Moderna Covid-19 vaccine which was beyond the use date to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the Moderna Covid-19 vaccine which was beyond the use date to patient) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the Moderna Covid-19 vaccine which was beyond the use date to patient). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered the Moderna Covid-19 vaccine which was beyond the use date to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No other medications were provided. No treatment medications were reported.  Pharmacist's stated that the beyond the use date is 09Dec2021 at 10:00PM. Administered the vaccine from 10Dec2021-13Dec2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range..     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.   Reporter reported that they got 10 vials Moderna vaccine (037C21A) delivered on 24-May-2021 and immediately placed the vaccine into refrigerated storage. Then stated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use. Reporter reported that the vaccine was given unknown amount to patient past 30-day beyond use date (BUD). Patient did not report any adverse events or symptoms.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-415889 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that the beyond the use date is 09Dec2021 at 10:00PM.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In December 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home). In December 2021, EXPIRED PRODUCT ADMINISTERED (administered the Moderna Covid-19 vaccine which was beyond the use date to 14 patients in a nursing home) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   The reporter stated that the beyond the use date was 09-Dec-2021 at 10:00 pm. The vaccine was administered from 10-Dec-2021 to 13-Dec-2021. Number of doses/vials was 14; date the vial was initially stored in the refrigerator was 28-Nov-2021 (in the afternoon); it was not known to the reporter if the vials underwent any temperature excursions.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: 800-900 (Inconclusive) 800-900 range.     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.  It was reported that the patient did not report any adverse events or symptoms post 24 hours of vaccination.  On 24 May 2021 the vaccine was placed into the refrigerated storage. The vials had a 30-day expiration date and administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use. An antibody test was done on all of them  and the patients antibody numbers were in the 800-90 0 range.   This case was linked to (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Pharmacist's stated They administered the vaccine from 10Dec2021-13Dec2021.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with vaccine which was beyond the use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was beyond the use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was administered from 10Dec2021-13Dec2021 No concomitant and treatment information were reported by the reporter.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: Vaccine given to patient after 30 day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient after 30 day mark) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient after 30 day mark). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to patient after 30 day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) All the patient's antibody numbers were in the 800-900 range.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment mediations were reported. Vials delivered in on 24May2021 and immediately placed the vaccine into refrigerated storage. The doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and they administered this vaccine to patients after this 30-day mark.  No adverse events or symptoms were reported.   This case was linked to MOD-2021-415889 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to (Patient Link).
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given to unknown amount of patient past 30-day BUD/ expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.  Reporter stated that on 24-May-2021 vaccines were received and immediately placed vaccines into refrigerated storage and they administered this vaccine to patients after this 30 day mark. That vaccine vials were never punched until use.  Reporter also stated that patient did not report any adverse events and symptoms. And also stated that they performed an antibody test on all of the patients and antibody numbers were in the 800-900 range.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: Administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 range (Inconclusive) Antibodies numbers were in the range of 800-900.     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  Patient did not report any adverse events or symptoms
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: Administered this vaccine to patients after this 30-day mark; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered this vaccine to patients after this 30-day mark) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) Antibody numbers were in the 800-900 range.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient did not report any adverse events or symptoms post 24 hours after vaccination.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: A week to 10 days after the shot she experienced covid arm; A week to 10 days after the shot, she experienced red itchy swollen; A week to 10 days after the shot, she experienced red itchy swollen arm; A week to 10 days after the shot, she experienced red itchy swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (A week to 10 days after the shot she experienced covid arm), VACCINATION SITE PRURITUS (A week to 10 days after the shot, she experienced red itchy swollen), VACCINATION SITE ERYTHEMA (A week to 10 days after the shot, she experienced red itchy swollen arm) and VACCINATION SITE SWELLING (A week to 10 days after the shot, she experienced red itchy swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (A week to 10 days after the shot she experienced covid arm), VACCINATION SITE PRURITUS (A week to 10 days after the shot, she experienced red itchy swollen), VACCINATION SITE ERYTHEMA (A week to 10 days after the shot, she experienced red itchy swollen arm) and VACCINATION SITE SWELLING (A week to 10 days after the shot, she experienced red itchy swollen). At the time of the report, VACCINATION COMPLICATION (A week to 10 days after the shot she experienced covid arm), VACCINATION SITE PRURITUS (A week to 10 days after the shot, she experienced red itchy swollen), VACCINATION SITE ERYTHEMA (A week to 10 days after the shot, she experienced red itchy swollen arm) and VACCINATION SITE SWELLING (A week to 10 days after the shot, she experienced red itchy swollen) outcome was unknown.            No Concomitant medications were reported. No Treatment mediations were reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Follow-up received included no new information.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.). On 16-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received their Moderna 2nd dose which was only 3 weeks (22 days) after the first dose.) 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 medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 16-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose). On 16-Dec-2021, ACCIDENTAL UNDERDOSE (gave a 0.25 ml of the Moderna Covid-19 vaccine to a patient who was supposed to get a full dose for his 3rd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Expiration date was reported as 06Ap22021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Headache, Nausea
Clinical narrative: feeling under the weather; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling under the weather), NAUSEA (nausea) and HEADACHE (headache) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cancer (history of tongue and lymph node cancer from 4 years ago) and Cancer. Concomitant products included LOSARTAN for Blood pressure high, METOPROLOL and AMLODIPINE for an unknown indication.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced FEELING ABNORMAL (feeling under the weather), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, FEELING ABNORMAL (feeling under the weather), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Dec-2021, Blood pressure measurement: 181/105 (High) 181/105.         No treatment medications were reported.  The doctor was suggested to that patient on 13dec2021 to switch her blood pressure medication from losartan to valsartan and she has not yet started the new medication.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Influenza like illness, Migraine
Clinical narrative: like a flu; suffer migraines; Cough; have temperature; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature), CHILLS (chills) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Concomitant medication of the patient was not reported.   After the headache, the patient put some fresh water in the head. Treatment information for rest of the events were not reported by the reporter.   This case was linked to MOD-2021-416050 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: like a flu; suffer migraines; Cough; have temperature; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature) and CHILLS (chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature), CHILLS (chills) and HEADACHE (headache). At the time of the report, INFLUENZA LIKE ILLNESS (like a flu), MIGRAINE (suffer migraines), COUGH (Cough), PYREXIA (have temperature), CHILLS (chills) and HEADACHE (headache) outcome was unknown.            Concomitant medication of the patient was not reported.   After the headache, the patient put some fresh water in the head. Treatment information for rest of the events were not reported by the reporter.   This case was linked to MOD-2021-416050 (Patient Link).
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: relatively mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (relatively mild fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (relatively mild fatigue). At the time of the report, FATIGUE (relatively mild fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to (Patient Link).