chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION; FEVER; HEADACHE; EXHAUSTION; MUSCLE ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was a Nurse (HCP), reported for herself. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. Age at time of vaccination 43 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-JUN-2021, the patient experienced fever, headache, exhaustion, muscle aches, and injection site pain. On 10-JUN-2022, the patient experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, exhaustion, muscle aches, injection site pain, and blurred vision. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: PRODUCT WAS EXPOSED TO A TEMPERATURE OF 35.15 DEGREE FAHRENHEIT FOR 30 MINUTES; ADMINISTRATION OF A DOSE FROM A VIAL THAT WAS STORED OUTSIDE THE RECOMMENDED STORAGE CONDITION; This spontaneous report received from a physician concerned a 50 year old female. The patient's height, and weight were not reported. The patient's past medical history included: fatigue, and fibromyalgia, and concurrent conditions included: non-smoker, and other pre-existing medical conditions included: The patient had no known allergies and was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, administered on 16-MAY-2022 for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported.  On 16-MAY-2022, the patient experienced administration of a dose from a vial that was stored outside the recommended storage condition. On an unspecified date, the patient experienced product was exposed to a temperature of 35.15 degree fahrenheit for 30 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of a dose from a vial that was stored outside the recommended storage condition and product was exposed to a temperature of 35.15 degree fahrenheit for 30 minutes was not reported. This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Patient details added. Suspect batch number and indication were updated. Expiration date added for suspect drug. On 08-Jun-2022: Follow-up received contains no new information.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (administration after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059A22A, 045J21A, 047B21A and 045A21A) for COVID-19 prophylaxis. The patient's past medical history included COVID-19. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022 at 10:55 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-Jun-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (administration after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (administration after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. The patient had no known allergy. It was unknown if patient had acute illness at the time of vaccination as well as unknown for chronic health conditions. There was no adverse reaction reported with the vaccine. It was reported that vaccine was thawed at the time of excursion. Vaccine was thawed at the time of excursion. Vaccines remained in travel cooler, had a temperature excursion on 6-Jun-2022. At 11:18 am vaccines where placed in refrigerator. 3 booster doses of the vial where given to patients prior to reporting excursion. No visible changes to vial was noted. A total of 1 vial was affected. It was reported that, On 06 Jun 2022 noticed that the datalogger from the travel cooler was out of range. It took approximately 6 mins for the temperature to be regulated. The datalogger failed to alert of the excursion of approximately 36 minutes. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2022: Reporter, Patient details and medical history added, suspect details updated.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022; expired doses of Moderna COVID-19 were administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (Kept in fridge on 07-Feb-2022 and administered on 08-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was reported that the patient received total 4 doses and the dose received on 8-Apr-2022 was the second booster. The vials were kept in refrigerator on 07-Feb-2022 and administered on 8-Apr-2022. The vial did not undergo any temperature excursions No treatment medication information was given.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022; Vaccines were administered beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines were administered beyond use date) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient took  booster of Moderna and took total 3 doses. Lot number 083J21A was refrigerated on 7-Feb-2022. Vial did not undergo any temperature excursion  It was reported that as per Moderna lot analysis regarding doses administered on March 11, 2022 and March 16, 2022 from lot number 033H21A, and doses administered on April 20, 2022 from lot number 083J21A, Moderna cannot guarantee patients received full protection against the Covid-19 virus.  Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow up received contains No new information
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022; 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) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses administered) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 07-Feb-2022 and administered on 11-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the vaccine was administered beyond the beyond use date. The vial was initially stored in the refrigerator on 07-Feb-2022. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Live Follow-up received contain Non significant information.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022; Expired doses of Moderna COVID-19 were administered beyond the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date.) and PRODUCT STORAGE ERROR (For lot 083J21A put in the fridge on 07Feb2022, and date of administration on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  It was reported that patient received total 4 doses, Vial did not undergo any temperature excursion.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow up received contain Non significant information
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 07-Feb-2022 and administered on 01-Apr-2022; Expired dose administered/Vaccine was administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered/Vaccine was administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 07-Feb-2022 and administered on 01-Apr-2022) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered/Vaccine was administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 07-Feb-2022 and administered on 01-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered/Vaccine was administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 07-Feb-2022 and administered on 01-Apr-2022) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was not reported. It was reported that, patient received total 3 doses and this was booster dose. Vial did not undergo any temperature excursion.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Live Follow up received contains non significant information.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022; Expired doses of Moderna COVID-19 were administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine was put in the fridge on 07-Feb-2022 and doses were administered on 12-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that, the patient received total 4 doses, and this was 2nd booster dose.  On 07-Feb-2022, the vials were initially stored in the refrigerator. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2022: Follow-up received contains no new information.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine put in the fridge on 07Feb2022 and doses were administered on 20APR2022; expired doses of Moderna COVID-19 were administered beyond the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 20APR2022) in an 87-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 20APR2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired doses of Moderna COVID-19 were administered beyond the beyond use date) and PRODUCT STORAGE ERROR (Vaccine put in the fridge on 07Feb2022 and doses were administered on 20APR2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   As per report Patient received 2nd booster dose   No concomitant medications were provided.  For LOT 083J21A the vials were initially stored in the refrigerator On 07 FEB 2022 ,. The vial did not undergo any temperature excursions.  No treatment medications were provided.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non-significant information.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 78-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was reported as unknown. Vaccine was expired on 07-Apr-2022.No  temperature excursions for the vials was reported. Total of 173 doses were reported with the lot number 070H21A.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document was received and contains non significant information.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter.  Number of doses/vials were 173 doses. It was unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.   No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up document includes non-significant information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received included non significant information of secondary reporter was added.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The expiry date was reported as 09-Nov-2021  Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up non-significant document received and updated in the narrative
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The date of vial initially stored in the refrigerator was unknown. Number of doses/vials were 168. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant live follow-up: Additional reporter added.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 102 doses were given from LOT 026C21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live non significant follow up. No new clinically significant information received.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Total number of vials were reported as 102 doses for LOT 026C21A The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was reported as unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains non-significant information.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Vial did not undergo temperature excursion. Total of 173 doses were given from LOT 070H21A. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non-significant follow up received with no new clinically significant information
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration. Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses. Dates of administration of vaccine were reported as 10-Nov-21, 11-Nov-21 The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that 168 doses were administered with Lot number 048C21A. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up documents received includes insignificant information (reporter details).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains no significant information.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The vial initially stored in the refrigerator was unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information, reporter added
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30 day use by date or after manufacture day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture day of expiry) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture day of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date or after manufacture day of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Total number of doses were 102 doses and the vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products were not provided. It was reported that the vial did not undergo temperature excursion and it was unknown when the vial was initially stored in the refrigerator. Treatment medications were not reported. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non-significant information.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case. Expiration date was: 09-NOV-2021. Number of doses/vials:168 doses. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The Dose administered after 30-day Use By Date or after manufacturer date of expiry  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  Dates of administration of vaccine were reported as 8Apr2022, 12Apr2022 and 13Apr2022.  The vial did not undergo any temperature excursions.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received, contains reporter details was updated.