chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated after the expiration date). Concomitant medications details were not reported by the reporter. Reportedly, at the time of unannounced visit by an representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the health department which were looked well but later on the day stated that were uncompliant due to the same lot of Moderna vaccines had expired on 07-Jul-2022. Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, had to scan the code to determine the actual expiration code, thus failed to did by not reading carefully the packing slip. Treatment details were not reported by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient was vaccinated after the expiration date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient was vaccinated after the expiration date).    At the time of an unannounced visit by a Moderna representative on 28-Sep-2022, 50 doses of Moderna vaccines were left in the health department which were looked well after but they were uncompliant since that lot of Moderna vaccines had expired on 07-Jul-2022.  Additionally it was mentioned that the expiration code on the packaging slip was not the expiration code, instead they had to scan the QR code to determine the actual expiration code, which they failed, by not reading carefully the packing slip.  The patient had received the expired vaccine on 26-Aug-2022.  Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given. No treatment medication reported.   This case refers to patient-14 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant information was reported by the reporter. It was reported as on 08-OCT-2022, 09-OCT-2022 and 10-OCT-2022 they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. No treatment information was reported by the reporter. This case is of patient 24 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication was provided.  It was reported that on 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. Treatment medication was not provided by the reporter. This case contains information about patient-4 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dose administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medications were reported.  It was reported that total 26 doses of Pediatric vials of Moderna COVID-19 Vaccine were administered to adult patients instead of Bivalent booster doses on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022.  No treatment details were reported.  This Case is for patient 23 out of 26 patients
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given. No treatment medication reported.   This case refers to patient-15 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medication was provided.  It was reported that on 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster.   Treatment medication was not provided by the reporter.  This case contains information about patient-5 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    Concomitant medication not reported. Treatment medication not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    Concomitant product use was not provided by the reporter. It was reported that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dose administered to adult patient from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported. On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccine was administered. Reporter was not aware of any AEs after the vaccines were given. No treatment medication reported.   This case refers to patient- 1 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medicine were reported. It was reported that on 8Oct2022, 9Oct2022 and 10Oct2022 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster were administered. Reporter was not aware of any AEs after the vaccines were given.  This case is for the 9th adult patient out of 26 adult patients. No treatment medicine were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dose administered to adult patient from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vials instead of bivalent vaccine).    This case contains information for the second patient out of 26 patients as described by the reporter.  No concomitant medication information was reported.   The reporter stated that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster doses. The reporter was not aware of any adverse events after the vaccines were administered.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No relevant concomitant medications were reported.   On 8 Oct 2022, 9 Oct 2022 and 10 Oct 2022 vaccines were administered.   No treatment medication reported.   This case is of patient 13 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant product use was reported.   HCP stated on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022 they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster. Reporter was not aware of any AEs after the vaccine was given.   No treatment information was provided.  Case for the patient 10 out of 26 patients.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Dose administered to adult patient from pediatric vial instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Dose administered to adult patient from pediatric vial instead of bivalent vaccine).    This case contains information for the 11th patient out of 26 patients as described by the reporter.  No concomitant medication information was reported.   The reporter stated that on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, they administered 26 doses to adult patients from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster doses. The reporter was not aware of any adverse events after the vaccines were administered.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown 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 WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administration error: 26 doses administered to adult patients from pediatric vials instead of bivalent vaccine).    No concomitant medications were reported. No treatment medications were reported.  Reporter stated on 08-Oct-2022, 09-Oct-2022 and 10-Oct-2022, 26 doses to adult patients were administered from pediatric vials of Moderna COVID-19 Vaccine instead of bivalent booster.  Reporter was not aware of any AEs after the vaccines were given.  This case is for the 12th adult patient out of 26 adult patients.
Sex: F
Vaccine: COVID19
Symptoms: Complication of pregnancy, Maternal exposure during pregnancy
Clinical narrative: she received her first vaccine dose on 05Mar2021, a couple of days later she found out she was pregnant; she started having complications with her pregnancy; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient. A 33-year-old pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number were not reported) via an unspecified route of administration on 05Mar2021, as single dose for COVID-19 immunization. The gestation period was 6 weeks. The patient's medical history and concomitant medications were not reported. On 05Mar2021, the patient exposed to vaccination during pregnancy and had received her first vaccine dose on 05Mar2021, a couple of days later she found out she was pregnant. She stated that when it was time to get her second dose she started having complications with her pregnancy and was told by her doctor not to take the second dose due to her complications and so she missed her appointment for her second dose. She was now 18 weeks pregnant and had spoken with her doctor who advised her that she should get her second dose and to call the hotline to find out if she would have to repeat the series. The patient stated that where she should got her second dose was no longer a vaccination site. She had declined assistance with finding an alternate location where Pfizer was being administered. The patient had received 1st Dose of the Pfizer COVID 19 Vaccine was scheduled for her 2nd Dose 26Mar2021. A week later after 1st Dose she found she was pregnant, the health care provider told her not to take 2nd Dose. Her health care provider told her it's now okay to take her COVID 19 Vaccine and wanted to know if she has to take her 1st Dose again or her 2nd Dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: event Drug exposure during pregnancy, first trimester was recoded to Maternal Exposure During Pregnancy, first trimester.  Follow-up (10Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (13Oct2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test, Skin hyperpigmentation
Clinical narrative: Rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later.; Rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 at 18:00 as dose 2, single (Lot number: FC3181) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Open angle glaucoma" (unspecified if ongoing), notes: Other medical history: Open angle glaucoma; "COVID-19", start date: 28Jan2021, stop date: 28Jan2021, notes: Positive. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER: 1, Batch/Lot No: EW0179, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 28Jul2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: RASH (disability), SKIN HYPERPIGMENTATION (disability) all with onset 21Aug2021, outcome "recovered with sequelae" and all described as "Rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later.". The events "rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of rash, skin hyperpigmentation includes Triamcinolone. Clinical course: Patient had no other vaccine in four weeks. No known allergies.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: Whole neck of prefilled syringe broke off; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: PAA167474) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "Whole neck of prefilled syringe broke off". Additional information: No patient involvement. The syringe was being disposed of after injection when the whole neck of the prefilled syringe broke off when they were safety clipping the needle.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blister infected, Lip swelling, Oral herpes, Scab
Clinical narrative: the blister has been crusted up and was aggravating; The crusty area has pus attached to it and left a deep hole in her lip; lips were swollen; fever blister; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 05:00 as dose 3 (booster), 15 ug single (Lot number: GH9697) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure abnormal"; "COVID", start date: 24Apr2022 (not ongoing), notes: She had been sick for 5 days when she tested positive for COVID. Concomitant medication(s) included: VALSARTAN taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization. The following information was reported: BLISTER INFECTED (non-serious) with onset 07Oct2022 at 06:00, outcome "unknown", described as "The crusty area has pus attached to it and left a deep hole in her lip"; ORAL HERPES (non-serious) with onset 07Oct2022 at 06:00, outcome "unknown", described as "fever blister"; LIP SWELLING (non-serious) with onset 07Oct2022 at 06:00, outcome "unknown", described as "lips were swollen"; SCAB (non-serious) with onset 11Oct2022, outcome "not recovered", described as "the blister has been crusted up and was aggravating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister infected. Additional information: 2 and a half days after getting the 3rd booster dose, around 6 AM Friday morning (07Oct2022), she noticed that her lips were swollen and noticed 3 huge blisters on her lip and not on the cluster and was advised by her doctor that it might have been a fever blister. Today (11Oct2022), the blister has been crusted up and was aggravating for her since she never had anything like this happen to her in her life. The crusty area has pus attached to it and left a deep hole in her lip. She attempted to send a picture over to her physician but for some reason the air was not good for pictures; she was asking if this could be a side effect of her shot; he did not think so at the time but sent medication over for a fever blister. She is curious because this thing eventually just crusted up and made a huge scab on her lip, the scab this morning (11Oct2022) fell off on it is own and underneath it was pus and the hole in her lip is several layers deep. It confused her that the 3rd booster dose was her 5th shot (as reported, pending clarification).  Follow-Up (14Oct2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: Immune thrombocytopenic purpura following Pfizer-BioNTech COVID-19 Vaccine with presenting features of petechiae, gum bleeding, epistaxis, and subconjunctival hemorrhage; This is a literature report for the following literature source(s): A 67-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "DM" (ongoing); "hypothyroidism" (ongoing); "depression" (ongoing); "B12 deficiency" (ongoing); "headaches" (ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNE THROMBOCYTOPENIA (medically significant), 14 days after the suspect product(s) administration, outcome "unknown", described as "Immune thrombocytopenic purpura following Pfizer-BioNTech COVID-19 Vaccine with presenting features of petechiae, gum bleeding, epistaxis, and subconjunctival hemorrhage". The patient underwent the following laboratory tests and procedures: Platelet count: 3 x10 3/mm3. The patient had symptoms 14 days after the first dose.; Sender's Comments: Based on the temporal relationship, the association between the event immune thrombocytopenia with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202200080418 Same article/drug/patient/event and different dose.;
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease -Artherosclerosis" (unspecified if ongoing). No known allergies. There were no concomitant medications. Other medication in 2weeks reported as no. Past drug history included: Prednisone for lung inflammation, notes: lung inflammation treated with prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included product=COVID 19 Treatment, brand=Paxlovid from 27Sep2022 to 01Oct2022 for treatment of COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events drug ineffective ,COVID-19  and the suspect drug  BNT162b2.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis reactive, Blood test, X-ray
Clinical narrative: reactive arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 49-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient reported she received Pfizer vaccine last September (year not reported, pending clarification). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: ARTHRITIS REACTIVE (medically significant), outcome "unknown", described as "reactive arthritis". After the 1st shot, she was fine, just a sore arm. But then 4 days after her 2nd dose she developed reactive arthritis. She stated it was debilitating she had to wear double knee and ankle braces and could barely walk. She has had blood work and markers (unknown results), xray confirming she did not have arthritis and it was reactive arthritis. The patient stated this ruined her life for 6 months and spread through her entire body. She also stated she lost work and can't function. She reported being healthy 49-year-old woman. She stated there have been 4 known cases for reactive arthritis from CDC. She also reported that in her social workplace that every single person either has had an adverse rection or someone in their family has had an adverse reaction, mentioned stroke and heart attack. She also reported that her best friend who is younger than her had side effect of leaky heart. Therapeutic measures were taken as a result of arthritis reactive.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201222423 same patient and product, different dose and events;US-PFIZER INC-202201224968 same patient and product, different dose and events;
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2 (BNT162B2), on 02May2022 at 17:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 59 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Tested positive, took paxlovid; (04Oct2022) Negative, notes: tested negative 48 hours apart on day 4 of treatment,; (10Oct2022) Positive, notes: then tested positive again with symptoms of same severity on 10Oct. Therapeutic measures were taken as a result of drug ineffective, covid-19.