chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Vials that was put in the fridge and after that refrozen and thawed again for adult male patient; No adverse event; Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that was put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Vials that was put in the fridge and after that refrozen and thawed again for adult male patient).    This case is for 45th  patient out of 100 patient's case. Concomitant product use was not provided by the reporter. Patient received additional booster dose. 100 male patients were received bivalent booster dose. Moderna COVID19 vaccine bivalent, dosage given was in ml but was unknown to the healthcare practitioner. Also, lot number was unknown to the healthcare practitioner. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) 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 (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.).    This case contains information for the 2 of 16 patients described by the reporter.  No concomitant medications were reported.  It was reported no adverse event reported on any of the patients involved.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients).    This case contains information for the 46 of 100 patients described by the reporter.  No concomitant medications were reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients are involved, lot numbers unknown to the HCP.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; vials that were put in the fridge and after that refrozen and thawed again; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given day before the day of report from vials that were put in the fridge and after that refrozen and thawed again, lot number unknown to the HCP.  No treatment medication was provided by reporter.  This case contains information for the 14th of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER CASE
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not applicable      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 49th out of 100 patients.  No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 15th out of 100 patients.  No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER CASE
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients).    Case contains the information regarding patient 16 of 100 reported.  Concomitant products were not reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, lot numbers unknown to the HCP.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) 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 (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    The case contains the information regarding patient 3 of 16 reported.  Concomitant products were not reported.  No adverse event was reported from any of the patients involved.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Jan-2023, 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 (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 4th of 16 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) 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 (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.).    The case contains the information regarding patient 5th of 16 reported.  Concomitant products were not reported.  No adverse event was reported from any of the patients involved.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  This case contains information for patient 70 out of 100 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11Jan2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.  This case contains information for the 71st of 100 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) 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 (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    Concomitant products were not provided. Treatment medication were not reported. This case contains information of 6th patient out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) 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 (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    This case contains information for the 7 of 16 patients described by the reporter.  No concomitant medications were reported.  It was reported no adverse event reported on any of the patients involved.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) 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 (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    This case contains information for the 8 of 16 patients described by the reporter.  No concomitant medications were reported.  It was reported no adverse event reported on any of the patients involved.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Wrong product administered
Clinical narrative: bilateral palms, bilateral soles of feet, erythematous/swollen; bilateral palms, bilateral soles of feet, erythematous/swollen; Pfizer Bivalent Dose Number: 1; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 33-year-old female patient (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Jan2023 at 15:00 as dose 1, single (Lot number: GL0446) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing), notes: Other medical history: hyperlipidemia; "prediabetes" (unspecified if ongoing), notes: Other medical history: prediabetes; "obesity" (unspecified if ongoing), notes: Other medical history: obesity. Concomitant medication(s) included: METFORMIN; SIMVASTATIN. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 04Jan2023 at 15:00, outcome "unknown", described as "Pfizer Bivalent Dose Number: 1"; ERYTHEMA (medically significant) with onset 06Jan2023, outcome "unknown", PERIPHERAL SWELLING (medically significant) with onset 06Jan2023, outcome "unknown" and all described as "bilateral palms, bilateral soles of feet, erythematous/swollen". The event "bilateral palms, bilateral soles of feet, erythematous/swollen" required physician office visit. Therapeutic measures were taken as a result of erythema, peripheral swelling.  Clinical course: AE treatment: Depomedrol 40mg and dexamethasone 4mg, prednisone, hydroxyzine, Clobetasol. It was unknown if other vaccine in four weeks. It was unknown if covid Prior vaccination. No, covid tested post vaccination. Known allergies: KNA.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2. Based on known drug safety profile, there is reasonable possibility of causal association between the event and BNT162B2. 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.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Positive Rapid Covid Test On 13Jan2023; Positive Rapid Covid Test On 13Jan2023; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 45-year-old male patient received BNT162b2,,  BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Nov2022 as dose 4 (booster), single (Lot number: GL0446) at the age of 45 years intramuscular, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EL3247), in right arm, on 18Mar2021 as dose 2, single (Lot number: EL3247), in right arm and on 01Nov2021 as dose 3 (booster), single (Lot number: FH8020), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "TYPE 2 diabetes mellitus" (unspecified if ongoing); "Hypertension (HTN)" (unspecified if ongoing); "High Cholesterol/Triglycerides" (unspecified if ongoing); "CAD (3 Cardiac Stents)" (unspecified if ongoing), notes: CAD (3 Cardiac Stents). Concomitant medication(s) included: NORVASC; ASPIRIN 81; METOPROLOL SUCCINATE; RANEXA [RANOLAZINE]; BRILINTA; LOSARTAN; JANUMET XR; VASCEPA; ATORVASTATIN; TERAZOSIN; FENOFIBRIC ACID; FEXOFENADINE. Past drug history included: Enalapril, reaction(s): "Allergy"; Cephalexin, reaction(s): "Allergy". There was no other vaccine in four weeks and there was no covid prior vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jan2023, outcome "not recovered" and all described as "Positive Rapid Covid Test On 13Jan2023". The event "positive rapid covid test on 13jan2023" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (13Jan2023) Positive, notes: positive rapid covid test on 13Jan2023; (10Jan2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: positive rapid covid test on 13Jan2023 from urgent care after teledoc visit. Symptoms of cough and chest congestion appeared evening of 12Jan2023. Paxlovid prescribed 13Jan2023, not yet picked up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 , BNT162b2 omi ba.4-5 to the Vaccination  failure (LOE) and Covid -19 cannot be ruled out.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Magnetic resonance imaging, Migraine, Nausea
Clinical narrative: migraine like headaches; nausea; brain fog; phonophobia; losing my balance when walking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 at 08:00 as dose 2, single (Lot number: EN6205) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: CELEBREX; ALLOPURINOL; TAMSULOSIN; PANTOPRAZOLE. Vaccination history included: BNT162b2 (Dose 1, lot number: EN6205, administration time: 08:00 AM, location: Left arm), administration date: 15Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (disability) with onset 18May2022, outcome "not recovered", described as "brain fog"; BALANCE DISORDER (disability) with onset 18May2022, outcome "not recovered", described as "losing my balance when walking"; MIGRAINE (disability) with onset 18May2022, outcome "not recovered", described as "migraine like headaches"; NAUSEA (disability) with onset 18May2022, outcome "not recovered"; PHONOPHOBIA (disability) with onset 18May2022, outcome "not recovered". The events "migraine like headaches", "nausea", "brain fog", "phonophobia" and "losing my balance when walking" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) no clear cause; SARS-CoV-2 test: (05Jan2023) Negative. Therapeutic measures were taken as a result of migraine, nausea, feeling abnormal, phonophobia, balance disorder. Clinical course: No other vaccine in four weeks. In May2022 daily, patient had migraine like headaches began, nausea began next, then brain fog, then phonophobia, until in October, he was losing his balance when walking. He could not attend his son's wedding reception. He offered to quit his job, but his boss gave flexibility to go home when symptoms were unbearable. He was diagnosed with migraines although all 3 neurologists said it historically doesn't begin at age 66. MRI's and a trip to reveal no clear cause. He believes this was one of the numerous neurological Pfizer vaccine injuries. He was on migraine preventative med and symptom remediation. He was hoping for intermittent fasting, exercise, and Vitamin D would help. Without help, he was headed for disability and resigning his job.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Phonophobia, SARS-CoV-2 test
Clinical narrative: migraine like headaches; nausea; brain fog; phonophobia; losing my balance when walking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2021 at 08:00 as dose 2, single (Lot number: EN6205) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. Concomitant medication(s) included: CELEBREX; ALLOPURINOL; TAMSULOSIN; PANTOPRAZOLE. Vaccination history included: BNT162b2 (Dose 1, lot number: EN6205, administration time: 08:00 AM, location: Left arm), administration date: 15Mar2021, when the patient was 64-year-old, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (disability) with onset 18May2022, outcome "not recovered", described as "brain fog"; BALANCE DISORDER (disability) with onset 18May2022, outcome "not recovered", described as "losing my balance when walking"; MIGRAINE (disability) with onset 18May2022, outcome "not recovered", described as "migraine like headaches"; NAUSEA (disability) with onset 18May2022, outcome "not recovered"; PHONOPHOBIA (disability) with onset 18May2022, outcome "not recovered". The events "migraine like headaches", "nausea", "brain fog", "phonophobia" and "losing my balance when walking" required physician office visit. The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (unspecified date) no clear cause; SARS-CoV-2 test: (05Jan2023) Negative. Therapeutic measures were taken as a result of migraine, nausea, feeling abnormal, phonophobia, balance disorder. Clinical course: No other vaccine in four weeks. In May2022 daily, patient had migraine like headaches began, nausea began next, then brain fog, then phonophobia, until in October, he was losing his balance when walking. He could not attend his son's wedding reception. He offered to quit his job, but his boss gave flexibility to go home when symptoms were unbearable. He was diagnosed with migraines although all 3 neurologists said it historically doesn't begin at age 66. MRI's and a trip to reveal no clear cause. He believes this was one of the numerous neurological Pfizer vaccine injuries. He was on migraine preventative med and symptom remediation. He was hoping for intermittent fasting, exercise, and Vitamin D would help. Without help, he was headed for disability and resigning his job.