chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, 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 POOR QUALITY 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 POOR QUALITY 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, POOR QUALITY 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 POOR QUALITY 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 82 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:Master case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (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 POOR QUALITY PRODUCT ADMINISTERED (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 (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, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 83rd 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 were 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: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vials were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given 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 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, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again).    No concomitant medication was reported.  Nurse reported that 100 bivalent boosters were given a day before reporting from vials that were put in the fridge and after that refrozen and thawed again.  No treatment information was provided.  This case contains information for the 85 of 100 adult male patients described by the 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: No adverse event, Poor quality product administered, 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 POOR QUALITY 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 POOR QUALITY 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, POOR QUALITY 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 POOR QUALITY 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).    This case for patient 86 out of 100 patients. Concomitant medications were not reported.  No treatment information was provided 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: COVID19-2
Symptoms: No adverse event, Poor quality product administered, 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 PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (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 POOR QUALITY 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, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (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.        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 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medications were not reported.   Spikevax COVID19 vaccine bivalent, the dosage given in ml was unknown to the HCP.  No treatment information was provided by the reporter.  This case for patient 87 out of 100 patients.   This case was linked to MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-697752:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (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 POOR QUALITY PRODUCT ADMINISTERED (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 (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, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (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         This case included information of patient 88th out of 100 patients.  No concomitant medication was provided by reporter.   No treatment medication was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 059A22A, 047C21A, 043L20A and 037K20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her second Moderna Covid 19 vaccine booster dose on 13-Jun-2022 and received an additional booster dose of the Moderna COVID-19 vaccine on 7-Jul-2022).    No concomitant product reported by the reporter. No treatment medication reported by the reporter.   This case was linked to MOD-2023-698246 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: his spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult patient received Pediatric Booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Adult patient received Pediatric Booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult patient received Pediatric Booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.         This case contains information for the 2nd of 3 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Treatment Medication use information was not provided by reporter.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received a 0.25ml Pediatric Dose instead of a 0.5ml Adult dose).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR7479B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-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 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received pediatric booster dose of Moderna COVID-19 vaccine from a vial with Blue Cap and Purple Border).    This case contains information for the 3rd of 3 adult patients described by the reporter.  Patient was not pregnant. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. NDC was provided as 80777-0275-99. No concomitant product was reported. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2023-698179 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698179:Master case - 1st adult patient
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Product storage error; Poor quality vaccine administered; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) 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 PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Product storage error), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 PRODUCT STORAGE ERROR (Product storage error) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    No concomitant medications were reported. No treatment medications were reported.  This case contains information for the 89 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: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.), PRODUCT STORAGE ERROR (11JAN2023 was beyond use date, administered on 14JAN2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (11JAN2023 was beyond use date, administered on 14JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.), PRODUCT STORAGE ERROR (11JAN2023 was beyond use date, administered on 14JAN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant medication was not reported.  Patient received Moderna bivalent 6m-5y of age dose after the beyond use date. 11-Jan-2023 was beyond use date and product was administered on 14-Jan-2023.  This case contains information for the 2nd of 3 child patients described by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, 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 POOR QUALITY 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 POOR QUALITY 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, POOR QUALITY 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 POOR QUALITY 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 90 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 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.).    No concomitant medications details were reported.  Patient received Moderna bivalent 6m-5y of age dose after the beyond use date. 11-Jan-2023 was beyond use date and product was administered on 14-Jan-2023.  No treatment medications details were reported.  This case contains information for the 3rd of 3 child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698191 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698191:first patient case
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 92th  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 it 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 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (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 POOR QUALITY PRODUCT ADMINISTERED (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 (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, POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (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 POOR QUALITY PRODUCT ADMINISTERED (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 91st 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 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752: case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, 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 POOR QUALITY 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 POOR QUALITY 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, POOR QUALITY 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.        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 (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).    This case contains information for the 93 of 100 patients described by the reporter.  No concomitant product was reported. No treatment information was 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: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: vials were put in the fridge and after that refrozen and thawed again; No adverse event; 100 bivalent boosters were given 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given 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 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, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials 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 POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials were put in the fridge and after that refrozen and thawed again).    No concomitant medication was reported.  Nurse reported that 100 bivalent boosters were given a day before reporting from vials that were put in the fridge and after that refrozen and thawed again.  No treatment information was provided.  This case contains information for the 94 of 100 adult male 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: case
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: ials that were put in the fridge and after that refrozen and thawed; 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 POOR QUALITY 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 (ials that were put in the fridge and after that refrozen and thawed) 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 (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 (ials that were put in the fridge and after that refrozen and thawed) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY 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 (ials that were put in the fridge and after that refrozen and thawed) 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 POOR QUALITY 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 (ials that were put in the fridge and after that refrozen and thawed).    Case contains the information regarding patient 95 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 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case