chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Jun-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-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant product use was not provided by the reporter.  On 10-Jun-2023, the vial was initially thawed.  On 14-Jun-2023, the vial was administered.  Treatment information was not provided.  This case contains information for the 11th patient out of 30 patients described by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up information received included Suspect details and narrative was updated.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Jun-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-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant product use was not provided by the reporter.  On 10-Jun-2023, the vial was initially thawed.  On 14-Jun-2023, the vial was administered.  Treatment information was not provided.  This case contains information for the 12th patient out of 30 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up information received included Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-Jun-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 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant product use was not provided by the reporter.  On 10-Jun-2023, the vial was initially thawed.  On 15-Jun-2023, the vial was administered.  Treatment information was not provided.  This case contains information for the 13th patient out of 30 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up information received included Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patinet 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Jun-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 17-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported.  2 administrations of 17 Jun 2023 and thaw date was 10 Jun 2023. No treatment medication reported.    This case was for the 14th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received include Vaccine information reported and inarrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-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-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medication information was provided.  The vial was thawed on 10Jun2023.  No treatment drug information was provided.  The case corresponds to 16th out of 30 patient as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up received, updated suspect drug start date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-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 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported. 3 administrations on 22 Jun 2023 and thaw date was 10 Jun 2023. No treatment medication reported.  This case was for the 17th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-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 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported. 3 administrations on 22 Jun 2023 and thaw date was 10 Jun 2023. No treatment medication reported.    This case was for the 18th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received include suspect vaccine details updated and Narrative updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-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 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported. 3 administrations of 23 Jun 2023 and thawed on 10 Jun 2023. No treatment medication reported.  This case was for the 19th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.; No adverse event; received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.) and NO ADVERSE EVENT (No adverse event) in a 9-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.) 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 (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (vaccine was initially stored in the refrigerator on 08-Jun-2023, beyond use date was 08-Jul-2023 and vaccine was administered on 10-Jul-2023.).    Concomitant product use was not provided by the reporter.  Expiry date of the suspect vaccine was reported as 06-Sep-2023. Dose was administered after 30-day use by date. Vial did not undergo any temperature excursions.  Treatment information was not provided.  This case contains information about patient 2nd out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733290 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733290:Same Report Patient 2
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 patients received expired Moderna Bivalent Covid-19 vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.) 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-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 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.) 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 EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine.).    Concomitant medications were not reported.  No treatment information was provided by the reporter.  This case belong to 4 th patient  out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-732810 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732810:Master Case ( Patient 4 )
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jun-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 23-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    Concomitant medication was not reported. The vial was initially thawed on 10-Jun-2023.  Treatment medication was not reported.  This case is for 21st patient out of 30 patients reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live Follow-up received contains Vaccine administration date.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jun-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 24-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug information was provided. The vial was initially thawed on 10Jun2023. No treatment drug information was provided.  The case corresponds to 22nd out of 30 patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Follow-up received, updated suspect drug administration date and I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-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 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 24th patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow-up information received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-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 30-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant medications were reported. The vial was initially thawed on 10-Jun-2023.  Treatment medications were not reported.  This case is for 25th patient out of 30 patients reported by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live significant follow-up received: Drug start date was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Jul-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 01-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No relevant concomitant medications were reported. On 27 Jun 2023 vial was thawed. No treatment medication reported.   This case was for the 27th patient out of 30 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Master case (Patient 1)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive for Covid-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Positive for Covid-19) in a 75-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K212A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy.    On 22-Feb-2022 at 3:34 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-Dec-2022, the patient experienced COVID-19 (Positive for Covid-19). At the time of the report, COVID-19 (Positive for Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Dec-2022, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-731472 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-731472:Bivalent case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jul-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 05-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023) 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 EXPIRED PRODUCT ADMINISTERED (We gave 30 doses of Moderna bivalent vaccine after manufacturer's expiration date of 08Jun2023).    No concomitant drug was reported.  On 27-Jun-2023, the vial was initially thawed.  No treatment drug was reported.   The case corresponds to 30th out of 30 patients who had received expired vaccine as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732645 (Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Live follow-up received: Suspect details and narrative was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732645:Mater Case (Patient 1)
Age: 18.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: 1st dose of the monovalent vaccine of the Moderna vaccine. For their second dose they received the monovalent Pfizer vaccine; Interchange of vaccine products; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 IMMUNISATION (1st dose of the monovalent vaccine of the Moderna vaccine. For their second dose they received the monovalent Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 IMMUNISATION (1st dose of the monovalent vaccine of the Moderna vaccine. For their second dose they received the monovalent Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (1st dose of the monovalent vaccine of the Moderna vaccine. For their second dose they received the monovalent Pfizer vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for COVID-19 IMMUNISATION (1st dose of the monovalent vaccine of the Moderna vaccine. For their second dose they received the monovalent Pfizer vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant medication not reported.   Treatment medication not reported.
Age: 4.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 08-JUN-2023 and the vaccine was administered on  10-JUL-2023; No adverse event; received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-JUN-2023 and the vaccine was administered on  10-JUL-2023) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-JUN-2023 and the vaccine was administered on  10-JUL-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-JUN-2023 and the vaccine was administered on  10-JUL-2023) 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 (received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-JUN-2023 and the vaccine was administered on  10-JUL-2023).    No concomitant medication was reported. It was reported that 2 patients had received expired Bivalent Pink Cap 3rd dose of Moderna COVID-19 vaccine on 10-Jul-2023. The vial was initially stored in the refrigerator on 08-JUN-2023. The BUD was reported as 8-Jul-2023. Dose administered after 30-day Use By Date. The vial size was reported as 0.4 ml. The vial did not undergo any temperature excursions. No treatment medication was reported.  This case contains information about patient 1st out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733291 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733291:Same Report Patient 2
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Vaccine was expired on 10-JUN-2023 which was administred on 14-JUL-2023; Patient received expired Moderna Bivalent vaccine as first dose of primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 10-JUN-2023 which was administred on 14-JUL-2023), WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 14-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 10-JUN-2023 which was administred on 14-JUL-2023) and WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 10-JUN-2023 which was administred on 14-JUL-2023), WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series) 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 (Vaccine was expired on 10-JUN-2023 which was administred on 14-JUL-2023) and WRONG PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine as first dose of primary series).    No concomitant medication was reported.  Date the vial initially stored in the refrigerator 13-JUL-2023.Expiration date was reported as 10-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Heart rate, Heart rate increased, Henoch-Schonlein purpura
Clinical narrative: Rash, feet up to her thighs.; She has high blood pressure now.; how bad her kidneys are affected; has a high resting heart rate; diagnosed with HSP; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), on 25Jan2022 as dose 2, single (Lot number: F51614) at the age of 12 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: number: 330368D, Expiration: Jun2022), administration date: 04Jan2022, when the patient was 12-year-old, for COVID-19 immunization. The following information was reported: HENOCH-SCHONLEIN PURPURA (non-serious) with onset Feb2022, outcome "not recovered", described as "diagnosed with HSP"; RASH (non-serious), outcome "not recovered", described as "Rash, feet up to her thighs."; HYPERTENSION (non-serious), outcome "unknown", described as "She has high blood pressure now."; RENAL DISORDER (non-serious), outcome "unknown", described as "how bad her kidneys are affected"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "has a high resting heart rate". The events "rash, feet up to her thighs." and "how bad her kidneys are affected" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, henoch-schonlein purpura, hypertension.  Additional information: Reporter reported for her daughter. Her and her daughter had adverse effects plus health problems. She wanted to report on her daughter first, since her daughter is worst. Her daughter's kidney specialist said it was from the vaccine. Less than a month after second covid vaccine her daughter got a really bad rash from her feet up to her thighs, and she was taken to the hospital and her doctor sent her to a kidney specialist. She was not admitted to the hospital. Did a lot of blood work and urine. She was diagnosed with HSP in late Feb2022, she does not know what HSP stands for. Treatment: she had to be put on steroids and another medication to get the rash to come down and antibiotics. Rash Outcome: Right now it is at an incline, the rash is not affecting her right now but giving her other problems. She has high blood pressure now and has to be on medication for that. She has a high resting heart rate, sometimes her heart rate goes between 150-160. Stated that the high blood pressure and high heartrate is from the HSP which she states is from the covid vaccine. Doctor did urinalysis and blood work and she is about to do a ultrasound on her kidneys. And will have to do a biopsy of her kidneys where she will have to stay overnight and be put to sleep, and see how bad her kidneys are affected.