chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 4 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown. The vial did not undergo any temperature excursions. Suspect vaccine expiry date was 11-May-2023.  It was reported that no adverse reactions have been reported by any patients.  No treatment medication was reported.  This case is reported for patient 6th out of 50 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 9 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 10 out of 50 patients.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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 (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown. The vial did not undergo any temperature excursions. Suspect vaccine expiry date was 11-May-2023.  It was reported that no adverse reactions have been reported by any patients.  No treatment medication was reported.  This case is reported for patient 12th out of 50 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-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 (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 14 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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 (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 33 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-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 (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 24 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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 (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 25 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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 (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023.) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023.).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown. The vial did not undergo any temperature excursions. Suspect vaccine expiry date was 11-May-2023.  It was reported that no adverse reactions have been reported by any patients.  No treatment medication was reported.  This case is reported for patient 16th out of 50 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-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 (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 18 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5Jun2023)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023; No adverse event; Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-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 (Dose to patient on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (Vaccine was expired on 11-May-2023 and was stored in referigerator on 04-Jun-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 19 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; No adverse event; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-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 (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 28 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5-JUN-2023)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023; No adverse event; Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) 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. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-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 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-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 (Dose administered to patient on 5-JUN-2023 from vials of the Moderna COVID-19 bivalent vaccine that was expired on 11-MAY-2023) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator on 04-JUN-2023 after expiration date 11-MAY-2023).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 20 out of 50 patients   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia
Clinical narrative: HYPOXIA
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fall, Fatigue, Myalgia
Clinical narrative: Patient reports severe muscle soreness, weakness, and fatigue in lower extremities resulting in two falls.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Per documentation, patient was given flu vax and sibling was given covid vax. On 1/3/23, MOC told PCP she believes patient was given Covid vax and not Flu, as she saw vaccine pulled from the same vial for both siblings on 10/17
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Deep vein thrombosis
Clinical narrative: ACUTE DVT OF LEFT FEMORAL VEIN ACUTE RESPIRATORY FAILURE
Age: 1.83
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: The physician ordered a moderna booster 6m-5y but was given the moderna booster 6-11y.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Malaise
Clinical narrative: Mild pain, moderate tenderness, redness and mild swelling below injection site noted the day after vaccination.  Mild feeling of malaise, headache and body aches for 1-2 days following vaccination.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Mild pain, moderate tenderness, redness and mild swelling below injection site noted the day after vaccination.  Mild feeling of malaise, headache and body aches for 1-2 days following vaccination.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Incoherent, Loss of consciousness
Clinical narrative: Vaccine was given in left deltoid and upon completion patient stated he started feeling like he was going to pass out.  At about 0925 patient began closing his eyes and becoming incoherent.  At that time we called the medical director for assistance and got a set of vitals.  Member was drifting in and out on consciousness at that time.  Member was laid down on the exam table. Another set of vitals was taken and member became more coherent as well.  At 0938 members was alert and oriented x3 and was sat up and another set of vitals was taken.  At 0943 member was stood up, member was able to stand without any issues.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Breakthrough Covid-19 Infection
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Anion gap, Blood bicarbonate, Blood chloride normal, Blood creatinine, Blood sodium normal
Clinical narrative: Injection site reaction, cellulitis to injection site
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Blood urea, Electrocardiogram, Glomerular filtration rate, Haematocrit, Haemoglobin decreased
Clinical narrative: Injection site reaction, cellulitis to injection site
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site cellulitis, Injection site reaction, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume
Clinical narrative: Injection site reaction, cellulitis to injection site
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Mean platelet volume normal, Metabolic function test, Platelet count, Red blood cell count decreased, Troponin
Clinical narrative: Injection site reaction, cellulitis to injection site
Age: 82.0
Sex: F
Vaccine: PNC20
Symptoms: Troponin T, White blood cell count
Clinical narrative: Injection site reaction, cellulitis to injection site
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: Pt fainted after administration
Age: 25.0
Sex: F
Vaccine: COVID19-2, HEP, MMR, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: Client found to be 7 weeks pregnant as of 08/07/2023.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic respiratory failure, Epilepsy, Respiratory failure
Clinical narrative: EPILEPSY, UNSPECIFIED CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Crying, Fall, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: After vaccines were administered, patient was sitting in a chair with mom's phone while sibling was being vaccinated. Patient was alert and oriented. Mom was holding sibling on her lap on exam table while myself and another nurse were each vaccinating and a third nurse was observing.  This was approximately 3-4 minutes after patient's vaccines were administered. Patient reportedly lost consciousness and fell over into a cabinet then slumped down onto the floor. Within 10-15 seconds, patient was crying and alert. She was laid on exam table for a brief examination. She was aware of her surroundings, diaphoretic and pale. A slight amount of blood was noted on left side of tongue in mouth but no other injuries were noted or palpated on head or body. Patient denied any pain or injuries. Within another minute, patient's color retuned to normal and patient was asking to go home. Mom was instructed to report incident to physician and to continue monitoring patient. After approximately 15 minutes, Mom left with patient.
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMRV
Symptoms: Tongue injury
Clinical narrative: After vaccines were administered, patient was sitting in a chair with mom's phone while sibling was being vaccinated. Patient was alert and oriented. Mom was holding sibling on her lap on exam table while myself and another nurse were each vaccinating and a third nurse was observing.  This was approximately 3-4 minutes after patient's vaccines were administered. Patient reportedly lost consciousness and fell over into a cabinet then slumped down onto the floor. Within 10-15 seconds, patient was crying and alert. She was laid on exam table for a brief examination. She was aware of her surroundings, diaphoretic and pale. A slight amount of blood was noted on left side of tongue in mouth but no other injuries were noted or palpated on head or body. Patient denied any pain or injuries. Within another minute, patient's color retuned to normal and patient was asking to go home. Mom was instructed to report incident to physician and to continue monitoring patient. After approximately 15 minutes, Mom left with patient.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Acute coronary syndrome, Hypoxia, Obstructive sleep apnoea syndrome
Clinical narrative: OBSTRUCTIVE SLEEP APNEA ACUTE CORONARY SYNDROME, UNSPECIFIED HYPOXEMIA
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Deafness, Electrocardiogram, Endoscopy upper gastrointestinal tract, Fatigue
Clinical narrative: ARM PAIN, FEVER CHILLS, NAUSEA VOMITING, DEVELOPED ESOPHAGEAL ULCER THAT REQUIRED SERIAL UPPER ENDOSCOPY.  OVER NEXT SEVERAL MONTHS TO PRESENT DATE HAS HEARING LOSS, FATIGUE, HEADACHE, UPSETTING DREAMS, OCCASIONAL GI UPSET, INANITION
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Laboratory test, Nausea, Nightmare, Oesophageal ulcer
Clinical narrative: ARM PAIN, FEVER CHILLS, NAUSEA VOMITING, DEVELOPED ESOPHAGEAL ULCER THAT REQUIRED SERIAL UPPER ENDOSCOPY.  OVER NEXT SEVERAL MONTHS TO PRESENT DATE HAS HEARING LOSS, FATIGUE, HEADACHE, UPSETTING DREAMS, OCCASIONAL GI UPSET, INANITION
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Starvation, Vomiting
Clinical narrative: ARM PAIN, FEVER CHILLS, NAUSEA VOMITING, DEVELOPED ESOPHAGEAL ULCER THAT REQUIRED SERIAL UPPER ENDOSCOPY.  OVER NEXT SEVERAL MONTHS TO PRESENT DATE HAS HEARING LOSS, FATIGUE, HEADACHE, UPSETTING DREAMS, OCCASIONAL GI UPSET, INANITION