chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Expired Rotarix (lyo) was administered to patients; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Rota (Rotarix lyophilized formulation) (batch number G973H, expiry date 01-JUL-2023) for prophylaxis.   On 17-JUL-2023, the patient received Rotarix lyophilized formulation. On 17-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: Expired Rotarix (lyo) was administered to patients). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Jul-2023 The reporter consented to follow-up. The patient received an expired dose of Rotarix lyophilized formulation, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: nurse administered only the adjuvant portion of the SHINGRIX vaccine; nurse administered only the adjuvant portion of the SHINGRIX vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: nurse administered only the adjuvant portion of the SHINGRIX vaccine) and inappropriate dose of vaccine administered (Verbatim: nurse administered only the adjuvant portion of the SHINGRIX vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 18-JUL-2023 A pharmacist reported that he/she worked at a pharmacy that supplies medication to a long-term care facility. The pharmacist received a call from the long term facility, Facility reported that a nurse administered only the adjuvant portion of the Shingrix vaccine. The reporter consented to follow up. The patient only received adjuvant which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Possible late second dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 18-JUL-2023, the patient received the 2nd dose of Shingrix. On 18-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Possible late second dose of Shingrix). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 Physician via sales representative reported that patient was possibly late for administration of second dose of Shingrix. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed Dose/missed a dose in between the 0 and 6 month dosing of twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Missed Dose/missed a dose in between the 0 and 6 month dosing of twinrix). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter reported that a patient missed a dose in between the 0 and 6 month dosing of Twinrix. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only liquid portion; Menveo only liquid portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA935A) for prophylaxis.   On 14-JUL-2023, the patient received Menveo. On 14-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid portion) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 Nurse calls to report only the liquid portion of Menveo was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email agreed.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 10-JUL-2023, the patient received Infanrix. On 10-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter was clinical manager. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal. The reporter stated that an expired dose of Infanrix was administered to a patient, which led to expired vaccine used.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: expired dose of Infanrix was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 17-JUL-2023, the patient received Infanrix. On 17-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: expired dose of Infanrix was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 19-JUL-2023 Clinical Manager states an expired dose of Infanrix was administered to a patient, which was already expired on 10 June 2023, which led to expired vaccine used. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient; administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 19-JUL-2023, the patient received Menveo. On 19-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient) and inappropriate dose of vaccine administered (Verbatim: administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 Nurse practitioner reported that another nurse administered today (July 19th 2023) the liquid portion only of Menveo to a 12 years old patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Nurse was not at the facility to provide patient's identifiers and vaccine lot number or expiration date. The reporter consented to follow up via postal. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had SHINGRIX shot #1 about two years ago but never had SHINGRIX shot #2; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 year prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: had SHINGRIX shot #1 about two years ago but never had SHINGRIX shot #2). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 The patient had Shingrix shot 1 about two years ago but never had Shingrix shot 2. (Prescriber was considering re-starting the series). Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; Shingle in her eye days after her second dose of SHINGRIX; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and ophthalmic herpes zoster (Verbatim: Shingle in her eye days after her second dose of SHINGRIX) (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroids). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and ophthalmic herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 19-JUL-2023 Reporter was a Field Representative that was at a work related lunch gathering. Field Representative states at lunch a Nurse Practitioner reports that a colleague, another nurse practitioner, was diagnosed with Shingle in her eye days after her second dose of Shingrix.   Nurse Practitioner reports to Field practitioner that this adverse event happened six months ago and was not reported. (AE Symptomatic) Also, reports that the shingles in eye was treated.  This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter consented to follow up. This case has been linked to the case US2023099643 reported by the same reporter.; Sender's Comments:  US-GSK-US2023099643:same reporter, different patient
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Vaccination after freezing; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Vaccination after freezing). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter reported that a patient received a dose of Menveo after being exposed at freezing conditions, which led to incorrect storage of vaccine. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Granuloma annulare, Immune system disorder
Clinical narrative: granuloma annulare; immune issue; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (granuloma annulare) and IMMUNE SYSTEM DISORDER (immune issue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced GRANULOMA ANNULARE (granuloma annulare) and IMMUNE SYSTEM DISORDER (immune issue). At the time of the report, GRANULOMA ANNULARE (granuloma annulare) and IMMUNE SYSTEM DISORDER (immune issue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that red blotches appeared on left arm. Then on left leg, below knee. Since then blotches had appeared on various parts of body. Diagnosed by Dermatologist and primary care physician as "Granuloma Annulare". Also with an immune issue. Blotches were not itchy or swollen just ugly to look at. IT was not going away, just increasing in number. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported.   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during breast feeding, No adverse event
Clinical narrative: No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 38-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Jun-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 20-Jun-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, 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 MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported. Index number was reported as UN-09730.   Reporter did not allow further contact
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 31-May-2023 and administered to patient on 17-JUL-2023; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administered to patient on 17-JUL-2023).    It was unknown patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 31-May-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 2 out of 19.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse Event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 3rd out of 19 adult patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master Case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was initially stored in the refrigerator 31-May-2023.  Vial was individual vial with multi dose 0.5 ML. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 4th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (patient 1)
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 31-May-2023 and administration of vaccine was 17-Jul-2023; No Adverse Event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 5th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 6th  out of 19 adult patients.    This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No Adverse Event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 7th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
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 31 May 2023 and vaccine was administered to patient after 30-day Use by Date; No Adverse event; Bivalent Moderna vaccine was administered to patient after 30-day Use by Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered to patient after 30-day Use by Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31 May 2023 and vaccine was administered to patient after 30-day Use by Date).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were provided.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  No treatment medication was provided.  This case contains information for the 8th out of 19 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) 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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was initially stored in the refrigerator on 31-May-2023.  Vial was individual vial with multi dose 0.5 ML.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 9th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761: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 31-May-2023 and administration of vaccine was 17-Jul-2023; No Adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 31-May-2023 and administration of vaccine was 17-Jul-2023).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 10 out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.; No adverse event; Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-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. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-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) .5 milliliter. On 17-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-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 (Bivalent Moderna vaccine was administered after date of expiry to 19 adult patients) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 31-May-2023 and vial was administered on 17-Jul-2023.).    It was unknown if the patient any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Vial was individual vial with multi dose 0.5 ML. Dose administered after 30-day Use by Date or after Manufacturer Date of Expiry. It was not reported if the vial undergoes any temperature excursions or not. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 11th out of 19 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-733761 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733761:Master case (Patient 1)