chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: she was inadvertently administered Engerix-B instead of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 59-year-old female patient who received HBV (Engerix B) (batch number AX225, expiry date 07-DEC-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 31-MAR-2023, the patient received Engerix B. On 31-MAR-2023, an unknown time after receiving Engerix B, the patient experienced wrong vaccine administered (Verbatim: she was inadvertently administered Engerix-B instead of Twinrix).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 1-Sept-2023 Pharmacist reported that the patient received a dose of Twinrix and when she came back for second dose, she was inadvertently administered Engerix-B instead of Twinrix.   The error was not discovered until the patient came back on one day before the reporting date (31st August 2023) for her next dose.   On 31st August 2023, the pharmacy did not administer anything to the patient.   At the time of reporting, no additional doses had been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient inadvertently administered Engerix-B instead of Twinrix as second dose, which led to wrong vaccine administered.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received an accidental 2nd dose on 30Aug2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA824A, expiry date 31-JAN-2024) for prophylaxis.   Concomitant products included MENVEO.   On 30-AUG-2023, the patient received the 2nd dose of Menveo. On 30-AUG-2023, an unknown time after receiving Menveo and an unknown time after receiving MENVEO, the patient experienced extra dose administered (Verbatim: received an accidental 2nd dose on 30Aug2023).  The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date 30 Aug 2023 A medical assistant reported that a patient received Menveo on 18Aug2022 and received an accidental 2nd dose on 30Aug2023, which led to extra dose administered.  No symptoms reported. The reporter consented to follow up via mail.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 and half year ago from 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: 2nd dose not received yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 05-SEP-2023 The healthcare professional wanted to confirm if they could administer the second dose to this patient.  Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: administered a dose of Boostrix on 06Sep2023 via intravenous route instead of intramuscular.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 06-SEP-2023, the patient received Boostrix (intravenous). On 06-SEP-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered a dose of Boostrix on 06Sep2023 via intravenous route instead of intramuscular.).  The outcome of the intramuscular formulation administered by other route 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: 6-Sept-2023 Pharmacist reported a nurse administered a dose of Boostrix via intravenous route instead of intramuscular.  At the time of reporting, the reporter did not had the dose lot number / expiration date, and did not had any patient information. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The patient received a dose of  Boostrix intravenously, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: mistakenly received a third dose of Shingrix a few months ago on an unknown date; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: mistakenly received a third dose of Shingrix a few months ago on an unknown date).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 07-SEP-2023 The patient (initials and DOB was unknown) mistakenly received a third dose of Shingrix a few months ago on an unknown date, which led to extra dose administered. Nothing else was reported. The physician/reporter was driving and did not have access to details (patient identifiers, dates, lot number) at the time of the call. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Failure to thrive, Foetal exposure during pregnancy
Clinical narrative: FAILURE TO THRIVE/POOR WEIGHT GAIN; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned an infant female. The patient's mother was enrolled in a non-company sponsored study. The patient's weight was 2.83 kilograms, and height was 21 inches. No concurrent conditions were reported. The patient's maternal medical history included multi gravida, low blood pressure. Concomitant medications included prenatal vitamins. Maternal obstetrical history included one previous pregnancy that resulted in live baby. The mother of infant had no history of tobacco, e-cigarettes, alcohol or recreational drug use. Maternal first day of the last menstrual period (LMP) was calculated to be 25-JUN-2020. The estimated delivery date (EDD) was reported to be 01-APR-2021. Type of pregnancy was not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number and expiry date was not reported) dose was not reported, 1 total administered on 12-MAR-2021 at gestational age 37 weeks and one day for covid-19 immunization, which was foetal exposure during pregnancy. The batch number was not reported and has been requested. Concomitant medications included minerals nos/vitamins nos for drug used for unknown indication. At gestational age 39 weeks and one day, the mother delivered a live, full-term, female neonate by cesarean method of delivery (C-section). Primary reason for C-section was previous C-section. The mother spent three days in hospital for the delivery. On an unspecified date in MAR-2021, Laboratory data included: Hearing test Not Reported. On an unspecified date in MAR-2022, at 12 months, the baby was diagnosed with failure to thrive/poor weight gain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy, and had not recovered from failure to thrive/poor weight gain. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and failure to thrive/poor weight gain, and foetal exposure during pregnancy as not related.  This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210726934.; Sender's Comments: V0: 20230916594-Failure to thrive/poor weight gain. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: PAIN IN KNEE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pain in knee. Treatment medications (dates unspecified) included: alpha-d galactosidase/amylase/bromelains/cellulase/glucoamylase/lipase/minerals nos/nattokinase/protease nos. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in knee. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 042H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 06-Sep-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, 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 06-Sep-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The 2.5mL vial was initially stored in the refrigerator on 05-Sep-2023. The 2 doses from 1 vial didn't underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 2 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739608 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739608:Patient 1
Sex: U
Vaccine: UNK
Symptoms: Vaccination site rash
Clinical narrative: had a reaction when had last Covid shot and ended up with Covid arm, had a rash; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE RASH (had a reaction when had last Covid shot and ended up with Covid arm, had a rash) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included COPD.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (had a reaction when had last Covid shot and ended up with Covid arm, had a rash). At the time of the report, VACCINATION SITE RASH (had a reaction when had last Covid shot and ended up with Covid arm, had a rash) outcome was unknown. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The patient was the reporter in this case.  No concomitant medications were reported.  The patient did not know if the patient had a reaction or a side effect to the vaccine. The patient wanted to know if the patient's chronic obstructive pulmonary disease was going to get worse or something similar could occur after the RSV vaccine or not.  The patient thought that the patient received the second or third dose of Moderna vaccine and did not remember about the dose number.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown.  The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.   It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. This case contains information for patient 2 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered shot to patient after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered shot to patient after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 3 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 4th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 6 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.  This case was reported for patient 7th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master Case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 8th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 12 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 15th out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.   Suspect product dosage text was reported as unknown.  The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.  This case contains information for patient 16 out of 16.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 9 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 06-Sep-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, 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 06-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The 2.5mL vial was initially stored in the refrigerator on 05-Sep-2023. The 2 doses from 1 vial didn't underwent any temperature excursions. No treatment medication was reported.  This case contains information about patient 1st out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739613 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739613:Patient 2
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours; no adverse event; 1 dose was administered after exposure to room temperature >24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered after exposure to room temperature >24 hours), PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7646C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-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 06-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered after exposure to room temperature >24 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was administered after exposure to room temperature >24 hours), PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours) 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 (1 dose was administered after exposure to room temperature >24 hours) and PRODUCT STORAGE ERROR (HCP is reporting that 1 dose was administered after exposure to room temperature and gt, 24 hours).    No concomitant medication was reported.  The vial was initially stored in the refrigerator at 10:06 AM on 28-AUG-2023. The vial did not undergo any temperature excursions. No treatment information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they were under the impression the expiration dates were extended and that this lot had an expiration date of 18Sep2023 but when they checked with the vial expiration checker it came up as 18Jun2023).    Concomitant medication details not reported by the reporter. Suspect product dosage text was reported as unknown. Treatment details was not reported by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Pain; Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) and PAIN (Pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Patient stated that he was very active.  The patient's past medical history included COVID-19 (The patient states he got COVID a year before the vaccines came out.).   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEADACHE (Headaches). On an unknown date, the patient experienced PAIN (Pain). The patient was treated with NORTRIPTYLINE at an unspecified dose and frequency; NAPROXEN at an unspecified dose and frequency and ERENUMAB (AIMOVIG [ERENUMAB]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches) and PAIN (Pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient stated that he was fully vaccinated with Moderna vaccines. Patient had not taken any of the boosters. About one month after he was fully vaccinated, he started developing really really really bad headaches. Patient thought it was allergies at first. Then he found that it was coming from scents and fragrances, like perfumes. He found that the headaches were coming from the vaccine. The patient's body was producing an immune response in contact with anything with a scent, causing these headaches. It was reported that more the exposure, the more intense these headaches became. It had been more acute over the years. The patient stated that there was nothing that can slow that down.  Patient took the triptans, different stroke medicines, almost everything in the market, injectables, none of those could slowed that down. The patient was on an injectable called Ajovy, which doesn't even slowed things down.  The patient further states that he had many headaches a day. It started from when he woke up to 11 at night. He had one right now. Patient was in extreme pain. It was nonstop, all day long. Patient stated that work was complete nightmare.  The patient added that he had never taken any vaccine. Patient had never taken the flu vaccine.  Patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2023: Live follow up received is non-significant.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (VACCINE GIVEN AFTER EXPIRATION DATE DUE TO TEMPERATURE CHANGE IN STORAGE).    Concomitant product use was not provided by the reporter.  It is unknown if the patient experienced any additional symptoms/events.   Treatment information was not provided.