chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st HepB vx 2017, 2nd dose Engerix-B 2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 14-year-old male patient who received HBV (Engerix B pediatric) for prophylaxis.   Previously administered products included Hepatitis-B vaccine (received first dose of unknown hepatitis B vaccine at 9 years of age).   On 19-SEP-2022, the patient received the 2nd dose of Engerix B pediatric. On 19-SEP-2022, an unknown time after receiving Engerix B pediatric, the patient experienced drug dose administration interval too long (Verbatim: 1st HepB vx 2017, 2nd dose Engerix-B 2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 16-Mar-2023 The reporter told that the patient received series of unknown hepatitis B vaccine when they were younger. The reporter did no consent to follow-up. The patient received the second dose of Engerix-B pediatric later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Muscle strain, Skin lesion
Clinical narrative: Shingles lesions, diagnosed with shingles; Shingles lesions, diagnosed with shingles; backache, thought it was a pulled muscle; thought it was a pulled muscle; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular). On 11-MAR-2023, 5 days after receiving Shingrix, the patient experienced back pain (Verbatim: backache, thought it was a pulled muscle) and pulled muscle (Verbatim: thought it was a pulled muscle). On 12-MAR-2023, the patient experienced shingles (Verbatim: Shingles lesions, diagnosed with shingles) and skin lesion (Verbatim: Shingles lesions, diagnosed with shingles). The outcome of the shingles, skin lesion, back pain and pulled muscle were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin lesion, back pain and pulled muscle to be related to Shingrix.     It was unknown if the company considered the shingles, skin lesion, back pain and pulled muscle to be related to Shingrix.   Additional Information: GSK receipt date: 16-Mar-2023 The patient who received her first dose of Shingirx and 5 days after vaccination, in the evening, she began having a backache and  thought it was a pulled muscle.   The next day she had the Shingles lesions. On 14th March 2023, the patient was diagnosed with full-blown shingles by her physician. The batch number was unknown but should be able to access it by contacting the pharmacy, which was entered in the vaccine facility details fields.  The reporter gave consent to contact her physician.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Apr2018, 2nd not yet; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in April 2018).   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: 1st dose Apr2018, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-MAR-2023 The provider wondered if they should restart series or complete series with the patient.   The reporter stated that any education on the situation would be helpful. The reporter consented to follow up.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Didn't get 2nd dose due to pandemic; This non-serious case was reported by a physician via call center representative and described the occurrence of social problem in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in March 2020).   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 social problem (Verbatim: Didn't get 2nd dose due to pandemic). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 16-MAR-2023 The reporter consented to follow up via email.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 16-MAR-2023, the patient received Havrix. On 16-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix 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: 16-MAR-2023 The nurse reported the case for a patient. The reporter reported that a patient was administered with a dose of expired Havrix vaccine. The reporter consented to follow up. Patient received a dose of Havrix on 16th March 2023 which was expired on 30th January 2023, which led to expired vaccine used
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). The action taken with Shingrix was unknown. The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 16-Mar-2023 The physician had a patient who got shingles before the 2nd dose appointment.  The patient would like to know the following as how often this happen (patients get shingles even after the initial dose has been administered), how long the patient need to wait to administer the 2nd dose if a patient had shingles in between the dose series and at what point the series need to be restarted if the patient has not receive the 2nd dose of Shingrix in over a year. The patient received Shingrix not too long ago, had shingles shortly after in a few months before 2nd dose in 6 months.  The provider wanted to know how long does she had to wait to administer the 2nd dose. The provider would like to know if it was been more than a year after the initial dose then what was the cutoff time for administering the 2nd dose and therefore restarting the series altogether. This was not pertaining to a particular patient. The provider wanted to know for her awareness as she encounters patients. There was no more information that the one provided in the message.  The adverse event was filed conservatively since it was mentioned that a patient got shingles after Shingrix and a possible late 2nd dose.  The reporter consented to follow-up. The case was linked with case US2023AMR042568, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR042568:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2022 never received the 2nd; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th June 2022).   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: 1st dose in 2022 never received the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-MAR-2023 The pharmacist had a patient who never got the second dose of Shingrix. The lot number was not available at the moment of the call. The follow-up accepted by mailing. The reporter consented to follow up.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1 dose years ago, never got the 2nd; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 5 years ago).   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: 1 dose years ago, never got the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 17-MAR-2023 The nurse reported that patient never got the 2nd dose. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 15Jun2018, 2nd not 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 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 15th June 2018 with batch number B9739 and expiry date 22nd November 2020).   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: 1st dose 15Jun2018, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:17-MAR-2023 The pharmacist reported that a patient never received the second dose.   At the time of reporting, a second dose had not been administered. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Only liquid portion administered; Only liquid portion administered; 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) (batch number AMVA902A, expiry date 31-JAN-2024) for prophylaxis.   On 16-MAR-2023, the patient received the 1st dose of Menveo. On 16-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion administered) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Mar-2023 The patient received only the liquid portion of Menveo.  The reporter gave information about the vaccine and patient.  The reporter approved to receive follow-up Consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient only received liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Feb2020, 2nd not 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 male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included havrix (received 1st dose in February 2020).   On an unknown date, the patient did not receive the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose Feb2020, 2nd not yet). 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: 17-Mar-2023 Pharmacist reported that a male patient received a dose of Havrix and the 2nd dose had not been administered at the time of reporting. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant administered; Only adjuvant administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAR-2023, the patient received Shingrix (intramuscular). On 16-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant administered) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Mar-2023 The patient was mistakenly injected with Shingrix adjuvant only (not reconstituted antigen). Nothing else was reported.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient only received adjuvant only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only liquid portion administered; Only liquid portion administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 45-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 17-MAR-2023, the patient received Menveo. On 17-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only liquid portion administered) and inappropriate dose of vaccine administered (Verbatim: Only liquid portion administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Mar-2023 The reporter stated that Menveo was not properly reconstituted and only the liquid portion was administered to a male patient.  The reporter consented to follow up via email. Information about the lot number and expiration date for the vaccine were asked but declined. The patient only received liquid portion only of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Eye pain
Clinical narrative: MADE EYEBALLS HURT, PRODUCT WAS KILLING EYES, EYES WERE GOING CRAZY; STRANGE SEVERE REACTION ABOUT 30 MINUTES POST VACCINATION; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chemical sensitivity, and dry skin, and other pre-existing medical conditions included: The patient had no illness at the time of vaccination, no past history of similar events, no adverse event after any previous vaccinations, no pre existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days. The patient was not pregnant at the time of vaccination and was not currently breastfeeding. The patient had no needle phobia or fear of vaccines. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 66 years old. No concomitant medications were reported. On 03-MAY-2021, the patient experienced strange severe reaction about 30 minutes post vaccination. The patient received neutrogena hydro boost gel-cream extra-dry skin (cream, topical, batch number: 11622VB1 expiry: UNKNOWN) dose and frequency were not reported from 01-FEB-2023 for dry skin.  On FEB-2023, the patient experienced made eyeballs hurt, product was killing eyes, eyes were going crazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with neutrogena hydro boost gel-cream extra-dry skin was not reported. The patient recovered from made eyeballs hurt, product was killing eyes, eyes were going crazy, and the outcome of strange severe reaction about 30 minutes post vaccination was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. 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 not reported, batch number: 041A21A expiry: 21-JUN-2021) dose was not reported, 1 total, administered on 06-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. Non-company suspect drugs included: nirmatrelvir/ritonavir (Paxlovid) (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from MAR-2023 for covid-19 treatment.  On MAR-2023, the patient tested positive for covid and then again 17 days after Paxlovid treatment. Symptoms were mild (confirmed clinical vaccination failure, and confirmed covid-19 infection). Laboratory data included: COVID-19 virus test Positive, Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20230351456. This report was associated with product quality complaint: 90000276278.; Sender's Comments: V0: 20230366649-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional clarifying statements or AE details were provided; The patient was administered a dose of VARIVAX that was involved in a temperature excursion.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-FEB-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot # W021740, which had been verified to be a valid lot #, expiration date: 10-JUL-2024) (strength, dose, and route of administration were not provided), administered for prophylaxis. The vaccine was stored at 14.7 degrees Fahrenheit (F) for 1 hour and 3 minutes. No previous excursions were reported. No additional clarifying statements or adverse events (AE) details were provided (no adverse event).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Patient received first dose moderna and secod dose pfizer bivalent; Patient received first dose moderna and secod dose pfizer bivalent; Patient received first dose moderna and secod dose pfizer bivalent; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent), COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent) and NO ADVERSE EVENT (No adverse event) in a 45-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and second dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent), COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent), COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose moderna and secod dose pfizer bivalent), INTERCHANGE OF VACCINE PRODUCTS (Patient received first dose moderna and secod dose pfizer bivalent) and COVID-19 IMMUNISATION (Patient received first dose moderna and secod dose pfizer bivalent).    Concomitant medications were not reported.   Patient received bivalent as the second dose of the primary series. Which is Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage from Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to 12 years.  Treatment medications were not reported.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; first dose received 0n 27-May-2022 and second dose on 27-Jul-2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On 27-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose received 0n 27-May-2022 and second dose on 27-Jul-2022).    Concomitant medications were not reported.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19. Treatment medications were not reported.   This case was linked to MOD-2023-714991 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023; No adverse event; Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     The patient had no known conditions.     On 24-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD), PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 Vaccine Bivalent were administered on 24MAR2023 BUD) and PRODUCT STORAGE ERROR (Bivalent Lot 017H22A moved from freezer to refrigerator on 02/22/2023 with a use by 03/23/2023 and 2 doses were then administered on the 03/24/2023).    Concomitant medications were not reported.  The patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered on 24-Mar-2023 BUD. Vials were moved from freezer to refrigerator fridge since 22-Feb-2023 with a use by 23-Mar-2024. Caller mentioned no AEs were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717193 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Live follow up received. Updated reporter details, suspect dosage details, event verbatim and narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717193:Master case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same date.; No adverse event; Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023, it was initially 13MAR2023 and administered on same date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Vaccine expired on 23FEB2023,  it was initially 13MAR2023 and administered on same date.).    No concomitant medications were reported. Pharmacist was called to report that 2 adult patients received expired first primary dose of Moderna COVID-19 vaccine from 2 different vials on 2 different dates Individual vials Vial size was reported as 5.5 ml. On 13MAR2023, the vial was initially stored in the refrigerator  The vial did not undergo any temperature excursions. No treatment medications were reported. This case contains information for the 2nd patient out of 2 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-717201 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717201:Patient No 01 (Master case)
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: Acute Erythema Multiforme; This literature-non-study case was reported in a literature article and describes the occurrence of ERYTHEMA MULTIFORME (Acute Erythema Multiforme) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.       No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA MULTIFORME (Acute Erythema Multiforme) (seriousness criterion medically significant). At the time of the report, ERYTHEMA MULTIFORME (Acute Erythema Multiforme) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had not experienced any adverse reactions with first two doses. The diagnosis was made clinically, and the patient course was followed for 8 weeks without complete resolution.  Company Comment: This is a literature non-study case concerning a 39-year-old, of unknown gender patient with no reported medical history, who experienced the serious (due to medically significant) expected AESI ERYTHEMA MULTIFORME. The event occurred 10 days after receiving the third dose of mRNA-1273 vaccine. It was reported that the patient had not experienced any adverse reactions with first two doses. The diagnosis was made clinically, and the patient course was followed for 8 weeks without complete resolution. The outcome of the event was reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Immunisation reaction
Clinical narrative: On the last one I had bad reactions/I had side effects from the last; my legs, felt like its been on the sun all day, can be sunburn; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (On the last one I had bad reactions/I had side effects from the last) and FEELING HOT (my legs, felt like its been on the sun all day, can be sunburn) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (On the last one I had bad reactions/I had side effects from the last) and FEELING HOT (my legs, felt like its been on the sun all day, can be sunburn). At the time of the report, IMMUNISATION REACTION (On the last one I had bad reactions/I had side effects from the last) and FEELING HOT (my legs, felt like its been on the sun all day, can be sunburn) outcome was unknown.            No concomitant medications were reported It was reported that the patient took 1, 2, 3 Moderna to avoid getting COVID.  No treatment medications were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: 65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month; This spontaneous case was reported by a physician and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Arthritis and Obesity.   In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (65 year old patient, after the Booster dose on FEB-2022, she started having her menstrual period every month) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient did not have any previous issues with her reproductive system, and she had never had uterine cancer or anything like that. No concomitant drug was reported. Reporter was asking for any reports of menstrual period in elderly, after receiving Moderna COVID-19 vaccine. Doctor stated that he was trying to work her up.  No treatment drug was reported.  Company comment.  This spontaneous case concerns a 65  year  old female patient, with relevant medical history of obesity, who received three doses of mRNA  1273 original vaccine and experienced the unexpected, serious (medically significant) event of postmenopausal haemorrhage. Latency cannot be properly assessed since exact onset date and vaccination date were not provided. The report stated that after the booster dose the patient started having her menstrual period every month. The outcome of the event was not recovered. No further clinical details were provided for medical reviewing. Patient´s mentioned medical history could be risk factor for the event. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.; No adverse event; Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.), PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In March 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.), PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.) and PRODUCT STORAGE ERROR (Moderna bivalent vaccine with a beyond use date of 15-Mar-2023 given to two patients after the BUD.).    Concomitant medication was not provided.  It was reported that vaccines were administered on 16-Mar-2023 and 17-Mar-2023. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-717104 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2023: Non significant follow up received. On 27-Mar-2023: Live Significant FU : Patient details and lot number added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717104:same reporter
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal, Gait disturbance, Mobility decreased
Clinical narrative: "I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet; I had no strength my body. I didn't have any energy; I couldn't get out of bed. I can barely walk, it's not a straight posture.; I can barely walk, it's not a straight posture; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL ("I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet), ASTHENIA (I had no strength my body. I didn't have any energy), MOBILITY DECREASED (I couldn't get out of bed. I can barely walk, it's not a straight posture) and GAIT DISTURBANCE (I can barely walk, it's not a straight posture) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced FEELING ABNORMAL ("I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet), ASTHENIA (I had no strength my body. I didn't have any energy), MOBILITY DECREASED (I couldn't get out of bed. I can barely walk, it's not a straight posture) and GAIT DISTURBANCE (I can barely walk, it's not a straight posture). On 20-Apr-2022, ASTHENIA (I had no strength my body. I didn't have any energy) had resolved. At the time of the report, FEELING ABNORMAL ("I felt electrodes on both sides of my forehead, my ears, the sides of my neck, my shoulders, & down to my feet), MOBILITY DECREASED (I couldn't get out of bed. I can barely walk, it's not a straight posture) and GAIT DISTURBANCE (I can barely walk, it's not a straight posture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. It was reported that patient took all the other Moderna shots without side effects, except this one.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Dose 1 received on 21-JAN-2021 and dose 2 received on 03-MAR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 21-JAN-2021 and dose 2 received on 03-MAR-2021) and NO ADVERSE EVENT (no adverse event) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 21-JAN-2021 and dose 2 received on 03-MAR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 21-JAN-2021 and dose 2 received on 03-MAR-2021) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 received on 21-JAN-2021 and dose 2 received on 03-MAR-2021).    No concomitant medications were reported. On 16-MAR-2022, the patient received fourth dose of Pfizer . On 03-OCT-2022, the patient received fifth dose of Moderna COVID-19 vaccine bivalent of Lot number AS7162B. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No adverse event; Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine; The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to report that adult patient received expired first primary dose of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vial was expired on 23-FEB-2023 and initially stored in the refrigerator on 02-MAR-2023).    No concomitant medication was reported.    The vial did not undergo any temperature excursions. No treatment information was reported.   This case is for patient 1 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-717206 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717206:Patient No 02