chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Extra dose given; Extra dose given; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number B32NG, expiry date 13-JUN-2025) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 30-MAR-2024) for prophylaxis.   Previously administered products included Boostrix (1st dose received on 14th June 2022 with batch number C5788BA and expiry date 14th October 2022) and Menveo (1st dose received on an unknown date with batch number AMVA659A and expiry date 30th January 2023).   On 19-JUN-2023, the patient received the 2nd dose of Boostrix. On an unknown date, the patient received the 2nd dose of Menveo. On 19-JUN-2023, an unknown time after receiving Boostrix and not applicable after receiving Menveo, the patient experienced extra dose administered (Verbatim: Extra dose given). On an unknown date, the patient experienced extra dose administered (Verbatim: Extra dose given). The outcome of the extra dose administered and extra dose administered were 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: 22-JUN-2023 A nurse called in to report that a patient accidentally received a second dose of Boostrix and Menveo one year after the first dose and wished to know how to proceed.  The information for both doses was given, including lot number, expiration date, patient information and vaccination event. The vaccine administration facility was the same as primary reporter. The information for Menveo was provided by a Menveo second line agent after the call was escalated.  The reporter consented to follow up. The patient received second dose of Boostrix and Menveo one year after first dose, which led to extra dose administered.
Sex: M
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Hepatitis B surface antibody negative, Inappropriate schedule of product administration, Therapy non-responder
Clinical narrative: Repeat titers 4-6 weeks after dose still low; physician collected hepatitis b titers in May 2023 and they were negative; Drug dose administration interval too long; This non-serious case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 10-month-old male patient who received HBV (Engerix B) (batch number C44K4, expiry date 07-DEC-2024) for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis, Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 19-MAY-2023, the patient received Engerix B 1 ml. On 11-APR-2006, the patient received the 3rd dose of Hepatitis B vaccine. On 13-JUN-2005, the patient received the 2nd dose of Hepatitis B vaccine. On 13-MAY-2005, the patient received the 1st dose of Hepatitis B vaccine. On 11-APR-2006, an unknown time after receiving Hepatitis B vaccine, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). In MAY-2023, the patient experienced therapy non-responder (Verbatim: physician collected hepatitis b titers in May 2023 and they were negative). On an unknown date, the patient experienced therapeutic response decreased (Verbatim: Repeat titers 4-6 weeks after dose still low ). The outcome of the therapy non-responder, therapeutic response decreased and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The medical assistant reported that the patient completed hepatits B series as a child. The reporter did not had documentation of which brand the patient received as a child.   The patient's physician collected hepatitis b titers in May 2023 and they were negative, so the physician ordered 1 mL dose of Engerix-B, which was administered.   The repeat titers 4 to 6 weeks after dose were still low, so physician has ordered for patient to finish out another 2 doses to repeat the series, but no further doses have yet been administered at the time of reporting. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received 3rd dose of Hepatitis B later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site discharge
Clinical narrative: an unknown amount dripped out of the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 2R375, expiry date 28-MAY-2024) for prophylaxis.   On 21-JUN-2023, the patient received Shingrix. On 21-JUN-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: an unknown amount dripped out of the injection site). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 22-Jun-2023 The pharmacist only had the patient's initials and stated that the approximate age was 60 years. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The pharmacist was administering a dose of Shingrix and an unknown amount dripped out of the injection site, which led to incomplete dose administered.
Sex: F
Vaccine: MENB
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: patient received only a half of the dose of Bexsero due to a syringe leak; syringe leak; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number J52PN, expiry date 31-MAR-2024) for prophylaxis.   On 22-JUN-2023, the patient received Bexsero. On 22-JUN-2023, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: patient received only a half of the dose of Bexsero due to a syringe leak) and syringe leak (Verbatim: syringe leak). The outcome of the incomplete dose administered and syringe leak were 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: 22-Jun-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. Earlier on the day of reporting, a patient received only a half of the dose of Bexsero due to a syringe leak, which led to incomplete dose administered and syringe leak.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired drug used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 23-JUN-2023, the patient received Kinrix. On 23-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired drug used). 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: 23-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter mailing address in health care professional details. The reporter consented to follow up. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 4 year child received Kinrix as 1st dose of IPV and DTaP; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Kinrix. In JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: 4 year child received Kinrix as 1st dose of IPV and DTaP). The outcome of the inappropriate schedule of vaccine administered 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: 23-JUN-2023 The reporter reported that the 4 years old patient received Kinrix vaccine in clinic this past week.  The reporter stated that afterward it was realized that the patient did not had any prior vaccinations.   The Kinrix vaccine was their first DTaP and IPV vaccine.   The reporter did not have exact date of administration, lot number or expiration date. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received Kinrix as a first dose of IPV and DTaP series, which led to Inappropriate schedule of vaccine administered. This case had been linked with US2023088089 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023088089:1 of 2
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: inadvertently administered the bexsero vaccine following a temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adolescent female patient who received Men B NVS (Bexsero) (batch number 5YP3L, expiry date 31-JAN-2026) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (right deltoid). On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: inadvertently administered the bexsero vaccine following a temperature excursion). The outcome of the incorrect storage of drug 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: 26-JUN-2023 The reporter consented to follow up. The reporter reported that patient was inadvertently administered the Bexsero vaccine following a temperature excursion, which led to incorrect storage of drug. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023088652:Same reporter
Age: 0.08
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: accidentally received a dose of Shingrix instead of the varicella vaccine; accidentally received a dose of Shingrix instead of the varicella vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 30-day-old female patient who received Herpes zoster (Shingrix) (batch number 22M3K, expiry date 29-FEB-2024) for prophylaxis.   On 28-APR-2023, the patient received the 1st dose of Shingrix. On 28-APR-2023, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: accidentally received a dose of Shingrix instead of the varicella vaccine) and inappropriate age at vaccine administration (Verbatim: accidentally received a dose of Shingrix instead of the varicella vaccine). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 26-JUN-2023 The reporter reported that a patient accidentally received a dose of Shingrix instead of the varicella vaccine and wished to know how to proceed.  The information about the vaccine, patient and event given.  The Vaccine Administration Facility was the same as Primary Reporter. They accepted to receive follow up and to have the case escalated. The reporter consented to follow up.  The patient received accidentally received a dose of Shingrix instead of the varicella vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose of Twinrix back back on 8/27/2019 and never came back to finish the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received HAB (Twinrix adult) for prophylaxis.   Previously administered products included Twinrix adult (received 1st dose on 27th August 2019 with batch number 3C422 and expiry date 27th April 2021).   On an unknown date, the patient did not receive the 2nd dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced incomplete course of vaccination (Verbatim: received the first dose of Twinrix back back on 8/27/2019 and never came back to finish the series). 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: 26-JUN-2023 The registered pharmacist reported the patient received the first dose of Twinrix and never came back to finish the series. The pharmacist inquired did the patient need to restart the Twinrix vaccine series.  The reporter did not consent to follow-up. Till the time of reporting the patient did not receive the 2nd dose of Twinrix adult, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthma, COVID-19 immunisation, Diabetes mellitus
Clinical narrative: DIABETES MELLITUS; REVACCINATION WITH DIFFERENT  COVID-19 VACCINE; ASTHMA; This spontaneous report received from a health care professional via other manufacturer (Moderna) concerned a 52 year old female. The patient's weight was 249 pounds, and height was 66 inches. The patient's concurrent conditions included: penicillin allergy, sulfa allergy, essential hypertension, obstructive sleep apnea, and dyslipidemia, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) The patient received additional non-company suspect vaccine included: Pfizer (tozinameran) (Dose number in series 2) (form of admin was not reported, intramuscular, batch number: FJ1611 expiry: UNKNOWN) dose was not reported, administered at left deltoid on 23-DEC-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with Pfizer (tozinameran) (Dose number in series 2)  The patient received additional non-company suspect vaccine included: Pfizer (tozinameran)  (Dose number in series 3) (form of admin was not reported, intramuscular, batch number: FM7553 expiry: UNKNOWN) dose was not reported, administered at right deltoid on 29-JUL-2022 for covid-19 prophylaxis.  On 02-AUG-2022, the patient experienced asthma (Dose number in series 3).  The patient received additional non-company suspect vaccine included Moderna (elasomeran) (Dose number in series 4) (form of admin was not reported, intramuscular, batch number: 069H22A expiry: UNKNOWN) 0.5 ml, administered on 01-JUN-2023 07:23 AM at right deltoid for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 4). Concomitant medications included simvastatin for dyslipidemia, and hydrochlorothiazide/lisinopril for essential hypertension.  On 06-JUN-2023, the patient experienced diabetes mellitus (Dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, tozinameran, and elasomeran was not applicable. The outcome of the diabetes mellitus, asthma and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230652203-diabetes mellitus. 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: MEDICAL HISTORY(Overweight). Therefore, this event is considered inconsistent with vaccine administration.
Age: 86.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in an 86-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter (Master case)
Age: 18.0
Sex: F
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 an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in an 18-year-old female patient 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.     No Medical History information was reported.    On 09-Jun-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Jun-2023,  after starting , 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)) (Intramuscular), 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.  No treatment information was reported.
Sex: M
Vaccine: COVID19-2
Symptoms: Flank pain, Loss of consciousness
Clinical narrative: Passed out for a few days with pain; Pain in kidney area.; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out for a few days with pain) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out for a few days with pain) (seriousness criterion medically significant) and FLANK PAIN (Pain in kidney area.). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out for a few days with pain) and FLANK PAIN (Pain in kidney area.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient passed out for a few days with pain. Pain in kidney area.  Treatment information was not provided. Company Comment: This is a spontaneous case concerning male patient of an unknown age with no reported medical history, who experienced the serious (due to medically significant) unexpected, event of loss of consciousness, which occurred on an unknown date after a dose of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5). It was reported that patient passed out for a few days and had pain in kidney area. The outcome of the event was reported as recovered. The benefit-risk relationship of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5) is not affected by this report.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: no adverse event; Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged; We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged), PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    In June 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. In June 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged), PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F) 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 POOR QUALITY PRODUCT ADMINISTERED (Moderna vaccine may have been used up until 6/19/2023,All impacted product has been damaged) and PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion, where the temperature reached above 46F for a total of 57 hours (for Lot AS7642B). The max temperature reached was 48.092F).    No concomitant medication was reported.  The vaccine was stored above 46F for a total of 57 hours (for Lot AS7642B). The maximum temperature reached was 48.092F. Lot AS7642B (Bivalent) was delivered on 04-JUN-2023 and placed in the freezer upon delivery. Lot was relocated to fridge on 17-JUN-2023 at 8:00AM and quarantined 19-JUN-2023 at 5pm. 1 open box was impacted. Moderna vaccine may have been used up until 19-JUN-2023. No treatment information was reported.
Age: 49.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: no adverse event; We had a patient that received an expired dose Moderna Bivalent vaccine; Patient that received first dose of primary series of Moderna Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 49-year-old 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. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We had a patient that received an expired dose Moderna Bivalent vaccine) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Vaccine was administered to patient after temperature excursion occurred.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypothyroidism.    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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Age: 70.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23; Vaccine was administered to patient after temperature excursion occurred.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that no confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 30-May-2023. Up to 14 vaccination were administered within this time line No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Age: 56.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse reported inadvertent administration of one dose of an expired bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reported inadvertent administration of one dose of an expired bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient 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.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (025A21A , First dose) on 10-Mar-2021, MODERNA COVID-19 VACCINE (003B21A , Second dose) on 07-Apr-2021, MODERNA COVID-19 VACCINE (018F21A  and Third dose) on 07-Dec-2021; for Product used for unknown indication: Hep B (HeplisaV). Past adverse reactions to the above products included No adverse event with Hep B (HeplisaV), MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and Moderna COVID-19 Vaccine. Concurrent medical conditions included Hypertension, Prediabetes and Hyperlipidemia.    On 19-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Jun-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 (Nurse reported inadvertent administration of one dose of an expired bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reported inadvertent administration of one dose of an expired bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse reported inadvertent administration of one dose of an expired bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: Administered an expired vaccine; Patient received first dose of primary series from Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 (Administered an expired vaccine), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine) and WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Age: 73.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered beyound 30-day use by date; Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT 1Q (Vaccines administered beyond 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 73-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
Age: 84.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in an 84-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
Age: 72.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Expired vaccine administered to patient; Vaccines administered after being in stored in fridge past 30 days; Patient received Moderna Bivalent vaccine as First dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event) in a 72-year-old 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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine as First dose) 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 (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient received Moderna Bivalent vaccine as First dose).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter