chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 011F21A, 031A21A and 011M21A) for COVID-19 prophylaxis.     Allergies to medications, food, and other products was reported as unknown. Acute illnesses at the time of vaccination and up to one month before was reported as unknown. It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19.  Concurrent medical conditions included Diabetes and Blood pressure high.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 9:26 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 9:26 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and vaccine was administered on 19-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Vaccines expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.  The event did not cause the patient to seek medical care. There was not any other potential causes and  it was unknown if the patient experienced a similar event in the past.  No treatment medications were provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 032H21A, 016M20A and 011L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Diabetic and Food allergy (Corn).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 8:57 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 19-May-2022 at 8:57 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 19-May-2022.).    No concomitant medications was reported. Event didn't cause the patient to seek medical care and they were no other potential causes. Vaccines expired on 13-May-2022. No treatment information was reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022; Dose administered post the expiration or beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A and 034F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:25 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:25 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022).    No concomitant medications information was reported.  Vaccines expired on 13-May-2022 were placed in refrigerator on 17-May-2022 and administered on 08-Jun-2022.  The event did not cause the patient to seek medical care. There was not any other potential causes and  it was unknown if the patient experienced a similar event in the past.  It was unknown if patient was allergic to medications, food, and other products. It was unknown if the patient had ever been diagnosed with/ tested positive for COVID-19. Acute illnesses at the time of vaccination and up to one month before were unknown. Chronic or long-standing health conditions were unknown.  No treatment medications were provided.   This case was linked to MOD-2022-598063 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022; Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 034F21A, 043B21A and 039A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:23 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 08-Jun-2022 at 10:23 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 13-May-2022 and was administered on 08-Jun-2022) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 and were stored in refrigerator on 17-May-2022).    No concomitant medications were reported.   The health care professional thought that Moderna had an extension like Pfizer, and though it would expire on the 13-Jul-2022 but it was expired on the 13-May-2022 and they realize this on the 08-Jun-2022.  Vials did not undergo any temperature excursion.  The event did not cause the patient to seek medical care. There were no other potential causes reported.  No treatment details were reported.   This case was linked to PR-MODERNATX, INC.-MOD-2022-586794 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-586794:Master case
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed with or tested positive for COVID-19.  It was unknown whether acute illnesses at the time of vaccination and up to one month before and chronic or long-standing health conditions.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna was administered on 01-FEB-2021 and second dose on 12-MAR-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was unknown.  No treatment medications were provided by the reporter.   This case was linked to MOD-2022-598060 (Patient Link).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose 1 was given on 10-May-2021 and dose 2 was given on 22-Jun-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was given on 10-May-2021 and dose 2 was given on 22-Jun-2021) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 022C21A) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to medications, food and other products. It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19. It was also unknown if the patient had any acute illnesses at the time of vaccination and up to one month before.  Concurrent medical conditions included Blood pressure high (No recent changes in condition status).   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 22-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was given on 10-May-2021 and dose 2 was given on 22-Jun-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 was given on 10-May-2021 and dose 2 was given on 22-Jun-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was unknown if any prescription medications, over-the-counter medications, dietary supplements or herbal remedies were taken by the patient at time of vaccination and/or at the time of the adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-585601 (Patient Link).
Age: 16.0
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information provided.; HCP called to inquire if a PROQUAD dose (first dose) that was administered to 16 year-old female patient on 2/9/2022 is a valid dose.; This spontaneous report was received from a registered nurse, referring to a 16-year-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2022, the patient was vaccinated with the first dose of measles, mumps, rubella, and varicella (OKA-MERCK) virus vaccine live (PROQUAD) (valid lot #U024507, expiration date: 02-FEB-2023, therapy type: rHA) (strength, dose, route of administration and anatomical location were not provided) (product administered to patient of inappropriate age) for prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: no adverse event; a pediatric vaccine was given to an adult patient; This spontaneous report as received from a licensed practical nurse refers to an adult patient of unknown age and gender. On 06-JUN-2022, the patient was vaccinated with a pediatric dose (0.5 mL) of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # W002938 exp date 18-NOV-2023) (route not provided) (incorrect dose administered).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Accidental overdose, No adverse event, Wrong product administered
Clinical narrative: No additional AE/PQC.; PROQUAD and VARIVAX was administered to a patient concomitantly instead of MMR II and VARIVAX; Accidental overdose; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, rHA, 0.5 ml/once, lot # W006587, expiration date: 23-AUG-2023, administered for prophylaxis (strength and route of administration were not provided) and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml/once, lot #U029496, expiration date: 21-SEP-2023, administered for prophylaxis (strength, and route of administration were not provided) concomitantly instead of measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live (MMR II) and varicella virus vaccine live (oka/merck) (VARIVAX) (wrong product administered and accidental overdose). No side effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; STERILE DILUENT vial stored improperly; improperly stored STERILE DILUENT was used as vaccine dilution; This spontaneous report was received from a pharmacist and refers to an patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 16-MAY-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, exact dose, lot #, expiration date and route of administration were not provided) for prophylaxis together with improperly stored sterile diluent (STERILE DILUENT) lot# T005074, expiration date 02-SEP-2022 (strength, dose description, lot #, expiration date and route of administration were not provided) for medication dilution (Product storage error, Product preparation issue).  On an unknown date, before the vaccination, the sterile diluent (STERILE DILUENT) underwent temperature excursion at -18.0 Fahrenheit degrees (F) for 288 hours. No previous temperature excursions were reported. No adverse events were reported (No adverse event).  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2205USA008373:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reports vaccine was administered after experiencing temperature excursion  ?    Names of vaccines involved (including lot/exp) VARIVAX  Lot: U02505 / Exp date: 8/13/2023        ?    Temperature -11.6C        ?    Time frame  0 hour 30 mi; No additional AE details; This spontaneous report was received from unspecified reporter and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   The caller reported that varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection was administered for prophylaxis on an unknown date after experiencing temperature excursion (Product storage error). Lot: U02505 is NOT valid for VARIVAX and does not match any company product as confirmed by lot verification team; expiration date was reported as 13-AUG-2023. Temperature was -11.6 C in a time frame of 0 hour 30 minutes 0 seconds. There was not previous temperature excursion. No additional adverse event (AE) details were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; VARIVAX administered after temperature excursion; This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 28-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter, subcutaneously, lot # U022321 was confirmed to be valid with expiration date 15-JUL-2023 for prophylaxis (site of administration was not reported). The administered dose was exposed to the temperature of 6 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. No additional adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE details; patient received a late second dose of GARDASIL 9; This spontaneous report was received from a registered nurse and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-JUN-2022, the patient received a late second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (dose: 0.5 milliliter, lot # T036442, expiration date: 09-APR-2023; strength and route were unknown) for prophylaxis.  Dose was scheduled for 31-MAR-2022 but was not administered until 16-JUN-2022 (Inappropriate schedule of product administration). No additional AE details or product quality compliant (PQC).
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional adverse effects; adult patient received pediatric dose of VAQTA.; adult patient received pediatric dose of VAQTA.; This spontaneous report was received from a medical assistant and refers to a 59-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 20-JUN-2022, the adult patient received one pediatric dose of Hepatitis A Vaccine, inactivated (VAQTA) lot # U016222 was confirmed to be valid with expiration date 06-FEB-2023, for prophylaxis (exact dose, route and site of administration were not reported). No additional adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; VARIVAX was delivered on 07JUN2022 after the receive by date of 06JUN2022 and was administered to a patient; This spontaneous report was received from a medical technologist lab manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not reported.   On 07-JUN-2022, varicella virus vaccine live (oka/merck) (VARIVAX), was delivered after receiving by date of 06-JUN-2022. On 15-JUN-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot number: W002599, expiration date: 24-JAN-2024; (strength, dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). Temperature and time frame were unknown. There was no reported previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) was reported (no adverse event).
Age: 77.0
Sex: F
Vaccine: PNC15
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AEs; patient was supposed to received PNEUMOVAX 23 today, but was administered VAXNEUVANCE today by mistake; This spontaneous report was received from a pharmacist and concerns a 77-year-old female patient. Her historical vaccinations included Pneumococcal vaccine polysacch 23V (PNEUMOVAX 23) administered on 14-APR-2009. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUN-2022, the patient was supposed to receive the second dose of Pneumococcal vaccine polysacch 23V (PNEUMOVAX 23), however she was administered with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) injection in dose of 0.5 ml once, lot number U036156, expiration date: 25-MAY-2023 (route and anatomical site of administration were not provided) for prophylaxis (wrong product administered). The patient experienced no side effects from administration and no additional adverse events were reported (no adverse event).
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: syncopal episode; This spontaneous report was received from a physician  via company representative referring to a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (strength, dose description, lot #, expiry date, anatomical location and route of administration were not provided) for prophylaxis, and subsequently, she experienced a syncopal episode. The subject sought medical attention and received epinephrine following the vaccination. It was reported that she recovered and was fine.   The causal relationship between syncopal episode and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.  Upon internal review, the event syncopal episode was determined to be medically significant.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event details available; PROQUAD  that have been stored outside of recommended range have been administered to patients; This spontaneous report has been received from the office manager referring a patient of an unknown age and gender.  The patient's medical history, concurrent conditions, and previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).  On an unknown date in 2022, reported as between 28-JUN-2022 and 01-JUL-2022, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD)  lot number W006585, expiration date: 23-AUG-2023, as prophylaxis (vaccination scheme, dose, anatomical location and route of administration were not provided) following a temperature excursion of 6°F up to 14°F for 0 hours 50 minutes 0 seconds; 14°F up to 46°F (15F) for 0 hours 30 minutes 0 seconds (product storage error). There was stated that no previous temperature excursion occurred. No additional adverse event were reported.; Sender's Comments:  US-009507513-2207USA000775: US-009507513-2207USA000771: US-009507513-2207USA000470: US-009507513-2207USA000561: US-009507513-2207USA000544: US-009507513-2207USA000552: US-009507513-2207USA000563: US-009507513-2207USA000765: US-009507513-2207USA000553:
Sex: U
Vaccine: VARZOS
Symptoms: Influenza
Clinical narrative: flu days; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient stated that could get the flu days after he/she got the vaccine for shingles. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: vaccine administered  IV not IM; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intravenous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: This case was reported by a Patient via interactive digital media. Shingrix vaccine was administered and went IV (Intravenous) not IM (Intramuscular). Additional Supportive Information: Shingrix vaccine was administered and went IV (Intravenous) not IM (Intramuscular),which led to intramuscular formulation administered by other route. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site haemorrhage, Wrong technique in product usage process
Clinical narrative: injection bleeding; withdrawing needle plunger was not done; This case was reported by a nurse via interactive digital media and described the occurrence of injection site hemorrhage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2022, the patient received Shingrix. On 26th June 2022, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and wrong technique in drug usage process. On an unknown date, the outcome of the injection site hemorrhage and wrong technique in drug usage process were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received from nurse via interactive digital media. On Sunday the patient had a Shingrix vaccine. The reporter stated that at nursing class that when you put an injection and you need to check for blood by withdrawing the needle plunger this was not done and there was bleeding which indicated to her/him. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: sore neck; This case was reported by a consumer via interactive digital media and described the occurrence of neck pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced neck pain. On an unknown date, the outcome of the neck pain was unknown.   It was unknown if the reporter considered the neck pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received a dose of Shingles vaccine and experienced sore neck. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Malaise, Wrong technique in product usage process
Clinical narrative: feeling very sick; Vaccine administered incorrectly/went into my bloodstream; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling unwell and wrong technique in drug usage process. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022  Reporter's Comments: This case was reported by patient via interactive digital media. The patient stated that the vaccine was administered incorrectly into the bloodstream and felt very sick. Additional Supportive Information: The vaccine was administered incorrectly into the bloodstream which led to wrong technique in drug usage process. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Illness
Clinical narrative: feeling horrible; getting sicker; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2022, unknown after receiving Shingles vaccine, the patient experienced feels awful and sickness. On an unknown date, the outcome of the feels awful and sickness were not recovered/not resolved.   It was unknown if the reporter considered the feels awful and sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient self-reported this case. The patient was feeling horrible and getting sicker the last 2 days.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shot 18 months ago didn´t get 2nd shot yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, 18 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient self-reported this case.  The patient asked ok to get his/her second shot. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 7 months between 1 and 2 dose; This case was reported by a consumer via interactive digital media 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 in November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient received 1st Shingrix vaccine in November 2021. It had been over 7 months before the day of reporting.  The patient asked if he/she could still get second vaccine. Additional Supportive Information: The patient received 1st dose of shingrix over 7 months before and till the time reporting the patient did not received 2nd dose which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 and 29- JUN-2022 Reporter's Comments: This case was related to patient 5 of the 5 patients mentioned in case narrative. The GlaxoSmithKline sales representative called GlaxoSmithKline response center the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix. The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patients genders, or route of administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 5 cases reported by the same reporter. The case US2022AMR100445 was identified as duplicate of US2022101093. The case US2022101093 would be voided, and all the future correspondence would be added in this case US2022AMR100445 which stands as a case of record for this patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022AMR100447:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 and 29- JUN-2022 Reporter's Comments: The GlaxoSmithKline sales representative called GlaxoSmithKline response center the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix. The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patients genders, or route of administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 5 cases reported by the same reporter. The case US2022AMR100447 was identified as duplicate of US2022101093. The case US2022101093 would be voided, and all the future correspondence would be added in this case US2022AMR100447 which stands as a case of record for this patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patient's genders, or route of administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate doseof vaccine administered. This case is 1 out of 5 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022AMR100447:Same reporter US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter US-GLAXOSMITHKLINE-US2022101093:duplicate/retained case
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 and 29- JUN-2022 Reporter's Comments: This case was related to patient 5 of the 5 patients mentioned in case narrative. The GlaxoSmithKline sales representative called GlaxoSmithKline response center the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix. The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patients genders, or route of administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 5 cases reported by the same reporter. The case US2022AMR100452 was identified as duplicate of US2022101093. The case US2022101093 would be voided, and all the future correspondence would be added in this case US2022AMR100452 which stands as a case of record for this patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100445:Same reporter US-GLAXOSMITHKLINE-US2022AMR100447:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022101093:duplicate case (deleted)
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site swelling; Injection site redness; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown.   It was unknown if the reporter considered the injection site swelling and injection site redness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Jun-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that could put ice on the injection site for the swelling and redness. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Loss of consciousness, Pain, Pyrexia
Clinical narrative: passed out; high fever; horrible headache; aches; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   In June 2022, the patient received the 2nd dose of Shingrix. In 2022, 4 days after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant). In June 2022, the patient experienced fever, headache and ache. On an unknown date, the outcome of the passed out was unknown and the outcome of the fever, headache and ache were recovered/resolved.   It was unknown if the reporter considered the passed out, fever, headache and ache to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-JUL-2022 Reporter's comments: This case was reported by consumer via interactive digital media. This case was reported by the patient's family member. The patient received his 2nd inoculation, 3 days before the date of reporting.  The patient had high fever, horrible headache, aches, and on the 4th day seemed fine, then passed out. The reporter asked how long before someone are back to normal health. In June 2022, less than a week after receiving Synflorix, the patient experienced fever, headache and ache. Additional supportive information: Follow-up would not possible, as no contact details were available.