Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: The caller said the patient did not experience any adverse events after the product was administered; The caller reported the only product admistered after the temperature excursion was GARDASIL 9; The caller said the GARDASIL 9 was administered on 17-JAN-2023. The caller said this was the second dose of GARDASIL 9 that the patient received. The caller did not have the date of adminsitration for the first dose, but said the patient's last vac; This spontaneous report was received from a registered nurse, referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On unknown dates in January 2023, multiple, unknown, separate patients were vaccinated with improperly stored (product storage error) doses of following vaccines: - diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) reported as pre-filled syringe, lot # was reported and confirmed as: U7124AA, expiration date was reported and confirmed as: 13-JUL-2024 (exact dose, site and route of administration were not provided) for prophylaxis;  - hepatitis b vaccine (recombinant) (RECOMBIVAX HB) pre-filled syringe, lot # was reported and confirmed as: U033519, expiration date was reported and confirmed as: 10-FEB-2024 (exact dose, site and route of administration were not provided) for prophylaxis;  - hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot # was reported and confirmed as: W010661, expiration date was reported and confirmed as: 19-OCT-2024 (exact dose, site and route of administration were not provided) for prophylaxis; - measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) lot # was reported and confirmed as: W009107, expiration date was reported and confirmed as: 04-DEC-2023; lot # was reported and confirmed as: U019290, expiration date was reported and confirmed as: 18-JUN-2023 (exact doses, sites and routes of administration were not provided) for prophylaxis; - pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) pre-filled syringe, lot # was reported and confirmed as: W027275, expiration date was reported and confirmed as: 09-JUL-2024 (exact dose, site and route of administration were not provided) for prophylaxis; - rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # reported and confirmed as: 1837117, expiration date reported and confirmed as: 24-MAR-2023; lot # reported and confirmed as: W004503, expiration date reported and confirmed as: 15-MAY-2023 (exact doses, sites and routes of administration were not provided) for prophylaxis; - measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot # was reported and confirmed as: W002782, expiration date was reported and confirmed as:24-JUL-2023; lot # was reported and confirmed as: W010526, expiration date was reported and confirmed as: 25-SEP-2023; lot # was reported and confirmed as: W024547, expiration date was reported and confirmed as: 31-JAN-2024; lot # was reported and confirmed as: W024980, expiration date was reported and confirmed as: 05-FEB-2024, administered for prophylaxis (exact doses, sites and routes of administration were not provided) for prophylaxis; - varicella virus vaccine live (oka/merck) (VARIVAX) lot # was reported and confirmed as: W022294, expiration date was reported and confirmed as: 13-JUL-2024 (exact dose, site and route of administration were not provided) for prophylaxis.  Temperature excursion information for diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), hepatitis b vaccine (recombinant) (RECOMBIVAX HB), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II), pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), rotavirus vaccine, live, oral, pentavalent (ROTATEQ): 8.4 degree Celsius for 10 minutes on 17-JAN-2023; previous temperature excursion: above 9.4 degree Celsius (9.4 degree Celsius) for 15 minutes on 12-JAN-2023. Temperature excursion information for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX): -12.9 degree Celsius for 20 minutes on 13-JAN-2023; no previous temperature excursion.   Additionally, on an unknown date, multiple, unknown, separate patients could be vaccinated with "mixed diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) vial" (exact dose, lot #, expiration date, route and site of administration were not provided) for prophylaxis (product use issue). There was no additional adverse event reported.   This case was considered to be non-valid due to multiple, non-identifiable patients.  Follow-up information has been received from a registered nurse (primary reporter) on 23-JAN-2023 via telephone call. The reporter called in response to Merck correspondence that she had received. The reporter stated that she did not have any patient data available during phone call and she would speak to her supervisor to determine if patients received any of the vaccines post temperature excursion and would provide information back to Merck, if available.  Follow-up information has been received from a nurse via telephone call on 31-JAN-2023. The nurse said she received a letter about misuse of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS), but she determined there was not any misuse that occurred. Confirmed with the reporter that no adverse events occurred with diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS). The nurse reported the only one product was administered after the temperature excursion, it was hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered to 1 patient. The patient was a 18-year-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not provided. On an unknown date in 2019, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (conflicting information, the vaccine reported as product unknown), (strength, exact dose, route and anatomical site of vaccination, lot# and expiration date were not provided) for prophylaxis. On 17-JAN-2023, the patient was vaccinated with a second, improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered in the right deltoid, intramuscularly, lot# W010661, expiration date 19-OCT-2024 (product storage error), (inappropriate schedule of product administration). The temperature excursion occurred as a result of a digital data logger. The vaccine was purchased with public funds. The patient did not experience any adverse events after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered (no adverse event), and there was no treatment provided after the vaccination. No further information was provided. This case was updated from non-valid to valid, as the improperly stored vaccine was administered to 1 female patient.