Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Improper storage of product in use; This spontaneous report was received from a nurse practitioner refers to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unspecified dates (the provided dates were incomplete, please refer to the source document), the patients were vaccinated with improperly stored doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE), formulation: prefilled syringe (PFS), lot # X019438, expiration date: 07-NOV-2025; lot # X019197, expiration date: 30-AUG-2025; measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD), formulation: injection, lot # X009734, expiration date reported as 20-SEP-2024, but upon internal validation established as 30-SEP-2024; lot # X018580, expiration date: 05-JAN-2025; varicella virus vaccine live (oka/merck)(VARIVAX), formulation: injection, lot# X020149, expiration date: 01-AUG-2025; lot # X012267, expiration date: 30-APR-2025; lot # X017484, expiration date: 25-JUN-2025; lot # X010534, expiration date: 11-APR-2025; lot # X021284, expiration date: 20-AUG-2025; measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II), formulation: injection, lot # W031980, expiration date reported as 16-OCT-2024 but upon internal validation established as 06-OCT-2024; lot # W026512, expiration date: 22-AUG-2024; hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), formulation: PFS, lot # 1957405, expiration date: 11-NOV-2025 (exact dose, route of administration and anatomical location were not provided); rotavirus vaccine, live, oral, pentavalent (ROTATEQ), formulation: oral liquid, lot # 1933912, expiration date: 21-APR-2024; lot # 1965641, expiration date: 19-SEP-2024; haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), formulation: intramuscular injection, lot # X003664, expiration date: 10-NOV-2025; lot # X013196, expiration date: 12-NOV-2025; On 24-JAN-2024, the patients were vaccinated with improperly stored doses of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419), formulation: PFS, lot # U7623AA, expiration date: 08-DEC-2025; and on unspecified dates with lot # U7535AA, expiration date reported as 30-SEP-2025 but upon internal validation stablished as 23-SEP-2025 (exact dose, route of administration and anatomical location were not provided for any vaccine or any dose) all administered as prophylaxis.   On 19-OCT-2023, administered doses of vaccines were exposed to the temperature excursion of 49.5 degrees Fahrenheit for 2 minutes (refrigerated vaccines); and total time in the range from -14 to -10 degrees Celsius for 27 minutes. On 04-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 28 minutes. On 06-DEC-2023, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 15 minutes. On 10-JAN-2024, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 24 minutes. On 22-JAN-2024, administered doses of vaccines were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 5 minutes. On an unknown date, administered doses of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # X021284) were exposed to the temperature excursion at total time in the range from -14 to -10 degrees Celsius for 29 minutes (frozen vaccines) (improper storage of product in use). No additional adverse event were reported.  Lot number (W031980) has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with rHA (recombinant Human albumin) status.  Follow up information was received from the nurse on 29-JAN-2024.  It was reported that varicella virus vaccine live (oka/merck)(VARIVAX) lot # X010534, expiration date:11-APR-2025 and lot # X012267, expiration date: 30-APR-2025, underwent a temperature excursion (TE) between -14 to -10 degree Celsius range during 9 hours and 27 minutes; and that the lot # X017484, expiration date: 25-JUN-2025, underwent the same range of TE during 8 hours 32 minutes. Also, it was stated that all the product were administered to multiple patients.  This is a non-valid case due to lack of patients' identifiers.  Follow-up information was received from the vaccine provider on 04-MAR-2024. It was reported that quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, lot #1957405, expiration date: 11-NOV-2025, intramuscularly (strength, dose description,, route of administration and anatomical site of administrition) for prophylaxis, lot number 1957405 is an invalid lot number for GARDASIL. Lot number [reported lot number] is a valid lot number for GARDASIL 9 by Lot Verification team (product lot number issue). Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was reported with route intramuscular (incorrect route of product administration).  Follow-up information was received from vaccine provider on 12-MAR-2024: This spontanous case refers to 11-years-old patient of unknown gender. Patients identifiers were updated. The patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # X010534, expiration date:11-APR-2025 subcutanousley.