Sex: U
Vaccine: HPV4, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Product reported as GARDASIL but lot # valid for GARDASIL 9; no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This non-valid spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On unknown dates since 31-DEC-2019, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931, expiration date on 26-JAN-2022, measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, lot# R008690, expiration date on 22-MAR-2020, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot# S023219, expiration date on 03-MAR-2022, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot# S030093, expiration date on 24-MAR-2021, and varicella virus vaccine live (oka/merck) (VARIVAX) lot# R020673, expiration date on 18-JUL-2020 (dose and route of administration were not provided for all). There was no adverse effect reported.  Administered doses of 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 (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes.  Administered doses of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion between -14 and -10 degrees Celsius (-11.2C) for 3 hour and 42 minutes. Digital data logger was involved. There were no previous temperature excursions reported. The outcome was provided as "supported".  This report is non-valid due to lack of patients' identifiers.  As of 30-JUL-2020, all telephone attempts to obtain follow-up information have been unsuccessful.  Follow-up information was received by the registered nurse on 12-AUG-2020. This case refers to a patient (gender and age not reported). No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. It was confirmed that on 06-MAR-2020 at 16:33, the patient was vaccinated with an improperly stored dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) lot # 1621931 (Reporter reported Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with lot # 1621931 which was not valid for Gardasil. However, lot # 1621931 is valid for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product lot number issue)), at a dose of 0.5 mL intramuscularly (IM) on the right arm (RA) and with an improperly stored dose meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) lot # U6585AA, at a dose of 0.5 mL IM on the RA. On the same day at 16:34, the patient received an improperly stored dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid "TDAP" lot # 9L39Z, at a dose of 0.5 mL IM on the left arm (LA). This is one of sixty cases received from the same reporter. This case was previously considered non-valid but per new information received it was determined to be valid. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002275: