Sex: U
Vaccine: HPV4, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Product reported as GARDASIL but lot # valid for GARDASIL 9; no adverse effects; Patient have been administered dose of improperly stored GARDASIL; 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.  This initial spontaneous valid information has been received from the nurse on 12-AUG-2020. Patient's demographics were updated. Patient had been vaccinated on 02-MAR-2020 at 17:37, with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 0.5 ml, at the right arm, by intramuscular route, with lot #R036912 which was not valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). However, lot #R036912 was valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Concomitantly, on this same date, patient received meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP). The Vaccine Information Statement (VIS) was given to the patient.  This is one of several reports received from the same source. 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: R036912; expirationdate: 23-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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-009507513-2008USA008885: US-009507513-2008USA008877: US-009507513-2008USA008876: US-009507513-2008USA008881: US-009507513-2008USA008889: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008890: US-009507513-2008USA008883: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2003USA002275: US-009507513-2008USA008886: US-009507513-2008USA008875: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008883: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008885: US-009507513-2008USA008887: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008890: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008896: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008899: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008932: US-009507513-2008USA008933: US-009507513-2008USA008904: