Sex: U
Vaccine: HPV4, HPV9, MNQ, TDAP, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; Product reported as GARDASIL but lot # valid for GARDASIL 9; Patient have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 02-MAR-2020 at 17:15, the patient was vaccinated with an improperly stored dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) lot # 1621931 (which was not valid for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL). However, lot # 1621931 is valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)) (expiration date 26-JAN-2022), at a dose of 0.5 mL, intramuscular on the left arm (LA); at 17:16, was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot # R020673, expiration date on 18-JUL-2020, at a dose of 0.5 mL, subcutaneous on the right arm (RA). On that same day, the patient also received diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (DTAP) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Administered dose of 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". No adverse event reported.   This is one of several reports received form the same reporter. 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:Original Case : 2003USA002275 US-009507513-2008USA008885: US-009507513-2008USA008883: US-009507513-2008USA008876: US-009507513-2008USA008889: US-009507513-2008USA008890: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008878: US-009507513-2008USA008879: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008886: US-009507513-2008USA008887: US-009507513-2008USA008888: US-009507513-2008USA008891: US-009507513-2008USA008892: US-009507513-2008USA008893: US-009507513-2008USA008894: US-009507513-2008USA008895: US-009507513-2008USA008896: US-009507513-2008USA008897: US-009507513-2008USA008898: US-009507513-2008USA008899: US-009507513-2008USA008900: US-009507513-2008USA008901: US-009507513-2008USA008902: US-009507513-2008USA008903: US-009507513-2008USA008904: US-009507513-2008USA008905: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008912: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008918: US-009507513-2008USA008919: US-009507513-2008USA008920: US-009507513-2008USA008921: US-009507513-2008USA008922: US-009507513-2008USA008923: US-009507513-2008USA008924: US-009507513-2008USA008925: US-009507513-2008USA008926: US-009507513-2008USA008927: US-009507513-2008USA008928: US-009507513-2008USA008929: US-009507513-2008USA008930: US-009507513-2008USA008931: US-009507513-2008USA008932: US-009507513-2008USA008933: US-009507513-2008USA008875: