Sex: U
Vaccine: HPV4, HPV9
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 was 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 20-MAR-2020 at 11:21, the patient was vaccinated with an improperly stored dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) lot # 1621931, expiration date on 26-JAN-2022 (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)), at a dose of 0.5 mL, intramuscular on the left arm (LA). 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. Digital data logger was involved. There were no previous temperature excursions reported. The outcome was provided as "supported". No adverse events 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:  2US-009507513-003USA002275:Original Case : 2003USA002275 US-009507513-2008USA008885: US-009507513-2008USA008890: US-009507513-2008USA008883: US-009507513-2008USA008889: US-009507513-2008USA008876: 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-009507513-2008USA008933: 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-009507513-2008USA008908: US-009507513-2008USA008900: 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-009507513-2003USA002275: