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; patient was administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 06-MAR-2020, the patient received improperly stored doses of several vaccines. At 13:52, the patient received an improperly stored doses of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid "TDAP" lot #9L39Z (expiration date not reported), 0.5 mL intramuscularly (IM) on the right arm (RA) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # 1621931 (expiration date 26-JAN-2022), 0.5 mL IM on the left arm (LA). On the same day at 13:53, the patient received an improperly stored dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) lot # U6585AA (expiration date not reported), 0.5 mL IM on the LA. All the vaccines were administered for prophylaxis. It was reported that HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was stored above 9 Celsius degrees (at 15.5 Celsius degrees) for 4 hours and 6 minutes; for the rest of the vaccines, no information was provided.  No adverse effects were reported. It was reported that a digital data logger was involved for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for the rest of the vaccines, it was not reported.  This was one of several cases received from the same reporter.  Reporter reported Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with 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). 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.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; 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: US-009507513-2008USA008889: US-009507513-2008USA008885: US-009507513-2008USA008876: US-009507513-2008USA008883: US-009507513-2008USA008884: US-009507513-2008USA008875: US-009507513-2008USA008880: US-009507513-2008USA008882: US-009507513-2008USA008890: US-009507513-2008USA008879: US-009507513-2008USA008881: US-009507513-2008USA008877: US-009507513-2008USA008878: 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-009507513-2008USA008908: 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: