Age: 13.0
Sex: U
Vaccine: HPV4, HPV9, MEN, TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient was vaccinated with GARDASIL 9 (lot validation confirm  lot #K006960 valid for GARDASIL); patient was vaccinated with GARDASIL 9 (lot validation confirm  lot #M014929 valid for GARDASIL); No adverse event (according to the HCP, if there is one she is not aware of it, does not see any AE in her records); The first dose given in the right arm of patient on 5/4/2015. A second dose given on 8/17/2016, third dose on 12/15/2016; This spontaneous report was received from a Physician and refers to a 13-year-old female patient regarding a case in litigation.  The patient's medical history, concurrent conditions previous drug reactions or allergies and concomitant therapies were not reported.  On 04-MAY-2015, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5ml/once, administered on the right arm, reporter reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # K006960 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), however, lot# K006960 is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with expiration date of 19-FEB-2017 (product lot number issue) (strength, and route of administration were not provided); diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (strength, formulation, lot #, expiry date, route of administration were not provided) on the left arm; and  meningococcal vaccine (MENINGOCOCCAL VACCINE) (strength, formulation, lot #, expiry date, and route of administration were not provided) on the left arm, all 3 vaccines administered for prophylaxis. Then, on 17-AUG-2016 the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5ml/once, administered on the left arm for prophylaxis, reporter reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # M014929 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), however, lot# M014929 is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with expiration date of 27-MAY-2017 (product lot number issue) (strength, and route of administration were not provided) (Inappropriate schedule of vaccine administered); subsequently, on 15-DEC-2016, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5ml/once, administered on the left arm for prophylaxis, reporter reported hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with lot # M014929 which was not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), however, lot# M014929 is valid for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) with expiration date of 27-MAY-2017 (strength, and route of administration were not provided). According to the reporter, no adverse event occurred, if there was one she was not aware of it, did not saw any adverse event in her records. Physician would be giving a fact witness testimony in late July.