Reporte zur Charge N000326

Symptomtext

Product Lot number issue; No adverse event; Extra GARDASIL 9 DOSE #4 administered on 03-AUG-2022; DOSE #1 administered on 15-NOV-2012 DOSE #3 administered on 22-MAY-2017; This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 15-NOV-2012, the patient administered first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) formulation vial (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), non valid lot# H013831), 0.5 milliliter, valid lot #H013831, expiration date: 06-MAR-2015, administered for prophylaxis (strength, and route of administration were not provided). On 22-JUL-2013, the patient administered second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) formulation vial (reported as hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), non valid lot# J002641), 0.5 milliliter, valid lot # J002641, expiration date: 10-DEC-2015, administered for prophylaxis (strength, and route of administration were not provided) (product lot number issue). On 22-MAY-2017, the patient administered third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) formulation vial, 0.5 milliliter, lot #N000326, expiration date: 14-OCT-2019, administered for prophylaxis (strength, and route of administration were not provided) (inappropriate schedule of product administration). 03-AUG-2022, the patient accidentally administered additional dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter, lot # 178076, expiration date: 09-NOV-2023, administered for prophylaxis (strength, and route of administration were not provided) (extra dose administered). It was because the patient's records had not reflected the previous completed series. No additional adverse event information was provided (no adverse event).