Sex: F
Vaccine: HPV4
Symptoms: Allergy to vaccine, Dizziness, Nausea, Vaccination site erythema, Vaccination site pain
Clinical narrative: Vaccination site soreness; Vaccination site redness; Vaccination site swelling; Allergic to GARDASIL; Nausea; Dizziness; This spontaneous report was received via pfizer from the patient's mother, regarding her daughther a female patient of unknown age. No information was provided regarding the patient's medical history or concurrent conditions. The patient was allergic to amoxicillin, penicillin, sulfamethoxazole-trimethoprim, azithromycin and cefdinir. The patient's historical vaccinesincluded  Hepatitis B Vaccine (Recombinant) (manufacturer unknown), Pneumococcal conjugate, haemophilus influenzae type b (Hib), Diphtheria (+) Tetanus (+) Pertussis (DTaP), inactivated poliovirus vaccine (IPV), influenza vaccine, Hepatitis A Vaccine, Inactivated (manufacturer unknown), varicella virus vaccine live (manufacturer unknown), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown), influenza a(h1n1)pdm09 vaccine inact and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and her concomitant vaccinations included Diphtheria (+) Tetanus (+) Pertussis (DTaP) and meningococcal conjugate (MENACTRA).  On 23-AUG-2017, the patient was vaccinated with first dose, 0.5 milliliters of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis (strength, anatomical location, route of administration, lot number and expiration date were not reported).  On an unknown date, the patient experienced and allergy to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) with redness, soreness and very visible swelling at the vaccination site with nausea, headache  and dizziness for a month; consequently it was decided to not receive the second dose.  The outcome of the events nausea and dizziness resolved on an unknown date and for the remaining events the outcome was not provided.  The reporter assessed the causal relationship between vaccination with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) and the events allergy to vaccine, redness, soreness and swelling at the vaccination site, nausea and dizziness as related.  The patient had a history of overdose on vaccination with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (case # 2108USA000378) and extra dose administered with inappropriate schedule of product administration on vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (Case # 2108USA000377).  Upon Internal review, the following changes are requested: Only Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was reported as being associated with the captured events and is the only suspect. The other vaccine products were captured as concomitant/historical drugs as appropriate. The events penicillin allergy, headache and lactose intolerance were deleted as they were not reported to be associated with Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).; Sender's Comments:  US-009507513-2108USA000378: US-009507513-2108USA000377: