Sex: F
Vaccine: HPV9, HPV9
Symptoms: Abdominal pain, Allergy test negative, Colonoscopy normal, Computerised tomogram normal, Eye swelling
Clinical narrative: provider suspected intussusception; possible cysts; odd fever that comes and goes throughout the day; intermittent abdominal pain; facial swelling, specifically swelling of the eyes and lips; This spontaneous report was received from a patient's mother and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history and concomitant therapies was provided. She did not have any known drug reactions or allergies.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (formulation, strength, exact dose, anatomical location, route of administration, lot# and expiry date were not provided) for prophylaxis. On 16-MAY-2019, she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection, lot # 1602283, expiry date was not provided but upon internal validation established as 16-AUG-2021 (strength, exact dose and anatomical location were not provided), the vaccine was prescribed by primary physician care because consumer was not sexually active and it was a recommended immunization. On 22-MAY-2019, the patient experienced facial swelling, specifically swelling of the eyes and lips. She went to the emergency room (ER) due to the swelling and was referred to a dermatologist. On an unknown date in August 2019, the patient began experiencing intermittent abdominal pain. On an unspecified date, an ultrasound was performed with a suspicion of intussusception, but reporter did not confirm if this was diagnosed. Additionally, on an unknown dates, computerized tomography (CT) scan and colonoscopy were performed, but no abnormalities were found. On an unspecified date, she was additionally prescribed by obstetrics and gynecology (OB/GYN) birth control for possible cysts (but no result was provided). On an unknown date, the patient also experienced an "odd fever" that came and went throughout the day. On an unknown date, she had an allergy tests performed, but no allergies had been found. The reporter stated that the patient experienced facial swelling and abdominal pain "randomly" and this occurred approximately once a month since a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The most recently symptoms were experienced on 11-NOV-2020 and abdominal pain had lasted approximately 5 weeks. It was reported that the patient visited the ER numerous times due to the events, but she had not been admitted to the hospital on any of the ER visits. She received unspecified treatment for the events. The reporter was requesting a LOT check. Outcome of the events was reported as not recovered. The causality assessment between the events and the suspect therapy was not provided.   Upon internal review, the event of intussusception was determined to be medically significant. 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: 1602283; expirationdate: 16-AUG-2021; deviceage and unit: 0 malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent