Age: 16.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Swelling face
Clinical narrative: with a red swollen area over lower right deltoid; swollen left jaw; swollen gums on the left side of her mouth; gum infection; her right arm had been tingling and painful; with a red swollen area over lower right deltoid; headache; her right eye and right side of her lips were swelling; her right eye and right side of her lips were swelling; cold sore in her mouth; right arm had been tingling; This report was obtained on request by the Company from the agency.  Information has been received from a registered nurse and refers to a 16-year-old no pregnant female patient. The patient's concurrent conditions included allergy to lactose free milk, and she was vaccinated with an unspecified vaccine and he had swollen painful jaw since 11-AUG-2019. There patient had nonchronic or long-standing health conditions. The patient had no concomitant therapy.  On 12-AUG-2019 at 08:45, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly in her left arm, lot number 1614897, expiration date not reported but upon internal validation stablished as 20-SEP-2021 (dosage was not reported); with the second dose of hepatitis a virus vaccine inactivated(HAVRIX), intramuscularly in her right arm, lot number PA99T (expiration date and dosage were not reported); and with the second dose of meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) intramuscularly in her right arm, lot number U8569AB (expiration date and dosage were not reported) all for prophylaxis.  On 12-AUG-2019 at 11:00, the patient reported to her mother that she had headache, and that her right eye and right side of her lips were swelling (eye swelling, lip swelling). The patient's mother thought this was due to nerves because of it being the first day of school. Then the next morning, the patient reported that she also had a cold sore in her moth (oral herpes). On 13-AUG-2019, the school nurse called the patient's mom and reported that she had a swollen left jaw and that she had swollen gums on the left side of her mouth (swelling face, gingival swelling), the nurse was not sure if the patient had wisdom teeth trying to came in or a gum infection (gingivitis). That day after work at 20:00, the patient reported to her mom that her right arm had been tingling and painful with a red swollen area over lower right deltoid and that the tingling had been happening since 12-AUG-2019 (reported as Monday) but she forgot to tell her (paraesthesia, pain in extremity, peripheral swelling, erythema). The patient went to emergency room and was treated with an unspecified allergy medication and then release home.  At the time of the report, the outcome of the events was unknown, however the reporter stated that the patient as no having symptoms at the time of the report.  The relatedness between the events of considered headache, peripheral swelling, erythema, pain in extremity, paraesthesia, gingivitis, gingival swelling, swelling face, oral herpes, lip swelling and eye swelling and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9); hepatitis a virus vaccine inactivated(HAVRIX) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA).   Follow-up information has been received from a registered nurse on 02-OCT-2020.  She reported receiving a vaccine adverse experience form and she stated, "there are no patient details on this so I'm not sure how to fill it out". Provided her with date of vaccination and she stated that she would try to figure out who the patient was and fill out the form. No further information available.  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: 1614897; expirationdate: 20-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent