Age: 30.0
Sex: F
Vaccine: HPV9
Symptoms: Angioedema, Chest discomfort, Electrocardiogram normal, Pruritus, Urticaria
Clinical narrative: noticed angioedemia, but decreased hives; hives and chest tightness persisted; At 1800, she noticed hives on her arms and chest; noted localized itching in both of her arms, which rapidly generalized.; This spontaneous report as received from a physician refers to a 30 year old (reported as 31, which is her current age) female patient, with no history of drug  allergy/hay fever or asthma. No pertinent medical history; only surgical history of ectopic pregnancy and wisdom teeth removal. Patient was adopted so no family history.   On 06-AUG-2020 at:13.00, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 mil intramuscular (lot # 1621929 has been verified to be a valid lot number, expiration date reported as 06-DEC-2021) for prophylaxis. Concomitant therapies included bupropion hydrochloride (WELLBUTRIN) during menstrual cycle (menorrhagia) and tranexamic acid.  On 06-AUG-2020, at 1400, the patient noted localized itching in both of her arms, which rapidly generalized. At 18.00, she noticed hives on her arms and chest and went to the emergency room at around 19.00. Exam was unchanged at that time. No breathing difficulties, normal electrocardiogram (ECG): was given diphenhydramine hydrochloride (BENADRYL) and famotidine (PEPCID). By 01.00, she had improved and was discharged on 07-AUG-2020. In the morning of the same day (07-AUG-2020), patient woke up with hives at around 09.00 and went to primary care provider. At 15.00 that afternoon, she had a lunch with friends and, later, had dinner with a single alcoholic beverage. Hives continued to worsen. At 23.00, hives and chest tightness persisted so she went back to emergency room. Vital signs were stable at that time, diphenhydramine hydrochloride (BENADRYL) and dexamethasone (DECADRON) were given. On 08-AUG-2020, at 01.00, she was discharged, with following treatments given: prednisone, cetirizine hydrochloride (ZYRTEC) and epinephrine pen; and went home. Woke up at 03.00 with hives again, took more oral diphenhydramine hydrochloride (BENADRYL). Woke up at 09.30 still itching/hives, and took diphenhydramine hydrochloride (BENADRYL). Patient got her prescriptions filled, which she noted helped the itching but not the hives. On 09-AUG-2020 and 10-AUG-2020, she noticed angioedema, but decreased hives. By 11-AUG-2020, she went to work. On 13-AUG-2020, prednisone taper finished. Normal on exam at that time per the reporting provider. Hence, on 13-AUG-2020 she improved and recovered from the events. The action taken with the suspect vaccine was not applicable.  Causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event of angioedema was considered 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: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No