Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Epistaxis, Headache, Injection site discomfort, Injection site pain, Injection site reaction
Clinical narrative: The patient was experiencing excessive hair loss /hair coming out in clumps; The patient was experiencing increased migraines; The patient was experiencing nose bleeds; The patient was experiencing injection site tender arm /arm tenderness; The patient was experiencing chills; The patient was experiencing right knee pain; The patient was experiencing stomach pain; The patient experienced injection site reactions; The patient reporting toxicity; The patient experienced tingling; The patient experienced injection site discomfort; The patient experienced minor headaches and over a month the headaches worsened; the patient feels convinced that that it triggered a autoimmune response; This spontaneous report was received from a physician and a nurse via a company representative regarding a 37 years old female patient. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies were not reported.     On 07-MAY-2019, the patient was vaccinated for prevention with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered intramuscularly (IM) (lot number: R028651 and expiration date: 27-JUL-2021) (strength, dose and anatomical location were not reported). On an unspecified date in July 2019 (reported as "about one month after the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), the patient experienced minor headaches (mild), tingling (paraesthesia) and injection site discomfort. It was reported that the headaches worsened over a month.   On 08-JUL-2019, the patient was vaccinated for prevention with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered IM (lot number: 1602284 and expiration date: 26-SEP-2021)(strength, dose and anatomical location were not reported). In addition, the patient did not mention any of the abovementioned side effects she was complaining until she went to the office the day after she received the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). On 09-JUL-2019 (also reported as next day), the patient noticed she was experiencing excessive hair loss, her hair was coming out in clumps (alopecia), chills, injection site tender arm, right knee pain (arthralgia), nose bleeds (epistaxis), stomach pain (abdominal pain upper), increased migraines, injection site reactions and the patient reported toxicity (poisoning). It was reported that blood panel, lipids and hormones tests were performed to the patient, but no results were provided.  Additionally, the patient felt convinced that that it triggered a autoimmune response (immune system disorder). At the reporting time, the patient had not recovered from all the aforementioned events, except for the event injection site discomfort which outcome was unknown.   The causality between all 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 poisoning was determined to be medically significant.