Received Jun 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | OT |
cardiac arrest; short term memory loss; This spontaneous report was received from a Physician and refers to a 13-year-old male patient with no known history of cardiac events, family history, or reaction to 1st dose of GARDASIL-9. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 30-MAY-2025, the patient received his second dose of Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9), (lot # and expiration date were not reported) for prophylaxis. On 02-JUN-2025, the patient experienced cardiac arrest at his lacrosse practice. The patient sought medical attention, was shocked 3 times and witnessed short term memory loss and has since recovered. The causal relationship between the events and Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9) was not provided. Upon internal review, the event of cardiac arrest was determined to be medically significant. Follow up information was received by telephone on 09-Jun-2025. It was reported that the patient had a diagnosis of Cranial stenosis as an infant. On 19-Jun-2024, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant intramuscular injection (GARDASIL 9) (lot #, expiration date, strength, route of administration, anatomical location not provided); and on 23-May-2025, he received the second dose of the vaccine (lot #, expiration date, strength, anatomical location not provided), both as prophylaxis. On this date, the patient's height was 61.5 inches, weight was 94.5 lbs and his blood pressure was 120/60 (units not provided). No other vaccinations were administered this day. On 27-May-2025, the patient experienced the events of cardiac arrest and amnesia (previously reported as 02-Jun-2025). Lot # is being requested and will be submitted if received.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2025-06-09 , MNSC number : 02815081 , CLIC number : , ESTAR number : , IRMS number : US-009507513-2292076 , Central date : 2025-06-09 , Classification : DMC, Attachment description : Minimal Data Entry , Safety case number : US-009507513-2292076
Medical History/Concurrent Conditions: Stenosis (Diagnosed as an infant)
Test Date: 20250523; Test Name: Height; Result Unstructured Data: 61.5 inches; Test Date: 20250523; Test Name: Weight; Result Unstructured Data: 94.5 lbs; Test Date: 20250523; Test Name: Blood pressure; Result Unstructured Data: 120/60 (units not provided)