Received May 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y007197 | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | OT |
Inbound call from HCP regarding GARDASIL 9. HCP states that she gave the first dose of GARDASIL 9 to her 18 year old male patient on Tuesday 6MAY2025 and the patient experienced immediate syncope. The patient then laid down and the syncope resolved w; This spontaneous report was received from a Nurse Practitioner and refers to a 18-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 06-May-2025, the patient started therapy with Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (TDAP), (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot number, and expiration date were not reported), as prophylaxis. The patient started therapy with meningococcal vaccine (strength, dose, dose number, frequency, vaccination scheme, route, anatomical location, lot number, and expiration date were not reported), as prophylaxis; it was reported that the patient did not experience any immediate symptoms with those vaccines. On the same date, a few minutes after, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) lot #Y007197, expiration date: 18-Aug-2026, 0.5ml, administered by Intramuscular route, first dose, (strength, frequency, vaccination scheme, and anatomical location were not reported), as Human Papillomavirus (HPV) prevention. On the same date, the patient experienced immediate syncope. The patient then laid down and the syncope resolved within 15 minutes. The patient sought medical attention and had been treated for the event. The causal relationship between the event syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9) was reported as related, but unknown with the other suspect vaccines. Upon internal review, the event was determined to be important medical event. This is one of four reports from the same reporter.