Received May 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y007197 | OT |
Immediate syncope; This spontaneous report was received from a Physician Assistant and refers to an 18-year-old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included Diphtheria tetanus pertussis vaccine (TDAP) and Meningococcal vaccine ("GFK"). On 06-May-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Y007197 confirmed as valid, expiration date: 18-Aug-2026), administered Intramuscularly (anatomical location not provided) as human papillomavirus (HPV) prevention. On the same date after vaccination, the patient experienced Immediate syncope. Therefore, the patient was laid down and the event recovered within 15 minutes. It was reported that the aforementioned concomitant vaccines were administered few minutes before Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), and the patient did not experience any immediate symptoms. Also, it was stated that there was a brand-new box of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and so far, they had given 3 doses out of this box and had had the same issue with each patient. Patient had not experienced any other issues. The causal relationship between Immediate syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported. Upon internal review, the event of Immediate syncope was determined to be medically significant. This is one of several cases reported by the same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-05-08 , MNSC number : 02802186 , CLIC number : , ESTAR number : , IRMS number : 02802186 , Central date : 2025-05-08 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
TDAP; meningococcal (GFK)