Received May 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y007197 | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
the patient experienced immediate syncope; This spontaneous report was received from a Physician Assistant (medical assistant) and refers to a 16-year-old female patient. The patient´s concomitant therapies included meningococcal vaccine (reported as ¨meningococcal [GFK]¨). The patient's medical history, concurrent conditions, past drug reactions and allergies were reported as none. On an unknown date, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), administered as prophylaxis (dose, formulation, anatomical site of injection, route of administration, lot number and expiration date were not provided). On 06-MAY-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), 0.5 mL, administered by Intramuscular route for HPV prevention (lot number Y007197 has been verified to be valid for Human Papillomavirus 9-valent Vaccine, Recombinant [GARDASIL 9], expiration date 18-AUG-2026; vaccination scheme frequency and anatomical site of injection were not provided). On that same date, the patient experienced immediate syncope. The patient laid down and the syncope resolved within 15 minutes (recovered). The reporter stated the patient was also vaccinated with meningococcal vaccine (reported as meningococcal ¨[GFK]¨) a few minutes before the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) vaccination and did not experience any immediate symptoms with that vaccine nor the syncope until the Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was administered. It was reported the patient sought medical attention for the event. The reporter stated this was a brand-new box of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and so far, they have given 3 doses out of this box and have had the same issue with each patient. They were told to discontinue the use of the product with this lot number. Additionally, they said they have been giving this vaccine for 8 years and have never seen a lot so consistently cause a reaction like this. Patient has not experienced any other issues. The causal relationship between the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the event was not provided. The reporter considered the event of syncope to be related to the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (reported as have never seen a lot so consistently cause a reaction like this). Upon internal review, the event of Syncope was considered to be medically significant. This is one of three reports from the same reporter.
meningococcal ¨(GFK)¨