Received Sep 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Z009260 | OT / LA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | — |
goosebumps; first Gardasil 9 injection in Aug2024/ second Gardasil 9 28Aug2025; numbness and tingling on the left side of his face; numbness and tingling on the left side of his face; headache; This spontaneous report was received from a mother's patient and refers to a 13-year-old male patient. The patient's medical history included exercise induced asthma and used a rescue inhaler as needed. On August 2024, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) for prophylaxis (strength, route of administration, anatomical location, lot number and expiration date were not reported). It was reported after first dose the patient did not had any problem. On 28-AUG-2025, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) injection, at a dose of 0.5 mL, administered by Intramuscular route in Left Deltoid for Prophylaxis (lot #Z009260, expiration date: 19-Aug-2027) (Inappropriate schedule of product administration). On the same date (reported as within 10 minutes of received his second injection), the patient developed goosebumps all over his body (Piloerection) and numbness and tingling on the left side of his face (Hypoaesthesia and Paraesthesia). He also experienced a headache. It was reported, the goosebumps and tingling resolved after half hour but the numbness on the left side of his face persisted and is not resolving or has had very little minor improvement; and headache resolved at an unknown time with no treatments. It was also mentioned he was still able to move his eyes and cheeks, and he did not have any drooping on 1 side of face, so she does not believe he has had any stroke-like symptoms, Bell's Palsy or anything like that. The causal relationship between the events of Hypoaesthesia, Paraesthesia, Piloerection and headache and Human Papillomavirus 9-valent Vaccine, Recombinant were not reporter. This is one of two reports from the same reporter.
Exercise induced asthma (uses a rescue inhaler as needed)