Received Dec 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | — |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
She complained she felt like her face was burning and was feeling faint; She complained she felt like her face was burning and was feeling faint; Her lips were pale; This spontaneous report was received from a physician and refers to a 11-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 05-Dec-2025, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), (dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis and with Tdap vaccine (manufacturer unknown) (dose, route of administration, anatomical location, indication, lot number and expiration date were not reported) in separate arms. On the same date, after waiting the recommended period patient left, but returned immediately, she complained she felt like her face was burning (Skin burning sensation), her lips were pale (Pallor) and was feeling faint and dizzy (Syncope). The HCP examined her, gave her something to eat as she had not eaten much that day when questioned, after the doctor examined her, she left, as she was feeling better, therefore the outcome of the events was reported as recovered. The causal relationship between the events and the suspect vaccines was not provided. Upon internal review, the event of syncope was determined to be medically significant (OME).