Received Feb 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | OT |
"severe injection site pain" / "the pain is spreading to her hand"; "could barley move her arm; patient "had to cancel after school activities"; This solicited report was received from patients mother and referres to a 13 -year-old female patient. The patient's concurrent conditions included thyroid disease and drug allergy to penicillin and amoxicillin. Concomitant medications included thyroid medication (not specified). On 29-JAN-2026, the patient was vaccinated with hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) at a dose of 0.5 ml, intramuscularly for the treatment of HPV (strength, dose number, anatomical site of application, lot number and expiration date were not provided). On that same date (reported as immediately following the administration), the patient had "severe injection site pain". Patient's mother reported that the patient "could barley move her arm" (Vaccination site movement impairment) and that the patient "had to cancel after school activities" due to the pain (Loss of personal independence in daily activities). Patient's mother reported that the patient feels that "the pain was spreading to her hand" (Vaccination site pain). Patient's mother reported that the only treatment for these symptoms that was given to the patient were ibuprofen and Tylenol. Patient's mother reported that the patient was "starting to feel better" but was still in pain (recovering). Patient's symptoms had continued through the night into 30-JAN-2026. At the time of reporting, the patient was recovering from the events. The causal relationship between the events and suspect vaccine were not provided.
Drug allergy (to penicillin, and amoxicillin); Dysthyroidism; Human papilloma virus infection