Received Feb 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | X024251 | OT |
diagnosed with functional neurological disorder/Doctors are saying the fainting is the result of this diagnosis; toothache; Drug reactions: AMOXYCILLIN/she broke out in hives; This spontaneous report was received from the patient's mother regarding her approximately 13-year-old daughter (female). The patient's medical history was not reported. Historical drugs included lurasidone hydrochloride (LATUDA). The patient's concurrent conditions included seasonal allergy and allergy to lurasidone hydrochloride (LATUDA). Concomitant medications included aripiprazole (ABILIFY) and topiramate (reported as ''topirmate''). On 08-NOV-2024, the patient was vaccinated with the second dos of human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 virus like particle (VLP) vaccine (yeast) (GARDASIL 9) injection, lot #X024251 (expiration date was not provided but upon validation it was found to be 15-MAY-2026), administered intramuscularly to prevent HPV (strength was not provided). On an unknown date, the patient started therapy with amoxicillin, administered for toothache (strength, formulation, dose, lot #, expiry date, and route of administration were not provided). After which she broke out in hives On an unknown date (after the second dose of the suspect vaccine), the patient began to experience side effects with the suspect vaccine, such as fainting, that was later diagnosed as functional neurological disorder (Conversion disorder), as the doctors thought was the cause of fainting. Therefore, the patient was admitted to the hospital (date of admission not reported), to seek medical attention, but no treatment was given for this event. The action taken with amoxicillin regarding the events was not reported. At the time of this report the patient ad not recovered from conversion disorder; the outcome of the remaining events was not provided. The causal relationship between amoxicillin and hives was not reported, but given wording and company guidelines it was considered as related; the causality between this suspect drug and toothache was considered as not related; and for conversion disorder was not reported. The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and all the events was not provided.
Drug hypersensitivity; Seasonal allergy; Toothache
ABILIFY; TOPIRAMATE; AMOXICILLIN