Received Apr 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | — | OT |
not feeling well; fever; chills; This spontaneous report was received from an office manager and referred to a currently 21-year-old female patient. The patient's medical history included paracetamol (TYLENOL) allergy. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) injection, administered by intramuscular route for vaccination (dose, strength, anatomical site, lot # and expiration date were not reported). On an unknown date (reported as following the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9)), the patient experienced fever and chills. The patient was not given any treatment for the fever and chills and had resolved on an unknown date (reported as by the time that the patient had called the office to report the side effects). On an unknown date, the patient experienced not feeling well. The patient had been the 3rd dose in the series and was declined due to the patient not feeling well. The 3rd dose had been scheduled on 21-MAR-2025. The outcome of not feeling well was not reported. The action taken with the suspect vaccine was withdrawn. The causal relationship between all events and suspect vaccine was not reported. The reporter considered all events to be life-threatening. Lot # is being requested and will be submitted if received.
Medical History/Concurrent Conditions: Allergy NOS