Received Apr 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 2 | Y018416 | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | — | OT |
Vaccination site subcutaneous mass; vaccination site scar; vaccination site redness; vaccination site swelling; vaccination site blister; Blister rupture; vaccination site discharge; This Spontaneous report was received from Physician and referred to a 12 -year-old Female patient. The patient's medical history included Asthma. The patient's past medications and concomitant medications were not reported. On 11-Nov-2025, the patient started therapy with Human Papillomavirus Nonavalent (Types 6, 11, 16, 18, 31, 33, 45, 52, 58; S. cerevisiae) (Gardasil 9) (Batch/Lot Number: unkown, expiration date: unknown) dose form was Suspension for injection via Intramuscular. On 18-Dec-2024, the patient received the second dose of GARDASIL 9 (Batch/Lot Number: Y018416, expiration date: 13-Feb-2027) via Intramuscular for routine vaccination. On 18-Dec-2025, the patient experienced vaccination site redness and vaccination site swelling. On an unknown date the patient experienced vaccination site blister, blister rupture (reported as "Caller stated a blister then developed on top of the swelling that eventually popped and was draining a clear, sanguineous fluid for a few weeks") and vaccination site discharge. In approximately 2026 the patient experienced vaccination site scar (reported as "small but prominent scar that I don't think will go away"). The physician reported "although I don't know if that made a difference or if time made it better" and he prescribed the patient an antibiotic (Cephalexin). On 03-Mar-2026, the patient had an ultrasound done and the reading showed a subcutaneous mass. In Mar-2026, the patient recovered from vaccination site mass, blister rupture, vaccination site discharge, vaccination site erythema, vaccination site swelling, vaccination site vesicles. At the time of reporting, the patient had not recovered from vaccination site scar. The causalities for the events vaccination site mass, blister rupture, vaccination site discharge, vaccination site erythema, vaccination site swelling, vaccination site vesicles, vaccination site scar were unknown. The Physician considered the events vaccination site mass, blister rupture, vaccination site discharge, vaccination site erythema, vaccination site swelling, vaccination site vesicles, vaccination site scar to be non-serious.
Medical History/Concurrent Conditions: Asthma
Test Date: 20260303; Test Name: ultrasound; Result Unstructured Data: The reading showed a subcutaneous mass