Received Feb 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | UNK | — | LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Extensive swelling of vaccinated limb; Fatigue; Headache; Myalgia; Pyrexia; Syncope; Vaccination site erythema; Vaccination site pruritus; Myopericarditis; Abdominal pain; Arthralgia; Chills; Vaccination site pain; Rash; Seizure; Cough; Information was obtained on a request by The Company from the Regulatory Administration (RA) (agency # AU-TGA-0000844682) via a Public Case Detail on 02-FEB-2026. This spontaneous report was received from a/an Consumer or other non health professional via Regulatory Administration (RA) and refers to a(n) 17-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-Jun-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9), in Left Arm; Boostrix (Diphtheria vaccine toxoid;Pertussis vaccine acellular 3-component;Tetanus vaccine toxoid) (Injection Site: Right arm); Menquadfi (Meningococcal vaccine A/C/Y/W conj (tet tox)) (Injection Site: Left arm), all for Prophylaxis. All strength, dose, route, lot # and expiration date was not reported. On an unknown date, the patient experienced Abdominal pain, Arthralgia, Chills, Extensive swelling of vaccinated limb (swelling extended past elbow or shoulder), Fatigue/tiredness, Headache, Myalgia (Muscle/body aches), Myopericarditis, Pyrexia (Fever), Syncope (Fainted/loss of consciousness) with other symptoms at faint: Cough, Vaccination site erythema (Redness), Vaccination site pruritus (Itching), and Vaccination site pain (Pain), and "Sek". On 11-Jun-2025, the patient experienced Cough. On 13-Jun-2025, the patient experienced Seizure/convulsion (start: 2 or more days after vaccination, length: more than 30 minutes). On 14-Jun-2025, the patient experienced Rash; rash location (not at injection site): Face/Head/Neck, Chest/Back, Arms; symptoms with rash: None of the above; rash start: More than 72 hours (3 days); rash length: More than 24 hours. Fever: "NA deg C." Previous vaccine reactions: No. Reported reaction: Myopericarditis. The patient recovered/resolved from the event of Rash on 17-Jun-2025. At the reporting time, the outcome of Abdominal pain, Arthralgia, Chills, Cough, Extensive swelling of vaccinated limb, Fatigue, Headache, Myalgia, Myopericarditis, Pyrexia, Syncope, Vaccination site erythema, Vaccination site pruritus, Seizure and Vaccination site pain was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. The reporter considered all events to be related to (Causality possible) all suspect products. Upon internal review, the events of Myopericarditis, Syncope and Seizure were determined to be medically significant.; Sender's Comments: Priority : 4 , Is case serious : No , Index user : , Index date : 2026-02-02 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : AU-TGA-0000844682 , Central date : 2026-02-02 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :