Received Nov 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (INFANRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | UNK | — | — |
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | UNK | — | — |
left thigh cellulitis at injection site; Lethargy; fever; redness; limited weight bearing on left leg; Information was obtained on a request by The Company from the agency (AU-TGA-0000840719) via a Public Case Detail. This spontaneous report was received from a physician and referred to a 4-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 23-May-2025 at 10:00, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) in right leg (strength, dose, route, lot # and expiration date were not reported), Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) in left leg (strength, dose, route, lot # and expiration date were not reported) and Diphtheria vaccine toxoid(+)Pertussis vaccine acellular 3-component(+)Tetanus vaccine toxoid (INFANRIX) in left leg (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. On 23-May-2025, the patient experienced fever and lethargy. On 24-May-2025, the patient experienced left thigh cellulitis at injection site (vaccination site cellulitis), ongoing symptoms of redness (erythema), limited weight bearing on left leg (weight bearing difficulty). On an unknown date in May 2025, the patient was hospitalized because of vaccination site cellulitis, fever, and lethargy. At the reporting time, the patient had not recovered from all the events. The agency considered all the events to be possibly related to the suspect vaccines.