Received Mar 11, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | UNK | — | LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Type III immune complex mediated reaction; Extensive swelling of vaccinated limb; Vaccination site reaction; This spontaneous report was received from the regulatory authority (AU-TGA-0000855601) on 09-MAR-2026. This spontaneous report was received from physician, referring to a 1-year-old female patient. The patient's medical history and concomitant medications were not reported. No previous vaccine reactions. On 06-Jul-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live lyophilisate and solvent for solution for injection for Prophylaxis (anatomical location not provided), Act hib (HIB vaccine conj (tet tox)) and Tripacel (Diphtheria vaccine toxoid; Pertussis vaccine acellular 4-component; Tetanus vaccine toxoid) in left arm (indication not reported); all vaccines (strength, dose, route of administration, lot number and expiration date were not reported). On evening 06-Jul-2023, during bathtime noticed redness at site. Got progressively worse- swelling extended over shoulder and towards elbow. Swelling, redness, hard to touch, unsettled, reduced use of arm. Arthus reaction (Extensive swelling of vaccinated limb, Type III immune complex mediated reaction and severe Vaccination site reaction). Symptoms lasted 2-3 weeks approximately for swelling and redness to resolved. The causality for events Extensive swelling of vaccinated, Type III immune complex mediated reaction, and Vaccination site reaction was reported as causality possible. Upon internal review, the event Type III immune complex mediated reaction was determined to be Medically Significant.