Received Mar 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | — | — |
| HEPA | HEP A (VAQTA) | MERCK & CO. INC. | 2 | — | — |
| PPV | PNEUMO (PNEUMOVAX) | MERCK & CO. INC. | 1 | — | — |
Arthralgia; Weight bearing difficulty; Vaccination site reaction; Information was obtained on a request by the Company from the agency via a Public Case Detail from a physician concerning a 4-year-old (conflicting information, the age was also reported as 5 years old) female patient, who was due annual flu vaccine. The patient was referred by pediatrics and the patient was admitted to the hospital due to the suspected metabolic bone disorder in December 2024. The patient denied any previous vaccine reactions. The patient's historical drugs, and concomitant drugs were not reported. On 19-DEC-2024, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported); second dose of Hepatitis A Vaccine, Inactivated (VAQTA) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported); and Diphtheria vaccine toxoid(+) Pertussis vaccine acellular 5-component (+) Polio vaccine inact 3v (MRC 5) (+) Tetanus vaccine toxoid (QUADRACEL) (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). On 20-DEC-2024, the patient experienced significant pain and oedema in right thigh and knee (arthralgia) day after vaccinations administered on the ward, unable to weight bear (weight bearing difficulty), resulting in readmission. On the same day, the patient experienced vaccination site reaction. On an unknown date, the patient received ultrasound scan (USS) with clear result. After orthopedic review, antibiotics were used. On 28-AUG-2025, the patient was discharged. At the time of reporting, the outcome of the events above was unknown. The reporter considered the events above were related to the suspected vaccines. The reporter considered the vaccination site reaction was other medically important condition.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2026-03-09 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : AU-TGA-0000857104 , Central date : 2026-03-09 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Bone metabolism disorder
Medical History/Concurrent Conditions: Hospitalization
Test Name: ultrasound scan; Result Unstructured Data: clear