Received Nov 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Confusional state; Fatigue; Musculoskeletal pain; Nausea; Information was obtained on a request by the Company from the agency via regulatory authority (AU-TGA-0000839177). This Spontaneous report was received from Consumer or other non-health professional and referred to a 45-year-old Female patient. The patient's medical history included hypothyroidism, sciatica, dry eye syndrome, slight rash from latex. The patient's concomitant medications included: Tradename not specified (duloxetine hydrochloride), Tradename not specified (levothyroxine sodium), and Tradename not specified (sodium valproate). On an unspecified date, patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) which was reconstituted on a sterile diluent (strength, dose, frequency, route of administration, site of administration, lot #, expiration date, and indication were not provided). On unspecified dates, the patient was vaccinated with other suspect vaccines including COVID-19 Vaccine (TNS) (COVID-19 Vaccine (Type not specified)) and Twinrix Adult 720/20 Formulation (Hepatitis a virus antigen; Hepatitis B surface antigen recombinant) (strength, dose, frequency, route of administration, site of administration, lot #, expiration date, and indication were not provided). The patient reported she was becoming very nauseated (Nausea) after receiving multiple vaccinations. She informed her doctor that she might have an autoimmune disorder due to hypothyroidism (Medical history), but her doctor disagreed. She received a fourth vaccination for COVID-19 as her local pharmacy recommended that individuals should get vaccinated from COVID every year. She was overdue for the Hepatitis A&B booster, as well as for chickenpox. Additional reported reactions were tiredness/exhaustion (Fatigue), confusion (Confusional state) and musculoskeletal pain, on unspecified dates. The outcome of nausea was not provided. At the time of reporting, the patient had not recovered from confusional state, fatigue and musculoskeletal pain. The causal relationship between all the events and varicella virus vaccine live (Oka/Merck) (VARIVAX) was considered as possible.
Medical History/Concurrent Conditions: Dry eye syndrome; Hypothyroidism; Latex allergy; Sciatica
Tradename not specified (duloxetine hydrochloride); Tradename not specified (levothyroxine sodium); Tradename not specified (sodium valproate)