Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
jaundice; Chest pain, pressure or discomfort; Chest pain, pressure or discomfort; Joint aches/pain; Muscle/body aches; Fatigue or tiredness; Headache; Local reactions: Redness; Fever; Local reactions: Redness; Case reference number AU-BN-2025-000628 initially downloaded from regulatory authority is a spontaneous case received from consumer via Health Authority (ID: 757649) on 07-Apr-2025, and concerns a *56-year-old* male patient. The patient's relevant medical history details were not provided. *The patient's concomitant medications included paracetamol and ibuprofen (brand names: unknown).* *The patient's current condition included pain and fever. * On *27-Oct-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, route or site of administration for unknown indication. On an unspecified date *in Oct-2022*, an unknown amount of time after the vaccination with Jynneos, the patient developed injection site reaction, local reactions: redness, fever, headache, muscle/body aches, joint aches/pain, fatigue or tiredness, chest pain, pressure or discomfort. *On an unspecified date, an unknown amount of time after the vaccination with Jynneous, the patient developed jaundice.* *On an unspecified date, reported symptoms had an impact on the patient's work, study or normal daily activities, causing to miss four days.* *The event management of injection site reaction was conducted through the self. * At the time of *the follow-up report, the patient did not recover from 'chest discomfort', 'chest pain', 'arthralgia', 'fatigue', headache, 'injection site reaction', 'myalgia', fever, 'injection site redness', and it was unknown if the patient recovered from jaundice.* The reporter *assessed the events 'chest discomfort', 'chest pain', 'arthralgia', 'fatigue', headache, 'injection site reaction', 'myalgia', fever, 'injection site redness',and jaundice as non-serious and possibly related to Jynneos.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up downloaded from regulatory authority received from a consumer via Health Authority (ID: AU-TGA-0000757649) on 17-Jul-2025: patient details, reporter details, causality and seriousness of the event, vaccination date, event management and additional events.; Reporter's Comments: A 56-year-old male patient experienced non-serious events of chest discomfort, chest pain, arthralgia, fatigue, headache, injection site reaction, injection site erythema, myalgia and pyrexia on an unspecified date, within approximately four days after vaccination with Jynneos for unknown indication. Reportedly, the patient also experienced jaundice, unknown time after vaccination with suspect product. Fatigue, headache, injection site reaction, injection site erythema, myalgia and pyrexia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI. Jaundice and chest discomfort are unlisted and unexpected. Chest pain and arthralgia are listed and expected per CCDS v7 and Product Monograph, whilst unexpected per USPI. The patient's relevant medical history and concomitant medication details were not provided, concomitant medications included paracetamol and ibuprofen while current condition included pain and fever. The outcome was was not resolved for all events except jaundice (unknown for jaundice). Causality is assessed as related for all reported events due to suggestive temporal relationship (except jaundice), known product safety profile (with exception of jaundice and chest discomfort), lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. This case is considered as non-serious.; Sender's Comments: A 56-year-old male patient experienced non-serious events of chest discomfort, chest pain, arthralgia, fatigue, headache, injection site reaction, injection site erythema, myalgia and pyrexia on an unspecified date, within approximately four days after vaccination with Jynneos for unknown indication. Reportedly, the patient also experienced jaundice, unknown time after vaccination with suspect product. Fatigue, headache, injection site reaction, injection site erythema, myalgia and pyrexia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI. Jaundice and chest discomfort are unlisted and unexpected. Chest pain and arthralgia are listed and expected per CCDS v7 and Product Monograph, whilst unexpected per USPI. The patient's relevant medical history and concomitant medication details were not provided, concomitant medications included paracetamol and ibuprofen while current condition included pain and fever. The outcome was was not resolved for all events except jaundice (unknown for jaundice). Causality is assessed as related for all reported events due to suggestive temporal relationship (except jaundice), known product safety profile (with exception of jaundice and chest discomfort), lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. This case is considered as non-serious.
Medical History/Concurrent Conditions: Fever; Pain
PARACETAMOL; IBUPROFEN