Received Jul 31, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Fatigue or tiredness; Lethargy; Abdominal pain; Joint aches/pain; Muscle/body aches; Palpitations; Chills (shivering and feeling cold); Headache; Local reactions: Pain, Swelling, Itching; Local reactions: Pain, Swelling, Itching; Local reactions: Pain, Swelling, Itching; Local reactions: Pain, Swelling, Itching; Case reference number AU-BN-2025-000624 initially downloaded from regulatory authority is a spontaneous case received from consumer via Health Authority (ID: 757655) on 07-Apr-2025 and concerns a *35-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 *24-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 October-2022*, an unknown amount of time after the vaccination with Jynneos, the patient developed *local reactions of pain, swelling, itching, chills (shivering and feeling cold) headache, muscle/body aches, joint aches/pain abdominal pain, palpitation and lethargy* *On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed fatigue or tiredness.* *The event management of injection site reaction was conducted through the self.* At the time of the *follow up* report, it was unknown if the patient recovered from events of palpitations, abdominal pain, 'arthralgia', 'chills', headache, 'injection site reaction', lethargy, 'myalgia', *'injection site pain', 'injection site swelling', 'injection site itching', and 'fatigue'*. The reporter assessed the events *palpitations, abdominal pain, 'arthralgia', 'chills', headache, 'injection site reaction', lethargy, 'myalgia', *'injection site pain', 'injection site swelling', 'injection site itching', and 'fatigue'*. 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: 757655) on 17-Jul-2025: patient details, reporter details, causality and seriousness of the event, vaccination date, event management, additional events of injection site pain, injection site swelling, injection site itching, and fatigue.; Reporter's Comments: A 35-year-old male patient experienced non-serious events of palpitations, abdominal pain, arthralgia, chills, headache, injection site reaction, injection site pain, injection site swelling, injection site pruritus, lethargy and myalgia on an unspecified date, within approximately one week after the patient was vaccinated with Jynneos for unknown indication. Fatigue occurred unknown time after vaccination with suspect product. Palpitations, chills, headache, injection site reaction, injection site pain, injection site swelling, injection site pruritus, fatigue and myalgia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst lethargy is unlisted and unexpected. Abdominal 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 unknown. All reported events are assessed as related due to suggestive temporal relationship (except for fatigue), known product safety profile (for palpitations, chills, headache, injection site reaction, injection site pain, injection site swelling, injection site pruritus, fatigue, abdominal pain arthralgia and myalgia), 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 35-year-old male patient experienced non-serious events of palpitations, abdominal pain, arthralgia, chills, headache, injection site reaction, injection site pain, injection site swelling, injection site pruritus, lethargy and myalgia on an unspecified date, within approximately one week after the patient was vaccinated with Jynneos for unknown indication. Fatigue occurred unknown time after vaccination with suspect product. Palpitations, chills, headache, injection site reaction, injection site pain, injection site swelling, injection site pruritus, fatigue and myalgia are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst lethargy is unlisted and unexpected. Abdominal 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 unknown. All reported events are assessed as related due to suggestive temporal relationship (except for fatigue), known product safety profile (for palpitations, chills, headache, injection site reaction, injection site pain, injection site swelling, injection site pruritus, fatigue, abdominal pain arthralgia and myalgia), 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