Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
Jynneos vaccine was administered intradermally; Jynneos vaccine was administered intradermally; Shortness of breath; Local reactions Redness; Fatigue or tiredness; Local reactions Redness; Case reference number AU-BN-2025-000578 initially downloaded from regulatory authority is a spontaneous case without reporter received via Health Authority (ID: 762087) on 07-Apr-2025 and concerns male patient of unknown age. The patient's relevant medical history were not reported and concomitant medication *included paracetamol or ibuprofen*. *The patient's current condition included pain or fever.* On *28-Nov-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, *intradermally* for unknown indication (off label use and intradermal injection). On an unspecified date *in Nov-2022, an unknown amount of time after the vaccination with Jynneos, the patient *experienced redness fatigue or tiredness shortness of breath.* At the time of *follow-up* report, the patient *not recovered* from the events dyspnoea, fatigue and injection site erythema. *The reporter assessed the events dyspnoea, fatigue and injection site erythema 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 physician via Health authority (ID: AU-TGA-0000762087) on 02-Jul-2025: New information seriousness, causality, events details, vaccination detail and clinical course.; Reporter's Comments: A male patient of unspecified age was vaccinated with Jynneos intradermally for unknown indication, which is considered as off label use and intradermal injection. Reportedly, the patient experienced non-serious events of dyspnoea, fatigue, erythema and injection site erythema on an unspecified date, an unknown amount of time, also reported as in the next few days after the patient was vaccinated with Jynneos. Fatigue and injection site erythema are listed and expected for Jynneos per CCDS v7, and agencies, whilst dyspnoea and erythema are unlisted and unexpected. Off label use and intradermal injection are considered as listed per company convention. The patient's relevant medical history was not reported and concomitant medication included paracetamol or ibuprofen, current condition included pain or fever. The patient did not recover. Considering plausible temporal relationship, lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Off label use and intradermal injection are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age was vaccinated with Jynneos intradermally for unknown indication, which is considered as off label use and intradermal injection. Reportedly, the patient experienced non-serious events of dyspnoea, fatigue, erythema and injection site erythema on an unspecified date, an unknown amount of time, also reported as in the next few days after the patient was vaccinated with Jynneos. Fatigue and injection site erythema are listed and expected for Jynneos per CCDS v7, and agencies, whilst dyspnoea and erythema are unlisted and unexpected. Off label use and intradermal injection are considered as listed per company convention. The patient's relevant medical history was not reported and concomitant medication included paracetamol or ibuprofen, current condition included pain or fever. The patient did not recover. Considering plausible temporal relationship, lack of alternative explanation and since the contributory role of the suspect vaccine cannot be excluded, the causality is considered as related. Off label use and intradermal injection are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Fever; Pain
Comments: None
IBUPROFEN; PARACETAMOL