Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
Shortness of breath (SOB); The patient received Jynneos vaccine intradermally; The patient received Jynneos vaccine intradermally; Joint aches/pain; Palpitations; Fever; Muscle/body aches; Fatigue or tiredness; Injection site reaction; Local reactions: Redness, Swelling, Itching; Local reactions: Redness, Swelling, Itching; Local reactions: Redness, Swelling, Itching; Case reference number AU-BN-2025-000577 initially downloaded from regulatory authority is a spontaneous case received from *consumer* via Health Authority (ID: 762088) on 07-Apr-2025 and concerns 26-year-old male patient. The patient's relevant medical history and concomitant medication details were not provided. On *29-Nov-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, *intradermally* for unknown indication *(explicitly coded as 'intradermal injection' and off label use')*. On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient experienced shortness of breath (SOB). *On an unspecified date in Nov-2022, an unknown amount of time after the vaccination with Jynneos, the patient experienced localized redness, swelling, itching, fever, muscle/body aches, joint aches/pain, fatigue/tiredness and palpitations.* *At the time of follow-up report, it was unknown if the patient recovered from event of dyspnoea and the patient was not recovered from the events of arthralgia, fatigue, injection site reaction, injection site redness, injection site swelling, injection site itching, myalgia, palpitation and pyrexia.* *The reporter assessed the events of arthralgia, dyspnoea, fatigue, injection site reaction, , injection site redness, injection site swelling, injection site itching, myalgia, palpitation and pyreaxia 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 consumer via Health authority (ID: AU-TGA-0000762088) on 02-Jul-2025: New information included seriousness, causality, events details and vaccination details, patient's and reporter's details.; Reporter's Comments: A 26-year-old adult male patient was vaccinated with Jynneos intradermally for unknown indication, which is considered as intradermal injection and off label use. Reportedly, the patient experienced non-serious events palpitations, arthralgia, fatigue, injection site reaction, injection site redness, injection site swelling, injection site itching, myalgia and pyrexia on an unspecified date, an unknown amount of time, also reported as a few days after Jynneos vaccination. On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient experienced a non-serious event of shortness of breath. Palpitations, fatigue, injection site reaction, injection site redness, injection site swelling, injection site itching, myalgia and pyrexia are listed per CCDS V7 and expected per agencies. Arthralgia is listed per CCDS V7, expected per one agency and unexpected per another agency. Dyspnoea is unlisted and unexpected per CCDS V7, and agencies. Intradermal injection and off label use are considered as listed per company convention. Patient's relevant medical history and concomitant medications were not reported. The outcome was unknown. 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. Intradermal injection and off label use are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 26-year-old adult male patient was vaccinated with Jynneos intradermally for unknown indication, which is considered as intradermal injection and off label use. Reportedly, the patient experienced non-serious events palpitations, arthralgia, fatigue, injection site reaction, injection site redness, injection site swelling, injection site itching, myalgia and pyrexia on an unspecified date, an unknown amount of time, also reported as a few days after Jynneos vaccination. On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient experienced a non-serious event of shortness of breath. Palpitations, fatigue, injection site reaction, injection site redness, injection site swelling, injection site itching, myalgia and pyrexia are listed per CCDS V7 and expected per agencies. Arthralgia is listed per CCDS V7, expected per one agency and unexpected per another agency. Dyspnoea is unlisted and unexpected per CCDS V7, and agencies. Intradermal injection and off label use are considered as listed per company convention. Patient's relevant medical history and concomitant medications were not reported. The outcome was unknown. 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. Intradermal injection and off label use are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None