Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
The patient received Jynneos vaccine intradermal; The patient received Jynneos vaccine intradermal; Shortness of breath; Chills (shivering and feeling cold); Redness; Swelling; Nausea, Abdominal pain; Joint aches/pain; palpitations; Fatigue or tiredness; Headache; Redness, Swelling; Muscle/body aches; Fever; Chills (shivering and feeling cold); Nausea; Case reference number AU-BN-2025-000579 initially downloaded from regulatory authority is a spontaneous case without reporter received via Health Authority (ID: AU-TGA-0000762086) on 07-Apr-2025 and concerns a 59-year-old male patient. The patient's relevant medical history and concomitant medication details were not provided. On *26-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 in *Nov-2022*, an unknown amount of time after the vaccination with Jynneos, the patient *experienced redness, swelling, fever, chills (shivering and feeling cold), headache, muscle/body aches, Joint aches/pain, nausea, abdominal pain, fatigue or tiredness shortness of breath and palpitations.* *On an unspecified date, the patient was recovered from the events of abdominal pain, redness, swelling, chills, feeling cold, nausea, arthralgia, dyspnoea, fatigue, headache, injection site reaction, myalgia, palpitations and pyrexia.* *The reporter assessed the events of abdominal pain, redness, swelling, chills, feeling cold, nausea, arthralgia, dyspnoea, fatigue, headache, injection site reaction, myalgia, palpitations and pyrexia 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-0000762086) on 02-Jul-2025: New information included seriousness, causality, new events details and vaccination details.; Reporter's Comments: A 59-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 of dyspnoea, palpitations, abdominal pain, arthralgia, fatigue, headache, injection site reaction, myalgia, feeling cold, erythema, swelling, chills, nausea and pyrexia on an unspecified date, an unknown amount of time, also reported as in the next few days after Jynneos vaccination. Palpitations, fatigue, headache, injection site reaction, myalgia, chills, nausea and pyrexia are listed per CCDS V7 and expected per agencies. Arthralgia and abdominal pain are listed per CCDS V7, expected per one agency unexpected per another agency. Dyspnoea, feeling cold, erythema and swelling are 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 patient recovered from the events. 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 59-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 of dyspnoea, palpitations, abdominal pain, arthralgia, fatigue, headache, injection site reaction, myalgia, feeling cold, erythema, swelling, chills, nausea and pyrexia on an unspecified date, an unknown amount of time, also reported as in the next few days after Jynneos vaccination. Palpitations, fatigue, headache, injection site reaction, myalgia, chills, nausea and pyrexia are listed per CCDS V7 and expected per agencies. Arthralgia and abdominal pain are listed per CCDS V7, expected per one agency and unexpected per another agency. Dyspnoea, feeling cold, erythema and swelling are 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 patient recovered from the events. 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