Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
Shortness of breath; Redness; Swelling; Chest pain, pressure or discomfort; Chest pain, pressure or discomfort; Itching; Fatigue or tiredness; Injection site reaction; The patient received Jynneos intradermally; The patient received Jynneos intradermally; Case reference number AU-BN-2025-000532, initially downloaded from regulatory authority is a spontaneous case received from consumer via Health Authority (ID: 765740) on 07-Apr-2025 and concerns *30-years-old* male patient. The patient's relevant medical history and concomitant medication details were not provided. On *10-Jan-2023*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose *or site of administration, *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 developed redness, swelling, itching, fatigue or tiredness, chest pain, pressure or discomfort, shortness of breath* and injection site reaction. *As reported symptoms have caused an impact on work, study, or normal daily activities. * *On an unspecified date, the event of chest pain was managed in the hospital emergency department. * At the time of *follow-up* report, the patient *did not recover from events of 'chest pain', 'chest discomfort, shortness of breath, 'fatigue', redness, swelling, itching and injection site reaction. * *The reporter assessed the events of 'chest pain', 'chest discomfort, shortness of breath, 'fatigue', redness, swelling, itching and injection site reaction as non-serious and possibly related to the product of 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 health professional via Health authority (ID: AU-TGA-0000765740) on 02-Jul-2025: New information seriousness, causality, events details, patient details, Jynneos vaccination details and reporter's details.; Reporter's Comments: This case concerned a 30-year-old adult male patient, who was vaccinated with Jynneos vaccine, intradermally for unknown indication, which is considered as injection and off label use. Patient has experienced a non-serious event of dyspnoea, swelling, erythema, chest discomfort, pruritus, chest pain, fatigue, injection site reaction on unspecified date and time after Jynneos vaccination. Dyspnoea, swelling, erythema, and chest discomfort are unlisted and unexpected per CCDS V7, USPI and Product Monograph. Fatigue, injection site reaction are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI. Chest pain, and pruritus are listed and expected for Jynneos per CCDS v7, Product Monograph and unexpected per USPI. Patient's relevant medical history and concomitant medications were not reported. Outcome was not recovered/not resolved. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported events have been considered as related to Jynneos. 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: This case concerned a 30-year-old adult male patient, who was vaccinated with Jynneos vaccine, intradermally for unknown indication, which is considered as injection and off label use. Patient has experienced a non-serious event of dyspnoea, swelling, erythema, chest discomfort, pruritus, chest pain, fatigue, injection site reaction on unspecified date and time after Jynneos vaccination. Dyspnoea, swelling, erythema, and chest discomfort are unlisted and unexpected per CCDS V7, USPI and Product Monograph. Fatigue, injection site reaction are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI. Chest pain, and pruritus are listed and expected for Jynneos per CCDS v7, Product Monograph and unexpected per USPI. Patient's relevant medical history and concomitant medications were not reported. Outcome was not recovered/not resolved. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported events have been considered as related to Jynneos. 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