Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
Shortness of breath; Lethargy; Chest pain; Local reaction - Redness; Palpitations; Fainting/loss of consciousness; Fainting/loss of consciousness; Cough; Headache; Case reference number AU-BN-2025-000748 initially downloaded from Department of Health and Aged Care, Regulatory Administration (RA) is a spontaneous case received from consumer via Health Authority (TGA ID: 754307) on 07-Apr-2025 and concerns a 36-year-old male patient. The patient's relevant medical history and concomitant medication details were not provided. *The patient did not have previous vaccine reactions. * On *09-Sep-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, *more than 30 minutes* after the vaccination with Jynneos, the *patient experienced local reaction redness, headache, and cough during fainting/loss of consciousness. As reported, fainting/loss of consciousness lasted for more than five minutes. * On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed chest pain, *shortness of breath*, lethargy, and palpitations. *The event management of chest pain was reported as 'unknown'.* At the time of *follow up* report, it was unknown if the patient recovered from events of chest pain, cough, *shortness of breath*, headache, *'injection site redness'*, lethargy, and palpitations. The reporter *assessed the events of chest pain, cough, shortness of breath, headache, 'injection site redness', lethargy, palpitations, 'fainting' and 'loss of consciousness' as non-serious, however, the event 'fainting' and 'loss of consciousness' were assessed as serious due to seriousness criteria of medical significance. The reporter assessed the events of chest pain, cough, shortness of breath, headache, 'injection site redness', lethargy, palpitations, 'fainting' and 'loss of consciousness' 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 RA received from a consumer via Health Authority (TGA ID: AU-TGA-0000754307) on 17-Jul-2025: patient details, causality and seriousness of the event, vaccination date, event verbatim, outcome, event management, additional events.; Reporter's Comments: This case concerned a 36-year-old male patient, who experienced serious (medically significant) events of loss of consciousness and syncope, and non-serious events of dyspnoea, lethargy, chest pain, cough, palpitations, headache and injection site erythema on unspecified date, after the dose of Jynneos vaccine for unknown indication. Palpitations, headache and injection site erythema are listed and expected per CCDS v7 and Product Monograph and USPI, whilst loss of consciousness, dyspnoea, lethargy, are unlisted and unexpected. Chest pain, cough are listed and expected per CCDS v7 and Product Monograph, whilst unexpected per USPI. Syncope is listed and expected per CCDS v7 and USPI, whilst unexpected per Product Monograph. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. 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. This case is considered as serious due to medically significant criteria.; Sender's Comments: This case concerned a 36-year-old male patient, who experienced serious (medically significant) events of loss of consciousness and syncope, and non-serious events of dyspnoea, lethargy, chest pain, cough, palpitations, headache and injection site erythema on unspecified date, after the dose of Jynneos vaccine for unknown indication. Palpitations, headache and injection site erythema are listed and expected per CCDS v7 and Product Monograph and USPI, whilst loss of consciousness, dyspnoea, lethargy, are unlisted and unexpected. Chest pain, cough are listed and expected per CCDS v7 and Product Monograph, whilst unexpected per USPI. Syncope is listed and expected per CCDS v7 and USPI, whilst unexpected per Product Monograph. The patient's relevant medical history and concomitant medication details were not provided. The outcome was unknown. 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. This case is considered as serious due to medically significant criteria.
Comments: None