Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
Fatigue or tiredness; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; The patient received Jynneos vaccine intradermally; The patient received Jynneos vaccine intradermally; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Anaphylaxis; Red sores, blisters; Local reactions: Pain, Redness, Swelling extending past elbow/shoulder; Lethargy; Lip or tongue swelling; Itching rash on face/head/neck/chest/back/arms/legs; Lip or tongue swelling; Headache; Case reference number AU-BN-2025-000627 initially downloaded from the Department of Health and Aged Care, Regulatory Administration (RA) is a spontaneous case received from a consumer via the Health Authority (TGA ID: 757651) on 07-Apr-2025 and concerns a 58-year-old male patient. The patient's relevant medical history and concomitant medication details were not provided. On *30-Oct-2022*, the patient was vaccinated with Jynneos (batch number: unknown) *intradermally* at an unknown dose, route, or site of administration for an unknown indication (explicitly coded as 'off-label use' and 'intradermal injection'). On an unspecified date *in Oct-2022*, an unknown amount of time after the vaccination with Jynneos, the patient developed* local reactions: pain and redness, swelling extending past the elbow/shoulder, itching rash on the face, head, neck, chest, arms and legs, rash occurred with lip or tongue swelling, the rash started seven to 72 hours after vaccination, and lasted more than 24 hours, headache, red sores and blisters, anaphylactic reaction and injection site reaction. * *On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed fatigue or tiredness. * At the time of the *follow-up* report, it was unknown if the patient recovered from the events of anaphylaxis, 'blister', 'extensive swelling of vaccinated limb', headache, 'injection site reaction', lethargy, 'lip swelling', 'rash pruritic', 'swollen tongue', *'injection site pain', 'injection site redness', 'injection site swelling ' and 'fatigue'.* The reporter *assessed the events of anaphylaxis, 'blister', 'extensive swelling of vaccinated limb', headache, 'injection site reaction', lethargy, 'lip swelling', 'rash pruritic', 'swollen tongue', 'injection site pain', 'injection site redness', 'injection site swelling ' and 'fatigue' as *non-serious however, the event of anaphylactic reaction was assessed as serious due to medical significance. The reporter assessed the events of anaphylaxis, 'blister', 'extensive swelling of vaccinated limb', headache, 'injection site reaction', lethargy, 'lip swelling', 'rash pruritic', 'swollen tongue', 'injection site pain', 'injection site redness', 'injection site swelling ' and 'fatigue' as possibly related to the product of Jynneos.* Follow-up downloaded from the RA received from a consumer via the Health Authority (TGA ID: AU-TGA-0000757651) on 17-Jul-2025: New information included patient details, dosing information, onset date of vaccination, seriousness and causality assessment.; Reporter's Comments: A 58-year-old male patient, who was vaccinated with Jynneos vaccine, intradermally for unknown indication, which is considered as injection and off label use. Patient had experienced a serious event of anaphylactic reaction (medical significance) and non-serious events of blister, extensive swelling of vaccinated limb, headache, injection site reaction, injection site pain, injection site erythema, injection site swelling, lethargy, lip swelling, rash pruritic, fatigue and swollen tongue on an unspecified date, an unknown amount of time (7 to 72 hours, as reported) after the patient was vaccinated with Jynneos for unknown indication. Anaphylactic reaction, headache, fatigue, injection site pain, injection site erythema, injection site swelling and injection site reaction are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst blister, extensive swelling of vaccinated limb, lethargy, lip swelling, rash pruritic and swollen tongue are unlisted and unexpected. 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. Injection and off label use are not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A 58-year-old male patient, who was vaccinated with Jynneos vaccine, intradermally for unknown indication, which is considered as injection and off label use. Patient had experienced a serious event of anaphylactic reaction (medical significance) and non-serious events of blister, extensive swelling of vaccinated limb, headache, injection site reaction, injection site pain, injection site erythema, injection site swelling, lethargy, lip swelling, rash pruritic, fatigue and swollen tongue on an unspecified date, an unknown amount of time (7 to 72 hours, as reported) after the patient was vaccinated with Jynneos for unknown indication. Anaphylactic reaction, headache, fatigue, injection site pain, injection site erythema, injection site swelling and injection site reaction are listed and expected for Jynneos per CCDS v7, Product Monograph and USPI, whilst blister, extensive swelling of vaccinated limb, lethargy, lip swelling, rash pruritic and swollen tongue are unlisted and unexpected. 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. Injection and off label use are not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
Comments: None