Received Aug 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | ID |
Possible anaphylaxis; Body aches; Lip or tongue swelling; Lip or tongue swelling; Joint aches/pain; Local reactions: Pain, Redness, Swelling, Itching; Local reactions: Pain, Redness, Swelling, Itching; Local reactions: Pain, Redness, Swelling, Itching; Local reactions: Pain, Redness, Swelling, Itching; Local reactions: Pain, Redness, Swelling, Itching; Fever; Headache; Muscle aches; Fatigue or tiredness; Intradermal injection of Jynneos; Intradermal injection of Jynneos; Rash on arms; Case reference number AU-BN-2025-000764 initially downloaded from Regulatory Administration is a spontaneous case received from consumer via Health Authority (ID: AU-TGA-0000754054) on 07-Apr-2025 and concerns a *33-year-old* male patient. The patient's relevant medical history was not provided. *The patient had no previous vaccine reactions.* The patient's concomitant medication details *included paracetamol and ibuprofen (brand names: unknwon).* *The patient's current condition included pan and fever. * On *11-Sep-2022*, the patient was vaccinated with Jynneos (batch number: unknown) at an unknown dose, *intradermally* at unknown site of administration for unknown indication *(explicitly coded as 'intradermal injection' and 'off label use')*. *On an unspecified date, seven to 72 hours after the vaccination with Jynneos, the patient developed a rash on the arms. It occurred with lip or tongue swelling. The rash lasted for more than 24 hours.* On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient developed an injection site reaction, *local reactions: pain, redness, swelling and itching, fever, headache, muscle and body aches, joint aches/pain, fatigue or tiredness and possible anaphylaxis.* At the time of the *follow-up* report, it did not recover from the events *fever, headache, 'muscle pain', 'general body pain ', 'arthralgia ', 'fatigue', 'lip swelling', 'swollen tongue', 'ash over arms', 'injection site reaction', 'injection site pain', 'injection site erythema', 'injection site swelling', 'injection site pruritus' and anaphylaxis, as reported symptoms ongoing.* The reporter *assessed* the events of fever, headache, 'muscle pain', 'general body pain ', 'arthralgia ', 'fatigue', 'lip swelling', 'swollen tongue', 'ash over arms', 'injection site reaction', 'injection site pain', 'injection site erythema', 'injection site swelling', 'injection site pruritus' and anaphylaxis as not serious, however the event anaphylactic reaction was assessed as serious due to seriousness criteria of medically significance. The reporter assessed all events of fever, headache, 'muscle pain', 'general body pain ', 'arthralgia ', 'fatigue', 'lip swelling', 'swollen tongue', 'ash over arms', 'injection site reaction', 'injection site pain', 'injection site erythema', 'injection site swelling', 'injection site pruritus' and anaphylaxis as 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 a consumer via Health authority (ID: AU-TGA-0000754054) on 17-Jul-2025: New information included updated patient details, additional events, outcome, seriousness, causality and Jynneos dosing information.; Reporter's Comments: This case concerned a 33-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 serious (medically significant) event of anaphylaxis and non-serious events of pain, lip swelling, swollen tongue, arthralgia, pyrexia, rash, headache, myalgia, fatigue, injection site reaction, injection site pain, injection site erythema, injection site swelling, injection site pruritus, on unspecified date, after the dose of Jynneos vaccine for unknown indication. Pyrexia, rash, headache, myalgia, fatigue, injection site reaction, injection site pain, injection site erythema, injection site swelling, injection site pruritus are listed and expected per CCDS v7 and Product Monograph of [withheld] and [withheld], whilst pain, lip swelling, swollen tongue are unlisted and unexpected. Arthralgia is listed and expected per CCDS v7 and Product Monograph of [withheld], whilst unexpected per [withheld]. Intradermal injection and off label use are considered as listed as per company convention. The patient's relevant medical history was not provided, and concomitant medication details includes paracetamol and ibuprofen. The outcome was not recovered. 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 33-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 serious (medically significant) event of anaphylaxis and non-serious events of pain, lip swelling, swollen tongue, arthralgia, pyrexia, rash, headache, myalgia, fatigue, injection site reaction, injection site pain, injection site erythema, injection site swelling, injection site pruritus, on unspecified date, after the dose of Jynneos vaccine for unknown indication. Pyrexia, rash, headache, myalgia, fatigue, injection site reaction, injection site pain, injection site erythema, injection site swelling, injection site pruritus are listed and expected per CCDS v7 and Product Monograph of [withheld] and [withheld], whilst pain, lip swelling, swollen tongue are unlisted and unexpected. Arthralgia is listed and expected per CCDS v7 and Product Monograph of [withheld], whilst unexpected per [withheld]. Intradermal injection and off label use are considered as listed as per company convention. The patient's relevant medical history was not provided, and concomitant medication details includes paracetamol and ibuprofen. The outcome was not recovered. 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.
Medical History/Concurrent Conditions: Fever; Pain
PARACETAMOL; IBUPROFEN