Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | IM |
The patient developed induration at the injection site pretty big and 3-4 cm; The patient received Jynneos intramuscularly; Case reference number US-BN-2025-001182 is a spontaneous case report initially received from a physician via Communication (reference number: USBAV25-1684) on 10-Jul-2025 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not reported. On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose intramuscularly at unknow site of administration for unknown indication (explicitly coded as 'inappropriate route of vaccination') On an unspecified date, unknown amount of time after vaccination, the patient developed an induration at the injection site that was pretty big three to four centimeter. At the time of initial report, the patient was not recovered from the event of 'injection site induration'. The reporter assessed the event of 'injection site induration' as non-serious, and causality as possibly related to Jynneos. No further information provided.; Reporter's Comments: This case concerns a male patient of unknown age, who had received the first dose of Jynneos vaccine, intramuscularly for an unknown indication, which is considered as 'inappropriate route of vaccination. Patient has experienced a non-serious event of injection site induration on unspecified date, after the dose of Jynneos vaccine for unknown indication. Injection site induration is listed and expected per CCDS v7 and USPI. Inappropriate route of vaccination is considered as listed as per company convention. The patient's past medical history and concomitant medication details were not provided. Outcome is not recovered. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported event have been considered as related to Jynneos. Inappropriate route of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a male patient of unknown age, who had received the first dose of Jynneos vaccine, intramuscularly for an unknown indication, which is considered as 'inappropriate route of vaccination. Patient has experienced a non-serious event of injection site induration on unspecified date, after the dose of Jynneos vaccine for unknown indication. Injection site induration is listed and expected per CCDS v7 and USPI. Inappropriate route of vaccination is considered as listed as per company convention. The patient's past medical history and concomitant medication details were not provided. Outcome is not recovered. However, considering plausible temporal relationship and plausible biological mechanism the contributory role of the suspect vaccine cannot be excluded, and the reported event have been considered as related to Jynneos. Inappropriate route of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.