Sex: F
Vaccine: SMALLMNK
Symptoms: Erythema, Incorrect route of product administration, Peripheral swelling, Pustule, Skin lesion
Clinical narrative: Forearm, where the patient had vaccine, got swollen and red; Forearm, where the patient had Jynneos vaccine, got swollen and red; Jynneos vaccine was administered to the patient intradermally; The patient had pustule lesions behind her ear lobe that were umbilicated and resembled a dot on the top of the lesion; The patient had pustule lesions behind her ear lobe that were umbilicated and resembled a dot on the top of the lesion; Case reference number US-BN-2022-002357 is a spontaneous case report initially received on 12-Sep-2022 from a physician via agency (reference number: USBAV22-1356) and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not reported.  On 30-Aug-2022, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at an unknown dose, the forearm, intradermally for monkeypox prophylaxis (explicitly coded as 'Inappropriate route of vaccination').  On an unspecified date, an unknown amount of time after the vaccination, the patient's forearm got red and swollen.  On 01-Sep-2022, two days after the vaccination, the patient had pustule lesions behind the earlobe. The pustules were umbilicated and resembled a dot on the top of the lesion.   The patient had no treatment given due to adverse events.  On 06-Sep-2022, also reported as six days after, the patient's five-year-old child had the same lesion on the hands, arms, and legs, and no did not have a fever.   On 12-Sep-2022, also reported as six days after, the patient two-year-old child started with the same lesion on the hands, arms, and legs, and did not have a fever.  These looked like a pimple that developed into a pustule, and as the reporter stated they looked exactly the same as that reporter saw in the older people with monkeypox.   The patient had a PCR test for monkeypox, with no results at the time of this report, and the reporter was not sure if the patient should be tested for vaccinia.   At the time of this report, the outcome of all reported events was unknown.  The reporter assessed the events of red and swollen forearm and pustule lesions as non-serious and related to the Jynneos.  Additional information received on 13-Sep-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of Jynneos, at an unknown dose, the forearm, intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination. Reportedly, on an unspecified date, an unknown amount of time after the vaccination, the patient experienced non-serious events of peripheral swelling and erythema. On the day 2 after the vaccination, the patient experienced non-serious events of pustule and skin lesion. The event of peripheral swelling is listed for Jynneos according to the agency1 v1 and unlisted per agency2, whilst the events of erythema, pustule and skin lesion are unlisted per agency1 v1 and agency2. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. The outcome of all reported events was unknown, as reported. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of peripheral swelling, erythema, pustule, and skin lesion have been considered as related to Jynneos. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of Jynneos, at an unknown dose, the forearm, intradermally for monkeypox prophylaxis, which is considered as inappropriate route of vaccination. Reportedly, on an unspecified date, an unknown amount of time after the vaccination, the patient experienced non-serious events of peripheral swelling and erythema. On the day 2 after the vaccination, the patient experienced non-serious events of pustule and skin lesion. The event of peripheral swelling is listed for Jynneos according to the agency 1 v1 and unlisted per agency 2, whilst the events of erythema, pustule and skin lesion are unlisted per agency 1 v1 and agency 2. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not reported. The outcome of all reported events was unknown, as reported. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of peripheral swelling, erythema, pustule, and skin lesion have been considered as related to Jynneos. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.