Sex: M
Vaccine: SMALLMNK
Symptoms: Insomnia, Pain, Swelling, Underdose, Urticaria
Clinical narrative: Jynneos vaccine administered intradermally; Jynneos vaccine administered at dose 0.1 ml; The patient hasn't slept for 2 days; The swelling is huge the size of a golf ball and it is 'travelling up veins and veins are turning black around the site'; The pain is unbearable, it hurts when the patient lifts something or extends arm; It started as a welt; The swelling is huge the size of a golf ball and it is 'travelling up veins and veins are turning black around the site'; Case reference number US-BN-2022-002158 is a spontaneous case report initially received on 29-Aug-2022 from consumer via Communications (reference number: USBAV22-1208) and concerns a 61-year-old male patient.  The patient's medical history was not provided.  The patient's past vaccinations included Smallpox vaccine in 1961.  On 27-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number unknown), at dose reported as 0.1 ml, administered intradermally in right forearm next to elbow as monkeypox prophylaxis (explicitly coded as 'incorrect route of product administration' and 'underdose').  On the same day, the patient developed a welt that went down.  On 28-Aug-2022, one day after the first vaccine, the welt started to get bigger. The swelling was huge the size of a golf ball and it was traveling up patient's veins that were turning black around the site. It looked horrible and the pain was unbearable. The patient hadn't slept for two days. It hurt when the patient was lifting something or extending his arm.  At the time of this report, the outcome of the events 'injection site bruising', 'insomnia', 'injection site swelling' and 'injection site pain' was not resolved/ongoing.  The reporter assessed all reported events as non serious and related to Jynneos vaccine.  Additional information received on 29-Aug-2022 included local BN case ID.; Reporter's Comments: A 61-year-old make patient developed a welt that went down, on the same day when he was vaccinated with the first dose of Jynneos vaccine, at dose reported as 0.1 ml, administered intradermally in right forearm next to elbow as monkeypox prophylaxis which is considered as incorrect route of product administration and underdose. One day after the first vaccine, the welt started to get bigger and the swelling was huge (size of a golf ball) and it was traveling up patient's veins that were turning black around the site (which looked horrible) and the pain was unbearable. The patient hadn't slept for two days and it hurt when the patient was lifting something or extending his arm. Insomnia is unlisted and unexpected, injection site bruising is listed however unexpected while injection site pain and injection site swelling are listed and expected according to RA v1 and RA for Jynneos. Incorrect route of product administration and underdose are both considered listed per company conventions. The outcome of injection site bruising, insomnia, injection site swelling and injection site pain was not resolved. The patient's medical history and concomitant medications were not provided while past vaccinations included Smallpox vaccine in 1961. Considering plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded, injection site pain, injection site swelling and injection site bruising are all assessed as related to suspect product. Insomnia is assessed as related due to plausible temporal relationship and since contributory role of the suspect product cannot be fully excluded. Incorrect route of product administration and underdose are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 61-year-old make patient developed a welt that went down, on the same day when he was vaccinated with the first dose of Jynneos vaccine, at dose reported as 0.1 ml, administered intradermally in right forearm next to elbow as monkeypox prophylaxis which is considered as incorrect route of product administration and underdose. One day after the first vaccine, the welt started to get bigger and the swelling was huge (size of a golf ball) and it was traveling up patient's veins that were turning black around the site (which looked horrible) and the pain was unbearable. The patient hadn't slept for two days and it hurt when the patient was lifting something or extending his arm. Insomnia is unlisted and unexpected, injection site bruising is listed however unexpected while injection site pain and injection site swelling are listed and expected according to RA v1 and RA for Jynneos. Incorrect route of product administration and underdose are both considered listed per company conventions. The outcome of injection site bruising, insomnia, injection site swelling and injection site pain was not resolved. The patient's medical history and concomitant medications were not provided while past vaccinations included Smallpox vaccine in 1961. Considering plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded, injection site pain, injection site swelling and injection site bruising are all assessed as related to suspect product. Insomnia is assessed as related due to plausible temporal relationship and since contributory role of the suspect product cannot be fully excluded. Incorrect route of product administration and underdose are both assessed as not related to suspect product but to human factor. The case is non-serious.