Sex: M
Vaccine: SMALLMNK
Symptoms: COVID-19, Dizziness, Feeling hot, Headache, Injection site pain
Clinical narrative: Couldn't focus on anything with vision; Patient's vision was blurry; COVID; Headache; The arm where the patient was injected was painful at the injection site and the site was swollen; The arm where the patient was injected was painful at the injection site and the site was swollen; The patient was feeling hot; Two bumps on leg, kind of hurt; Dizziness; Case reference number US-BN-2022-001907 is a spontaneous case report initially received on 16-Aug-2022 from a consumer via agency (reference number: USBAV22-1019) and concerns a 30-year-old male patient.  The patient's current medical condition included fatigue.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient received co-suspect Lasix (furosemide), at an unknown dose or route of administration, for unknown indication.  On 11-Aug-2022, the patient was vaccinated with Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at an unknown dose, route or site of administration, for unknown indication. On the same date, the patient experienced headache, pain and swelling at the injection site, dizziness, developed two bumps on the leg, which were next to each other and hurt, was feeling hot - but did not check the temperature because it came again and again. It was also reported that the headache was the most prominent thing and was kind of annoying.  On an unspecified date, reported also as two days after Lasix, an unknown amount of time after the vaccination with Jynneos, the patient couldn't focus on anything with vision.  On an unspecified date, reported also as yesterday, the patient experienced dizziness once.  On an unspecified date, reported also as today, the patient's vision was blurry.   On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient experienced COVID. It was also reported that the patient thought it was the long COVID.  At the time of this report, the outcome of all events was unknown.  The reporter did not provide seriousness assessment for the events. It was reported that fatigue and COVID were not related to Jynneos, and the rest of the events were assessed as related to Jynneos.  Additional information received from Bavarian Nordic on 16-Aug-2022 included the local BN case ID.; Reporter's Comments: A 30-year-old male patient experienced headache, pain and swelling at the injection site, dizziness, developed two bumps on the leg and was feeling hot on the day 0 after the vaccination with Jynneos vaccine at an unknown dose, route or site of administration, for unknown indication. Reportedly, on an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient couldn't focus on anything with vision, experienced dizziness once and his vision was blurry. On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient experienced COVID. Injection site pain, injection site swelling, and headache are listed for Jynneos and dizziness is listed and unlisted per agency. Visual impairment, vision blurred, feeling hot, nodule and COVID-19 are unlisted for Jynneos per the both agency. The patient's current medical condition included fatigue and medical history and concomitant medication details were not provided. The outcome of all events was unknown, as reported. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the events, injection site pain, injection site swelling, headache, dizziness, visual impairment, vision blurred, feeling hot and nodule have been considered as related to Jynneos. COVID-19 has been considered as not related to the suspect vaccine, but to a widespread viral infection. This case is considered as non-serious.; Sender's Comments: A 30-year-old male patient experienced headache, pain and swelling at the injection site, dizziness, developed two bumps on the leg and was feeling hot on the day 0 after the vaccination with Jynneos vaccine at an unknown dose, route or site of administration, for unknown indication. Reportedly, on an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient couldn't focus on anything with vision, experienced dizziness once and his vision was blurry. On an unspecified date, an unknown amount of time after the vaccination with Jynneos, the patient experienced COVID. Injection site pain, injection site swelling, and headache are listed for Jynneos according to the agency and dizziness is listed per agency and unlisted per another agency. Visual impairment, vision blurred, feeling hot, nodule and COVID-19 are unlisted for Jynneos per the agency and other agency. The patient's current medical condition included fatigue and medical history and concomitant medication details were not provided. The outcome of all events was unknown, as reported. Since the evaluation did not find enough evidence to completely exclude a contributory role of the suspect vaccine to the development of the events, injection site pain, injection site swelling, headache, dizziness, visual impairment, vision blurred, feeling hot and nodule have been considered as related to Jynneos. COVID-19 has been considered as not related to the suspect vaccine, but to a widespread viral infection. This case is considered as non-serious.