Sex: M
Vaccine: SMALLMNK
Symptoms: Dizziness, Electrocardiogram normal, Headache, Nausea
Clinical narrative: Headache; Nausea; Dizziness and lightheadedness; Case reference number US-BN-2022-001740 is a spontaneous case report initially received on 02-Aug-2022 from a consumer via Communications (reference number: USABAV22-0774) and concerns a 57-year-old male patient.  The patient's relevant medical history and concomitant medications were not reported.  On 23-Jul-2022, the patient was vaccinated with Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00004), at an unknown dose or route of administration, for unknown indication.  As reported, the first two days after the vaccine, the patient felt great. The reporter stated that the patient tolerated all vaccines well, even the Covid ones.  On an unspecified date, reported also as Monday after the vaccine, an unknown amount of time after the vaccination, the patient experienced a headache, nausea, and dizziness. The patient took Tylenol for treatment and the headache and nausea went away, but the dizziness and lightheadedness stayed.  On 28-Jul-2022, five days after the vaccination, the patient went to the doctor. The patient's vitals were measured and an electrocardiogram was performed. All results were good.  On 31-Jul-2022, eight days after the vaccine, the patient felt better.  The reporter did not provide seriousness assessment. The reporter stated that these reactions were thought they were coincidental with the vaccine, however, the patient's doctor said that this was happening due to the vaccine.  Additional information received on 03-Aug-2022 included the local case ID.; Reporter's Comments: A 57-year-old male patient experienced a headache, nausea, and dizziness, unknown time after he was vaccinated with Jynneos vaccine, at an unknown dose or route of administration, for unknown indication. Headache and nausea were resolved after corrective treatment but the dizziness and lightheadedness stayed. Headache and nausea are both listed and expected according to guidelines for Jynneos while dizziness is listed per guidelines however unexpected per other guidelines. Reportedly, eight days after the vaccine, the patient felt better. The patient's relevant medical history and concomitant medications were not reported. Considering compatible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded, all reported events are assessed as related. The case is considered as non-serious.; Sender's Comments: A 57-year-old male patient experienced a headache, nausea, and dizziness, unknown time after he was vaccinated with Jynneos vaccine, at an unknown dose or route of administration, for unknown indication. Headache and nausea were resolved after corrective treatment but the dizziness and lightheadedness stayed. Headache and nausea are both listed and expected according to guidelines for Jynneos while dizziness is listed per guidelines however unexpected per other guidelines. Reportedly, eight days after the vaccine, the patient felt better. The patient's relevant medical history and concomitant medications were not reported. Considering compatible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded, all reported events are assessed as related. The case is considered as non-serious.