Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Fever; Sweating; Nausea; Chills with very bad shivering; Occasional headaches; Case reference number US-BN-2022-002320 is a spontaneous case report initially received on 07-Sep-2022 from a consumer (reference number: USBAV22-1319), 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 patients received the first dose of the Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: unknown) at an unknown dose, route, or site of administration for the monkeypox (as reported).  As reported, the patient didn't have any symptoms after the first received dose.  On an unspecified date, an unknown amount of time after the first dose, the patients received the second dose of the Jynneos vaccine (batch number: unknown) at an unknown dose, route, or site of administration.  On an unspecified date, reported as two days after the second dose, the patient developed a fever, sweating, nausea, chills with very bad shivering, and occasional headaches that he never had (as reported). The patient was taking Tylenol and ibuprofen as a treatment every six hours and did not know for how long he will continue the treatment.  At the time of this report, the outcome of the reported events was not resolved/ongoing.  The reporter assessed the events as non-serious and possibly related to Jynneos.  The reporter also stated that the patient was trevaeling seven days prior, where he was food to mosquitos (as reported), and was wondering if maybe events were due to some potential diseases.  Additional information received from Bavarian Nordic on 09-Sep-2022 included confirmation of country of occurrence and the local case ID.  Non-significant case correction performed for information received on 14-Sep-2022 to include an additional reference number and to update the reporter's state and city.; Reporter's Comments: A male patient of unknown age developed a fever, sweating, nausea, chills with very bad shivering, and occasional headaches, two days after the second dose (which was administered unknown time after the first dose) of the Jynneos vaccine, at an unknown dose, route, or site of administration. Hyperhidrosis is listed however unexpected while pyrexia, nausea, chills and headache are all listed and expected according to insert. The outcome of all reported events was not resolved and reportedly the patient was taking Tylenol and ibuprofen as a treatment. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related for all reported events due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A male patient of unknown age developed a fever, sweating, nausea, chills with very bad shivering, and occasional headaches, two days after the second dose (which was administered unknown time after the first dose) of the Jynneos vaccine, at an unknown dose, route, or site of administration. Hyperhidrosis is listed however unexpected while pyrexia, nausea, chills and headache are all listed and expected according to insert. The outcome of all reported events was not resolved and reportedly the patient was taking Tylenol and ibuprofen as a treatment. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related for all reported events due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. The case is non-serious.