Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Erythema, Incorrect route of product administration, Injection site pruritus, Rash macular
Clinical narrative: Red patches around body, they looked like hives, but no irruption, they were just red spots; fever; Jynneos was administered intradermal; The patient received the Jynneos vaccine and it itched really bad; Chills; Case reference number US-BN-2022-002652 is a spontaneous case report initially received on 21-Sep-2022 from other health professional via Agency (reference number: USBAV22-1479) and concerns 51-year-old male patient.  The patient's medical history included a reaction to a COVID-19 vaccine (further described as 'got really sick').  The patient's concomitant medication details were not provided. Previous vaccines included COVID-19 vaccine (brand name unknown), at an unknown dose, site or route of administration, for unknown indication.  On 07-Sep-2022, the patient was vaccinated with the first dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00019) at an unknown dose, administered intradermal at an unknown site of administration for monkeypox prophylaxis (explicitly coded as 'intradermal injection'). On the same day, the patient's injection site itched really bad.  On an unspecified date, reported as 'three to four days later', the patient developed some red patches around body, which looked like hives, but no irruption, they were just red spots on patient's trunk that spread to arms and legs and were then on face (looked like had acne). They did not itch.  On an unspecified date, the patient took Benadryl, had fever of 98.9 degrees Fahrenheit and chills for two days.  On an unspecified date, the events of 'fever' and 'chills' were resolved. The patient stated that his trunk doesn't look bad as it was.  At the time of this report, the outcome for the event of 'injection site itching' was unknown and for the event of 'redness' and 'hives' was recovering/resolving.  The reporter assessed these events as non-serious and possibly related to the Jynneos..  Additional information received on 21-Sep-2022 included local BN case ID.; Reporter's Comments: A 51-year-old male patient experienced the non-serious event of injection site pruritus, on the same day following vaccination with first dose of Jynneos, applied intradermally for monkeypox prophylaxis (explicitly coded as intradermal injection). Three or four days following the dose administration, the patient experienced the non-serious event of urticaria-like rash. The patient also experienced the non-serious events of chills and fever. The patient took Benadryl. Fever and chills had resolved, the urticaria-like rash had improved. Outcome for injection site pruritus was unknown. Urticaria is listed per CCDS V1.0 but unlisted per the PI for Jynneos. Injection site pruritus, chills and fever are listed per PI and CCDS. Intradermal injection is considered listed per company convention. The patient's medical history included a past reaction to a COVID-19 vaccine. Concomitant medications were unknown, but past vaccines included COVID-19 vaccine. Considering the known safety profile of Jynneos, the events are assessed as related to the suspect vaccine. Intradermal injection is not related to Jynneos, but to the human factor.; Sender's Comments: A 51-year-old male patient experienced the non-serious event of injection site pruritus, on the same day following vaccination with first dose of Jynneos, applied intradermally for monkeypox prophylaxis (explicitly coded as intradermal injection). Three or four days following the dose administration, the patient experienced the non-serious event of urticaria-like rash. The patient also experienced the non-serious events of chills and fever. The patient took Benadryl. Fever and chills had resolved, the urticaria-like rash had improved. Outcome for injection site pruritus was unknown. Urticaria is listed per CCDS V1.0 but unlisted per the PI for Jynneos. Injection site pruritus, chills and fever are listed per PI and CCDS. Intradermal injection is considered listed per company convention. The patient's medical history included a past reaction to a COVID-19 vaccine. Concomitant medications were unknown, but past vaccines included COVID-19 vaccine. Considering the known safety profile of Jynneos, the events are assessed as related to the suspect vaccine. Intradermal injection is not related to Jynneos, but to the human factor.