Age: 59.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chills, Fatigue, Incorrect route of product administration, Injection site pain, Pyrexia
Clinical narrative: Jynneos was administered intradermally; I do have a little rash in the last couple of days on my buttocks area; I may have had some fatigue; The injection site is a little tender and it lasted for a little bit; I had the fever and chills on Sunday night; I had the fever and chills on Sunday night; Case reference number US-BN-2022-002192 is a spontaneous case report initially received from a consumer via Communication (reference number: USBAV22-1226) on 30-Aug-2022 and concerns a 59-year-old male patient.  The patient's medical history was not provided.  The patient's concomitant vaccines included shingles vaccine (as reported, brand name unknown).  The patient's concomitant medication details were not provided.   On 27-Aug-2022, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number not provided) administered in the forearm at an unknown dose for unknown indication (explicitly coded as Incorrect route of product administration').  On 28-Aug-2022, one day after the vaccination with Jynneos, the patient developed fever and chills.   On an unspecified date, the patient recovered from the events of 'pyrexia' and 'chills'.  On an unspecified date, unknown amount of time after the vaccination with Jynneos, the patient developed a little rash on buttocks area, had some fatigue and tender injection site that lasted for a little bit.  At the time of this report the outcome of the events 'rash' and 'fatigue' was unknown, and the patient recovered from the event 'injection site pain'.  The reporter assessed all events as non-serious and possibly related to Rabipur.   Additional information received from Bavarian Nordic on 31-Aug-2022 included local BN case ID.; Reporter's Comments: A 59-year-old male patient developed fever and chills, one day after he was vaccinated with Jynneos, administered in the forearm at an unknown dose for unknown indication which is considered as incorrect route of product administration. Unknown time after the vaccination with Jynneos, the patient developed a little rash on buttocks area, fatigue and tender injection site. Rash is listed however unexpected while pyrexia, chills, fatigue and injection site pain are all listed and expected according to RA v1 and RA. Incorrect route of product administration is considered listed per company convention. The outcome for pyrexia, chills and injection site pain was resolved while the outcome for rash and fatigue was unknown. The patient's medical history and concomitant medication were not provided while concomitant vaccines included shingles vaccine. Causality for rash, pyrexia, chills, fatigue and injection site pain is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 59-year-old male patient developed fever and chills, one day after he was vaccinated with Jynneos, administered in the forearm at an unknown dose for unknown indication which is considered as incorrect route of product administration. Unknown time after the vaccination with Jynneos, the patient developed a little rash on buttocks area, fatigue and tender injection site. Rash is listed however unexpected while pyrexia, chills, fatigue and injection site pain are all listed and expected according to RA v1 and RA. Incorrect route of product administration is considered listed per company convention. The outcome for pyrexia, chills and injection site pain was resolved while the outcome for rash and fatigue was unknown. The patient's medical history and concomitant medication were not provided while concomitant vaccines included shingles vaccine. Causality for rash, pyrexia, chills, fatigue and injection site pain is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.