Sex: M
Vaccine: SMALLMNK
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Jynneos vaccine was administered intradermally; Fever 102 degrees Fahrenheit; Terrible chills; Body aches; Felt like was "hit by a train", like had a virus, like the flu; Felt like was "hit by a train", "felt like had a virus, like the flu; Injection site reaction; red and sore; Injection site reaction; red and sore; Case reference number US-BN-2022-002027 is a spontaneous case report initially received on 23-Aug-2022 from a consumer via Communications (reference number: USBAV22-1142) and concerns a 50-year-old male patient.  The patient's medical history included covid-19, which the patient experienced twice.  The patient's concomitant medication details were not provided.  On 18-Aug-2022, the patient was vaccinated with Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number: FDP00018), at an unknown dose, administered intradermally, for monkeypox prophylaxis (explicitly coded as 'inappropriate route of vaccination'). On the same day, the patient's injection site was red and sore.  On 21-Aug-2022, three days after the vaccination, the patient experienced fever (102 degrees Fahrenheit), terrible chills and body aches, the patient felt like "hit by a train", felt like had a virus, and like the flu. The patient felt the same as when with covid-19.  On 22-Aug-2022, the patient felt much better, but the symptoms were not all resolved.  The reporter assessed these events as non-serious and possibly related to the product.  Additional information received from Bavarian Nordic on 24-Aug-2022 included the local BN case ID.; Reporter's Comments: A 50-year-old male patient experienced the non-serious events of injection site was red and sore on day 0, following vaccination with 1st dose of Jynneos, administered at an unknown dose for monkeypox prophylaxis, intradermally (which is considered inappropriate route of vaccination). On day 3, the patient experienced the non-serious events of pyrexia, terrible chills, body aches, flu-like symptoms and malaise. On day 4, the patient was feeling much better, although the events had not resolved entirely. The events of general body pain, malaise and flu-like symptoms are unlisted per RA but listed per RA V1.0. The events of injection site erythema, injection site pain, pyrexia and chills are listed per RA and RA V1.0. Inappropriate route of vaccination is considered listed per company conventions. The patient's relevant medical history included two previous COVID-19 infections. No concomitant medications information was present. Considering the short event latency, the known product safety profile, as well as that the symptoms started resolving on day 4, the events are considered related to Jynneos. Inappropriate route of vaccination is considered not related but related to human factor.; Sender's Comments: A 50-year-old male patient experienced the non-serious events of injection site was red and sore on day 0, following vaccination with 1st dose of Jynneos, administered at an unknown dose for monkeypox prophylaxis, intradermally (which is considered inappropriate route of vaccination). On day 3, the patient experienced the non-serious events of pyrexia, terrible chills, body aches, flu-like symptoms and malaise. On day 4, the patient was feeling much better, although the events had not resolved entirely. The events of general body pain, malaise and flu-like symptoms are unlisted per RA but listed per RA V1.0. The events of injection site erythema, injection site pain, pyrexia and chills are listed per RA and RA V1.0. Inappropriate route of vaccination is considered listed per company conventions. The patient's relevant medical history included two previous COVID-19 infections. No concomitant medications information was present. Considering the short event latency, the known product safety profile, as well as that the symptoms started resolving on day 4, the events are considered related to Jynneos. Inappropriate route of vaccination is considered not related but related to human factor.