Sex: F
Vaccine: SMALLMNK
Symptoms: Abdominal discomfort, Abdominal pain, Burning sensation, Chills, Exposure to communicable disease
Clinical narrative: Solid pustule on abdomen; itching on shoulder; more like a papule; Feeling of burning, itching; Feeling of burning, itching; The night after vaccine the patient experienced chills and body aches/ slightly painful; The night after vaccine the patient experienced chills and body aches; Intradermal injection; First Jynneos administration was too deep so had to be repeated; First Jynneos administration was too deep so vaccination was repeated; Case reference number US-BN-2022-003548 is a spontaneous case initially received on 26-Sep-2022 from health care professional via Company (reference number: USBAV22-1531) and concerns a 42-year-old female patient.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date, the patient was in a contact with monkeypox positive patient.  On 21-Sep-2022, the patient was vaccinated with a dose of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating; batch number unknown), at a dose of 0.1 mL, intradermally (explicitly coded as 'Intradermal injection'), in left forearm, for post exposure prophylaxis. The vaccine was administered after the second attempt, as in the first attempt the vaccine went to deep (explicitly coded as 'Wrong technique in product usage process' and 'Inappropriate schedule of vaccine administered').  On an unspecified date, reported as the night after the vaccine, the patient experienced chills and body aches.  On an unspecified date, reported as Friday evening, the patient experienced burning, itching, slightly painful spot on her abdomen and did not look.  On an unspecified date, reported as Saturday morning, the patient looked and saw two extra dermal lesions. One of them located on her abdomen and the second one located on her shoulder, the same arm where the vaccine was administered. The patient, who is a physician at the same time, described her pustules the same size with following characteristics: solitary, raised, firm and continues to be itchy, burning and little painful and not spreading, and more like a papule. No surrounding redness or streaking. Lesions popped up but did not progress.  On an unspecified date, reported as at night or in the morning, the patient took an ibuprofen (brand name unknown, dose not provided), in order to relief symptoms.   At the time of this report, the outcome for the events of 'Pustule', 'Burning sensation', 'Itching papule', 'Pruritus', 'Pain' and 'Chills' was provided as 'not resolved/ongoing'.  The reporter did not provide seriousness assessment of the events. The reporter assessed all the events as possibly related to Jynneos.   Additional information received from Bavarian Nordic on 27-Sep-2022 included local BN case ID.  Additional information received from Bavarian Nordic on 03-Oct-2022 stated the case was deemed not to be a PQC since there was no product quality defect and the case was a medical information inquiry.  This case is linked with US-BN-2022-003549 due to the same reporter.; Reporter's Comments: A 42-year-old female patient developed non-serious events chills and body aches on the night after two doses of Jynneos were administered, which is considered inappropriate schedule of vaccine administered. It was reported that in the first attempt the vaccine went to deep (wrong technique in product usage process), and the vaccine was administered intradermally after the second attempt. Unspecified amount of time after the vaccination the patient developed non-serious events pustule on abdomen, papule on the shoulder, burning and itching. Papule, pustule and burning sensation are unlisted, body aches and chills are listed per CCDS v1 and the Agency, and pruritus is listed per CCDS and unlisted per the Agency. Inappropriate schedule of vaccine administered, wrong technique in product usage process and intradermal injection are listed by convention. The patient's medical history and concomitant medication were not provided. Considering plausible temporal relationship, all events have been considered as related to Jynneos. Inappropriate schedule of vaccine administration, wrong technique in product usage process and intradermal injection are not related to Jynneos, but to a human factor.; Sender's Comments: A 42-year-old female patient developed non-serious events chills and body aches on the night after two doses of Jynneos were administered, which is considered inappropriate schedule of vaccine administered. It was reported that in the first attempt the vaccine went to deep (wrong technique in product usage process), and the vaccine was administered intradermally after the second attempt. Unspecified amount of time after the vaccination the patient developed non-serious events pustule on abdomen, papule on the shoulder, burning and itching. Papule, pustule and burning sensation are unlisted, body aches and chills are listed per CCDS v1 and the Agency, and pruritus is listed per CCDS and unlisted per the Agency. Inappropriate schedule of vaccine administered, wrong technique in product usage process and intradermal injection are listed by convention. The patient's medical history and concomitant medication were not provided. Considering plausible temporal relationship, all events have been considered as related to Jynneos. Inappropriate schedule of vaccine administration, wrong technique in product usage process and intradermal injection are not related to Jynneos, but to a human factor.