Sex: F
Vaccine: SMALLMNK
Symptoms: Injection, Product administered at inappropriate site, Swelling
Clinical narrative: Minor localized swelling; Jynneos administered at right forearm.; Jynneos vaccine was administered intradermally instead of subcutaneously; Case reference number US-BN-2022-004689 is a spontaneous case received from other health professional on 15-Nov-2022 via Communication (reference number: USBAV22-1954) and concerns a *32-years-old* female patient.  The patient's medical history and concomitant medication details were not provided.  On 12-Nov-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, *batch number: FDP00003*) at dose of 0.5 ml, administered intradermally (explicitly coded as 'intradermal injection') at *right forearm (explicitly coded as 'product administered at inappropriate site')* and for monkeypox prophylaxis.  *On unspecified date, the patient experienced minor localized swelling.*  The case is linked to US-BN-2022-004690 (same reporter).  Additional information received on 15-Sep-2022 from Bavarian Nordic included local BN case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from other health care professional on 02-Dec-2022 included patient initials and age, vaccine details: batch number, expiration date, anatomical site location and dosage for first dose of Jynneos vaccine. New non-event 'product administered at inappropriate site' and new event 'swelling' were added.; Reporter's Comments: A 32-year-old female patient of unknown age received 0.5 mL of Jynneos, applied intradermally at right forearm (considered as product administered at inappropriate site) for monkeypox prophylaxis (which is considered intradermal injection). Unknown time after vaccination, the patient experienced minor localized swelling. Swelling is considered unlisted and unexpected according to RA v1 and RA for Jynneos while intradermal injection and product administered at inappropriate site are both considered listed per company conventions. The outcome was unknown. The patient's medical history and concomitant medications were not reported. Swelling is conservatively assessed as related since contributory role of the suspect product cannot be fully excluded at this point. Intradermal injection and product administered at inappropriate site are both considered as not related to Jynneos, but to the human factor. The case is non-serious.; Sender's Comments: A 32-year-old female patient of unknown age received 0.5 mL of Jynneos, applied intradermally at right forearm (considered as product administered at inappropriate site) for monkeypox prophylaxis (which is considered intradermal injection). Unknown time after vaccination, the patient experienced minor localized swelling. Swelling is considered unlisted and unexpected according to RA v1 and RA for Jynneos while intradermal injection and product administered at inappropriate site are both considered listed per company conventions. The outcome was unknown. The patient's medical history and concomitant medications were not reported. Swelling is conservatively assessed as related since contributory role of the suspect product cannot be fully excluded at this point. Intradermal injection and product administered at inappropriate site are both considered as not related to Jynneos, but to the human factor. The case is non-serious.