Sex: M
Vaccine: SMALLMNK
Symptoms: Product administered at inappropriate site
Clinical narrative: Concerned; Deltoid was slightly sore; hurt when lifting up the arm; Jynneos vaccine injected intramuscularly; second dose of Jynneos administered 25 days after the first dose; second dose of Jynneos administered in the tricep; Case reference number US-BN-2022-001821 is a spontaneous case report initially received on 09-Aug-2022 from a health care professional via Bavarian Nordic and concerns a 39-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 22-Jul-2022, the patient was vaccinated with the first dose of Jynneos vaccine (smallpox and monkeypox vaccine, live, nonreplicating; batch number: unknown) at a dose of 0.5 milliliters, administered intramuscularly in an unspecified deltoid region, for monkeypox prophylaxis (explicitly coded as 'inappropriate route of vaccination').  On an unspecified date, reported also as one or two days after the vaccination, the patient's deltoid was slightly sore and hurt when lifting the arm up and when raised the elbow up and outward.  On an unspecified date, reported also as *after maybe three days*, the patient recovered from 'injection site muscle pain'.  On 05-Aug-2022, as reported, the patient realized that the location was possible incorrect, and the patient was 99.9 percent sure that the vaccination was administered intramuscularly in the deltoid, reported also remembering that the band aid went there; had no bump at all in the skin; felt the needle go deep, and was very concerned over the effectiveness of the vaccine.  *On 16-Aug-2022, 25 days after the first dose (explicitly coded as 'Inappropriate schedule of vaccine administration'), the patient was vaccinated with second dose of Jynneos (batch number: unknown), administered subcutaneously in triceps (explicitly coded as 'Vaccine administered at inappropriate site'), at an unknown dose.*  *It was confirmed that the patient did not experience any adverse events after the second dose.*  At the time of this report, it was unknown whether the patient recovered from the event of worry.  The events 'injection site muscle pain' and 'worry' were assessed as non-serious and related to Jynneos.   Additional information received on 09-Aug-2022 from Bavarian Nordic included additional events, patient and vaccination information, and Agency reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up received from a healthcare professional on 31-Aug-2022 included information that the patient was not at all nauseous after the shot and had not vomited, which caused these two events to be deleted. It was also stated that the patient had no other adverse events due to Jynneos.  Follow-up received from a healthcare professional on 14-Sep-2022 included additional vaccination doses for the first and second doses of Jynneos, event details and confirmation that the patient had no adverse reactions after the second dose.; Reporter's Comments: A 39-year-old male patient experienced slightly sore deltoid which hurts when lifting the arm up, one or two days after he was vaccinated with the first dose of Jynneos vaccine, at dose of 0.5mL, administered intramuscularly in unspecified deltoid region, for monkeypox prophylaxis which is considered as inappropriate route of vaccination. About three days later, the patient recovered from injection site muscle pain. Reportedly, the patient was very concerned over the effectiveness of the vaccine. 25 days following the first dose, the second dose of Jynneos was administered subcutaneously in the triceps (which is considered inappropriate schedule of vaccine administered and vaccine administered at an inappropriate site). The patient experienced no adverse events following the second dose. Anxiety is unlisted and unexpected according to CCDS v1 and PI. Injection site pain is listed and expected. Incorrect route of product administration, inappropriate schedule of vaccine administered and vaccine administered at an inappropriate site are considered listed per company convention. The outcome of the event of anxiety was unknown. The patient's medical history and concomitant medication details were not provided. Causality assessment is related for injection site pain due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Anxiety is also assessed as related as contributory role of the suspect product cannot be fully excluded. Incorrect route of product administration, inappropriate schedule of vaccine administered and vaccine administered at an inappropriate site are considered not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 39-year-old male patient experienced slightly sore deltoid which hurts when lifting the arm up, one or two days after he was vaccinated with the first dose of Jynneos vaccine, at dose of 0.5mL, administered intramuscularly in unspecified deltoid region, for monkeypox prophylaxis which is considered as inappropriate route of vaccination. About three days later, the patient recovered from injection site muscle pain. Reportedly, the patient was very concerned over the effectiveness of the vaccine. 25 days following the first dose, the second dose of Jynneos was administered subcutaneously in the triceps (which is considered inappropriate schedule of vaccine administered and vaccine administered at an inappropriate site). The patient experienced no adverse events following the second dose. Anxiety is unlisted and unexpected according to CCDS v1 and PI. Injection site pain is listed and expected. Incorrect route of product administration, inappropriate schedule of vaccine administered and vaccine administered at an inappropriate site are considered listed per company convention. The outcome of the event of anxiety was unknown. The patient's medical history and concomitant medication details were not provided. Causality assessment is related for injection site pain due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Anxiety is also assessed as related as contributory role of the suspect product cannot be fully excluded. Incorrect route of product administration, inappropriate schedule of vaccine administered and vaccine administered at an inappropriate site are considered not related to suspect product but to human factor. The case is non-serious.