Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | 96867 | ID / LA |
Jynneos vaccines were administered at dose of 0.1 ml intradermally; Jynneos vaccines were administered at dose of 0.1 ml intradermally; Case reference number US-BN-2024-002867 is a spontaneous case initially received from other health care professional via Med Communications (reference number: USBAV24-2977) on 11-Nov-2024 and concerns a *31-year-old, male* patient. The patient's medical history and concomitant medication details were not provided. On *02-November-2024*, the patient received dose of Jynneos vaccine (batch number: *96867; expiration date: 30-Apr-2026*) at dose 0.1 ml, intradermally *in the left forearm*, for unknown indication (explicitly coded as 'Intradermal injection' and 'vaccine underdose'). *The patient did not received any further doses of Jynneos vaccine. * At the time of the *follow-up*, it was unknown if the patients experienced any adverse events due to Jynneos. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from health care professional on 17-Jan-2025: New information included dosing information, demografic information of the patient.; Reporter's Comments: This case report concerns an unspecified number of patients of unspecified gender or age. The patients received doses of Jynneos vaccines, at dose 0.1 ml, intradermally, at unknown site of administration for unknown indication which is considered as intradermal injection and vaccine underdose. Injection and underdose are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.Based on the follow-up information received, there is no change in the Company's assessment.; Sender's Comments: This case report concerns an unspecified number of patients of unspecified gender or age. The patients received doses of Jynneos vaccines, at dose 0.1 ml, intradermally, at unknown site of administration for unknown indication which is considered as intradermal injection and vaccine underdose. Injection and underdose are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.Based on the follow-up information received, there is no change in the Company's assessment.
Comments: NONE