Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 1 | Unknown | — |
The patient had a local reaction of pain, redness, and swelling; The patient had a local reaction of pain, redness, and swelling; The patient had a local reaction of pain, redness, and swelling; The patient received one dose of Jynneos and decided not to get the second dose; Case reference number US-BN-2024-002039 is a spontaneous case initially received from other health care professional via Communications (reference number USBAV24-1334) on 11-Jun-2024 and concerns a patient of unspecified age or gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received the first dose of Jynneos (batch number: unknown), at unknown dose, route or site administration, for indication reported as prevention of smallpox and monkeypox disease. On an unspecified date, the patient had a local reaction of pain, redness, and swelling, and as reported, the patient decided not to get the second dose of Jynneos (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient recovered from local reaction of pain, redness and swelling. The reporter assessed the events of local reaction of pain, redness and swelling as non-serious and possibly related to the product of Jynneos. Non-significant case correction performed for information received from VAERS on 05-Aug-2024 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240611-96496f to US-BAVARIAN NORDIC A/S-US-BN-2024-002039, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unspecified age or gender had a local reaction of pain, redness, and swelling, an unknown amount of time after the patient received the first dose of Jynneos for indication reported as prevention of smallpox and monkeypox disease, and as reported, the patient decided not to get the second dose of Jynneos, which is considered as inappropriate schedule of vaccine administered. Pain, erythema and swelling are unlisted and unexpected for Jynneos according to the CCDS v6 and USPI, whilst inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Jynneos. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age or gender had a local reaction of pain, redness, and swelling, an unknown amount of time after the patient received the first dose of Jynneos for indication reported as prevention of smallpox and monkeypox disease, and as reported, the patient decided not to get the second dose of Jynneos, which is considered as inappropriate schedule of vaccine administered. Pain, erythema and swelling are unlisted and unexpected for Jynneos according to the CCDS v6 and USPI, whilst inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Jynneos. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None