Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | UNK | Unknown | — |
The JYNNEOS vaccine was given after being held at two to eight degree Celsius for five weeks and according to new package insert it could be held at two to eight degree Celsius for four weeks.; The JYNNEOS vaccine was given after being held at two to eight degree Celsius for five weeks and according to new package insert it could be held at two to eight degree Celsius for four weeks.; Case reference number US-BN-2024-002733 is a spontaneous case initially received from a consumer via Communications (reference number: USBAV24-2909) on 04-Nov-2024 and concerns a patient of unknown gender and age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose, route or site of administration, for unknown indication. As reported, the Jynneos vaccine was given after being held at two to eight degrees Celsius for five weeks and according to new package insert it could be held at two to eight degrees Celsius for four weeks (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos. Non-significant case correction downloaded from VAERS on 09-Dec-2024 included additional reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241104-fcbee0 to US-BAVARIAN NORDIC A/S-US-BN-2024-002733, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unknown gender and age was vaccinated with a dose of Jynneos, at an unknown dose, route or site of administration, for unknown indication. Reportedly, the Jynneos vaccine was given after being held at two to eight degrees Celsius for five weeks and according to new package insert it could be held at two to eight degrees Celsius for four weeks which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown gender and age was vaccinated with a dose of Jynneos, at an unknown dose, route or site of administration, for unknown indication. Reportedly, the Jynneos vaccine was given after being held at two to eight degrees Celsius for five weeks and according to new package insert it could be held at two to eight degrees Celsius for four weeks which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.