Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | Unknown | — |
The second dose of Jynneos vaccine was administered to a patient five days past the expiration date; The expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials; Case reference number US-BN-2024-002436 is a spontaneous case initially received from pharmacist via Communications (reference number USBAV24-2262) on 06-Sep-2024 and concerns a patient of unspecified gender or age. 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 an unknown dose, route or site for administration, for unknown indication. On an unspecified date, unknown amount of time after the first dose, as reported five days pass the expiration date and the patient received the second dose of Jynneos (batch number: unknown), at an unknown dose, route or site of administration (explicitly coded 'expired vaccine used'). As reported the expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials (explicitly coded 'product expiration date missing'). 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 07-Oct-2024 included: new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240906-07185c to US-BAVARIAN NORDIC A/S-US-BN-2024-002436, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unspecified gender or age received the second dose of Jynneos five days pass the expiration date which is considered as expired vaccine used. Reportedly, the expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials which is considered as product expiration date missing. Expired product administered and product expiration date issue 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. Expired product administered and product expiration date issue are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified gender or age received the second dose of Jynneos five days pass the expiration date which is considered as expired vaccine used. Reportedly, the expiry date of Jynneos vaccine was only on the cartoon box and not on the individual vials which is considered as product expiration date missing. Expired product administered and product expiration date issue 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. Expired product administered and product expiration date issue are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2262:
Comments: None