Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| SMALLMNK | SMALLPOX + MONKEYPOX (JYNNEOS) | BAVARIAN NORDIC | 2 | FDP00019 | ID |
Patients received Jynneos vaccine via intradermal route previously stored in a freezer between -18.7ºF to -16ºF since June 2024, when received vaccines; Patients received Jynneos vaccine via intradermal route previously stored in a freezer between -18.7ºF to -16ºF since June 2024, when received vaccines; Patients received Jynneos vaccine via intradermal route previously stored in a freezer between -18.7ºF to -16ºF since June 2024, when received vaccines; Patient female, 40 years old received only one dose of Jynneos vaccine and did not come back for second dose; Patient female, 25 years old received second dose of Jynneos 37 days after the first dose; Case reference number US-BN-2024-002887 is a spontaneous case report initially received from other health professional via agency (reference number: USBAV24-3275) on 11-Dec-2024 and concerns three (two female 40-years-old and 25-years-old and one male 37-years-old) patients. The patient's relevant medical history and concomitant medications were not provided. As reported, Jynneos vaccines have been stored in a freezer between -18.7ºF to -16ºF since June 2024, when received vaccines. HCP stated that administration has been involved and Jynneos were administered to three different patients intradermally (explicitly coded as 'product storage error', product administration error' and intradermal injection'). On 02-Jun-2024, the patient (number 1, female 40-years old), patient (number 2, female 25-years old) and patient (number 3, male 37-years old) received first dose of Jynneos vaccine (batch number: FDP00019 and expiration date: 31-Oct-2024) at 0.1 milliliter, intradermally on unknown site of administration for unknown indication (explicitly coded as intradermal injection'). As reported, the patient (number 1, female 40-years old), did not come back for second dose, received only first dose (explicitly coded as incomplete course of vaccination'). On 02-Jul-2024, 30 days after the first dose, the patient (number 3, male 37-years old) received second dose of Jynneos vaccine (batch number: FDP00019 and expiration date: 31-Oct-2024) at 0.1 milliliter, intradermally on unknown site of administration (explicitly coded as intradermal injection'). On 09-Jul-2024, 37 days after the first dose, the patient (number 2, female 25-years old) received second dose of Jynneos vaccine (batch number: FDP00019 and expiration date: 31-Oct-2024) at 0.1 milliliter, intradermally on unknown site of administration (explicitly coded as intradermal injection' and inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. Additional information received from a HCP via agency on 11-Dec-2024 included confirmation of additional reference numbers (USBAV24-3283 and USBAV24-3280). Non-significant case correction received from VAERS on 14-Feb-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241211-a567a0 to US-BAVARIAN NORDIC A/S-US-BN-2024-002887, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: This case report concerns three (two female 40-years-old and 25-years-old and one male 37-years-old) patients. Reportedly, Jynneos vaccines have been stored in a freezer between -18.7ºF to -16ºF since June 2024, when received vaccines. HCP stated that administration has been involved and Jynneos were administered to three different patients intradermally, considered as product storage error, product administration error and intradermal injection. Reportedly, the patient (number 1, female 40-years old), patient (number 2, female 25-years old) and patient (number 3, male 37-years old) received first dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration for unknown indication, considered as intradermal injection. As reported, the patient (number 1, female 40-years old), did not come back for second dose, received only first dose which is considered as incomplete course of vaccination. 30 days after the first dose, the patient (number 3, male 37-years old) received second dose of Jynneos vaccine, at dose of 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection. 37 days after the first dose, the patient (number 2, female 25-years old) received second dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection and inappropriate schedule of vaccine administered. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case report concerns three (two female 40-years-old and 25-years-old and one male 37-years-old) patients. Reportedly, Jynneos vaccines have been stored in a freezer between -18.7ºF to -16ºF since June 2024, when received vaccines. HCP stated that administration has been involved and Jynneos were administered to three different patients intradermally, considered as product storage error, product administration error and intradermal injection. Reportedly, the patient (number 1, female 40-years old), patient (number 2, female 25-years old) and patient (number 3, male 37-years old) received first dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration for unknown indication, considered as intradermal injection. As reported, the patient (number 1, female 40-years old), did not come back for second dose, received only first dose which is considered as incomplete course of vaccination. 30 days after the first dose, the patient (number 3, male 37-years old) received second dose of Jynneos vaccine, at dose of 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection. 37 days after the first dose, the patient (number 2, female 25-years old) received second dose of Jynneos vaccine, at 0.1 milliliter, intradermally on unknown site of administration which is considered as intradermal injection and inappropriate schedule of vaccine administered. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error, injection, incomplete course of vaccination and inappropriate schedule of product administration are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None