Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: Some patients were given ID (intradermal) dose; Thawed Jynneos vaccines were mistakenly put in the freezer upon receipt, and then 32 doses were administered to 31 patients; Thawed Jynneos vaccines were mistakenly put in the freezer upon receipt, and then 32 doses were administered to 31 patients; Case reference number US-BN-2024-002688 is a spontaneous case initially received from a nurse via agency (reference USBAV24-2814) on 24-Oct-2024 and concerns the patients of unknown age and gender (multi).  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, some Jynneos vaccine dose was received that was short dated and refrigerated in September and it was unpacked and put in the freezer. So, it had been frozen for about four weeks. Vaccines were mistakenly put it in the freezer, and the doses that were administered were received thawed, they were frozen and then re-thawed before administration. The vaccine was shipped refrigerated but it was mistakenly put in the freezer upon receipt (explicitly coded as 'product storage error').  On an unspecified date, the patients were vaccinated with Jynneos vaccine (32 doses were administered to 31 unique patients) (batch number: FDP0017, expiration date: 31-Oct-2024) at unknown dose, some of them were administered intradermally and some subcutaneously for unknown indication (explicitly coded as 'intradermal injection' and 'product administration error).  At the time of the initial report, the patients did not experience any adverse event due to Jynneos.  No further information was provided.; Reporter's Comments: This case concerns patients of unknown age and gender. Reportedly, the vaccine was shipped refrigerated but it was mistakenly put in the freezer upon receipt which is considered as product storage error. On an unspecified date, the patients were vaccinated with Jynneos vaccine (32 doses were administered to 31 unique patients) at unknown dose, some of them were administered intradermally and some subcutaneously for unknown indication which is considered as intradermal injection and product administration error. Product storage error, injection and product administration error are all considered listed per company conventions. At this point, the patients did not experience any adverse event due to Jynneos. The patients' medical history and concomitant medication details were not provided. Product storage error, injection and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns patients of unknown age and gender. Reportedly, the vaccine was shipped refrigerated but it was mistakenly put in the freezer upon receipt which is considered as product storage error. On an unspecified date, the patients were vaccinated with Jynneos vaccine (32 doses were administered to 31 unique patients) at unknown dose, some of them were administered intradermally and some subcutaneously for unknown indication which is considered as intradermal injection and product administration error. Product storage error, injection and product administration error are all considered listed per company conventions. At this point, the patients did not experience any adverse event due to Jynneos. The patients' medical history and concomitant medication details were not provided. Product storage error, injection and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.