Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, Incorrect route of product administration, Product storage error
Clinical narrative: Jynneos vaccine was stored in the refrigerator at 4-8 degrees Celsius from 01-May until present, before they were administered to six patients, past shelf life.; Jynneos vaccine was stored in the refrigerator at 4-8 degrees Celsius from 01-May until present, before they were administered to six patients, past shelf life.; Jynneos vaccine was stored in the refrigerator at 4-8 degrees Celsius from 01-May until present, before they were administered to six patients, past shelf life.; Jynneos vaccine was administered intradermally; Case reference number US-BN-2024-002705 is a spontaneous case initially received from a physician via agency (reference number: USBAV24-2887) on 01-Nov-2024 and concerns six patients of unspecified age and gender (multi-6).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, six patients were vaccinated; five patients received one dose, and one patient received two doses of Jynneos (batch number: *FDP00017), 0.1 milliliter, intradermally*, at unknown site of administration, for unknown indication. It was reported that Jynneos had an excursion issue and was stored in the refrigerator *at 4-8 degrees Celsius from 01-May until present* before being administered to patients, past shelf life (explicitly coded as 'expired vaccine used', 'product storage error', 'product administration error' and 'intradermal injection').  *The reporter assessed that the vaccines were received frozen from Government on 01-May, and after that they were put into the fridge for thawing. The medical doctor added out of the 40 doses, 31 were remaining. *  At the time of the initial report, it was unknown if the patients experienced any adverse events due to Jynneos.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from the physician on 06-Nov-2024. New information included: Jynneos administration information, new event intradermal injection added and information that vaccines were received frozen and that they were put into the fridge for thawing, 40 doses were added out, and that 31 were remaining.; Reporter's Comments: This case report concerns six patients of unspecified age and gender. Reportedly, six patients were vaccinated, five patients received one dose, and one patient received two doses of Jynneos, intradermally, for unknown indication. It was reported that Jynneos had an excursion issue and was stored in the refrigerator at 4-8 degrees Celsius from 01-May until present before being administered to patients, past shelf life, which is considered as expired vaccine used, product storage error, product administration error and intradermal injection. Expired product used, product storage error, intradermal injection and product administration error are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. The patients' medical history and concomitant medication details were not provided. Expired product used, product storage error, intradermal 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 report concerns six patients of unspecified age and gender. Reportedly, six patients were vaccinated, five patients received one dose, and one patient received two doses of Jynneos, intradermally, for unknown indication. It was reported that Jynneos had an excursion issue and was stored in the refrigerator at 4-8 degrees Celsius from 01-May until present before being administered to patients, past shelf life, which is considered as expired vaccine used, product storage error, product administration error and intradermal injection. Expired product used, product storage error, intradermal injection and product administration error are all considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. The patients' medical history and concomitant medication details were not provided. Expired product used, product storage error, intradermal injection and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.