Sex: U
Vaccine: SMALLMNK
Symptoms: Unevaluable event
Clinical narrative: Patients (number 2, male and patient (number 4, male) did not receive second dose of Jynneos vaccine yet; Patient (number 1, male) received second dose 37 days after first dose of Jynneos vaccine; The Jynneos vaccine was stored in the fridge since 08-sep-2024, when they received it, until today; Case reference number US-BN-2024-002777 is a spontaneous case report initially received from a nurse via agency (reference number: USBAV24-2999) on 13-Nov-2024 and concerns four patients (three male and one female) of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  As reported, since 08-Sep-2024, the Jynneos stored in the fridge when received it, until today. (explicitly coded as 'product storage error').  On 01-Oct-2024, the patient (number 1, male) and patient (number 2, male) received first dose of Jynneos vaccine (batch number: 96867) at unknown dose, route or site of administration for unknown indication.  On 04-Oct-2024, the patient (number 3, female) received first dose of Jynneos vaccine (batch number: 96867) at unknown dose, route or site of administration.  On 07-Oct-2024, the patient (number 4, male) received first dose of Jynneos vaccine (batch number: 96867) at unknown dose, route or site of administration.  On 01-Nov-2024, 28 days after administration of the first dose of Jynneos, patient (number 3, female) received second dose of Jynneos vaccine (batch number: 96867) at unknown dose, route or site of administration.  On 07-Nov-2024, 37 days after administration of the first dose, patient (number 1, male) received second dose of Jynneos vaccine (batch number: 96867) at unknown dose, route or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  It was reported that patient (number 2, male) and patient (number 4, male) did not receive second dose of Jynneos vaccine yet (explicitly coded as 'incomplete course of vaccination').  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 nurse via agency on 13-Nov-2024 included confirmation of additional reference numbers.; Reporter's Comments: Some of the four patients (three male and one female) of unspecified age received the first dose of Jynneos vaccine for unknown indication. As reported, since 08-Sep-2024, the Jynneos was stored in the fridge when received it, until today, which is considered as product storage error. 37 days after the administration of the first dose, patient (number 1, male) received the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered. It was reported that the patient (number 2, male) and the patient (number 4, male) did not receive the second dose of Jynneos vaccine yet, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination, inappropriate schedule of product administration and product storage error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination, inappropriate schedule of product administration and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Some of the four patients (three male and one female) of unspecified age received the first dose of Jynneos vaccine for unknown indication. As reported, since 08-Sep-2024, the Jynneos was stored in the fridge when received it, until today, which is considered as product storage error. 37 days after the administration of the first dose, patient (number 1, male) received the second dose of Jynneos vaccine, which is considered as inappropriate schedule of vaccine administered. It was reported that the patient (number 2, male) and the patient (number 4, male) did not receive the second dose of Jynneos vaccine yet, which is considered as incomplete course of vaccination. It was unknown if the patients experienced any adverse events due to Jynneos vaccine. Incomplete course of vaccination, inappropriate schedule of product administration and product storage error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination, inappropriate schedule of product administration and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.