Sex: U
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patients administered Jynneos vaccine that was stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccine was colder than intended; The patients administered Jynneos vaccine that was stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccine was colder than intended; Patients received Jynneos vaccine intradermaly instead of subcutaneous route; Four patients received the second dose of Jynneos on day 27, 29, 44 and 49 respectively; Case reference number US-BN-2024-000060 is a spontaneous case report initially received from a nurse via Company (reference number: USBAV24-0085) on 15-Jan-2024 and concerns *male patients aged 25, 27, 63, 30, 45, 49, 22, 59, 57, 24, 35, 36 years old and 19-year old female patient*.  The patient's medical history and concomitant medication details were not provided.  *On 31-Aug-2022, the 25-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 31-Aug-2022, the 27-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.5 milliliter via subcutaneous route and unknown site of administration, for an unknown indication.*  *On 21-Sep-2022, the 63-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 21-Sep-2022, the 30-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 21-Sep-2022, the 45-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 28-Sep-2022, the 19-year-old female patient received the first dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*   *On 28-Sep-2022, 28 days after the first dose, the 27-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.5 milliliter via subcutaneous route and unknown site of administration.*  *On 29-Sep-2022, the 49-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 19-Oct-2022, 28 days after the first dose, the 63-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00005, expiry date: 31-Aug-2023), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection').*  *On 19-Oct-2022, 28 days after the first dose, the 45-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection').*  *On 26-Oct-2022, 28 days after the first dose, the 19-year-old female patient received the second dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection').*  *On 26-Oct-2022, 27 days after the first dose, the 49-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection' and 'inappropriate schedule of vaccine administered').*  *On 07-Dec-2022, the 22-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 18-Dec-2022, the 59-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 04-Jan-2023, 28 days after the first dose, the 22-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00013, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection').*  *On 10-Jan-2023, the 36-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 31-Jan-2023, the 35-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 31-Jan-2023, 44 days after the first dose, the 59-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection' and 'inappropriate schedule of vaccine administered').*  *On 28-Feb-2023, 28 days after the first dose, the 35-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection').*  *On 02-May-2023, the 24-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 31-May-2023, 29 days after the second dose, the 24-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection' and 'inappropriate schedule of vaccine administered').*  *On 14-Jul-2023, the 57-year-old male patient received the first dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration, for an unknown indication (explicitly coded as 'intradermal injection').*  *On 01-Sep-2023, 49 days after the first dose, the 57-year-old male patient received the second dose of the Jynneos vaccine (batch number: FDP00014, expiry date: 30-Sep-2024), at a dose of 0.1 milliliter via intradermal route and unknown site of administration (explicitly coded as 'intradermal injection' and 'inappropriate schedule of vaccine administered')*.  As reported, administered Jynneos doses were stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer where the temperature of the vaccines was colder than intended (explicitly coded as 'product storage error' and 'product administration error').  *As reported, every patient who was vaccinated met the CDC criteria and none has a known exposure or symptoms.*  This case is linked with US-BN-2024-000126 (same reporter).  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from nurse on 30-Jan-2024: New information included confirmation on the number of patients, gender, initials and age, first and second dosage information of Jynneos vaccine and added 'inappropriate schedule of vaccine administered'.; Reporter's Comments: This case concerns multiple patients who were vaccinated with Jynneos vaccines that were stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer, which is considered product storage error and product administration error. Four patients received the second dose of Jynneos on day 27, 29, 44 and 49 respectively, which is considered as inappropriate schedule of vaccine administered. Additionally it was reported that the patients received the vaccine intradermally, instead of subcutaneously. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are listed by convention. No associated adverse events were reported. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are not related to the suspect product, but to a human action. The case is non-serious.; Sender's Comments: This case concerns multiple patients who were vaccinated with Jynneos vaccines that were stored at the wrong temperature of minus 22 degrees Fahrenheit in the freezer, which is considered product storage error and product administration error. Four patients received the second dose of Jynneos on day 27, 29, 44 and 49 respectively, which is considered as inappropriate schedule of vaccine administered. Additionally it was reported that the patients received the vaccine intradermally, instead of subcutaneously. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are listed by convention. No associated adverse events were reported. Intradermal injection, inappropriate schedule of vaccine administered, product storage error and product administration error are not related to the suspect product, but to a human action. The case is non-serious.