Sex: U
Vaccine: SMALLMNK
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Injection, Product administration error, Product storage error
Clinical narrative: Jynneos was refrigerated, but it was placed in the freezer (-20 degrees Celsius), then thawed again and administered to the patients; Jynneos was refrigerated, but it was placed in the freezer (-20 degrees Celsius), then thawed again and administered to the patients; Jynneos vaccines were administered intradermally; Patients received the second dose of Jynneos more than four weeks after the previous dose; No information for several patients regarding second Jynneos dose within 28 days; Case reference number US-BN-2022-004979 is a spontaneous case report initially received on 29-Dec-2022 from a health professional via Communication (reference number: USBAV22-2186) and concerns *194* patients:   The patients' medical history and concomitant medication details were not provided.  On an unspecified date, the Jynneos vaccine (batch number: *FDP00014*) was refrigerated, then placed in the freezer (-20 degrees Celsius), thawed again (explicitly coded as 'product storage error'), and administered to *194* patients (explicitly coded 'product administration error') for an unknown indication.  *On 23-Sep-2022, six patients had their first vaccination with Jynneos (batch number: FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, 13 patients had their second vaccination with Jynneos (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and one patient had the second vaccination with Jynneos (batch number FDP00014), an unknown amount of time after the first vaccination, of unknown dosage, subcutaneously in the left arm ('product administration error').*  *On 29-Sep-2022, another ten patients had their first vaccination with Jynneos (batch number: FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and another three patients had a first vaccination with Jynneos (batch number FDP00014) of unknown dosage, subcutaneously in the right left arm (one patient) or the left arm (two patients; explicitly coded as 'product administration error'). On the same day, an unknown amount of time after the first vaccination,  another five patients had the second vaccination with Jynneos (batch number FDP00014) of unknown dosage, four patients intradermally in the left arm, and one intradermally in the right arm (explicitly coded as 'intradermal injection' and 'product administration error'), and another two patients had second vaccination with Jynneos (batch number FDP00014), an unknown amount of time after the first vaccination, of unknown dosage subcutaneously in the left arm (explicitly coded as 'product administration error').*  *On 30-Sep-2022, 12 patients had their first vaccination with Jynneos (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and another patient had first vaccination with Jynneos (batch number unknown) of unknown dosage, subcutaneously in the left arm (explicitly coded as 'product administration error'). On the same day, an unknown amount of time after the first vaccination, another six patients had their second vaccination with Jynneos (batch number FDP00014) of unknown dosage in the left arm intradermally (explicitly coded as 'intradermal injection' and 'product administration error'), and one patient had second vaccination with Jynneos (batch number FDP00014) of unknown dosage in the left arm subcutaneous (explicitly coded as 'product administration error').*  *On 06-Oct-2022, ten patients had their first vaccination with Jynneos (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, another four patients had their second vaccination with Jynneos (batch number unknown) of unknown dosage in the left arm intradermally (explicitly coded as 'intradermal injection' and 'product administration error'), and one patient had second vaccination with Jynneos (batch number FDP00014) of unknown dosage in the left arm subcutaneous (explicitly coded as 'product administration error').*  *On 07-Oct-2022, five patients had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and one patient had the second Jynneos vaccination, an unknown amount of time after the first vaccination, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 13-Oct-2022, five patients had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally, four patients in the left arm and one patient in the right arm (explicitly coded as 'intradermal injection' and 'product administration error')), and another six patients had a first vaccination with Jynneos (batch number FDP00014) of unknown dosage, subcutaneously in the right arm (explicitly coded as 'product administration error'). On the same day, an unknown amount of time after the first vaccination, three patients had the second Jynneos vaccination intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 14-Oct-2022, one patient had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 20-Oct-2022, 14 patients had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, another 10 patients had their second Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 21-Oct-2022, one patient had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, subcutaneously in the left arm (explicitly coded as 'product administration error').*  *On 27-Oct-2022, four patients had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, 13 patients had the second Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and another two patients had the second Jynneos vaccine (batch number FDP00014) of unknown dosage, subcutaneously one in the left arm, and one in the right arm (explicitly coded as 'product administration error').*  *On 28-Oct-2022, five patients had the second Jynneos vaccine (batch number unknown) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and one patient had the second Jynneos vaccine (batch number FDP00014) an unknown amount of time after the first vaccination, of unknown dosage, subcutaneously in the right arm (explicitly coded as 'product administration error').*  *On 03-Nov-2022, six patients had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally five in the left arm and one in the right arm (explicitly coded as 'intradermal injection' and 'product administration error') and three patients had had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, subcutaneously in the left arm (explicitly coded as, and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, 10 patients had the second dose of Jynneos (batch number FDP00014) intradermally in the left arm seven patients, and in the right arm three patients (explicitly coded as 'intradermal injection' and 'product administration error'), and another three patients had the second dose of Jynneos (batch number FDP00014) subcutaneously in the left one patient, and in the right arm two patients (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 04-Nov-2022, one patient had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and two more patients had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, subcutaneously in the right arm (explicitly coded as, and 'product administration error').*  *On 10-Nov-2022, six patients had the first Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally five in the left arm and one in the right arm (explicitly coded as 'intradermal injection' and 'product administration error') and one patient had the first Jynneos vaccine (batch number FDP00014) of unknown dosage, subcutaneously in the right arm (explicitly coded as, and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, another 12 patients had the second Jynneos vaccine (batch number FDP00014) of unknown dosage, intradermally 10 in the left arm and two in the right arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 11-Nov-2022, one patient had the second vaccination with Jynneos (batch number FDP00014) of unknown dosage intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and another patient had had the second vaccination with Jynneos (batch number FDP00014) an unknown amount of time after the first vaccination, of unknown dosage, subcutaneously in the left arm (explicitly coded as, and 'product administration error').*  *On 17-Nov-2022, five patients had the first Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, another 12 patients had the second  Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally  in the left arm 11 patients, and one in the right arm (explicitly coded as 'intradermal injection' and 'product administration error') and one more patient was vaccinated with the second  Jynneos vaccination (batch number FDP00014) of unknown dosage, subcutaneously in the left arm (explicitly coded as, and 'product administration error').*  *On 18-Nov-2022, an unknown amount of time after the first vaccination, one patient had the second Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 01-Dec-2022, seven patients had the first Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, another 12 patients had the second Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally in the left arm 11 patients and one patient in the right arm. (explicitly coded as 'intradermal injection' and 'product administration error'), another patient had the second Jynneos vaccination (batch number FDP00014) an unknown amount of time after the first vaccination of unknown dosage, subcutaneously in the left deltoid (explicitly coded as, and 'product administration error').*  *On 12-Dec-2022 one patient had the first Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally in the right arm (explicitly coded as 'intradermal injection' and 'product administration error'), and another two patients had the first Jynneos vaccination (batch number FDP00014) of unknown dosage, subcutaneously in the left arm (explicitly coded as, and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, eight patients had the second Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally in the two patients in the right arm and six in the left arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *On 15-Dec-2022, four patients had the first Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally in the left arm (explicitly coded as 'intradermal injection' and 'product administration error'), and one patient had the first Jynneos vaccination (batch number FDP00014) of unknown dosage, subcutaneously in the left arm (explicitly coded as, and 'product administration error'). On the same day, an unknown amount of time after the first vaccination, nine patients had the second Jynneos vaccination (batch number FDP00014) of unknown dosage, intradermally eight patients in the left arm and one patient in the right arm (explicitly coded as 'intradermal injection' and 'product administration error').*  *Some of the patients, from the 61 patients who received both the first and second doses of Jynneos (batch number: FDP00014) received the second dose of Jynneos more than four weeks apart from the first dose (explicitly coded as 'inappropriate schedule of vaccine administered'). There is no information regarding administration of second Jynneos dose for several patients who received the first dose during October, November or December 2022 (explicitly coded as 'incomplete course of vaccination').*  *As reported, no adverse reactions were reported or observed in the office after administration of Jynneos. *  Additional information received on 30-Dec-2022 included local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up received from the other healthcare professional on 27-Jan-2023 included the number of patients to which affected vaccines of Jynneos were administered.  Additional information received from the other healthcare professional on 03-Feb-2023 included confirmation of number of patients, additional patient's details, batch number, dates (which caused additional non-event of 'inappropriate schedule of vaccine administered' and 'incomplete course of vaccination' to be added), anatomical location, and route of every administered dose.  Additional information received from the other healthcare professional on 06-Feb-2023 included confirmation that no patient experienced any adverse event.; Reporter's Comments: In this case Jynneos vaccine was refrigerated, but it was placed in the freezer (-20 degrees Celsius), then thawed again and then 194 patients were vaccinated at an unknown doses or sites of administration, intradermally, some subcutaneous, for an unknown indication, which is considered as product storage error and product administration error. Some of the patients, from the 61 patients who received both the first and second doses of Jynneos received the second dose of Jynneos more than four weeks apart from the first dose, which is considered as inappropriate schedule of vaccine administered. There is no information regarding administration of second Jynneos dose for several patients who received the first dose during October, November or December 2022, which is considered as incomplete course of vaccination. Product storage error, product administration error, inappropriate schedule of vaccine administered, incomplete course of vaccination and intradermal injection are all considered listed per company conventions. No associated adverse events were reported. The patients' medical history and concomitant medication details were not provided. Product storage error, product administration error, inappropriate schedule of vaccine administered, incomplete course of vaccination and intradermal injection are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: In this case Jynneos vaccine was refrigerated, but it was placed in the freezer (-20 degrees Celsius), then thawed again and then 194 patients were vaccinated at an unknown doses or sites of administration, intradermally, some subcutaneous, for an unknown indication, which is considered as product storage error and product administration error. Some of the patients, from the 61 patients who received both the first and second doses of Jynneos received the second dose of Jynneos more than four weeks apart from the first dose, which is considered as inappropriate schedule of vaccine administered. There is no information regarding administration of second Jynneos dose for several patients who received the first dose during October, November or December 2022, which is considered as incomplete course of vaccination. Product storage error, product administration error, inappropriate schedule of vaccine administered, incomplete course of vaccination and intradermal injection are all considered listed per company conventions. No associated adverse events were reported. The patients' medical history and concomitant medication details were not provided. Product storage error, product administration error, inappropriate schedule of vaccine administered, incomplete course of vaccination and intradermal injection are all assessed as not related to suspect product but to human factor. The case is non-serious.