Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: 33 patients received Jynneos after the beyond use date of 19-Apr-2023; Jynneos vaccine administered intradermally at 0.1 mL; The patient received the second dose of Jynneos 13 days after the first dose; Case reference number US-BN-2023-000959 is a spontaneous case report initially received on 23-May-2023 from a nurse via Communication (reference number: USBAV23-0685) and concerns *33* patients of unknown gender.  The patients were born on 12-May-1962 (61 years), 26-Aug-1998 (24 years), 03-Apr-1985 (38 years), 24-May-1995 (27 years), 06-Oct-1997 (25 years),14-Apr-1991 (32 years), 23-Oct-1986 (36 years), 04-Apr-1990 (33 years), 08-Aug-1959 (63 years), 29-Sep-1975 (47 years), 26-Nov-1978 (44 years), 31-Jul-1996 (26 years), 06-Feb-1972 (51 years), 03-Sep-1991 (31 years), 08-May-1961 (62 years), 24-Sep-1963 (59 years), 05-Jan-1985 (38 years), 23-Jan-1964 (59 years), 02-Oct-1970 (52 years), 21-Jan-1962 (61 years), 24-Jul-1964 (58 years), 21-Aug-1962 (60 years), 26-Jul-1953 (69 years), 25-Apr-1995 (28 years), 25-Feb-1966 (57 years), 30-Mar-1976 (47 years), 05-Aug-1964 (58 years), 12-Feb-1980 (43 years), 01-Dec-1991 (31 years), 16-Feb-1986 (37 years), 22-Jul-1988 (34 years), 05-Jun-1998 (24 years) and on 25-Mar-1956 (67 years).  The patients' medical history and concomitant medication details were not provided.  On 20-Apr-2023, two patients were vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with beyond use date (BUD) on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection') and one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 21-Apr-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection') and one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD) on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 24-Apr-2023, one patient was vaccinated with the *first dose* of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 25-Apr-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 26-Apr-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD) on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').  On 27-Apr-2023, three patients were vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').  On 28-Apr-2023, one patient was vaccinated with the *first* dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 02-May-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection') and one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 04-May-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 05-May-2023, three patients were vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').  On 09-May-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').  On 10-May-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection') and one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the left *upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 11-May-2023, *13 days after the first dose of Jynneos (administered on 28-Apr-2023), the patient was vaccinated with the second dose of Jynneos (batch number: FDP00019; expiration date: Oct-24) (explicitly coded as 'Inappropriate schedule of vaccine administered')* and two patients were vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 15-May-2023, two patients were vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 16-May-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').  On 17-May-2023, two patients were vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection') and one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 18-May-2023, one patient was vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used').  On 22-May-2023,*28 days after the first dose (administered on 24-Apr-2023) the patient was vaccinated with the second* dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.5 mL, administered subcutaneously, in the *left upper arm*, for monkeypox (explicitly coded as 'expired vaccine used') and three patients were vaccinated with a dose of Jynneos (batch number: FDP00019; expiration date: Oct-24), with BUD on 19-Apr-2023, at a dose of 0.1 mL, administered intradermally in the *left forearm*, for monkeypox (explicitly coded as 'expired vaccine used' and 'intradermal injection').  As reported, Jynneos vaccine was stored correctly at refrigerator temperatures with no excursions and that that was in an outpatient clinic, contributing factors were human error on data entry into electronic medical record (EMR) and at time of administration, and system design of both EMR which did not allow for both BUD and expiration dates, and packaging design of the vaccine which also made it hard to have a BUD on each vial.  At the time of *this follow up report*, the patients *did not experience* any adverse event due to Jynneos vaccination.  Additional information received on 24-May-2023 included local case ID number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from the nurse on 16-Jun-2023: New information included date of birth and age for 33 patients with vaccination dates, indication, dosages and routes of Jynneos administrations.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from the reporter on 28-Jun-2023: New information included site of administration for each dose administered, confirmation that two patients received two expired doses of Jynneos which caused additional non-event to be added and confirmation that no patient experienced any adverse event due to Jynneos.; Reporter's Comments: This case concerns 35 adult patients (aged between 24 and 69 years old) of unspecified gender who were vaccinated with Jynneos at an unknown site of administration, for monkeypox. The patients received vaccines from batch FDP00019 with beyond use date (BUD) prior to the dates of vaccination, which is considered expired product administered. 19 patients received Jynneos at a dose of 0.1 mL, intradermally (which is considered intradermal injection). Reportedly, one patient was vaccinated with the second dose of Jynneos on the day 13 after the first dose, which is considered as inappropriate schedule of vaccine administered. 16 patients received subcutaneous Jynneos at a dose of 0.5 mL. Reportedly, the vaccines were stored correctly at refrigerator temperatures with no excursions. No associated adverse events were reported. Expired product administered, inappropriate schedule of vaccine administered and intradermal injection are considered listed per company convention. The patients' medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns 35 adult patients (aged between 24 and 69 years old) of unspecified gender who were vaccinated with Jynneos at an unknown site of administration, for monkeypox. The patients received vaccines from batch FDP00019 with beyond use date (BUD) prior to the dates of vaccination, which is considered expired product administered. 19 patients received Jynneos at a dose of 0.1 mL, intradermally (which is considered intradermal injection). Reportedly, one patient was vaccinated with the second dose of Jynneos on the day 13 after the first dose, which is considered as inappropriate schedule of vaccine administered. 16 patients received subcutaneous Jynneos at a dose of 0.5 mL. Reportedly, the vaccines were stored correctly at refrigerator temperatures with no excursions. No associated adverse events were reported. Expired product administered, inappropriate schedule of vaccine administered and intradermal injection are considered listed per company convention. The patients' medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.