Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3003908 | — |
Patient took Vivotif capsules stored at room temperature with maximum temperature reached for 67 degree farhenheit and the time out of range was one month; Patient took Vivotif capsules stored at room temperature with maximum temperature reached for 67 degree farhenheit and the time out of range was one month; Case reference number US-BN-2024-000161 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0262) on 07-Feb-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, Vivotif doses were stored out of the refrigerator. The patient did not refrigerate the Vivotif and received it on the beginning of January, but the patient leaves on Friday, patient took Vivotif for every 48 hours and started refrigerating the vaccine a couple days ago but it wasn't in the sun, it was 67 degrees in the bedroom (explicitly coded as 'product storage error') On an unspecified date, the patient took the first affected dose of Vivotif (batch number: unknown) at unknown dose, via oral use for unknown indication (explicitly codes as 'product administration error'). On an unspecified date, an unknown amount of time after the first dose of Vivotif reported as every 48 hours, the patient took the second dose of Vivotif (batch number: 3003908) at unknown dose, via unknown route (explicitly codes as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first affected dose of Vivotif, although Vivotif doses were stored out of the refrigerator. The patient did not refrigerate the Vivotif and received it on the beginning of January, but as the patient planned to leave, the patient took Vivotif for every 48 hours and started refrigerating the vaccine a couple days before, but it wasn't in the sun, it was 67 degrees in the bedroom, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif reported as every 48 hours, the patient took the second dose of Vivotif, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first affected dose of Vivotif, although Vivotif doses were stored out of the refrigerator. The patient did not refrigerate the Vivotif and received it on the beginning of January, but as the patient planned to leave, the patient took Vivotif for every 48 hours and started refrigerating the vaccine a couple days before, but it wasn't in the sun, it was 67 degrees in the bedroom, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif reported as every 48 hours, the patient took the second dose of Vivotif, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None