Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004008 | — |
The patient took Vivotif last year after it was in purse for 4-5 hours; The patient took Vivotif last year after it was in purse for 4-5 hours; The patient took Vivotif last year after it was in purse for 4-5 hours; The patient forgot to take a pill one day so took it next day and then skipped a day before taking the next dose; Case reference number US-BN-2025-001005 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV25-1296) on 02-Jun-2025 and concerns a female patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date also reported as last year, the patient took Vivotif after it was in purse for four to five hours (batch number: unknown) at unknown dose, route or site of administration for unknown indication (explicitly coded as 'product storage error', 'product temperature excursion issue' and 'product administration error'). On unspecified date, the patient forgot to take one pill one day so took it the next day and then skipped a day before taking the next dose (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if patient experienced any of adverse events due to Vivotif No further information was provided.; Reporter's Comments: This case concerned a female patient of unspecified age. As reported on unspecified date, the patient took Vivotif vaccine which was outside the refrigerator (in her purse for 4-5 hours) for unknown indication, which is considered as 'product storage error', 'product temperature excursion issue' and product administration error'. On unspecified date, the patient skipped a day before taking the next dose which is considered as 'inappropriate schedule of product administered'. At the time of initial report, it was unknown if patient experienced any of adverse events due to Vivotif. Product storage error, product temperature excursion issue, product administration error and inappropriate schedule of product administration are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue, product administration error and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerned a female patient of unspecified age. As reported on unspecified date, the patient took Vivotif vaccine which was outside the refrigerator (in her purse for 4-5 hours) for unknown indication, which is considered as 'product storage error', 'product temperature excursion issue' and product administration error'. On unspecified date, the patient skipped a day before taking the next dose which is considered as 'inappropriate schedule of product administered'. At the time of initial report, it was unknown if patient experienced any of adverse events due to Vivotif. Product storage error, product temperature excursion issue, product administration error and inappropriate schedule of product administration are considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue, product administration error and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE