Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient took second dose of Vivotif that was outside the refrigerator for 30 hours and a half; The patient took second dose of Vivotif that was outside the refrigerator for 30 hours and a half; The patient took second dose of Vivotif that was outside the refrigerator for 30 hours and a half; Case reference number US-BN-2025-001019 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1323) on 05-Jun-2025 and concerns a female patient of unspecified age, *reported as around 50 years old*. The patient's medical history and concomitant medication details were not provided. On an unspecified date at 4 o'clock, *also reported as on Monday, 02-Jun-2025 (to be confirmed) * the patient took the first dose of Vivotif (batch number: unknown) orally, at an unknown dose, for indication *typhoid immunisation.* On an unspecified date, *also reported as on Wednesday, 04-Jun-2025 (to be confirmed) * , an unknown amount of time from the first dose, *also reported as 48 hours after the first dose*, the patient took the second dose of Vivotif (batch number: unknown) orally, at an unknown dose. Vivotif was outside the refrigerator for 30 hours and a half (explicitly coded as 'product storage error', 'product temperature excursion issue' and 'product administration error'). At the time of the *follow-up* report, it was unknown if the patient experienced any adverse events due to Vivotif. Additional information received from the consumer on 05-Jun-2025, included patient information and a new reference number USBAV25-1324. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from a pharmacist via Communication (reference number: USBAV25-1342) on 06-Jun-2025: New information included additional reporter, potential dates of the vaccination, patient's age, and updated indication.; Reporter's Comments: A female patient born in 1961, took first dose of Vivotif, orally, at unknown dose, for typhoid immunisation. The patient took first dose of Vivotif, orally, at unknown dose, for indication oral active immunization. 48 hours from the first dose, the patient took second dose of Vivotif, orally, (at unknown dose),however, Vivotif was outside of refrigerator for 30 hours and a half which is considered as product storage error, product temperature excursion issue and product administration error. Product storage error, product temperature excursion issue and product administration error are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. 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 and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient, took first dose of Vivotif, orally, at unknown dose, for typhoid immunisation. The patient took first dose of Vivotif, orally, at unknown dose, for indication oral active immunization. 48 hours from the first dose, the patient took second dose of Vivotif, orally, (at unknown dose),however, Vivotif was outside of refrigerator for 30 hours and a half which is considered as product storage error, product temperature excursion issue and product administration error. Product storage error, product temperature excursion issue and product administration error are all considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. 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 and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE