Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004299 | PO / MO |
The patient left Vivotif out of the fridge for approximately eight hours and product was in a bag with a pack of ice; Three capsules experienced the temperature excursion, second dose was taken after the temperature excursion; The patient left Vivotif out of the fridge for approximately eight hours and product was in a bag with a pack of ice; Patient took first dose of Vivotif on 09-Jun-2025 and second dose on 15-Jun-2025; Case reference number US-BN-2025-001074 is a spontaneous case report initially received from a pharmacist via agency (reference number: USBAV25-1418) on 16-Jun-2025 and concerns a male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On 09-Jun-2025, the patient took first dose of Vivotif vaccine (batch number: 3004299), orally at unknown dose for unknown indication. On an unspecified date, the patient left Vivotif out of the fridge for approximately eight hours and product was in a bag with a pack of ice (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 15-Jun-2025, six days after first dose, the patient took second dose of affected Vivotif vaccine (batch number: 3004299), orally at unknown dose. (explicitly coded as 'inappropriate schedule of vaccine administered' and 'product administration error'). At the time of the 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 male patient of unspecified age left Vivotif out of the fridge for approximately eight hours and product was in a bag with a pack of ice, which is considered as product storage error and product temperature excursion issue. Reportedly, six days after first dose, the patient took second dose of affected Vivotif vaccine, which is considered as inappropriate schedule of vaccine administered and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product temperature excursion issue, product administration error, product storage error and inappropriate schedule of product administration are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product temperature excursion issue, product administration error, product storage 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: A male patient of unspecified age left Vivotif out of the fridge for approximately eight hours and product was in a bag with a pack of ice, which is considered as product storage error and product temperature excursion issue. Reportedly, six days after first dose, the patient took second dose of affected Vivotif vaccine, which is considered as inappropriate schedule of vaccine administered and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product temperature excursion issue, product administration error, product storage error and inappropriate schedule of product administration are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product temperature excursion issue, product administration error, product storage 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.