Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004333 | — |
The patient took Vivotif vaccine which had temperature excursion. The patient estimated that the product reached for those two to three hours would have been 70°F; The patient took Vivotif vaccine which had temperature excursion. The patient estimated that the product reached for those two to three hours would have been 70°F; The patient took Vivotif vaccine which had temperature excursion. The patient estimated that the product reached for those two to three hours would have been 70°F; Case reference number US-BN-2025-001274 is a spontaneous case initially received from a physician's assistant via Communications (reference number: USBAV25-1754) on 17-Jul-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, since Vivotif stayed at room temperature for a maximum of 12 hours, and this was 3 separate periods of time. The excursion was actually over the same 24 hour period and some of them are theoretical excursions. After the patient left the clinic after being given Vivotif, patient kept it with for a couple of hours and when got home put it in the cooler protected, with ice packs. Over the course of a couple of hours, it partially melted but not completely melted. The patient was driving over a period of 24 hours and would replace the ice bags when they were melted or partially melted. When patient got home the next day around midday, put it in the fridge and was there from there on. Therefore, the only real excursion was when patient was out of the clinic with Vivotif for about 2-3 hours before got home and put it in the cooler with ice packs. Max temperature patient estimated that product reached for those 2-3 hours would have been 70°F (explicitly coded as 'product temperature excursion issue', and 'product storage error temperature too high'). The patient completed the treatment course. On an unspecified dates, the patient took unspecified number of doses reported as the patient completed treatment of Vivotif (batch number:3004333), at unknown dose, route or site of administration for unknown indication (explicitly coded as 'product administration error') . At the time of the report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No additional information was provided.; Reporter's Comments: A male patient of unspecified age took unspecified number of doses of Vivotif reported as the patient completed treatment of Vivotif for unknown indication, which had temperature excursion. The patient estimated that the product reached for those two to three hours would have been 70°F, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error 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 took unspecified number of doses of Vivotif reported as the patient completed treatment of Vivotif for unknown indication, which had temperature excursion. The patient estimated that the product reached for those two to three hours would have been 70°F, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None