Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004211 | PO / MO |
The patient took four doses of Vivotif which did not refrigerate; The patient took four doses of Vivotif which did not refrigerate; The patient took four doses of Vivotif which did not refrigerate; The recommendation to refrigerate vaccine was in small print; Case reference number US-BN-2025-000937 is a spontaneous case report initially received from a consumer via agency (reference number: USBAV25-1103) on 12-May-2025 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, as reported the patient did not refrigerate Vivotif vaccine and the *the recommendation to refrigerate vaccine was in small print* (explicitly coded as 'product storage error', 'product temperature excursion issue' and *'product label font size complaint'*). On an unspecified dates, the patient took four doses defected Vivotif vaccines (batch number: 3004211) at an unknown dose, orally for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Need for significant correction identified on 29-May-2025, for the information received on 12-May-2025 included missed event added product label font size complaint. Non-significant follow up received from Bavarian Nordic on 27-May-2025 included new reference number; Reporter's Comments: A female patient of unspecified age did not refrigerate Vivotif vaccine which is considered as product storage error and product temperature excursion issue. Patient stated that the recommendation to refrigerate is in small print, which is considered as product use complaint. The patient took four doses of defected Vivotif vaccines at an unknown dose, orally for unknown indication which is considered as product administration error. The patient's relevant medical history and concomitant medications were not provided. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product administration error, product storage error, product temperature excursion issue and product use complaint are considered as listed as per company convention. Product administration error, product storage error, product temperature excursion issue and product use complaint are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age did not refrigerate Vivotif vaccine which is considered as product storage error and product temperature excursion issue. Patient stated that the recommendation to refrigerate is in small print, which is considered as product use complaint. The patient took four doses of defected Vivotif vaccines at an unknown dose, orally for unknown indication which is considered as product administration error. The patient's relevant medical history and concomitant medications were not provided. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product administration error, product storage error, product temperature excursion issue and product use complaint are considered as listed as per company convention. Product administration error, product storage error, product temperature excursion issue and product use complaint are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.