Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004368 | — |
The patient took Vivotif every day; Vivotif was never kept in refrigerator; Vivotif was never kept in refrigerator; Vivotif was never kept in refrigerator; Case reference number US-BN-2025-001901 is a spontaneous case initially received from consumer via Bavarian Nordic (reference number: CASE-001023) on 03-Dec-2025 and concerns a patient of unknown gender and age. The patient's medical history and concomitant medication details were not provided. On unknown dates, the patient took the Vivotif (batch number: 3004368, expiration date: Oct-2026) every day at an unknown dose and route of administration for an unknown indication. As reported the patient took the Vivotif every day and never kept the Vivotif in refrigerator (explicitly coded as 'inappropriate schedule of vaccine administered', product temperature excursion issue', product storage error', product administration error'. The reporter also stated that the capsules of Vivotif had never been put in refrigerator. At the time of the initial report, it was unknown if the patient experienced any adverse events due to the Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unknown gender and age took the Vivotif for an unknown indication. As reported the patient took the Vivotif every day and never kept the Vivotif in refrigerator, which is considered as inappropriate schedule of vaccine administered, product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to the Vivotif vaccine. Inappropriate schedule of vaccine administered, product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. Inappropriate schedule of vaccine administered, 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 patient of unknown gender and age took the Vivotif for an unknown indication. As reported the patient took the Vivotif every day and never kept the Vivotif in refrigerator, which is considered as inappropriate schedule of vaccine administered, product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to the Vivotif vaccine. Inappropriate schedule of vaccine administered, product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. Inappropriate schedule of vaccine administered, 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.