Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
Lethargic; Chills; Not feeling that great; The patient was not aware that Vivotif need to be refrigerated and took the first dose; The patient was not aware that Vivotif need to be refrigerated and took the first dose; The patient was not aware that Vivotif need to be refrigerated and took the first dose; The patient took only one dose of Vivotif vaccine; Case reference number US-BN-2025-000160 is a spontaneous case initially received from consumer via Communications (reference number: USBAV25-0178) on 23-JAN-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided On an unspecified date, as reported, the patient was not aware that Vivotif needs to be refrigerated (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 20-Jan-2025, after three or four days, on day zero, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose reported as one out of four capsules, orally for travelling. As reported, the patient received one dose of Vivotif (explicitly coded as 'incomplete course of vaccination' and 'product administration error'). On an unspecified date, unknown of time after Viviotif vaccine, the patient was not feeling that great, had chills and was lethargic. At the time of the initial report, it was unknown if the patient recovered from the events of 'feeling unwell', chills and lethargic. ' The reporter assessed the events of 'feeling unwell', chills and lethargic as non-serious and possibly related to the product of Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age was not aware that Vivotif needs to be refrigerated, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of Vivotif, reported as one out of four capsules for travelling. As reported, the patient received one dose of Vivotif, which is considered as incomplete course of vaccination and product administration error. On an unspecified date, an unknown of time after Viviotif vaccine, the patient experienced non-serious events of not feeling that great, had chills and was lethargic. Chills and malaise are listed for Vivotif per CCDS v8 and unexpected per USPI, whilst lethargy is unlisted and unexpected. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age was not aware that Vivotif needs to be refrigerated, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of Vivotif, reported as one out of four capsules for travelling. As reported, the patient received one dose of Vivotif, which is considered as incomplete course of vaccination and product administration error. On an unspecified date, an unknown of time after Viviotif vaccine, the patient experienced non-serious events of not feeling that great, had chills and was lethargic. Chills and malaise are listed for Vivotif per CCDS v8 and unexpected per USPI, whilst lethargy is unlisted and unexpected. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. Product administration error, product storage error, product temperature excursion issue and incomplete course of vaccination are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.