Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient left Vivotif capsules out for two weeks on a maximum temperature of 70 Fahrenheit and took one capsule after excursion; The patient left Vivotif capsules out for two weeks on a maximum temperature of 70 Fahrenheit and took one capsule after excursion; The patient left Vivotif capsules out for two weeks on a maximum temperature of 70 Fahrenheit and took one capsule after excursion; Case reference number US-BN-2025-01016 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV25-1327) on 05-Jun-2025 and concerns a 42-years-old male patient. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, the patient left Vivotif capsules out for two weeks on a maximum temperature of 70 Fahrenheit (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 05-Jun-2025, the patient took first dose of affected Vivotif vaccine (batch number: unknown), orally at unknown dose as pre-travel immunisation (explicitly coded as '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 42-years-old male patient left Vivotif capsules out for two weeks on a maximum temperature of 70 Fahrenheit which is considered as product storage error and product temperature excursion issue. The patient took first dose of affected Vivotif vaccine, oally at unknown dose as pre-travel immunisation which is considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 42-years-old male patient left Vivotif capsules out for two weeks on a maximum temperature of 70 Fahrenheit which is considered as product storage error and product temperature excursion issue. The patient took first dose of affected Vivotif vaccine, oally at unknown dose as pre-travel immunisation which is considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.