Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
Patient took three doses of Vivotif vaccine that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days; Patient took three doses of Vivotif vaccine that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days; Case reference number US-BN-2024-000096 is a spontaneous case report initially received from a physician via Med Communication (reference number: USBAV24-0151) on 23-Jan-2024 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took first, second and third dose of Vivotif (batch number: unknown), at a dose reported as one capsule, orally, for unknown indication. It was reported that patient took three capsules of Vivotif vaccine from the box that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days (explicitly coded as 'product storage error' and 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided. Non-significant case correction performed on 09-Feb-2024 for the information received on 24-Jan-2024 included: additional reference numbers.; Reporter's Comments: A female patient of unspecified age took three capsules of Vivotif vaccine for unknown indication, from the box that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error have been considered as 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 took three capsules of Vivotif vaccine for unknown indication, from the box that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None