Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3003907 | PO / MO |
The reporter took first dose of Vivotif which was three days in the counter, maximum temperature reached 70 Fahrenheit; The reporter took first dose of Vivotif which was three days in the counter, maximum temperature reached 70 Fahrenheit; Case reference number US-BN-2024-000665 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0547) on 21-Mar-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. As reported, the reporter took Vivotif from pharmacy which prescribed by doctor, nobody said anything that needed to be refrigerated, so for first three days Vivotif was sitting on the counter. Maximum temperature reached 70 Fahrenheit. On 20-Mar-2024, the patient took the first dose of Vivotif (batch number: 3003907), at an unknown dose, orally, for typhoid immunization (explicitly coded as 'Product administration error' and 'Product storage 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 male patient of unspecified age took the first dose of Vivotif, which was for first three days sitting on the counter (maximum temperature reached 70 Fahrenheit), for typhoid immunization, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage 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 male patient of unspecified age took the first dose of Vivotif, which was for first three days sitting on the counter (maximum temperature reached 70 Fahrenheit), for typhoid immunization, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage 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