Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient took one dose of Vivotif vaccine which left at room temperature for nine hours time frame, maximum temperature reached was temperature 62 Fahrenheit; The patient took one dose of Vivotif vaccine which left at room temperature for nine hours time frame, maximum temperature reached was temperature 62 Fahrenheit; Case reference number US-BN-2024-001870 is a spontaneous case report initially received from a physician via Med Communications (reference number USBAV24-0928) on 06-May-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit. (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 female patient of unspecified age took a dose of Vivotif for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details 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 a dose of Vivotif for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details 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