Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
The patient left Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit; The patient left Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit; Case reference number US-BN-2024-001746 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0616) on 01-Apr-2024 and concerns a 43-years-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit. On 01-Apr-2024, the patient took the first dose of Vivotif (batch number: unknown), orally, at unknown dose or site administration for unknown indication (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. Additional information received from health care professional via Med Communications on 02-Apr-2024 included clarification about the age of patient.; Reporter's Comments: A 43-year-old female patient took the first dose of Vivotif, after the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit, for unknown indication, 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 43-year-old female patient took the first dose of Vivotif, after the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit, for unknown indication, 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