Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004008 | PO / MO |
The patient took third dose of Vivotif which left in his envelope in car overnight about 26 hours; The patient took third dose of Vivotif which left in his envelope in car overnight about 26 hours; Case reference number US-BN-2024-001941 is a spontaneous case report initially received from other health care professional via Med Communications (reference number USBAV24-1122) on 22-May-2024 and concerns a 19-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 18-May-2024, the patient took the first dose of Vivotif (batch number: 3004008), at unknown dose, orally, for unknown indication reported as pre travel. On 20-May-2024, two days after first dose of Vivoitf, the patient took the second dose of Vivotif (batch number: 3004008), at unknown dose, orally. On an unspecified date, as reported, the patient left in car Vivotif with his envelope overnight for about 26 hours, the temperature was cool but was not at a normal refrigerated temperature (explicitly coded 'Product storage error'). On 22-May-2024, two days after second dose of Vivoitf, the patient took the third dose of Vivotif (batch number: 3004008), at unknown dose, orally (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 19-year-old male patient left in car Vivotif with his envelope overnight for about 26 hours (the temperature was cool but was not at a normal refrigerated temperature) which is considered as product storage error. Two days after second dose of Vivoitf, the patient took the third dose of Vivotif, at unknown dose, orally which is considered as product administration error. Product storage error and product administration error are both considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient left in car Vivotif with his envelope overnight for about 26 hours (the temperature was cool but was not at a normal refrigerated temperature) which is considered as product storage error. Two days after second dose of Vivoitf, the patient took the third dose of Vivotif, at unknown dose, orally which is considered as product administration error. Product storage error and product administration error are both considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None