Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004041 | — |
The patient took one dose of Vivotif vaccine which was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit; The patient took one dose of Vivotif vaccine which was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit; Case reference number US-BN-2024-001725 is a spontaneous case report initially received from a physician via Med Communications (reference number USBAV24-0574) on 27-Mar-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 was left one box of Vivotif vaccine at ambient temperature for six hours, maximum temperature was 68 Fahrenheit. On an unspecified date the patient took dose of Vivotif (batch number: 3004041), at unknown dose, reported as one pill, route or site administration for indication reported as 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 female patient of unspecified age took a dose of Vivotif, that was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit, for indication reported as immunization, which is considered as product administration error and product storage error. No associated adverse events were reported. Product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took a dose of Vivotif, that was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit, for indication reported as immunization, which is considered as product administration error and product storage error. No associated adverse events were reported. Product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.
Comments: None