Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient took the third dose of Vivotif vaccine was stored at 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours; The patient took the third dose of Vivotif vaccine was stored at 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours; Case reference number US-BN-2024-001918 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-1046) on 14-May-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first and second dose of Vivotif (batch number: unknown), at an unknown, dose, orally, for unknown indication. On an unspecified date, the third dose of Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours (explicitly coded as 'Product storage error'). On unspecified date, an unknown amount of time after second dose of Vivotif, the patient took the affected third dose of Vivotif (batch number: unknown), at an 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 events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unknown age took the affected third dose of Vivotif for unknown indication after Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events 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 unknown age took the affected third dose of Vivotif for unknown indication after Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events 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