Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The patient took fourth dose of Vivotif vaccine which had 12 hours temperature excursion was below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees; The patient took fourth dose of Vivotif vaccine which had 12 hours temperature excursion was below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees; Case reference number US-BN-2024-001906 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number USBAV24-1019) on 13-May-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, reported as every other day, the patient took the first, second and third dose of Vivotif (batch number: unknown), at unknown dose or route of administration, for typhoid immunization. On an unspecified date, as reported the patient packed the last capsule in thermos with ice at the bottom and the fourth dose was as reported compromised. As reported, the temperature excursion was 12 hours, below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees (explicitly coded as 'product storage error'). On an unspecified date, reported as every other day, the patient took the fourth dose of Vivoitf (batch number: unknown), at unknown dose or route of administration (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 female patient of unspecified age took the fourth dose of Vivoitf for typhoid immunization, after as reported the patient packed the last capsule in thermos with ice at the bottom and the fourth dose was as reported compromised. As reported, the temperature excursion was 12 hours, below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees, 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 female patient of unspecified age took the fourth dose of Vivoitf for typhoid immunization, after as reported the patient packed the last capsule in thermos with ice at the bottom and the fourth dose was as reported compromised. As reported, the temperature excursion was 12 hours, below 35.6 Fahrenheit degrees but not below minus four Fahrenheit degrees, 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