Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004007 | PO / MO |
Patient took one capsule of Vivotif, and Vivotif left out of fridge for 48 hours at max temperature of 68 degrees Fahrenheit and then patient took second dose; Patient took one capsule of Vivotif, and Vivotif left out of fridge for 48 hours at max temperature of 68 degrees Fahrenheit and then patient took second dose; Case reference number US-BN-2024-001828 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0824) on 23-Apr-2023 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, as reported patient came back home from pharmacy and patient took first dose of Vivotif vaccine (batch number: 3004007), at unknown dose (capsule), orally, for indication reported taken prior to travel. Patient left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit (explicitly coded as 'product storage error temperature too high). On unspecified date, as reported two days after first dose, patient took second dose of Vivotif vaccine (batch number: 3004007), at unknown dose (capsule), orally (explicitly coded as 'product administration error'). At the time of 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 left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit, which is considered as product storage error temperature too high. On unspecified date, as reported two days after first dose, the patient took the second dose of Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration 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 left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit, which is considered as product storage error temperature too high. On unspecified date, as reported two days after first dose, the patient took the second dose of Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration 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