Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
The patient took one capsule of Vivotif and the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius; The patient took one capsule of Vivotif and the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius; Case reference number US-BN-2024-000079 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0114) on 18-Jan-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient took a dose of Vivotif (batch number: unknown), at a dose reported as one capsule, orally, for unknown indication. As reported, the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius (explicitly coded as 'product storage error' and 'product administration error'). At the time of this report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided. Non-significant case correction was received on 14-Feb-2024 from the reporter, included confirmation that they have no further information regarding this case.; Reporter's Comments: A female patient of unspecified age took a dose of Vivotif for unknown indication. As reported, the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius, which is considered as product storage error and 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 took a dose of Vivotif for unknown indication. As reported, the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius, which is considered as product storage error and 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