Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3003852 | PO / MO |
Vivotif vaccine was stored at approximately 70 Fahrenheit degrees for at least 24 hours and the patient already started treatment; Vivotif vaccine was stored at approximately 70 Fahrenheit degrees for at least 24 hours and the patient already started treatment; Case reference number US-BN-2024-001777 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0668) on 05-Apr-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, as reported, the patient left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. As reported, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated (explicitly coded as 'product storage error'). On an unspecified date, the patient took the first dose of Vivotif (batch number: 3003852), at unknown dose, orally for unknown indication (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 left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. Reportedly, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated which is considered as product storage error. The patient took the first dose of Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both considered listed per company conventions. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. Reportedly, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated which is considered as product storage error. The patient took the first dose of Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both considered listed per company conventions. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None