Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004007 | PO / MO |
The patient took second dose of Vivotif vaccine which was in refrigerator which stopped working no longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit.; The patient took second dose of Vivotif vaccine which was in refrigerator which stopped working no longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit.; Case reference number US-BN-2024-001903 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0998) on 09-May-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, the patient took first dose of Vivotif (batch number: 3004007), at unknown dose, orally, for unknown indication reported as pre travel. On an unspecified date, as reported in some point yesterday, the patient's refrigerator stopped working and the patient notice that in the morning, it was not longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit (explicitly coded as 'product storage error'). On 09-May-2024, an unknown amount of time after first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004007), at 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 event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient's (unspecified age) refrigerator stopped working and the patient noticed that in the morning, it was not longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit, which is considered as product storage error. Reportedly, the patient took the second dose of Vivotif for unknown indication reported as pre travel, 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 medical history and concomitant medication details 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's (unspecified age) refrigerator stopped working and the patient noticed that in the morning, it was not longer than 18 hours, the temperature did not get above 55 degrees Fahrenheit, which is considered as product storage error. Reportedly, the patient took the second dose of Vivotif for unknown indication reported as pre travel, 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 medical history and concomitant medication details 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.