Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
Patient started immunization course with unrefrigerated Vivotif vaccine, maximum temperature was below 77 degrees of Fahrenheit for 24 hours; Patient started immunization course with unrefrigerated Vivotif vaccine, maximum temperature was below 77 degrees of Fahrenheit for 24 hours; Case reference number US-BN-2024-001897 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV24-0985) on 09-May-2024 and concerns a patient of unspecified age or gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient started immunization course with unknown number of doses of Vivotif (batch number: unknown), at an unknown dose or route of administration, for unknown indication. As reported, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours (explicitly coded as 'product storage error temperature too high' and '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 provided.; Reporter's Comments: A patient of unspecified age or gender started immunization course with unknown number of doses of Vivotif, at an unknown dose or route of administration, for unknown indication. Reportedly, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours which is considered as product storage error temperature too high and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age or gender started immunization course with unknown number of doses of Vivotif, at an unknown dose or route of administration, for unknown indication. Reportedly, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours which is considered as product storage error temperature too high and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None