Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient received first dose of Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated; The patient received first dose of Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated; Case reference number US-BN-2024-002912 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-3349) on 19-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. As reported, the patient is travelling in two weeks and had left the Vivotif in the counter for 2 weeks. On unspecified date, the patient received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated (batch number: unknown) at a dose of one capsule, orally, for indication reported as travelling (explicitly coded as product storage error temperature too high', and '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 unknown age received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated, at a dose of one capsule, orally, for indication reported as travelling 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 medical history and concomitant medication details 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 female patient of unknown age received first dose of defected Vivotif capsule when it had been in the counter for about a week and a half and then skipped a day and took second dose without being refrigerated, at a dose of one capsule, orally, for indication reported as travelling 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 medical history and concomitant medication details 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