Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient took doses of Vivotif at room temperature, did not store in the refrigerator; The patient took doses of Vivotif at room temperature, did not store in the refrigerator; Case reference number US-BN-2024-001948 is a spontaneous case initially received from a health care professional via Med Communications (reference number: USBAV24-1145) on 24-May-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took doses of Vivotif (batch numbers: unknown), without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi (explicitly coded as 'product storage error' 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 unspecified age took doses of Vivotif, without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi which is considered as product storage error 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. 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 took doses of Vivotif, without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi which is considered as product storage error 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. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.