Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
In the box of Vivotif was only two pills instead of four, because of that patient delayed the third dose; In the box of Vivotif was only two pills instead of four, because of that patient delayed the third dose; Case reference number US-BN-2024-001884 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0965) on 08-May-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication was not provided. On an unspecified date, as reported, the patient bought vaccine to travel but in the box there was only two pills instead of four (explicitly coded as 'Package dosage units missing') On unspecified dates, the patient took first and second dose off Vivotif (batch number: unknown), orally, at an unknown dose, for unknown indication. On unspecified date, unknown amount of time after first dose of Vivotif, as reported, the patient missed a dose last night and today the patient took third dose of Vivotif (batch number: unknown), orally, at an unknown dose (explicitly coded as 'Inappropriate schedule of vaccine administered'). 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 bought vaccine to travel but in the box, there was only two pills instead of four, which is considered as package dosage units missing. Reportedly, the patient missed a dose last night and today the patient took third dose of Vivotif after the patient took the first and the second dose of Vivotif for unknown indication, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product packaging quantity issue and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product packaging quantity issue and inappropriate schedule of product administration 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 of unspecified age bought vaccine to travel but in the box, there was only two pills instead of four, which is considered as package dosage units missing. Reportedly, the patient missed a dose last night and today the patient took third dose of Vivotif after the patient took the first and the second dose of Vivotif for unknown indication, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product packaging quantity issue and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication was not provided. Product packaging quantity issue and inappropriate schedule of product administration have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None