Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patients took Vivotif every other day with food instead of taking it on empty stomach; Case reference number US-BN-2024-002412 is a spontaneous case report initially received from a consumer via Emergent BioSolutions (reference number: EMG2024-928) on 29-Aug-2024 and concerns two patients unspecified age, husband and wife. The patients' medical history and concomitant medication details were not provided. On an unspecified date, reported as every other day, the patients took the first, second, third and fourth dose of Vivotif vaccine (batch number: unknown), at a dose of capsule, orally, for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach (explicitly coded as ' Product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from Med Communications on 29-Aug-2024, at 09:04, included additional reference number, route of Vivotif administration, dosage, and patients' details. Additional information received from Med Communications on 29-Aug-2024, at 09:05 included additional reference number.; Reporter's Comments: Two patients of unspecified age, husband and wife took the first, second, third and the fourth dose of Vivotif vaccine for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two patients of unspecified age, husband and wife took the first, second, third and the fourth dose of Vivotif vaccine for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE