Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient took the first dose of Vivotif vaccine which was kept out of the refrigerator for about one week; The patient took the first dose of Vivotif vaccine which was kept out of the refrigerator for about one week; Case reference number US-BN-2024-002133 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1448) on 24-Jun-2024 and concerns a 14-year-old male patient. The patient's medical history and concomitant medication were not provided. On 23-Jun-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown) at dose of one capsule, orally for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge for five days, from 17-Jun-2024 (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 14-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and the vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error 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 14-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and the vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None