Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004045 | PO / MO |
The patient took the first dose of Vivotif vaccine which was out of refrigerator for less than 48 hours; The patient took the first dose of Vivotif vaccine which was out of refrigerator for less than 48 hours; Case reference number US-BN-2024-002667 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2782) on 21-Oct-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as on Friday night, the patient picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours (explicitly coded as 'product storage error'). On 20-Oct-2024, reported as on Sunday morning, the patient took the first dose of affected Vivotif (batch number: 3004045), at a dose of one capsule, orally, for indication reported as pretravel in November (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. Non-significant follow-up was downloaded from VAERS on 09-May-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20241021-1c46b8 to US-BAVARIAN NORDIC A/S-US-BN-2024-002667, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unspecified age picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours which is considered as product storage error. The patient took the first dose of affected Vivotif, at a dose of one capsule, orally, for indication reported as pretravel in November which is considered as 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 the Vivotif vaccination. 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 unspecified age picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours which is considered as product storage error. The patient took the first dose of affected Vivotif, at a dose of one capsule, orally, for indication reported as pretravel in November which is considered as 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 the Vivotif vaccination. 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