Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient was feeling a little woozy; The patient took four Vivotif vaccine capsules, after meals, but Vivotif was not refrigerated.; The patient took four Vivotif vaccine capsules, after meals, but Vivotif was not refrigerated.; Case reference number US-BN-2024-002400 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-2111) on 26-Aug-2024, and concerns a 75-year-old patient, unspecified gender. The patient's medical history was not provided, reported that the patient was in good health. The patient's concomitant medication details were not reported. On an unspecified date, reported as one every other day for four days, after meals, the patient took the four Vivotif (batch number: unknown) capsules, at an unknown dose, orally, for typhoid immunization. The patient didn't notice it had to be refrigerated (explicitly coded as 'product storage error' and 'product administration error'). On an unspecified date, the patient experienced a feeling of a little woozy. At the time of the initial report, it was unknown if the patient had recovered from the woozy event. The reporter assessed the event of woozy as not serious and possibly related to Vivotif. Additional information received from healthcare professional via agency on 27-Aug-2024 included additional reference number and additional reporter. 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-20240826-2bfea1 to US-BAVARIAN NORDIC A/S-US-BN-2024-002400, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 75-year-old patient of unspecified gender didn't notice that Vivotif had to be refrigerated when taking the four Vivotif capsules, (at an unknown dose, orally, for typhoid immunization) which is considered as product storage error and product administration error. Unknown time after starting suspect product the patient experienced a feeling of a little woozy. Product storage error and product administration error are both considered listed per company conventions. Dizziness is listed according to CCDS v8 however unexpected according to USPI. At this point, it was unknown if the patient had recovered from dizziness. The patient's medical history was not provided, reported that the patient was in good health and concomitant medication details were not reported. Dizziness is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. 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 75-year-old patient of unspecified gender didn't notice that Vivotif had to be refrigerated when taking the four Vivotif capsules, (at an unknown dose, orally, for typhoid immunization) which is considered as product storage error and product administration error. Unknown time after starting suspect product the patient experienced a feeling of a little woozy. Product storage error and product administration error are both considered listed per company conventions. Dizziness is listed according to CCDS v8 however unexpected according to USPI. At this point, it was unknown if the patient had recovered from dizziness. The patient's medical history was not provided, reported that the patient was in good health and concomitant medication details were not reported. Dizziness is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. 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. USBAV24-2111:
Comments: NONE