Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
The patient got sick with flu and pneumonia; The patient got sick with flu and pneumonia; The patient did not resume Vivotif for two to three weeks after she recovered from her illness, but she did complete the series; Case reference number US-BN-2024-002525 is a spontaneous case initially received from pharmacist via Communications (reference number USBAV24-2444) on 19-Sep-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 the patient took the first dose of Vivotif vaccine (batch number: unknown), the dose was unknown, orally, for typhoid immunization. On an unspecified date, unknown amount of time after vaccination with Vivotif, the patient got sick with the flu and pneumonia. On an unspecified date, reported as two or three days later the patient started treatment with unspecified antibiotic. On an unspecified date, two or three weeks later, the patient recovered from flu and pneumonia, reported as recovered from illness. On an unspecified dates, as reported the patient did not resume Vivotif for two to three weeks after the patient recovered from illness, but the patient did complete the series the Vivotif vaccination (batch number: unknown), the dose, route or site of administration were unknown (explicitly coded as 'Inappropriate schedule of vaccine administered'). The reporter assessed the events of flu and pneumonia as non-serious, however the event of pneumonia was assessed as serious due to criteria of medically significance. Causality assessment for both events was assessed as possibly related to Vivotif. No further information was provided. Non-significant case correction received from VAERS on 04-Nov-2024 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240919-815382 to US-BAVARIAN NORDIC A/S-US-BN-2024-002525, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unspecified age got sick with the flu and pneumonia (medical significance) on an unspecified date, unknown amount of time after the patient took the first dose of Vivotif vaccine for typhoid immunization. The patient did not resume Vivotif for two to three weeks after she recovered from her illness, but she did complete the series, which is considered as inappropriate schedule of product administration. Pneumonia and influenza are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.; Sender's Comments: A female patient of unspecified age got sick with the flu and pneumonia (medical significance) on an unspecified date, unknown amount of time after the patient took the first dose of Vivotif vaccine for typhoid immunization. The patient did not resume Vivotif for two to three weeks after she recovered from her illness, but she did complete the series, which is considered as inappropriate schedule of product administration. Pneumonia and influenza are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to medical significance.
Comments: None