Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004368 | PO / MO |
The patient took second dose of Vivotif three days after the first dose; lower abdominal pain (worse she has experienced; worse than severe menstrual cramping; Intense abdominal cramping; Little bit of nausea; Case reference number US-BN-2025-001942 is a spontaneous case initially received from other health professional via Bavarian Nordic (reference number: CASE-001127) on 10-Dec-2025 and concerns a 28-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 08-Dec-2025, the patient took the first dose of Vivotif vaccine (batch number: 3004368), at one dosage form, via oral route * for traveling to high-risk region. * On the same day, one hour after taking Vivotif vaccine, the patient experienced intense abdominal cramping a little bit of nausea. As reported abdominal cramp was very painful more painful than menstrual cramps. There was no sign of diarrhea, vomiting and fever. It was reported that, the patient changed to AM dosing and was able to tolerate with only very mild cramping and after changing to AM dosing (empty stomach) nausea was much improved. The patient had no gastrointestinal (GI) issues prior to starting vaccine. It was reported that, the PM dosing before bedtime contributed to the events of abdominal cramps' and nausea'. On an unspecified date, twelve hours after the event onset, the patient was recovered from abdominal cramps. On 09-Dec-2025, one day after the first dose of Vivotif, the patient experienced lower abdominal pain (worse she has experienced; worse than severe menstrual cramping). On 11-Dec-2025, three days after the first dose, the patient took the second dose of Vivotif vaccine (batch number: 3004368), at one dosage form, via oral route * for traveling to high-risk region. * (explicitly coded as inappropriate schedule of vaccine administration'). On 13-Dec-2025, two days after the second dose, the patient took the third dose of Vivotif vaccine (batch number: 3004368), at one dosage form, via oral route * for traveling to high-risk region. * On 15-Dec-2025, two days after third dose, the patient took the fourth dose of Vivotif vaccine (batch number: 3004368), at one dosage form, via oral route * for traveling to high-risk region. * On an unspecified date, the patient recovered from the event abdominal cramping' and nausea' and * 'lower abdominal pain'* The reporter assessed events of abdominal cramps', nausea' and *lower abdominal pain as non-serious with moderate* intensity and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the event of lower abdominal pain'. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up received from other health professional via on 07-Jan-2026 via Bavarian Nordic: New information included patient initials and age, product dosing details, outcome for events abdominal cramps' and nausea, and severity were added. New events lower abdominal pain and inappropriate schedule of vaccine administration was added. Follow up received from other health professional on 15-Jan-2026 via Bavarian Nordic: New information included, Vivotif indication, and duration, outcome, severity details added for event lower abdominal pain. Additional information received from other health professional on 28-Jan-2026 included no further information available; Reporter's Comments: A 28-year-old female patient experienced non-serious events of abdominal pain and nausea on the same date, one hour after the patient took the first dose of Vivotif vaccine for traveling to high-risk region. Reportedly, one day after the first dose of Vivotif, the patient experienced a non-serious event of lower abdominal pain. The patient took the second dose three days after the first, third dose two days after the second and the fourth dose of Vivotif two days after the third, which is considered as inappropriate schedule of product administration. Abdominal pain and nausea are listed and expected for Vivotif per CCDS v9 and USPI, and abdominal pain lower is considered as listed and expected. 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 compatible temporal relationship, known vaccine safety profile and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.; Sender's Comments: A 28-year-old female patient experienced non-serious events of abdominal pain and nausea on the same date, one hour after the patient took the first dose of Vivotif vaccine for traveling to high-risk region. Reportedly, one day after the first dose of Vivotif, the patient experienced a non-serious event of lower abdominal pain. The patient took the second dose three days after the first, third dose two days after the second and the fourth dose of Vivotif two days after the third, which is considered as inappropriate schedule of product administration. Abdominal pain and nausea are listed and expected for Vivotif per CCDS v9 and USPI, and abdominal pain lower is considered as listed and expected. 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 compatible temporal relationship, known vaccine safety profile and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as related to the suspect vaccine. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. For regulatory reporting purposes, this case is considered related.
Comments: NONE.