Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 5 | 3004343 | — |
Patient administered one dose of Vivotif which was unrefrigerated; Patient administered one dose of Vivotif which was unrefrigerated; Patient administered one dose of Vivotif which was unrefrigerated; The patient took second, third, fourth and fifth dose of Vivotif two weeks after fist dose; The patient took nine doses of Vivotif; after the first three pills of new Vivotif capsules, the patient experienced nausea and lightheadedness; after the first three pills of new Vivotif capsules, the patient experienced nausea and lightheadedness; Case reference number US-BN-2025-001748 is a spontaneous case initially received from a consumer via Bavarian Nordic Safety (case number CASE-000529) on 30-Oct-2025 and concern a 60-years-old female patient. The patient's *concurrent medical history included high blood pressure and cholesterol* The patient's concomitant medication details *included pravastatin (Brand name: unknown) for cholesterol and high blood pressure medication. The patient reported that she was taking a lot of medications.* On unspecified date, patient did not refrigerate Vivotif vaccine. (explicitly coded as Product temperature excursion issue', Product storage issue'). On *31-Oct-2025*, the patient administered one first (one pill which was unrefrigerated) dose of Vivotif (batch number: 3004343; expiration date: unknown) one pill, orally for travelling. (explicitly coded as Product administration error ). On 10-Nov-2025 *(to be confirmed, also reported on 24-Nov or 26-Nov), two weeks after the first dose, the patient took the second dose of Vivotif (batch number: unknown), unknown dose, one pill on each date orally for travelling (explicitly coded as 'inappropriate schedule of vaccine administered'). On 12-Nov-2025, two weeks after the first dose and two days after the second dose the patient took the third dose of Vivotif (batch number: unknown), unknown dose, one pill on each date orally for travelling (explicitly coded as 'inappropriate schedule of vaccine administered'). On an unspecified date, after the first three pills of new Vivotif capsules, the patient experienced nausea and lightheadedness and it was not serious, it was just irritating. On 14-Nov-2025, two weeks after the first dose and two days after the third dose the patient took the fourth dose of Vivotif (batch number: unknown), unknown dose, one pill on each date orally for travelling (explicitly coded as 'inappropriate schedule of vaccine administered'). On 16-Nov-2025, two weeks after the first dose and two days after the fourth dose the patient took the fifth dose of Vivotif (batch number: unknown), unknown dose, one pill on each date orally for travelling (explicitly coded as 'extra dose administered' and 'inappropriate schedule of vaccine administered'). On an unspecified date, *reported as after about five days in total after event onset*, the patient recovered from the event of 'nausea' and 'lightheadedness', as reported the patient was fine and did not have any of these symptoms. *It was reported that the patient did not receive treatment for the events.* The report assessed events 'nausea' and 'lightheadedness' as non-serious and *certainly related to Vivotif* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from the consumer on 17-Dec-2025: New information included Vivotif dosing details and indication. The patient age was added. New events of nausea and lightheadedness were added with other details. Follow up information received from the consumer on 14-Jan-2026: New information included Vivotif dosing information, concomitant medication, medical history, treatment details, event duration, outcome, causality, severity.; Reporter's Comments: This case concerns a 60-years-old female patient. As reported patient administered one dose of Vivotif vaccine, which was not refrigerated, for an indication of travelling, which is considered as product temperature excursion issue, product storage error and product administration error. As reported patient, took second dose after two weeks from the first dose, which is considered as inappropriate schedule of product administered. Patient experienced non serious events of dizziness and nausea after the third dose of Vivotif. Also, patient took fifth dose, which is an extra dose administered. Nausea is listed as per CCDS v9 and expected per USPI, whilst dizziness is listed and unexpected. Product temperature excursion issue, product storage error, inappropriate schedule of product administered, extra dose administered and product administration error are considered as listed per company convention. The patient's medical history included high blood pressure and cholesterol, and concomitant medication details includes pravastatin. Outcome is recovered. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported events (dizziness and nausea), is assessed as possibly related to suspect. Product temperature excursion issue, product storage error, inappropriate schedule of product administered, extra dose administered and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a 60-years-old female patient. As reported patient administered one dose of Vivotif vaccine, which was not refrigerated, for an indication of travelling, which is considered as product temperature excursion issue, product storage error and product administration error. As reported patient, took second dose after two weeks from the first dose, which is considered as inappropriate schedule of product administered. Patient experienced non serious events of dizziness and nausea after the third dose of Vivotif. Also, patient took fifth dose, which is an extra dose administered. Nausea is listed as per CCDS v9 and expected per USPI, whilst dizziness is listed and unexpected. Product temperature excursion issue, product storage error, inappropriate schedule of product administered, extra dose administered and product administration error are considered as listed per company convention. The patient's medical history included high blood pressure and cholesterol, and concomitant medication details includes pravastatin. Outcome is recovered. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported events (dizziness and nausea), is assessed as possibly related to suspect. Product temperature excursion issue, product storage error, inappropriate schedule of product administered, extra dose administered and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Medical History/Concurrent Conditions: Blood pressure high; Cholesterol
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