Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
Patient experienced mild nausea after first, second and one hour after third dose of Vivotif.; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Case reference number US-BN-2024-002703 is a spontaneous case initially received from a physician via Med Communications (reference number: USBAV24-2858) on 30-Oct-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of Vivotif (batch number: unknown) one capsule, orally for travelling. On unspecified date, reported as after the first dose of Vivotif, patient experienced mild nausea. On unspecified date, unknown amount of time after the first dose, the patient took the second of Vivotif (batch number: unknown) one capsule, orally. On an unspecified date, reported as after second dose of Vivotif, the patient again experienced mild nausea. On 29-Oct-2024, unknown amount of time after the first dose, reported as yesterday, the patient took the third dose of Vivotif (batch number: unknown) one capsule, orally. On the same day, one hour after the third dose, the patient experienced nausea, short of breath, dizziness, muscle pain, muscle ache and patient was generally weak. As reported the patient did not seek or take any treatment. On an unspecified date, reported as today at 09:00 am, the patient recovered from the events nausea, short of breath, dizziness, muscle pain, muscle ache and weakness generalized, since it was reported that patient was completely back to normal. The reporter assessed the events of nausea, short of breath, dizziness, muscle pain and weakness generalized as non-serious and as possibly related to Vivotif. 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-20241030-e193ae to US-BAVARIAN NORDIC A/S-US-BN-2024-002703, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unspecified age experienced two episodes of a non-serious event of nausea on unspecified dates, reported as after the patient took the first and the second dose of Vivotif for travelling. Reportedly, on the day 0 after the third dose, the patient experienced non-serious events of nausea, short of breath, dizziness, muscle pain, muscle ache and the patient was generally weak. Nausea is listed and expected for Vivotif per CCDS v8 and USPI, whilst dyspnoea is unlisted and unexpected. Dizziness, myalgia and asthenia are listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age experienced two episodes of a non-serious event of nausea on unspecified dates, reported as after the patient took the first and the second dose of Vivotif for travelling. Reportedly, on the day 0 after the third dose, the patient experienced non-serious events of nausea, short of breath, dizziness, muscle pain, muscle ache and the patient was generally weak. Nausea is listed and expected for Vivotif per CCDS v8 and USPI, whilst dyspnoea is unlisted and unexpected. Dizziness, myalgia and asthenia are listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
Comments: None.