Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004298 | PO / MO |
being super shaky; Hot flashes; chills; super weak; the patient had really bad nausea, along with the headache; the patient had really bad nausea, along with the headache; Migraine; head was pounding; Case reference number US-BN-2025-000963 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV25-1178) on 21-May-2025 and concerns female patient (DOB: XX-Jan-2002). The patient's medical history and concomitant medication details were not provided. On 18-May-2025, the patient took first dose of Vivotif (batch number: 3004298), at unknown dose, orally for unknown indication. On 19-May-2025, the patient had a severe migraine, and patient head was 'pounding' and could not get out of bed and had to stay in a dark room all day. On 20-May-2025, the patient took second dose of Vivotif (batch number: 3004298), at unknown dose, orally. On unspecified date, reported as yesterday, the patient had really bad nausea, along with headache. On unspecified date, reported as today, the patient had same thing. Patient also reported being super shaky, super weak, having chills and hot flashes. On an unspecified date, the patient took aspirin for the headache. At the time of the initial report, it was unknown if the patient recovered from the events of 'migraine', 'headache', 'nausea', 'nervousness', 'weakness', 'chills' and 'hot flashes'. The reporter assessed the events of 'migraine', 'headache', 'nausea', 'nervousness', 'weakness', 'chills' and 'hot flashes' as non-serious. The reporter assessed the events of 'migraine', 'headache', 'nausea', 'nervousness', 'weakness', 'chills' and 'hot flashes' as possibly related to Vivotif. No further information was provided.; Reporter's Comments: A female patient (DOB: XX-Jan-2002) experienced non-serious events of migraine, head was pounding, could not get out of bed and had to stay in a dark room all day, on the day 1 after the patient took the first dose of Vivotif for unknown indication. On unspecified date after the patient took the second dose of Vivotif, the patient experienced non-serious events of nausea along with headache. Also, on unspecified date, the patient had same thing, and the patient experienced non-serious events of super shaky, super weak, having chills and hot flashes. Nausea and headache are listed and expected for Vivotif per CCDS v8 and USPI, whilst migraine, nervousness and hot flush are unlisted and unexpected. Chills and asthenia are listed and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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 (DOB: 19-Jan-2002) experienced non-serious events of migraine, head was pounding, could not get out of bed and had to stay in a dark room all day, on the day 1 after the patient took the first dose of Vivotif for unknown indication. On unspecified date after the patient took the second dose of Vivotif, the patient experienced non-serious events of nausea along with headache. Also, on unspecified date, the patient had same thing, and the patient experienced non-serious events of super shaky, super weak, having chills and hot flashes. Nausea and headache are listed and expected for Vivotif per CCDS v8 and USPI, whilst migraine, nervousness and hot flush are unlisted and unexpected. Chills and asthenia are listed and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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