Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004171 | PO / MO |
A little bit of body aches; Hot behind eyes; Low energy; A little bit of tiredness; Slight headache; Case reference number US-BN-2025-001053 is a spontaneous case initially received from consumer via Communications (reference number: USBAV25-1374) on 11-Jun-2025 and concerns a 67-years-old female patient. The patient's medical history includes ehrlichiosis, a blood infection from a tick, also had cytomegalovirus (CMB) but not Epstein-Barr virus (EVB). The patient's concomitant medication details were not provided. On 05-Jun-2025, the patient took the first dose of Vivotif (batch number: 3004171) at unknown dose orally for indication typhoid immunization. On 07-Jun-2025, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004171) at unknown dose, orally. On 09-Jun-2025, four days after the first dose, the patient took the third dose of Vivotif (batch number: 3004171) at unknown dose, orally. On 11-Jun-2025, six days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004171) at unknown dose, orally. On an unspecified date, unknown time after the Vivotif administration, the patient presenting symptoms such as a little bit of body aches, a little bit of tiredness, complained about it was hot behind eyes, and maybe a slight headache, low energy. Tried to get a blood test to see if there could any findings. At the time of the initial report, it was unknown if the patient recovered from the events of 'general body pain', 'tiredness', 'headache' and 'energy decreased' and 'warmness in eyes'. The reporter assessed the events of 'general body pain', 'tiredness', 'headache', 'energy decreased' and 'warmness in eyes' as non-serious and possibly related to Vivotif. No further information was provided.; Reporter's Comments: This case concerns a 67-years-old female patient, who experienced non-serious events of pain, abnormal sensation in eye, asthenia, fatigue and headache after unspecified date and time after vaccination with the fourth dose of Vivotif for an indication of typhoid immunization. Fatigue and headache are listed and expected for Vivotif per CCDS v8 and USPI. Pain and abnormal sensation in eye are unlisted and unexpected for per CCDS v8 and USPI. Asthenia is listed per CCDS v8 and unexpected per USPI. The patient's medical history includes ehrlichiosis, a blood infection from a tick, also had cytomegalovirus (CMB) but not Epstein-Barr virus (EVB) and concomitant medication details were not provided. At the time of the initial report, it was unknown if the patient recovered from the events. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: This case concerns a 67-years-old female patient, who experienced non-serious events of pain, abnormal sensation in eye, asthenia, fatigue and headache after unspecified date and time after vaccination with the fourth dose of Vivotif for an indication of typhoid immunization. Fatigue and headache are listed and expected for Vivotif per CCDS v8 and USPI. Pain and abnormal sensation in eye are unlisted and unexpected for per CCDS v8 and USPI. Asthenia is listed per CCDS v8 and unexpected per USPI. The patient's medical history includes ehrlichiosis, a blood infection from a tick, also had cytomegalovirus (CMB) but not Epstein-Barr virus (EVB) and concomitant medication details were not provided. At the time of the initial report, it was unknown if the patient recovered from the events. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
Medical History/Concurrent Conditions: Cytomegalovirus syndrome (CMB but not EVB.); Ehrlichia canis infection; Tick-borne fever