Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 5 | 3003852 | PO / MO |
The patient took first dose of Vivotif vaccine with food; The patient received five doses of Vivotif; Patient experienced nausea after first dose of Vivotif; Case reference number US-BN-2024-000178 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0311) on 13-Feb-2024 and concerns a 62-years old male patient. The patient had no medical history and concomitant medications. On 13-Feb-2024, the patient took the first dose of Vivotif vaccine (batch number: 3003852, expiration date: 31-Mar-2024), one capsule, administered orally, for typhoid immunization. As reported, the patient took a dose of Vivotif vaccine with *meal* (explicitly coded as 'product administration error'). On the same day, as reported immediately after the eating, the patient experienced mild nausea. *On 13-Feb-2024, as reported within a few hours after taking Vivotif,* the patient recovered from the event of nausea. On 15-Feb-2024, three days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally. On 17-Feb-2024, five days after the first dose of Vivotif, the patient took the third dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally. On 19-Feb-2024, seven days after the first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally. On 21-Feb-2024, nine days after the first dose of Vivotif, the patient took the fifth dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally (explicitly coded as 'vaccine overdose'). It was reported that the patient completed the series and there were no adverse event reactions with subsequent doses taken one hour before meal. *As reported, the reporter was not aware of the sequence of lot numbers as the medication was self-administered and only dose lot number which with certainty taken was the first dose.* The reporter assessed the event of nausea as non-serious, and probably related to Vivotif. Additional information received from a nurse via Med Communications (reference number: USBAV24-0315) on 14-Feb-2024 included additional reporter, indication, expiration date, batch number of Vivotif vaccine, and additional reference number. Additional information received from a nurse on 15-Feb-2024 included confirmation of patient details and event details. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from nurse on 22-Feb-2024: New information included volume of the dose, patient initials and date of birth, confirmation that patient had no medical history and concomitant medication and that the patient experienced nausea. Follow-up received from the reporter on 04-Mar-2024: New information included details about additional doses of Vivotif, duration, seriousness, severity, and causality assessment for the event of nausea, and additional 'vaccine overdose'. Follow-up received from the reporter on 21-Mar-2024: New information included details about duration of the event of nausea, confirmation that reporter was not aware of the sequence of lot numbers for each dose separately and confirmation of batch number for the first dose of Vivotif.; Reporter's Comments: A 62-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient took a dose of Vivotif vaccine with food, which is considered as product administration error. On the same day, as reported immediately after the eating, the patient experienced mild nausea (non-serious event) which was resolved after couple of hours. Nine days after the first dose of Vivotif, the patient took the fifth dose of Vivotif, one capsule, orally which is considered as vaccine overdose. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI. Product administration error and overdose are both considered as listed per company convention. The patient had no medical history and concomitant medications. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the event of nausea has been considered as related to Vivotif. Product administration error and overdose are both assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 62-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient took a dose of Vivotif vaccine with food, which is considered as product administration error. On the same day, as reported immediately after the eating, the patient experienced mild nausea (non-serious event) which was resolved after couple of hours. Nine days after the first dose of Vivotif, the patient took the fifth dose of Vivotif, one capsule, orally which is considered as vaccine overdose. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI. Product administration error and overdose are both considered as listed per company convention. The patient had no medical history and concomitant medications. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the event of nausea has been considered as related to Vivotif. Product administration error and overdose are both assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.