Received Jul 28, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| CHOL | CHOLERA (VAXCHORA) | PAXVAX | 2 | Unknown | PO / MO |
Adult patient took 50 ml of Vaxchora vaccine; The patient took additional dose of Vaxchora one week after the initial dose; Case reference number US-BN-2024-002211 is a spontaneous case initially received from a consumer via agency (reference number USBAV24-1709) on 18-Jul-2024 and concerns a *34-year-old* female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the dose of Vaxchora (batch number: unknown), at dose of 50 ml, orally, for indication *reported as cholera* (explicitly coded as 'vaccine underdose'). *On unspecified date, reported as week later, the patient took additional dose of Vaxchora (batch number: unknown), at a dose of 100 ml, via unknown route, after talking to a doctor (explicitly coded as 'extra dose administered'). *As reported, the patient did not experience any adverse event due to Vaxchora vaccine. * All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from consumer on 06-Sep-2024: New information included patient's exact age, indication for Vaxchora administration, additional Vaxhora administration due to which extra dose was coded and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 34-year-old female patient took the dose of Vaxchora, at dose of 50 ml, orally, for indication reported as cholera, which is considered as vaccine underdose. On unspecified date, reported as week later, the patient took additional dose of Vaxchora, at a dose of 100 ml, via unknown route, after talking to a doctor, which is considered as extra dose administered. Underdose and extra dose administered are considered listed per company convention. The patient did not experience any adverse event due to Vaxchora vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 34-year-old female patient took the dose of Vaxchora, at dose of 50 ml, orally, for indication reported as cholera, which is considered as vaccine underdose. On unspecified date, reported as week later, the patient took additional dose of Vaxchora, at a dose of 100 ml, via unknown route, after talking to a doctor, which is considered as extra dose administered. Underdose and extra dose administered are considered listed per company convention. The patient did not experience any adverse event due to Vaxchora vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None