Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 5 | 3004085 | PO / MO |
The patient received first dose of Vivotif on Friday and second dose on Saturday instead of Sunday, the third dose on day four, the forth dose on day six, and fifth dose on day eight; The patient took five doses of Vivotif vaccine as it was suggested to the patient not to count the first administered dose; Case reference number US-BN-2024-002866 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-3250) on 09-Dec-2024 and concerns a 55-year-old male patient. The patient had no relevant medical history and concomitant medication details were not provided. On 06-Dec-2024, reported as Friday, the patient received the first dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally, for indication reported as pre travel. On 07-Dec-2024, one day after the first dose of Vivotif, the patient received the second dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally. As reported the patient received second dose of Vivotif on Saturday instead of Sunday (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 09-Dec-2024, three days after the first dose of Vivotif, the patient received the third dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered').* *On 11-Dec-2024, five days after the first dose of Vivotif, the patient received the fourth dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered').* *On 13-Dec-2024, seven five days after the first dose of Vivotif, the patient received the fifth dose of Vivotif (batch number: 3004085, expiration date: Mar-2025), at a dose of one capsule, orally (explicitly coded as 'Extra dose administered').* As reported, the patient was instructed to receive the third dose of Vivotif on 09-Dec-2024, and to take the last dose on Wednesday 11-Dec-2024 to get back on schedule. *The patient was suggested to not count dose administered on 06-Dec-2024 and complete a four dose schedule because it was not skiped a day between first and second dose of Vivotif and following follow up information provided from Bavarian Nordic.* *At the time of this follow up, the patient did not experience any adverse events due to Vivotif vaccine.* All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from the reporter on 23-Dec-2024, new information included: patient details, Vivotif dosing information for the third, fourth and fifth dose, batch number and expiration date for the first and second dose of Vivotif, confirmation that the patient did not experience any adverse events due to Vivotif vaccine.; Reporter's Comments: A 55-year-old male patient received the second dose of Vivotif, for indication reported as pre travel, one day after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Three days after the first dose, of Vivotif, the patient received the third dose of Vivotif at a dose of one capsule, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose of Vivotif, the patient received the fourth dose of Vivotif, at a dose of one capsule, orally which is also considered as inappropriate schedule of vaccine administered. Seven five days after the first dose of Vivotif, the patient received the fifth dose of Vivotif, at a dose of one capsule, orally which is considered as extra dose administered. Inappropriate schedule of product administration and extra dose administered are both considered as listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif vaccine. The patient had no relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and extra dose administered are assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 55-year-old male patient received the second dose of Vivotif, for indication reported as pre travel, one day after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Three days after the first dose, of Vivotif, the patient received the third dose of Vivotif at a dose of one capsule, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose of Vivotif, the patient received the fourth dose of Vivotif, at a dose of one capsule, orally which is also considered as inappropriate schedule of vaccine administered. Seven five days after the first dose of Vivotif, the patient received the fifth dose of Vivotif, at a dose of one capsule, orally which is considered as extra dose administered. Inappropriate schedule of product administration and extra dose administered are both considered as listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif vaccine. The patient had no relevant medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and extra dose administered are assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None