Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient develop rash after receiving two of four doses of the Vivotif vaccine; The patient received two of the four doses of the Vivotif vaccine; Case reference number US-BN-2024-000625 is a spontaneous case initially received from other health professional via Communications (reference number: USBAV24-0480) on 10-Mar-2024, received and concerns female patient of unknown age. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient took first dose of Vivotif vaccine (batch number: unknown), administered orally, at an unknown dose, for typhoid immunization. On unspecified date, unknown amount of time after first dose, the patient took second dose of Vivotif vaccine (batch number: unknown), administered orally, at an unknown dose. As reported, the patient was told to stop Vivotif vaccination (explicitly coded as 'inappropriate schedule of vaccine administered'). On unspecified date, unknown amount of time after second dose of Vivotif vaccine, as reported, the patient developed severe rash and was sent to the hospital, for unspecified duration. The patient was treated with high dose steroids for twelve days. On unspecified date, the patient recovered from the event of rash. As reported, it took twelve days of high dose steroids for the rash to resolve. The reporter assessed the event of rash as serious. Causality assessment was reported as possibly related. No further information was provided.; Reporter's Comments: A female patient of unknown age was told to stop Vivotif vaccination after she took the second dose (administered unknown time after the first dose) which is considered as inappropriate schedule of vaccine administered. The patient developed serious event of severe rash and was sent to the hospital, unknown time after the second dose of Vivotif vaccine. Reportedly, the patient was treated with high dose steroids for twelve days. Rash is listed and expected according to CCDS v8 and USPI for Vivotif while inappropriate schedule of product administration is considered listed per company convention. The outcome of rash was resolved. The patient's medical history and concomitant medications were not provided. Rash is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is serious due to seriousness criteria of hospitalization.; Sender's Comments: A female patient of unknown age was told to stop Vivotif vaccination after she took the second dose (administered unknown time after the first dose) which is considered as inappropriate schedule of vaccine administered. The patient developed serious event of severe rash and was sent to the hospital, unknown time after the second dose of Vivotif vaccine. Reportedly, the patient was treated with high dose steroids for twelve days. Rash is listed and expected according to CCDS v8 and USPI for Vivotif while inappropriate schedule of product administration is considered listed per company convention. The outcome of rash was resolved. The patient's medical history and concomitant medications were not provided. Rash is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is serious due to seriousness criteria of hospitalization.
Comments: None.