Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
Blisters on eyelids; The patient developed a rash eight-ten years ago on face after taking Vivotif; Case reference number US-BN-2024-000085 is a spontaneous case report initially received from a healthcare professional via Med Communications (reference number: USBAV24-0121) on 19-Jan-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), at an unknown dose, orally, for an unknown indication. On an unspecified date, an unknown amount of time after the vaccination with the Vivotif vaccine, as reported the patient developed a rash eight-ten years ago, on the face. The patient went to the emergency room, and they concluded that it was possibly related to the oral typhoid vaccine. The reporter added that the patient had blisters on eyelids, and the patient had nothing else implicated at the time like creams. The reporter asked if the crossover could be done between the oral vaccine and the injectable, if some had a reaction to the oral vaccine, they had the injectable and vice versa. As healthcare professional their preference would not be to repeat the oral vaccine because they did not know for sure if it was the vaccine, gelatin, or something else. At the time of the initial report, it was unknown if the patient recovered from the events of blisters on eyelids and a rash face. The reporter assessed the events of blisters on eyelids and rash face as non-serious. The reporter assessed causality assessment as related for the events of blisters and rash face to the Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of blister and rash on an unspecified date, an unknown amount of time after the patient took a dose of Vivotif for an unknown indication. Rash is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst blister is unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age experienced non-serious events of blister and rash on an unspecified date, an unknown amount of time after the patient took a dose of Vivotif for an unknown indication. Rash is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst blister is unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events have been considered as related to Vivotif. This case is considered as non-serious.
Comments: None.