Sex: F
Vaccine: TYP
Symptoms: Blood test normal, Product dose omission issue, Rash, Skin reaction
Clinical narrative: Missed 4th dose of Vivotif; Some skin reaction; A spontaneous report was received from a 72-year-old, White female patient (height: 167.64 cm and weight: 72.6 kg/160 pounds) on 02JUL2023 who had "some skin reaction" (PT: Skin reaction) and "missed 4th dose of Vivotif" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003789; expiry date: OCT2023) for immunisation.  The patient's medical history was reported as none and her concomitant medications, or known allergies were not reported.  It was reported that the patient took three doses of Vivotif with proper schedule, storage, and precautions on 25JUN2023, 27JUN2023 and 29JUN2023 respectively.  After taking the third dose, on the same day, the patient had some skin reaction. Initially, the patient thought that it was a mosquito bite, as she was on a picnic but then she realized that she already had insect repellent all over herself. Furthermore, she was supposed to take the fourth dose of Vivotif on 01JUL2023 which was missed. Additionally, the patient reported that the reaction was increasing like a diverse rash, it was all over her arms, right armpit axillary, face and back of her neck. The patient received no treatment for the reported event and her blood reports were normal when she had them "last time" (date unspecified).  The patient had not recovered from the event "some skin reaction", at the time of this report, while the outcome of the event "missed 4th dose of Vivotif" was not applicable.  The action taken with Vivotif with respect to the event "missed 4th dose of Vivotif" was not applicable and for "some skin reaction" it was drug withdrawn.  No additional information was reported.  Company comment: It was reported that a patient took three doses of Vivotif and after taking the third dose, on the same day, the patient had some skin reaction. This patient had also applied insect repellent all over herself on the same day before the reaction occurred. Furthermore, the patient did not take the 4th dose of Vivotif (product dose omission in error) and still her reaction was increasing to her arms, right armpit axillary, face and back of her neck. Considering the case information, along with the negative de-challenge, the causality of the skin reaction is assessed as unlikely (confounded by insect repellant). In addition, the causality of product dose omission in error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took three doses of Vivotif and after taking the third dose, on the same day, the patient had some skin reaction. This patient had also applied insect repellent all over herself on the same day before the reaction occurred. Furthermore, the patient did not take the 4th dose of Vivotif (product dose omission in error) and still her reaction was increasing to her arms, right armpit axillary, face and back of her neck. Considering the case information, along with the negative de-challenge, the causality of the skin reaction is assessed as unlikely (confounded by insect repellant). In addition, the causality of product dose omission in error is not applicable with Vivotif. The case is considered non serious as per medical assessment.