Sex: F
Vaccine: TYP
Symptoms: Product administration error, Wrong technique in product usage process
Clinical narrative: The patient took three of the four capsules with coffee on an empty stomach instead of with room for water; The patient took three of the four capsules with coffee on an empty stomach instead of with room for water; Case reference number US-BN-2023-010593 is a spontaneous case report initially received from a consumer via Med Communications (reference number: USBAV23-1967) on 27-Nov-2023 and concerns a female patient of an unspecified age.   The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified dates, reported as recently, the patient took the first, the second, the third and the fourth dose of Vivotif (batch number: not reported) at an unknown dose and route of administration for an unknown indication. As reported, the patient took three of the four capsules with coffee on an empty stomach as the patient was unaware that the vaccine had to be taken with room for water (explicitly coded as 'product administration error' and 'wrong technique in product usage process').  At the time of this initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  Additional information received on 27-Nov-2023 Manufacturer included updated patient demographics.  Non-significant case correction performed on 12-Jan-2024 for the information received on 27-Nov-2023 included: company comment corrected to include 'room temperature water' instead of 'room for water'.; Reporter's Comments: A female patient of an unspecified age took the first, the second, the third and the fourth dose of Vivotif at an unknown dose and route of administration for an unknown indication. Reportedly, the patient took three of the four capsules with coffee on an empty stomach as the patient was unaware that the vaccine had to be taken with room temperature water which is considered as product administration error and wrong technique in product usage process. Wrong technique in product usage process and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medication details were not provided. Wrong technique in product usage process and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of an unspecified age took the first, the second, the third and the fourth dose of Vivotif at an unknown dose and route of administration for an unknown indication. Reportedly, the patient took three of the four capsules with coffee on an empty stomach as the patient was unaware that the vaccine had to be taken with room temperature water which is considered as product administration error and wrong technique in product usage process. Wrong technique in product usage process and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's relevant medical history and concomitant medication details were not provided. Wrong technique in product usage process and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.