Sex: F
Vaccine: TYP
Symptoms: Headache, Product storage error
Clinical narrative: Administered 3 doses of incorrectly stored Vivotif; Headache; A spontaneous report was received from a 61-year-old female patient on 30JAN2023 who "administered 3 doses of incorrectly stored Vivotif" (PT: Product storage error) and experienced "headache" (PT: Headache). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003790) for immunisation.  The patient's medical history, concomitant medications, or known allergies was not reported.   On 24JAN2023 the patient took first dose of Vivotif followed by the second dose on 26JAN2023 and third on 28JAN2023 which were incorrectly stored at room temperature for a duration of 24 days. Reportedly, on an unknown date in JAN2023, after the second dose of Vivotif the patient experienced headache.  The patient recovered from the event of "headache" on an unknown date in JAN2023. The outcome of the event "administered 3 doses of incorrectly stored Vivotif" was not applicable.  No action was taken with Vivotif with respect to the event "headache" while the action taken with Vivotif with respect to the event "administered 3 doses of incorrectly stored Vivotif" was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer administered 3 doses of incorrectly stored Vivotif (product storage error) and experienced a headache. Considering the case information, the role of Vivotif cannot be ruled out and the causality of headache is assessed as possible. Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.  Significant follow-up information was received from the patient on 21FEB2023.  It was reported that the patient had problems with the right side of their head and was deaf (used a sign language interpreter). Reportedly, the patient had a cochlear implant on the right side of her head for which she had surgery in the past. Furthermore, it was reported that the patient gets pain on the right side of their head after taking malaria pills as well.  The patient was allergic to 8 different types of grass, mold, mildew, dust, mites, and oak and had no allergies to medication.  Reportedly, the patient might have taken malaria pills (co-suspect) at the time of vaccination.  It was reported that the patient took two tablets of Tylenol in the morning (as per reporting) for a headache, following which the headache went away the next day (exact date was not provided). Reportedly, the patient had six tablets of Tylenol within the last month (date not specified).  Moreover, the patient thought her headache was from the Vivotif but was not 100 percent sure.  Company comment: It was reported that a consumer administered 3 doses of incorrectly stored Vivotif (product storage error). This consumer had headache after receiving second dose of Vivotif.  In response to the event, she was successfully treated with Tylenol. Considering the case information, the role of Vivotif cannot be ruled out and the causality of headache is assessed as possible (confounded by malaria pills). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. This patient had a history of allergies. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer administered 3 doses of incorrectly stored Vivotif (product storage error). This consumer had headache after receiving second dose of Vivotif.  In response to the event, she was successfully treated with Tylenol. Considering the case information, the role of Vivotif cannot be ruled out and the causality of headache is assessed as possible (confounded by malaria pills). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. This patient had a history of allergies. The case is considered non-serious as per medical assessment.