chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Did not take the Vivotif according to the recommended schedule; A spontaneous report was received from a nurse on 07AUG2023 regarding a 21-year-old male patient who "did not take the Vivotif according to the recommended schedule" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 01AUG2023, at 7 am the patient received the first dose of Vivotif followed by the second dose on 03AUG2023 at 7 am, third on 04AUG2023 at 7 pm (instead of 7 am) and the fourth dose on 06AUG2023 at 7 am.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer did not take the Vivotif according to the recommended schedule (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer did not take the Vivotif according to the recommended schedule (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue, Product storage error
Clinical narrative: Third dose of Vivotif was missed; A spontaneous report was received from the other healthcare professional on 08AUG2023 regarding a male patient of unknown age whose "third dose of Vivotif was missed" (PT: Product dose omission issue). The patient took oral Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003850) for immunization.  The patient's medical history, concomitant medications, or allergies were not reported.  On 02AUG2023, the patient received the first dose of Vivotif followed by the second dose on 04AUG2023 via per oral route. Reportedly, after picking up the third dose, the patient forgot to refrigerate it for 48 hours and as a result missed taking the third dose of Vivotif.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer's third dose of Vivotif was missed (product dose omission issue) since he forgot to refrigerate it for 48 hours. Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer's third dose of Vivotif was missed (product dose omission issue) since he forgot to refrigerate it for 48 hours. Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took Vivotif that was left accidentally unrefrigerated; A spontaneous report was received from a male patient of unknown age on 16AUG2023 who "took Vivotif that was left accidentally unrefrigerated" (PT: Product storage error). The patient took an oral Vivotif capsule (typhoid vaccine live oral Ty21A; lot number: unknown) as a prophylactic vaccination for a travel.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient purchased the Vivotif vaccine more than a month ago as he would visit Africa in 15 days. Reportedly, the patient accidentally kept the medication unrefrigerated for 4-5 weeks at a temperature of not more than 77 degrees Fahrenheit and took the first dose on 15AUG2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif that was left accidentally unrefrigerated for 4-5 weeks (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif that was left accidentally unrefrigerated for 4-5 weeks (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the second dose of Vivotif without skipping a day; A spontaneous report was received from a nurse on 16AUG2023 regarding a patient of unknown age and gender who "took the second dose of Vivotif without skipping a day" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 15AUG2023 (a day before the report), the patient took the first dose of Vivotif via per oral route, and by mistake took the second dose on 16AUG2023, without skipping a day.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took the second dose of Vivotif without skipping a day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the second dose of Vivotif without skipping a day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took the typhoid vaccine but did not refrigerate it once she started taking it; A spontaneous report was received from physician on 20AUG2023 regarding a female patient of unknown age who "took the typhoid vaccine but did not refrigerate it once she started taking it" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the typhoid vaccine but did not refrigerate it once she started taking it. Reportedly, the typhoid vaccine was out of range for 8 days for a maximum temperature of more than 77 degrees Fahrenheit.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took the Vivotif but did not refrigerate it once she started taking it (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the Vivotif but did not refrigerate it once she started taking it (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif on day 1 and then took it on day 2 the following day; A spontaneous report was received from a nurse on 21AUG2023 regarding a patient of unknown age and gender who "took Vivotif on day 1 and then took it on day 2 the following day" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took Vivotif on day one and then took the next dose the following day, on day two.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif on day 1 and then took it on day 2 the following day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif on day 1 and then took it on day 2 the following day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission in error
Clinical narrative: Forgot to take dose 2 of Vivotif; A spontaneous report was received from a nurse on 22AUG2023 regarding a patient of unknown age and gender who "forgot to take dose 2 of Vivotif" (PT: Product dose omission in error). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the first dose of Vivotif, however, forgot to take second dose.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer forgot to take fourth dose of Vivotif (product dose omission in error). Further information regarding event is limited. 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 consumer forgot to take fourth dose of Vivotif (product dose omission in error). Further information regarding event is limited. The causality of product dose omission in error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took all 4 capsules of Vivotif in the evening; A spontaneous report was received from a nurse on 23AUG2023 regarding a male patient of unknown age who "took all 4 capsules of Vivotif in the evening" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or allergies were not reported.  On 22AUG2023, the oral typhoid vaccine was dispensed to the patient and was explained exactly how to take the vaccine, however, the patient took all four capsules of Vivotif that evening.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took all 4 capsules of Vivotif in the evening (inappropriate schedule of product administration). Further information regarding event is limited. The causality of Inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took all 4 capsules of Vivotif in the evening (inappropriate schedule of product administration). Further information regarding event is limited. The causality of Inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took 4th dose of Vivotif on an empty stomach and then 15 mins later had a bagel with honey; A spontaneous report was received from a male patient (other health care professional) of unknown age on 22AUG2023 who "took 4th dose of Vivotif on an empty stomach and then 15 mins later had a bagel with honey" (PT: Product administration error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the fourth dose of Vivotif via per oral route in the morning (as per the report) with an empty stomach and then 15 minutes later, when he was getting ready for a ride, he had a bagel with honey which he later realized that he was not supposed to have done that.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took 4th dose of Vivotif on an empty stomach and then 15 mins later had a bagel with honey (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took 4th dose of Vivotif on an empty stomach and then 15 mins later had a bagel with honey (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second dose of Vivotif on 17AUG2023 but did not take the third dose until 21AUG2023; A spontaneous report was received from a nurse practitioner on 23AUG2023 regarding a male patient of unknown age who "took second dose of Vivotif on 17AUG2023 but did not take the third dose until 21AUG2023" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) as a prophylactic vaccination against typhoid.  The patient's medical history, concomitant medications, or allergies were not reported.  On 15AUG2023, the patient took the first dose of Vivotif followed by the second dose on 17AUG2023. Reportedly, the patient did not take the third dose until 21AUG2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took second dose of Vivotif on 17AUG2023 but did not take the third dose until 21AUG2023 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took second dose of Vivotif on 17AUG2023 but did not take the third dose until 21AUG2023 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Age: 42.0
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second and third dose of Vivotif in a row; A spontaneous report was received from a 42-year-old female patient on 24AUG2023 who "took second and third dose of Vivotif in a row" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 20AUG2023, the patient took the first dose of Vivotif followed by the second dose on 22AUG2023 correctly however, took the third dose on 23AUG2023 instead of taking it on Thursday (24AUG2023).  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took second and third dose of Vivotif in a row (inappropriate schedule of product administration). Further information regarding event is limited. The causality of Inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took second and third dose of Vivotif in a row (inappropriate schedule of product administration). Further information regarding event is limited. The causality of Inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Left Vivotif in her purse for 24 hours and had taken one dose; A spontaneous report was received from a pharmacy technician on 29AUG2023 regarding a female patient of unknown age who "left Vivotif in her purse for 24 hours and had taken one dose" (PT: Product storage error). The patient took oral Vivotif capsule (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took one dose of Vivotif which was left in her purse for 24 hours. Reportedly, the patient did not know the exact temperature the medication was exposed to, however the reporter thought it could possibly have been above 77 F.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer left Vivotif in her purse for 24 hours and had taken one dose (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer left Vivotif in her purse for 24 hours and had taken one dose (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif as one pill per day for four days in a row; A spontaneous report was received from a medical assistant on 29AUG2023 regarding a female patient of unknown age who "took Vivotif as one pill per day for four days in a row" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took Vivotif as one pill per day for four days in a row instead of every other day.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif as one pill per day for four days in a row (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif as one pill per day for four days in a row (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Last pill of Vivotif was taken more than 48 hours ago; A spontaneous report was received from a physician on 04SEP2023 regarding a male patient of unknown age who had "last pill of Vivotif was taken more than 48 hours ago" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that a traveler took two doses of Vivotif. Reportedly, the patient took the second dose more than 48 hours ago from the third dose which was yet to be administered.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took the second dose of Vivotif more than 48 hours ago (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the second dose of Vivotif more than 48 hours ago (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Left Vivotif at room temperature and then took 1 capsule; A spontaneous report was received from a pharmacist on 06SEP2023 regarding a 54-year-old male patient who "left Vivotif at room temperature and then took 1 capsule" (PT: Product storage error). The patient took oral Vivotif capsule (typhoid vaccine live oral Ty21A; lot number: 3003852) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 29AUG2023, the patient picked up a batch of Vivotif and kept it at a room temperature of 72 degrees Fahrenheit until 04SEP2023. Reportedly, the patient took the first dose of the same batch of Vivotif on 05SEP2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer left Vivotif at room temperature and then took 1 capsule (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer left Vivotif at room temperature and then took 1 capsule (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took full series of Vivotif which was left out of fridge for week and a half; A spontaneous report was received from other healthcare professional on 07SEP2023 regarding a patient of unknown age and gender who "took full series of Vivotif which was left out of fridge for week and a half" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took full series of Vivotif and realized upon completion that the medication needed to be refrigerated. Reportedly, the medication was left out of fridge for week and a half.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took full series of Vivotif which was left out of fridge for week and a half (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took full series of Vivotif which was left out of fridge for week and a half (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed taking the second dose of Vivotif on day 3 and took it on day 4; A spontaneous report was received from a nurse practitioner on 07SEP2023 regarding a patient of unknown age and gender who "missed taking the second dose of Vivotif on day 3 and took it on day 4" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient missed taking the second dose of Vivotif on day 3 and took it on day 4.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer missed taking the second dose of Vivotif on day 3 and took it on day 4 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed taking the second dose of Vivotif on day 3 and took it on day 4 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second dose of Vivotif on day 2 by mistake; A spontaneous report was received from a nurse on 12SEP2023 regarding a 11-year-old male patient who "took second dose of Vivotif on day 2 by mistake" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 11SEP2023, the patient took the first dose of Vivotif, and took the second dose on 12SEP2023 by mistake.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took second dose of Vivotif on day 2 by mistake (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took second dose of Vivotif on day 2 by mistake (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product communication issue, Product storage error
Clinical narrative: Pharmacy didn't tell her that the Vivotif vaccine should be refrigerated; Took the third dose on day 6; Took Vivotif that was left at room temperature for 16-18 hours; A spontaneous report was received from a 66-year-old female patient on 15SEP2023 who "took Vivotif that was left at room temperature for 16-18 hours" (PT: Product storage error) as "pharmacy didn't tell her that the Vivotif vaccine should be refrigerated" (PT: Product communication issue) and "took the third dose on day 6" (Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient bought the Vivotif vaccine from the pharmacy who did not inform her that the vaccine should be refrigerated. Reportedly, the patient took the first two doses of Vivotif on 09SEP2023 and 11SEP2023 respectively, that were left out of the fridge at room temperature for 16-18 hours and reached a maximum temperature of 70 degrees Fahrenheit. Further, it was reported that the second two doses of Vivotif were refrigerated from the beginning, and she took the third refrigerated dose on 14SEP2023.  The outcome of the reported events was not applicable. The action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif that was left at room temperature for 16-18 hours (product storage error) as pharmacy didn't tell her that the Vivotif vaccine should be refrigerated (product communication issue) and took the third dose on day 6 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of product storage error, product communication issue, and inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif that was left at room temperature for 16-18 hours (product storage error) as pharmacy didn't tell her that the Vivotif vaccine should be refrigerated (product communication issue) and took the third dose on day 6 (inappropriate schedule of product administration). Further information regarding event is limited. The causality of product storage error, product communication issue, and inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took first dose of Vivotif with food; A spontaneous report was received from a nurse on 18SEP2023 regarding a 46-year-old male patient who "took first dose of Vivotif with food" (PT: Product administration error). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: 3003907) as typhoid prophylaxis.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient forgot to take the first dose of Vivotif without food and took it with food instead.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took first dose of Vivotif with food (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took first dose of Vivotif with food (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed last dose of Vivotif; A spontaneous report was received from a pharmacist on 18SEP2023 regarding a female patient of unknown age who "missed last dose of Vivotif" (PT: Product dose omission issue). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took three doses of Vivotif correctly and missed the last dose of Vivotif.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer missed last dose of Vivotif (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed last dose of Vivotif (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took the third dose of Vivotif on day 6; A spontaneous report was received from a 54-year-old male patient on 20SEP2023 who "took the third dose of Vivotif on day 6" (PT: Inappropriate schedule of product administration). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003852) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 15SEP2023, the patient took the first dose of Vivotif followed by the second dose on 17SEP2023. Reportedly, due to confusion, the patient took the third dose on 20SEP2023 instead of taking it on 19SEP2023.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took the third dose of Vivotif on day 6 (inappropriate schedule of vaccine administered). Further information regarding the medical history and concomitant medications is limited. The causality of inappropriate schedule of vaccine administered is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the third dose of Vivotif on day 6 (inappropriate schedule of vaccine administered). Further information regarding the medical history and concomitant medications is limited. The causality of inappropriate schedule of vaccine administered is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took the first dose of Vivotif which was not kept in refrigerator; A spontaneous report was received from a female patient of unknown age on 22SEP2023 who "took the first dose of Vivotif which was not kept in refrigerator" (PT: Product storage error). The patient took oral Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the first dose of Vivotif and realized that it was supposed to be kept in the refrigerator. Reportedly, it has been a week since she bought the medication from the pharmacy until the time of administration.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took the first dose of Vivotif which was not kept in refrigerator (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the first dose of Vivotif which was not kept in refrigerator (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif on Saturday and Sunday; A spontaneous report was received from a pharmacist on 25SEP2023 regarding a female patient of unknown age who "took Vivotif on Saturday and Sunday" (PT: Inappropriate schedule of product administration). The patient took oral Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  On 23SEP2023, Saturday, the patient took the first dose of Vivotif followed by the second dose on 24SEP2023, Sunday, instead of taking it on Monday.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif on Saturday and Sunday (inappropriate schedule of vaccine administered). Further information regarding the medical history and concomitant medications is limited. The causality of inappropriate schedule of vaccine administered is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif on Saturday and Sunday (inappropriate schedule of vaccine administered). Further information regarding the medical history and concomitant medications is limited. The causality of inappropriate schedule of vaccine administered is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Left two doses of Vivotif behind while he was traveling; A spontaneous report was received from a physician assistant on 26SEP2023 a regarding a male patient of unknown age who "left two doses of Vivotif behind while he was traveling" (PT: Product dose omission issue). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for travel.  The patient's medical history, concomitant medications, or allergies were not reported.  On 19SEP2023, the patient took the first dose of Vivotif followed by the second dose on 21SEP2023. Reportedly, the patient left the next two doses of the medication behind while he was traveling and would get those doses on 27SEP2023 and 29SEP2023, with the time-lapse of about one week between the second and third dose of Vivotif.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer left two doses of Vivotif behind while he was traveling (product dose omission issue). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer left two doses of Vivotif behind while he was traveling (product dose omission issue). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took the third and the fourth capsule of Vivotif that were stored at 61 degrees Fahrenheit; A spontaneous report was received from a female patient of unknown age on 02OCT2023 who "took the third and the fourth capsule of Vivotif that were stored at 61 degrees Fahrenheit" (PT: Product storage error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003850) for typhoid prophylaxis.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient completed the Vivotif course of four capsules. Reportedly, the third and fourth capsules of Vivotif were stored at 61 degrees Fahrenheit. The third capsule was at that temperature range for 12 hours and the fourth capsule was for over 24 hours.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took the third and the fourth capsule of Vivotif that were stored at 61 degrees Fahrenheit (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the third and the fourth capsule of Vivotif that were stored at 61 degrees Fahrenheit (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product communication issue, Product storage error
Clinical narrative: Completed the 4 doses of Vivotif without refrigerating the product; Patient misunderstood the recommendations; A spontaneous report was received from pharmacist on 04OCT2023 regarding a female patient of unknown age who "misunderstood the recommendations" (PT: Product communication issue) and "completed the 4 doses of Vivotif without refrigerating the product" (PT: Product storage error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that a patient picked up Vivotif a few days ago and misunderstood the recommendations as the patient completed four doses of Vivotif without refrigerating the product.  The outcome of the reported events was not applicable. The action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that the patient misunderstood the recommendations (product communication issue) for Vivotif storage and completed the 4 doses of Vivotif without refrigerating the product (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product communication issue and product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that the patient misunderstood the recommendations (product communication issue) for Vivotif storage and completed the 4 doses of Vivotif without refrigerating the product (product storage error). Further information regarding the medical history and concomitant medications is limited. The causality of product communication issue and product storage error is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed a dose of Vivotif; A spontaneous report was received from a nurse on 04OCT2023 regarding a patient of unknown gender and age who "missed a dose of Vivotif" (PT: Product dose omission issue). The patient took oral Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient missed a dose of Vivotif. The exact duration of the delay or which dose of Vivotif the patient was on was not known to the reporter.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer missed a dose of Vivotif (product dose omission issue). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed a dose of Vivotif (product dose omission issue). Further information regarding the medical history and concomitant medications is limited. The causality of product dose omission issue is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took all the doses of Vivotif daily instead of every other day; A spontaneous report was received from a pharmacist on 14OCT2023 regarding a patient of unknown gender and age who "took all the doses of Vivotif daily instead of every other day" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took all the doses of Vivotif daily instead of every other day.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took all the doses of Vivotif daily instead of every other day (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient took all the doses of Vivotif daily instead of every other day (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.