chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP, UNK
Symptoms: Labelled drug-drug interaction medication error, No adverse event
Clinical narrative: Concomitant administration of Vivotif and doxycycline; A spontaneous report was received from a pharmacist on 20APR2023 regarding a female patient who had "concomitant administration of Vivotif and doxycycline" (PT: Labelled drug-drug interaction medication error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation and doxycycline for acne.  The patient's medical history/allergies and concomitant medications were not reported.  It was reported that the patient took the first dose of Vivotif yesterday (as per the report), however, forgot that she was also concomitantly taking doxycycline once a day. It was confirmed that the patient did not experience any side effects with the concomitant administration of both the products.  The outcome of the reported event was not applicable. The action taken with Vivotif and doxycycline with respect to the reported event was not applicable.  No additional information was reported.  Company comment: A patient had concomitant administration of Vivotif and doxycycline (labelled drug-drug interaction medication error). Further information regarding the event is limited. Considering the nature of event, the causality of labelled drug-drug interaction medication error is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: A patient had concomitant administration of Vivotif and doxycycline (labelled drug-drug interaction medication error). Further information regarding the event is limited. Considering the nature of event, the causality of labelled drug-drug interaction medication error is assessed as possible. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Administered 1 dose of Vivotif that was unrefrigerated; A spontaneous report was received from a female patient of unknown age on 19JUN2023 who "administered 1 dose of Vivotif that was unrefrigerated" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003830) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient picked up the Vivotif from their pharmacy on Thursday 15JUN2023 and did not refrigerate it for approximately 40 hours. Reportedly, on 18JUN2023, Sunday, the patient administered one 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 administered 1 dose of Vivotif that was unrefrigerated (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 administered 1 dose of Vivotif that was unrefrigerated (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: No adverse event, Product storage error
Clinical narrative: Took Vivotif which was out of refrigerator for 4 hours; A spontaneous report was received from a female patient of unknown age on 23JUN2023 who "took Vivotif which was out of refrigerator for 4 hours" (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 known allergies were not reported.  It was reported that the patient kept the typhoid vaccine pill out of the refrigerator for 3-4 hours and then refrigerated them. Reportedly, the patient took all the doses of Vivotif and "it didn't react to anything".  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 which was out of refrigerator for 4 hours (product storage error) and did not experience any reaction. 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 which was out of refrigerator for 4 hours (product storage error) and did not experience any reaction. 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: M
Vaccine: TYP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Forgot to take fourth dose of Vivotif; A spontaneous report was received from a pharmacist on 27APR2023 regarding a 54-year-old male patient who "forgot to take fourth dose of Vivotif" (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 known allergies were not reported.  It was reported that the patient took the first 3 doses of Vivotif correctly and then did not take the fourth dose on day 7. Reportedly, the patient did not experience any side effects from 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 forgot to take fourth dose of Vivotif (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. 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 issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Took only three capsules of Vivotif instead of four; A spontaneous report was received from a registered nurse on 03MAY2023 regarding a patient of unknown age and gender who "took only three capsules of Vivotif instead of four" (PT: Incomplete course of vaccination). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient took only three capsules of Vivotif instead of four as the package was left out for several days. Reportedly, the patient has not yet taken the fourth capsule.  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 only three capsules of Vivotif instead of four (incomplete course of vaccination). Vivotif dose should be taken every other day, and the causality of incomplete course of vaccination is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took only three capsules of Vivotif instead of four (incomplete course of vaccination). Vivotif dose should be taken every other day, and the causality of incomplete course of vaccination is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Mistakenly took second dose of Vivotif on day 2 instead of day 3; A spontaneous report was received from other healthcare professional on 06MAY2023 regarding a male patient of unknown age who "mistakenly took second dose of Vivotif on day 2 instead of day 3" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient was prescribed Vivotif and was instructed to take the vaccine every other day. Reportedly, the patient took his first dose on the first day and mistakenly took the next dose on second day instead of the third 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 mistakenly took second dose of Vivotif on day 2 instead of day 3 (inappropriate schedule of product administration). Vivotif dose should be taken every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer mistakenly took second dose of Vivotif on day 2 instead of day 3 (inappropriate schedule of product administration). Vivotif dose should be taken every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second dose of Vivotif on day 2 instead of day 3; A spontaneous report was received from pharmacist on 06MAY2023 regarding a patient of unknown age and gender who "took second dose of Vivotif on day 2 instead of day 3" (PT: Inappropriate schedule of product administration). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient took the first dose of Vivotif correctly. However, took the second dose on the second day instead of the third 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 second dose of Vivotif on day 2 instead of day 3 (inappropriate schedule of product administration). Vivotif dose should be taken every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: It was reported that a consumer took second dose of Vivotif on day 2 instead of day 3 (inappropriate schedule of product administration). Vivotif dose should be taken every other day. The causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Took third dose of Vivotif on day 4; A spontaneous report was received from a pharmacist on 09MAY2023 regarding a 21-year-old female patient who "took third dose of Vivotif on day 4" (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 known allergies were not reported.  On 05MAY2023, the patient took the first dose of Vivotif followed by the second dose on 07MAY2023 correctly. However, she took the third dose on 08MAY2023 incorrectly and has not yet taken her fourth dose. Reportedly, the patient did not experience any side effects from the 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 took third dose of Vivotif on day 4 (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. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took third dose of Vivotif on day 4 (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. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Left Vivotif at room temperature for 4-5 days; A spontaneous report was received from a 22-year-old female patient on 11MAY2023 who "left Vivotif at room temperature for 4-5 days" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003824) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered two doses of Vivotif on 09MAY2023 and 11MAY2023 respectively, which were left at room temperature for 4-5 days.  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 for 4-5 days (product storage error). 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.; Sender's Comments: It was reported that a consumer left Vivotif at room temperature for 4-5 days (product storage error). 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.
Sex: F
Vaccine: TYP
Symptoms: Alcohol use, Product administration error
Clinical narrative: Consumed alcohol within an hour of Vivotif administration; A spontaneous report was received from a pharmacy student on 15MAY2023 regarding a female patient of unknown age who had "consumed alcohol within an hour of Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) administration" (PT: Product administration error) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient consumed alcohol within an hour of taking a 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 patient consumed alcohol within an hour of Vivotif (product administration error). Considering the nature of event, the causality of product administration 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 patient consumed alcohol within an hour of Vivotif (product administration error). Considering the nature of event, the causality of product administration error 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: Forgot to take their third dose of Vivotif on Tuesday and instead took it on Wednesday evening; A spontaneous report was received from nurse on 25MAY2023 regarding a patient of unknown age and gender who "forgot to take their third dose of Vivotif on Tuesday and instead took it on Wednesday evening" (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 known allergies were not reported.  It was reported that the patient forgot to take their third dose of Vivotif on Tuesday, 23MAY2023 and instead took it on Wednesday evening, 24MAY2023. Reportedly, the patient had no side effects from 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 forgot to take their third dose of Vivotif on Tuesday and instead took it on Wednesday evening (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. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer forgot to take their third dose of Vivotif on Tuesday and instead took it on Wednesday evening (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. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Administered the dose-2 of Vivotif along with the food; Delayed the Dose-2 by a day; A spontaneous report was received from a 29-year-old female patient on 30MAY2023 who "administered the dose-2 of Vivotif along with the food" (PT: Product administration error) and "delayed the dose-2 by a 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 known allergies were not reported.  On 27MAY2023, the patient received the first dose of Vivotif followed by the second dose which was delayed by a day on 30MAY2023. Reportedly, the patient administered the second dose along with food. Furthermore, it was reported that she did not experience any unusual symptoms after the administration.  The outcome of the reported events 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 administered dose-2 of Vivotif along with the food (product administration error) and delayed the dose-2 by a day (inappropriate schedule of product administration). Considering the nature of the events, the causality of product administration error and inappropriate schedule of product administration is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer administered dose-2 of Vivotif along with the food (product administration error) and delayed the dose-2 by a day (inappropriate schedule of product administration). Considering the nature of the events, the causality of product administration error and inappropriate schedule of product administration is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP, UNK
Symptoms: Labelled drug-drug interaction medication error
Clinical narrative: Started taking Amoxicillin on the day between dose 3 and 4 of Vivotif; The spontaneous report was received from other health care professional on 01JUN2023 regarding a patient of unknown age and gender who "started taking amoxicillin on the day between dose 3 and 4 of Vivotif " (PT: Labelled drug-drug interaction medication error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation and amoxicillin for an unknown indication.  The patient's medical history/allergies and concomitant medications were not reported.  It was reported that the patient took the first three doses of oral typhoid vaccine as prescribed and then started taking amoxicillin on the day between the third and the fourth dose of Vivotif.  The outcome of the reported event was not applicable. The action taken with Vivotif and amoxicillin with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer started taking amoxicillin on the day between dose 3 and 4 of Vivotif (labelled drug-drug interaction medication error). Considering the nature of event, the causality of labelled drug-drug interaction medication 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 started taking amoxicillin on the day between dose 3 and 4 of Vivotif (labelled drug-drug interaction medication error). Considering the nature of event, the causality of labelled drug-drug interaction medication 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: Missed taking the dose of Vivotif as per the recommended schedule; A spontaneous report was received from a nurse on 02JUN2023 regarding a male patient of unknown age who "missed taking the dose of Vivotif as per the recommended schedule" (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 known allergies were not reported.  On 26MAY2023, the patient took the third dose of Vivotif and was supposed to take the fourth dose on 28MAY2023 which he missed until 30MAY2023.  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 consumer missed taking the dose of Vivotif as per the recommended schedule (Inappropriate schedule of product administration) and took it on 30-May-2023 instead of 28-May-2023. Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif.; Sender's Comments: It was reported that consumer missed taking the dose of Vivotif as per the recommended schedule (Inappropriate schedule of product administration) and took it on 30-May-2023 instead of 28-May-2023. Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took third dose of Vivotif on day 4; A spontaneous report was received from pharmacist on 10JUN2023 regarding a male patient of unknown age who "took third dose of Vivotif on day 4" (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 known allergies were not reported.  On 06JUN2023 at 07:30 am, the patient took the first dose of Vivotif followed by the second dose on 08JUN2023 at 7:30 am. Reportedly, the patient mistakenly took the third dose on 09JUN2023 at 7:30 and would take the fourth dose on 11JUN2023 at 7:30 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 took the third dose of Vivotif 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.; Sender's Comments: It was reported that a consumer took the third dose of Vivotif 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.
Sex: M
Vaccine: TYP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Forgot to take fourth dose of Vivotif; A spontaneous report was received from nurse on 12JUN2023 regarding a male patient of unknown age who "forgot to take fourth dose of Vivotif" (PT: Product dose omission in error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient had taken three doses of Vivotif on time and was due for the fourth dose on 11JUN2023 but forgot to take it. Reportedly, the patient did not have any side effects due to the 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 consumer forgot to take fourth dose of Vivotif (product dose omission in error) and did not experience any reaction. Further information regarding event is limited. The causality of product dose omission in error is not applicable with Vivotif.; Sender's Comments: It was reported that consumer forgot to take fourth dose of Vivotif (product dose omission in error) and did not experience any reaction. Further information regarding event is limited. The causality of product dose omission in error is not applicable with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed all the three doses of Vivotif following incorrect storage; A spontaneous report was received from pharmacist on 12JUN2023 regarding a 21-year-old female patient who "missed all the three doses of Vivotif following incorrect storage" (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 known allergies were not reported.  On 08JUN2023, the patient received the first dose of Vivotif following which she did not store the medication in the refrigerator. Reportedly, the patient missed all the three doses following incorrect storage.  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 all the three doses of Vivotif following incorrect storage (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed all the three doses of Vivotif following incorrect storage (product dose omission issue). Further information regarding event is limited. The causality of product dose omission issue 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 the first dose of Vivotif which was kept unrefrigerated for 48 hours; A spontaneous report was received from pharmacist on 12JUN2023 regarding a patient of unknown age and gender who "took the first dose of Vivotif which was kept unrefrigerated for 48 hours" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient had administered one dose of Vivotif which was kept unrefrigerated for 48 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 first dose of Vivotif which was kept unrefrigerated for 48 hours (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif.; Sender's Comments: It was reported that a consumer took the first dose of Vivotif which was kept unrefrigerated for 48 hours (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed to take his second dose of Vivotif; A spontaneous report was received from nurse on 12JUN2023 regarding a 24-year-old male patient who "missed to take his second dose of Vivotif" (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 known allergies/ sensitivities were reported as none.  It was reported that the patient was prescribed four doses of Vivotif; to take one capsule on alternate days as he was planning to visit countries. On 09JUN2023, Friday, the patient received the first dose of Vivotif however missed to take his second dose on 11JUN2023, Sunday.  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 to take his second 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 to take his second 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: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Taken all 4 of the doses of Vivotif without refrigeration; A spontaneous report was received from nurse practitioner on 13JUN2023 regarding a patient of unknown age and gender who had "taken all 4 of the doses of Vivotif without refrigeration" (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 known allergies were not reported.  It was reported that the patient received four doses of Vivotif from the pharmacy which were not refrigerated for 48 hours. Reportedly, the patient took all the four doses of Vivotif and did not experience any side effects after taking them.  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 had taken all 4 of the doses of Vivotif without refrigeration (product storage error) and did not experience any reaction. 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 had taken all 4 of the doses of Vivotif without refrigeration (product storage error) and did not experience any reaction. 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: Product storage error
Clinical narrative: Product was exposed to greater than 77 F; A spontaneous report was received from a female patient of unknown age on 16JUN2023 who took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003832) for immunisation and the "product was exposed to greater than 77 F" (PT: Product storage error).  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that although Vivotif was not exposed to over 77 Fahrenheit (F) during storage, however, once she picked up the vaccine from the pharmacy, she took about 45 minutes to go home, and the product was exposed to greater than 77 F during the transit as it was a hot day. Reportedly, the patient took all the four pills of Vivotif. Furthermore, it was reported that the last pill was stored at room temperature for about four 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 all 4 Vivotif capsules but the product was exposed to greater than 77 F (product storage error) when she picked it up from the pharmacy. 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 all 4 Vivotif capsules but the product was exposed to greater than 77 F (product storage error) when she picked it up from the pharmacy. 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 administration error
Clinical narrative: Took all 4 doses of the Vivotif with food; A spontaneous report was received from a pharmacist on 17JUN2023 regarding a patient of unknown age and gender who "took all 4 doses of the Vivotif with food" (PT: Product administration error). The patient received Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient took all the four doses of Vivotif with food instead of taking it an hour before having the meal.  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 doses of the 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 all 4 doses of the 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: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took 3 capsules of Vivotif in 4 days; A spontaneous report was received from a pharmacist on 22JUN2023 regarding a patient of unknown age and gender who "took 3 capsules of Vivotif in 4 days" (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 known allergies were not reported.  It was reported that the patient took three capsules of Vivotif in four days. Reportedly, the patient took one capsule every day and did not take the fourth 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 took three capsules of Vivotif in four days (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 three capsules of Vivotif in four days (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, Product communication issue, Product storage error
Clinical narrative: Patient was not informed that Vivotif should be refrigerated; Consecutively took two doses of Vivotif on Thursday and Friday; Took Vivotif that was unrefrigerated; A spontaneous report was received from a male patient of unknown age on 26JUN2023 who was "not informed that Vivotif should be refrigerated" (PT: Product communication issue) and he "took Vivotif that was unrefrigerated" (PT: Product storage error) and "consecutively took two doses of Vivotif on Thursday and Friday" (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 known allergies were not reported.  It was reported that the patient was prescribed Vivotif, oral typhoid medication, and was not informed that it should be refrigerated. Reportedly, the patient administered one dose of Vivotif on Tuesday morning (20JUN2023) and one on Thursday morning (22JUN2023) that was kept out the entire time. Furthermore, the patient restarted the dosing of Vivotif on Friday afternoon (23JUN2023) and Sunday (25JUN2023). The restarted doses were stored and administered appropriately.  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.  Based on the information available in the document two individual case safety reports 23000279 (male) and 23000280 (female) were created and cross linked in the database.  Company comment: It was reported that a consumer was not informed that Vivotif should be refrigerated (product communication issue) and he took Vivotif that was unrefrigerated (product storage error). He also took two doses of Vivotif consecutively on Thursday and Friday (inappropriate schedule of product administration). Further information regarding event is limited. The causality of product communication issue, product storage error, 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 was not informed that Vivotif should be refrigerated (product communication issue) and he took Vivotif that was unrefrigerated (product storage error). He also took two doses of Vivotif consecutively on Thursday and Friday (inappropriate schedule of product administration). Further information regarding event is limited. The causality of product communication issue, product storage error, and 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: Patient was not informed that Vivotif should be refrigerated; Consecutively took two doses of Vivotif on Thursday and Friday; Took Vivotif that was unrefrigerated; A spontaneous report was received a caregiver on 26JUN2023 regarding a female patient of unknown age who was "not informed that Vivotif should be refrigerated" (PT: Product communication issue) and "took Vivotif that was unrefrigerated" (PT: Product storage error) and "consecutively took two doses of Vivotif on Thursday and Friday" (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 known allergies were not reported.  It was reported that the patient was prescribed Vivotif, oral typhoid medication, and was not informed that it should be refrigerated. Reportedly, the patient administered one dose of Vivotif on Tuesday morning (20JUN2023) and one on Thursday morning (22JUN2023) that was kept out the entire time. Furthermore, the patient restarted the dosing of Vivotif on Friday afternoon (23JUN2023) and Sunday (25JUN2023). The restarted doses were stored and administered appropriately.  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.  Based on the information available in the document two individual case safety reports 23000279 (male) and 23000280 (female) were created and cross linked in the database.; Sender's Comments: It was reported that a consumer was not informed that Vivotif should be refrigerated (product communication issue) and she took Vivotif that was unrefrigerated (product storage error). She also took two doses of Vivotif consecutively on Thursday and Friday (inappropriate schedule of product administration). Further information regarding event is limited. The causality of product communication issue, product storage error, and 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: Inappropriate schedule of product administration
Clinical narrative: Took the Vivotif pills consecutively every single day for 4 days; A spontaneous report was received nurse on 26JUN2023 regarding a patient of unknown age and gender who "took the Vivotif pills consecutively every single day for 4 days" (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 known allergies were not reported.  It was reported that the patient took Vivotif every single day for 4 days instead of taking it every other day and then stopped.  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 pills consecutively every single day for 4 days (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 pills consecutively every single day for 4 days (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 dose omission issue
Clinical narrative: Missed a dose of Vivotif; A spontaneous report was received from pharmacist on 26JUN2023 regarding 11-year-old female child who "missed a dose of Vivotif" (PT: Product dose omission issue). The patient administered Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history was none and concomitant medications, or known allergies were not reported.  It was reported that the patient missed a dose of Vivotif. Further, there was no information on the dosing schedule of the patient and on which day the dose was missed.  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 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 a 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: Product communication issue, Product storage error
Clinical narrative: No one had instructed him to place Vivotif in the refrigerator; Administered 1 dose of Vivotif that was kept at room temperature for 3 weeks; A spontaneous report was received from a male patient of unknown age on 26JUN2023 who "administered 1 dose of Vivotif that was kept at room temperature for 3 weeks" (PT: Product storage error) and "no one had instructed him to place Vivotif in the refrigerator" (PT: Product communication issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003850) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient brought Vivotif home from the pharmacy three weeks ago and kept the medication at room temperature as no one instructed him to place it in the refrigerator. Reportedly, the patient administered one dose of Vivotif on 26JUN2023, that was kept at room temperature for 3 weeks.  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 administered 1 dose of Vivotif that was kept at room temperature for 3 weeks (product storage error) since no one had instructed him to place Vivotif in the refrigerator (product communication issue). The causality of product storage error and product communication 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 administered 1 dose of Vivotif that was kept at room temperature for 3 weeks (product storage error) since no one had instructed him to place Vivotif in the refrigerator (product communication issue). The causality of product storage error and product communication issue is not applicable with Vivotif. The case is considered non serious as per medical assessment.