chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Did not take fourth dose on day 7; A spontaneous report was received from a pharmacist on 24JAN2023. On an unknown date, a patient (age and gender unknown) started taking Vivotif capsule (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. The patient "did not take fourth dose on day 7" (PT: Product dose omission issue).  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient did not take fourth dose on day 7. The outcome of the reported event was not applicable. The action was 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 fourth dose on day 7 (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 did not take fourth dose on day 7 (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: Inappropriate schedule of product administration
Clinical narrative: Patient took two doses on the first and fourth day; A spontaneous report was received from a pharmacist on 24JAN2023. It described a patient (age and gender unknown) who "took two doses on the first and fourth day" (PT: Inappropriate schedule of product administration). The patient took Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies was not reported.  It was reported that the patient took two doses of Vivotif on the first and fourth day instead of following the scheduled period (days 01, 03, 05, and 07).  The outcome of the reported event was not applicable. The action was 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 two doses on the first and fourth 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. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took two doses on the first and fourth 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. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Forgot to take second dose of Vivotif on day 3 and took it on the 4th day; A spontaneous report was received from a pharmacist on 07FEB2023 regarding a female patient (age unknown) who "forgot to take second dose of Vivotif on day 3 and took it on the 4th day" (PT: Inappropriate schedule of product administration). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies was not reported.  On an unknown date (day 1) at 7:00 PM, the patient took first dose of Vivotif and then forgot to take second dose on day 3 at 7:00 PM. Reportedly, the patient took the second dose on fourth day in the morning at 9:00 AM.  The outcome of the reported event was not applicable. The action was 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 forgot to take second dose of Vivotif on day 3 and took it on the 4th 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. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient forgot to take second dose of Vivotif on day 3 and took it on the 4th 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. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose-3 of Vivotif was delayed by 12 hours; A spontaneous report was received from a 53-year-old female patient on 07FEB2023 whose "dose-3 of Vivotif was delayed by 12 hours" (PT: Inappropriate schedule of product administration). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies was not reported.  It was reported that the patient's third dose of Vivotif was delayed by 12 hours. Additionally, the patient confirmed that she did not experience any side effects.  The outcome of the reported event was not applicable. The action was 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 whose dose-3 of Vivotif was delayed by 12 hours (inappropriate schedule of product administration). Vivotif should be taken every other day, and the causality of an 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 patient whose dose-3 of Vivotif was delayed by 12 hours (inappropriate schedule of product administration). Vivotif should be taken every other day, and the causality of an 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 dose omission issue
Clinical narrative: Took Vivotif on Monday and forgot to take it on Wednesday; A spontaneous report was received from a nur Vivotif se on 10FEB2023 regarding a female patient (age unknown) who "took on Monday and forgot to take it on Wednesday" (PT: Product dose omission in error). The patient took the Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies was not reported.  It was reported that the patient took a dose of Vivotif on 06FEB2023 (Monday) and forgot to take it on 08FEB2023 (Wednesday).  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 Monday and forgot to take it on Wednesday (product dose omission in error). Vivotif dose should be taken every other day, and the causality of product dose omission in error 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 took Vivotif on Monday and forgot to take it on Wednesday (product dose omission in error). Vivotif dose should be taken every other day, and the causality of product dose omission in error is 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: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: Missed the fourth dose of Vivotif; A spontaneous report was received from a pharmacist on 13FEB2023 regarding a female patient who "missed the fourth dose of Vivotif" (PT: Incomplete course of vaccination). The patient took the Vivotif (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 dose of Vivotif on 29JAN2023 followed by the second on 31JAN2023 and the third on 02FEB2023; however, missed taking the fourth dose. Reportedly, the patient had left for the trip.  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 the fourth dose of Vivotif (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 missed the fourth dose of Vivotif (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: No adverse event, Product storage error
Clinical narrative: Left Vivotif at room temperature for at least 48 hours or more; A spontaneous report was received from a male patient (age unknown) on 13FEB2023 who "left Vivotif at room temperature for at least 48 hours or more" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient obtained Vivotif from the pharmacy and was not instructed to store it in the refrigerator. Reportedly, the patient took two Vivotif capsules that were left at room temperature for at least 48 hours or more. The patient experienced no other side effects. Furthermore, the patient stated that he would not take further doses of Vivotif that were left outside the refrigerator.  Additionally, the patient did not provide the lot number of Vivotif as he threw out the box.  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 at least 48 hours or more (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 at least 48 hours or more (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: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received second dose of Vivotif at 72 hours; A spontaneous report was received from a nurse on 28FEB2023 regarding an 18-year-old male patient who "received second dose of Vivotif at 72 hours" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 23FEB2023, Thursday afternoon, the patient received the first dose of Vivotif. Reportedly, the second dose of Vivotif was scheduled on Saturday (25FEB2023) afternoon. However, the patient was away; therefore, he administered the second dose at 72 hours on 26FEB2023 (Sunday evening) instead of 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 received second dose of Vivotif at 72 hours (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 received second dose of Vivotif at 72 hours (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
Clinical narrative: Took Vivotif on days 1, 3, 7 and 9; A spontaneous report was received from a nurse on 06MAR2023 regarding a 64-year-old female patient who "took Vivotif on days 1, 3, 7 and 9" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (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 on days 1, 3, 7 and 9 instead of days 1, 3, 5, and 7.  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 days 1, 3, 7 and 9 (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 Vivotif on days 1, 3, 7 and 9 (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
Clinical narrative: Patient had taken Vivotif on days 1 and 2; A spontaneous report was received from a pharmacist on 06MAR2023 regarding a female patient (age unknown) who "had taken Vivotif on days 1 and 2" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 05MAR2023, the patient took the first dose of Vivotif, followed by the second dose on the second day instead of the third day. Reportedly, the patient had not taken any more capsules yet.  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 Vivotif on days 1 and 2 (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 had taken Vivotif on days 1 and 2 (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: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed to take the dose 4 of Vivotif; A spontaneous report was received from a pharmacist on 08MAR2023 regarding a male patient (age unknown) who "missed to take the dose 4 of Vivotif" (PT: Product dose omission issue). The patient took the Vivotif (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 the first two doses of Vivotif on an unknown date, followed by the third dose on 05MAR2023. However, the patient missed taking 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 missed taking dose 4 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 missed taking dose 4 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: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif capsules every day for 4 days in a row; A spontaneous report was received from a patient (age and gender unknown) on 10MAR2023 who "took Vivotif capsules every day for 4 days 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 known allergies were not reported.  It was reported that the patient misread the prescription, asking to take "one capsule by mouth every other day" and took Vivotif capsules every day for four days in a row instead. Reportedly, the patient took the last dose of Vivotif on Tuesday 07MAR2023 and did not experience any side effects.  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 capsules every day for 4 days in a row (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 Vivotif capsules every day for 4 days in a row (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, No adverse event
Clinical narrative: Took second and third dose of Vivotif on Wednesday and Thursday; A spontaneous report was received from a female patient of unknown age on 16MAR2023 who "took second and third dose of Vivotif on Wednesday and Thursday" (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 the first three doses of Vivotif on an unspecified date on Monday, Wednesday and Thursday instead of Monday, Wednesday and Friday as scheduled. Reportedly, there were no adverse events noticed.  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 on Wednesday and Thursday (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 second and third dose of Vivotif on Wednesday and Thursday (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: U
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: Missed to take the last two doses of Vivotif; A spontaneous report was received from a pharmacist on 21MAR2023 regarding a patient of unknown age and gender who "missed to take the last two doses 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.  On 15MAR2023, the patient received the first dose of Vivotif followed by the second dose on 17MAR2023. Reportedly, the patient missed to take the other two doses on 19MAR2023 and 21MAR2023, respectively.  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 the last two doses 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 missed to take the last two doses 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: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Took the fourth dose of Vivotif on day 6; A spontaneous report was received from a male patient of unknown age on 24MAR2023 who "took the fourth dose of Vivotif on day 6" (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 on days 1, 3, 5 and 6 instead of days 1, 3, 5, and 7. Reportedly, the patient did not experience any side effects.  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 fourth dose of Vivotif on day 6 (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 the fourth dose of Vivotif on day 6 (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: M
Vaccine: TYP
Symptoms: No adverse event, Product administration error
Clinical narrative: Took 2 capsules of Vivotif on day 1 and 2 capsules on day 2; A spontaneous report was received from a nurse on 04APR2023 regarding a 41-year-old male patient who "took 2 capsules of Vivotif on day 1 and 2 capsules on day 2" (PT: Product administration 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 administered two capsules of Vivotif on day one and two capsules on day two. Furthermore, it was stated that the patient did not experience any side effects.  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: A consumer took 2 capsules of Vivotif on day 1, and 2 capsules on day 2 (product administration error). Vivotif dose should be taken every other day, and the causality of product administration error is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.  On 09MAY23023, ad-hoc review was performed. The causality assessment for the event of "Took 2 capsules of Vivotif on day 1 and 2 capsules on day 2 (PT: Product administration error) " was updated from not reported to not related per medical assessment. The causality assessment as noted in the company comment is 'not applicable'.; Sender's Comments: A consumer took 2 capsules of Vivotif on day 1, and 2 capsules on day 2 (product administration error). Vivotif dose should be taken every other day, and the causality of product administration error 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, No adverse event
Clinical narrative: Took the last dose of Vivotif on day 6; A spontaneous report was received from a caregiver on 04APR2023 regarding an 18-year-old male patient who "took the last dose of Vivotif on day 6" (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 administered Vivotif on days 1, 3, 5 and 6. Furthermore, it was stated that the patient did not experience any side effects.  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 the last dose of Vivotif on day 6 (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 patient took the last dose of Vivotif on day 6 (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: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Product dose omission issue
Clinical narrative: Missed to take the dose 4 of Vivotif; A spontaneous report was received from a nurse on 04APR2023 regarding a 19-year-old male patient who "missed to take the dose 4 of Vivotif " (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.  On an unknown date, in DEC2022 the patient received three doses of Vivotif as per the schedule. However, he missed taking the fourth dose. Reportedly, the patient did not experience any side effects and was not on any other medications.  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 missed to take the dose 4 of Vivotif (incomplete course of vaccination). Considering the nature of the event, the causality of incomplete course of vaccination 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 patient missed to take the dose 4 of Vivotif (incomplete course of vaccination). Considering the nature of the event, the causality of incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Administered Vivotif 30 minutes after food; A spontaneous report was received from a nurse on 10APR2023 regarding a 54-year-old female patient who "administered Vivotif 30 minutes after food" (PT: Product administration 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.  On 09APR2023, the patient administered a fourth dose of Vivotif 30 minutes after having the food.  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 54-year-old female consumer took Vivotif 30 minutes after food (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.; Sender's Comments: It was reported that a 54-year-old female consumer took Vivotif 30 minutes after food (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Labelled drug-drug interaction medication error, No adverse event
Clinical narrative: Started antibiotic course after first dose of Vivotif; Did not complete rest of the Vivotif regimen; A spontaneous report was received from a nurse on 18APR2023 regarding a 62-year-old female patient who "started antibiotic course after first dose of Vivotif" (PT: Labelled drug-drug interaction medication error) and "did not complete rest of the Vivotif regimen" (PT: Incomplete course of vaccination). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization and Macrobid (nitrofurantoin) for an unknown indication.  The patient's medical history/allergies and concomitant medications were not reported.  On 04APR2023 the patient received the first dose of Vivotif. Reportedly, the patient was prescribed Macrobid along with Vivotif which was initiated on 05APR2023. The patient completed the antibiotic course on 14APR2023. Additionally, the patient did not complete the Vivotif regimen and did not experience any side effects.  The outcome of the reported events was not applicable. The action taken with Vivotif and Macrobid with respect to the reported events was not applicable.  No additional information was provided.  Company comment: It was reported that a consumer started antibiotic course after first dose of Vivotif (labelled drug-drug interaction medication error) and did not complete rest of the Vivotif regimen (incomplete course of vaccination). Vivotif doses should be taken every other day and there should be a gap of at least three days between Vivotif and antibiotic doses. Considering the nature of the events, the causality of labelled drug-drug interaction medication error and incomplete course of vaccination 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 started antibiotic course after first dose of Vivotif (labelled drug-drug interaction medication error) and did not complete rest of the Vivotif regimen (incomplete course of vaccination). Vivotif doses should be taken every other day and there should be a gap of at least three days between Vivotif and antibiotic doses. Considering the nature of the events, the causality of labelled drug-drug interaction medication error and incomplete course of vaccination is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Only took one dose of Vivotif; A spontaneous report was received from a pharmacist on 01MAY2023 regarding a female patient of unknown age who "only took one dose of Vivotif" (PT: Incomplete course of vaccination). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003823) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 27MAR2023, Thursday, the patient took the first dose of Vivotif and did not administer any doses since then.  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 only took one dose of Vivotif (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 patient only took one dose of Vivotif (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: Product administration error
Clinical narrative: Took last dose of Vivotif 45 minutes after lunch; A spontaneous report was received from a registered nurse on 02MAY2023 regarding a male patient of unknown age who "took last dose of Vivotif 45 minutes after lunch" (PT: Product administration 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 took the three doses of Vivotif on days 1, 3 and 5 appropriately. However, took the last dose 45 minutes after eating lunch. Reportedly, he had no other 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 took last dose of Vivotif 45 minutes after lunch (product administration error). Considering the nature of event, the causality of product administration error 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 took last dose of Vivotif 45 minutes after lunch (product administration error). Considering the nature of event, the causality of product administration error is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Second dose of Vivotif was kept unrefrigerated for more than 48 hours before taking; A spontaneous report was received from a pharmacist on 25APR2023 regarding a patient of unknown age and gender whose "second dose of Vivotif was kept unrefrigerated for more than 48 hours before taking" (PT: Product storage error). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003832) 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, kept the second dose unrefrigerated for more than 48 hours, at a temperature greater than room temperature before taking it.  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: A consumer reported that the second dose of Vivotif was kept unrefrigerated for more than 48 hours before taking (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: A consumer reported that the second dose of Vivotif was kept unrefrigerated for more than 48 hours before taking (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: Product administration error
Clinical narrative: Took protein bar 15 minutes after Vivotif; A spontaneous report was received from a nurse on 04MAY2023 regarding a 20-year-old female patient who "took protein bar 15 minutes after Vivotif" (PT: Product administration 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.  On 04MAY2023, the patient took the fourth dose of Vivotif and had a protein bar 15 minutes after administering the 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: A consumer took protein bar 15 minutes after Vivotif (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the 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: A consumer took protein bar 15 minutes after Vivotif (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the 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: F
Vaccine: TYP
Symptoms: Vaccination error
Clinical narrative: Took Vivotif directly after eating on a full stomach; A spontaneous report was received from a pharmacist on 09MAY2023 regarding a female patient of unknown age who "took Vivotif directly after eating on a full stomach" (PT: Product administration 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 administered Vivotif directly after eating, on a full stomach. Reportedly, the patient did not experience any side effects.  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: A consumer took Vivotif directly after eating on a full stomach (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the 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: A consumer took Vivotif directly after eating on a full stomach (product administration error). Vivotif dose should be taken at least one hour before a meal. Considering the nature of the 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: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Forgot to take her third dose of Vivotif and was out of town; A spontaneous case was received from a pharmacist on 17MAY2023 regarding a 51-year-old female patient who "forgot to take her third dose of Vivotif and was out of town" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's concomitant medication and known allergies were not reported and her medical history was reported as none.  On 13MAY2023 the patient took her first dose of Vivotif followed by the second dose on an unknown date in MAY2023. Reportedly, the patient forgot to take the doses with her while going out of town and her third dose of Vivotif was due on 17MAY2023.  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 provided.  Company comment: It was reported that a consumer forgot to take her third dose of Vivotif and was out of town (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 her third dose of Vivotif and was out of town (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: F
Vaccine: TYP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Administered 4 capsules of Vivotif as one dose; A spontaneous report was received from pharmacist on 22MAY2023 regarding a 40-year-old female patient who "administered 4 capsules of Vivotif as one dose" (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 19MAY2023, the patient administered four capsules of Vivotif as one dose. Reportedly, the patient did not experience any side effects and was advised to seek immediate medical help in the event of any symptoms.  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 administered 4 capsules of Vivotif as one dose (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 patient administered 4 capsules of Vivotif as one dose (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.
Age: 89.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The injection site was swollen, red, warm to the touch, and painful.; The injection site was swollen, red, warm to the touch, and painful.; The injection site was swollen, red, warm to the touch, and painful.; The injection site was swollen, red, warm to the touch, and painful.; This spontaneous report was received from a medical assistant and refers to an 89-year-old female patient. The patient's medical history and concurrent conditions were not reported. No other reactions to any other vaccines were reported. Concomitant medications included rosuvastatin, acetylsalicylic acid (ASPIRINE), estradiol, vitamins not otherwise specified (NOS), probiotics NOS, magnesium, calcium and ubidecarenone (+) vitamin e NOS (COQ10 COMPLEX).   On 21-FEB-2024, the patient started therapy with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) pre-filled syringe, 0.5 milliliter, (lot #X014729, expiration date: 22-NOV-2024), administered intramuscularly in the left deltoid for prophylaxis (strength was not provided).  On an unknown date in February 2024, the injection site was swollen, red, warm to the touch, and painful (vaccination site warmth, vaccination site swelling, vaccination site erythema, vaccination site pain) and on 22-FEB-2024 (reported as the next day of vaccination), the patient reported all the above-mentioned events. The patient was prescribed doxycycline 100 mg for 10 days when the symptoms were reported. It was not known how long the symptoms lasted. On an unknown date in February 2024, the patient recovered from the events and on 26-FEB-2024, when the health care professional (HCP) spoke with the patient, she stated that she was "totally fine". Moreover, the HCP reported the product had been discarded and was unavailable for retrieval.   The causal relationship between vaccination site warmth, vaccination site swelling, vaccination site erythema, vaccination site pain and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.