chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient who received the Vivotif Vaccine a year ago, but took all four capsules in four consecutive days instead of following the vaccination schedule; Case reference number US-BN-2023-010722 is a spontaneous case report initially received from a pharmacist via Company (reference number: USBAV23-2142) on 20-Dec-2023 and concerns a patient of unknown age and unknown gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose and site of administration via oral use for unknown indication.  On an unspecified date, an unknown amount of time after the first dose of Vivotif the patient took the second dose of Vivotif (batch number: unknown) at unknown dose and site of administration via oral use.  On an unspecified date, an unknown amount of time after the first dose of Vivotif the patient took the third dose of Vivotif (batch number: unknown) at unknown dose and site of administration via oral use.  On an unspecified date, an unknown amount of time after the first dose of Vivotif the patient took the fourth dose of Vivotif (batch number: unknown) at unknown dose and site of administration via oral use. As reported the patient who received the Vivotif Vaccine a year ago but took all four capsules in four consecutive days instead of following the vaccination schedule (explicitly coded as inappropriate schedule of vaccine administered). Now the patient was wondering whether he should repeat the vaccination.  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender received the Vivotif Vaccine a year ago but took all four capsules in four consecutive days instead of following the vaccination schedule which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender received the Vivotif Vaccine a year ago but took all four capsules in four consecutive days instead of following the vaccination schedule which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Patients took Vivotif in Novembar, approximately 22 days after the expiration date; Case reference number US-BN-2023-010725 is a spontaneous case report initially receive from pharmacist via Communications (reference number: USBAV23-2147) on 21-Dec-2023 and concerns two patients, a male (23-Jun-19XX) and a female (23-Feb-19XX) (husband and wife)).  The patients' medical history and concomitant medication were not provided.  On unspecified date in November, the patients were vaccinated with Vivotif (batch number: 3003790), at unknown dose, orally, for unknown indication. The patients took Vivotif, approximately 22 days after the expiration date (31-Oct-2023) and the patients realized that the product expired when they finished courses, as reported (explicitly coded as 'expired vaccine used').  At the time of initial report, it was unknown if the patients experienced any adverse event due to Vivotif vaccine.  Additional information received from Bavarian Nordic on 21-Dec-2023 included new reference number.; Reporter's Comments: Two adult patients were vaccinated with Vivotif (batch number: 3003790), approximately 22 days after the expiration date. No associated adverse events were reported. Expired vaccine administered is listed per company convention. The patients' relevant medical history and concomitant medication were not reported. Expired vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: Two adult patients were vaccinated with Vivotif (batch number: 3003790), approximately 22 days after the expiration date. No associated adverse events were reported. Expired vaccine administered is listed per company convention. The patients' relevant medical history and concomitant medication were not reported. Expired vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Took Vivotif on day 1 and day 2; A spontaneous report was received from sales representative on 13FEB2023 regarding a patient of unknown age and gender who "took Vivotif on day 1 and day 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.  It was reported that the patient missed a dose of Vivotif at the scheduled time and took it on day 1 and day 2 instead of days 1 and 3.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif on day 1 and day 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 took Vivotif on day 1 and day 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: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered Vivotif on day 1 and 2; A spontaneous report was received from other health care professional on 14FEB2023 regarding a female patient (age unknown) who "administered Vivotif on day 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.  It was reported that the patient administered the doses of Vivotif on day 1 and 2 instead of days 1 and 3.  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 Vivotif on day 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 patient administered Vivotif on day 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: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took two doses of Vivotif before realizing she had not kept this medication in the refrigerator; A spontaneous report was received from a pharmacist on 20FEB2023 regarding a female patient (age unknown) who "took two doses of Vivotif before realizing she had not kept this medication in the refrigerator" (PT: Product storage 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 were not reported.  It was reported that the patient took two doses of Vivotif before realizing she had not kept the medication in the refrigerator.  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 two doses of Vivotif before realizing she had not kept this medication in the refrigerator (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 patient took two doses of Vivotif before realizing she had not kept this medication in the refrigerator (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: Inappropriate schedule of product administration
Clinical narrative: Took the fourth dose of Vivotif on day 9; A spontaneous report was received from a nurse on 21FEB2023 regarding a 47-year-old female who "took the fourth dose of Vivotif on day 9" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) as a prophylactic vaccination for travel.  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 12FEB2023 followed by the second and third dose on 14FEB2023 and 16FEB2023 respectively. However, she did not make it back to the town for her fourth dose on 18FEB2023 and took it on 20FEB2023. Reportedly, the reporter was not aware of any other side effects reported by the patient.  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 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 the fourth dose of Vivotif on day 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: Product storage error
Clinical narrative: Administered Vivotif capsules stored at room temperature for 3 days; A spontaneous report was received from caregiver on 20FEB2023 regarding a female patient (age unknown) who "administered Vivotif capsules stored at room temperature for 3 days" (PT: Product storage 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 were not reported.  It was reported that the patient administered three doses of Vivotif capsules herself which were stored at room temperature for three days. Reportedly, the capsules were exposed to a temperature of 60 degrees Fahrenheit (F).  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer administered Vivotif capsules stored at room temperature for 3 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 administered Vivotif capsules stored at room temperature for 3 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: M
Vaccine: TYP
Symptoms: Wrong technique in product usage process
Clinical narrative: Chewed and swallowed one dose of Vivotif; A spontaneous report was received from a pharmacist on 23FEB2023 regarding a 07-year-old male patient who "chewed and swallowed one dose of Vivotif" (PT: Wrong technique in product usage process). 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 chewed and swallowed one dose of Vivotif instead of swallowing normally. Reportedly, the patient had no other side effects due to 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 chewed and swallowed one dose of Vivotif (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process 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 chewed and swallowed one dose of Vivotif (wrong technique in product usage process). Considering the nature of the event, the causality of wrong technique in product usage process is assessed as not applicable to Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Administered the first dose of Vivotif which was stored at 71 F for about 10 days; A spontaneous report was received from a 78-year-old female patient on 27FEB2023 who "administered the first dose of Vivotif which was stored at 71 F for about 10 days" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003789, expiry date: OCT2023) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  On 27FEB2023, the patient administered the first dose of Vivotif, which was stored at 71 degrees Fahrenheit (F) for about 10 days. 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 administered the first dose of Vivotif which was stored at 71 F for about 10 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 administered the first dose of Vivotif which was stored at 71 F for about 10 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: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took the third capsule of Vivotif with food; A spontaneous report was received from a nurse on 17MAY2023 regarding a 15-year-old male patient who "took the third capsule of Vivotif with 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.  It was reported that the patient took the third capsule of Vivotif on day five with food. Furthermore, it was reported that all the other capsules of Vivotif were taken appropriately by the patient.  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 capsule of Vivotif with 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. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the third capsule of Vivotif with 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. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Took 2 capsules of the expired Vivotif; A spontaneous report was received from a pharmacist on 17MAY2023 regarding a 69-year-old female patient who "Took 2 capsules of the expired Vivotif" (PT: Expired product administered). 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 2 capsules of Vivotif that expired on an unknown date in APR2023. Reportedly, no side effects were experienced by the patient from taking the expired capsules 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 provided.  Company comment: It was reported that a consumer took 2 capsules of the expired Vivotif (expired product administered). Considering the nature of the event, the causality of expired product administered is assessed as not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took 2 capsules of the expired Vivotif (expired product administered). Considering the nature of the event, the causality of expired product administered is assessed as not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Did not administer Vivotif one hour before a meal; A spontaneous report was received from a pharmacist on 17MAY2023 regarding a 32-year-old female patient who "did not administer Vivotif one hour before a meal" (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 16MAY2023, the third dose of Vivotif was scheduled which was not administered by the patient one hour before 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 provided.  Company comment: It was reported that a consumer did not administer Vivotif one hour before a meal (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: It was reported that a consumer did not administer Vivotif one hour before a meal (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 administration error
Clinical narrative: Had grapes within 5 minutes of Vivotif; A spontaneous report was received from a female patient of unknown age on 29JUN2023 who had "grapes within 5 minutes of 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.  It was reported that the patient administered first dose of Vivotif on 29JUN2023 and had grapes within 5 minutes of Vivotif administration.  The outcome of the reported event was not applicable. The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer had grapes within 5 minutes of Vivotif (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 had grapes within 5 minutes of Vivotif (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 use complaint, Wrong technique in product usage process
Clinical narrative: Could not swallow the Vivotif capsule; Mixed the contents of the capsule in little amount of water and drank it; A spontaneous report was received from pharmacist on 01JUL2023 regarding a patient of unknown age and gender who "could not swallow the Vivotif capsule" (PT: Product use complaint) and "mixed the contents of the capsule in little amount of water and drank it" (PT: Wrong technique in product usage process). 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 who was prescribed Vivotif was not able to swallow the capsule hence mixed the contents of the capsule in little amount of water and drank it.  The outcome of the reported events was not applicable. The action taken with Vivotif with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer could not swallow the Vivotif capsule (product use complaint) and mixed the contents of the capsule in little amount of water and drank it (wrong technique in product usage process). Further information regarding event is limited. The causality of product use complaint and wrong technique in product usage process is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer could not swallow the Vivotif capsule (product use complaint) and mixed the contents of the capsule in little amount of water and drank it (wrong technique in product usage process). Further information regarding event is limited. The causality of product use complaint and wrong technique in product usage process is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed the third dose of Vivotif; A spontaneous report was received from a pharmacist on 03JUL2023 regarding patient of unknown age and gender who "missed the third dose of Vivotif" (PT: Product dose omission issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; National Drug Code (NDC): 69401-0000-02; batch number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were reported was reported.  It was reported that the patient took two doses of Vivotif on Wednesday, 28JUN2023 and on Friday, 30JUN2023 respectively and would not be able to take more doses until this week (as per the report).  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 third dose of Vivotif (product dose omission issue) and would not be able to take more doses until this week. 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 the third dose of Vivotif (product dose omission issue) and would not be able to take more doses until this week. 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: F
Vaccine: TYP
Symptoms: Product physical issue
Clinical narrative: One of the Vivotif capsule was not intact/pink and white covering of the capsule was separated; A spontaneous report was received from a 29-year-old female patient on 05JUL2023 regarding "one of the Vivotif capsule was not intact/pink and white covering of the capsule was separated" (PT: Product physical issue). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003832; expiry date: FEB2024) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient picked up Vivotif prescription from the pharmacy and noticed that one of the Vivotif capsules was not intact as the pink and white covering of the capsule was separated. Further, the patient could not confirm whether the capsule was broken or had a crack on it.  Reportedly, there was no damage or tampering to the packaging.  On 05JUL2023, the patient took the third dose of Vivotif and requested for replacement of one damaged capsule, so she could complete the full course by 07JUL2023.  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.  The case was assessed as invalid as the damaged product was not administered by the patient.  Company comment: A non-valid case with the report that the patient picked up Vivotif prescription from the pharmacy and noticed that one of the Vivotif capsules was not intact as the pink and white covering of the capsule was separated (product physical issue) even though the packaging itself was undamaged. Further information is limited. The causality of product physical issue is not applicable with Vivotif.  On 12JUL2023, the investigation associated with this product quality complaint was completed and the final Complaint Report was retrieved on 02OCT2023. The investigation noted that the complaint rate is 0.003%. Based on this result, no further manufacturing investigation required. The consumer did not administer impacted capsule, impact to a consumer can thus be excluded.; Sender's Comments: A non-valid case with the report that the patient picked up Vivotif prescription from the pharmacy and noticed that one of the Vivotif capsules was not intact as the pink and white covering of the capsule was separated (product physical issue) even though the packaging itself was undamaged. Further information is limited. The causality of product physical issue is not applicable with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered the first three doses of Vivotif subsequently; A spontaneous report was received from a 79-year-old male patient on 11JUL2023 who had "administered the first three doses of Vivotif subsequently" (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 first three doses of Vivotif subsequently on 27JUN2023, 28JUN2023 and 29JUN2023 respectively instead of recommended administration. Additionally, the fourth dose of Vivotif was administered on 01JUL2023.  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.   Based on the information available in the document two individual case safety reports 23000312 (husband) and 23000313 (wife) were created and cross linked in the database.  Company comment: It was reported that a consumer administered the first three doses of Vivotif subsequently (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 administered the first three doses of Vivotif subsequently (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. 23000313:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administered the first three doses of Vivotif subsequently; A spontaneous report was received from other caregiver on 11JUL2023 regarding a 69-year-old female patient who had "administered the first three doses of Vivotif subsequently" (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 first three doses of Vivotif subsequently on 27JUN2023, 28JUN2023 and 29JUN2023 respectively instead of recommended administration. Additionally, the fourth dose of Vivotif was administered on 01JUL2023.  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.  Based on the information available in the document two individual case safety reports 23000312 (husband) and 23000313 (wife) were created and cross linked in the database.  Company comment: It was reported that a consumer administered the first three doses of Vivotif subsequently (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 administered the first three doses of Vivotif subsequently (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. 23000312:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Taken Vivotif 2 days in a row; A spontaneous report was received from pharmacy technician on 11JUL2023 regarding a female patient of unknown age who had "taken Vivotif 2 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.  On 10JUL2023, the patient took the first dose of Vivotif followed by the second dose in a row on 11JUL2023 instead on the alternate days as described in the label.  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 2 days in a row (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer had taken Vivotif 2 days in a row (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Lost the 4th dose of Vivotif and did not take it; A spontaneous report was received from registered nurse on 12JUL2023 regarding a patient of unknown age and gender who had "lost the 4th dose of Vivotif and did not take it" (PT: Product dose omission issue). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) as an immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient had administered 3 out of 4 doses of Vivotif properly and lost the fourth dose and did not take 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: It was reported that a patient had lost the 4th dose of Vivotif and did not take it (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 patient had lost the 4th dose of Vivotif and did not take it (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: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Administered Vivotif incorrectly; A spontaneous report was received from the other healthcare professional on 12JUL2023 regarding a female patient of unknown age who "administered Vivotif incorrectly" (PT: Product administration error). The patient took Vivotif (Typhoid vaccine live oral Ty21A; lot number: unknown) as an immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient had administered Vivotif incorrectly.  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 Vivotif incorrectly (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 administered Vivotif incorrectly (product administration error). Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Administered Vivotif that was left at room temperature for 6 days; A spontaneous report was received from a 46-year-old female patient on 14JUL2023 who had "administered Vivotif that was left at room temperature for 6 days" (PT: Product storage error). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: 3003832) as an immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered Vivotif that was left at room temperature for 6 days. Additionally, it was reported that the patient administered the fourth dose of Vivotif on 13JUL2023.  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.  Based on the information available in the document two individual case safety reports 23000323 (mother) and 23000324 (son) were created and cross linked in the database.  Company comment: It was reported that a consumer administered Vivotif that was left at room temperature for 6 days (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 Vivotif that was left at room temperature for 6 days (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. 23000324:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Took first dose of Vivotif unrefrigerated; A spontaneous report was received from a male patient of unknown age on 31JUL2023 who "took first dose of Vivotif unrefrigerated" (PT: Product storage error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 534071) as a prophylactic vaccination for typhoid.  The patient's medical history, concomitant medications, or allergies were not reported.  On 29JUL2023, the patient took the first dose of Vivotif which was kept in an air-conditioned house (unrefrigerated) at a temperature of 74 degrees Fahrenheit for 3 days. Reportedly, the patient would be travelling in mid-September.  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 in an air-conditioned house but was unrefrigerated for 3 days (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the first dose of Vivotif which was kept in an air-conditioned house but was unrefrigerated for 3 days (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Took the first dose of Vivotif with food; A spontaneous report was received from a nurse on 31JUL2023 regarding a patient of unknown age and gender who "took the first dose of Vivotif with food" (PT: Product administration error). The patient took oral Vivotif capsule (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the first dose of Vivotif with food despite precise indications.  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 with food (product administration error) despite precise indications. 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 the first dose of Vivotif with food (product administration error) despite precise indications. Further information regarding event is limited. The causality of product administration error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed to take third dose of Vivotif; A spontaneous report was received from a registered nurse on 01AUG2023 regarding a 59-year-old female patient who had "missed to take third dose of Vivotif" (PT: Product dose omission issue). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient administered two doses of Vivotif as per the schedule on Wednesday and Friday but missed taking the third dose on Sunday. Reportedly, the patient was going to administer the next dose on 01AUG2023 and found that she still had two doses left.  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 third 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 third 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: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif every day; A spontaneous report was received from nurse on 04AUG2023 regarding a 45-year-old patient of unknown gender who "took Vivotif every day" (PT: Inappropriate schedule of product administration). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunization.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient administered Vivotif every day instead of days 1,3,5 and 7 as prescribed.  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 a 45-year-old patient of unknown gender took Vivotif every day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a a 45-year-old patient of unknown gender took Vivotif every day (inappropriate schedule of product administration). Further information regarding event is limited. The causality of inappropriate schedule of product administration is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The first dose of Vivotif taken in proper storage conditions but all the other doses were not; A spontaneous report was received from pharmacist on 04AUG2023 regarding a patient of unknown gender and age who had "the first dose of Vivotif taken in proper storage conditions but all the other doses were not" (PT: Product storage error). The patient took oral Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003830) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that the patient took the first dose of Vivotif which was stored at proper storage conditions but took all the other doses that were not properly stored. Reportedly, the other doses of Vivotif were stored at temperature of less than 70 degrees Fahrenheit for total time of 8 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 took the first dose of Vivotif which was stored at proper storage conditions but took all the other doses that were not properly stored (product storage error). Further information regarding event is limited. The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took the first dose of Vivotif which was stored at proper storage conditions but took all the other doses that were not properly stored (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.