chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took one dose of Vivotif, it was left out of the fridge for one week, reached a maximum temperature of 78F; The patient took one dose of Vivotif, it was left out of the fridge for one week, reached a maximum temperature of 78F; Case reference number US-BN-2024-002499 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2391) on 16-Sep-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the Vivotif vaccine was left out of the fridge for one week, reached a maximum temperature of 78-degree Fahrenheit (explicitly coded as 'product storage error').  On 16-Sep-2024, the patient took the first dose of Vivotif (batch number: 3004044), at an unknown dose, orally use for typhoid immunization (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif.  No further information was provided.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif which was left out of the fridge for one week and reached a maximum temperature of 78-degree Fahrenheit (considered as product storage error) at an unknown dose, orally use for typhoid immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif which was left out of the fridge for one week and reached a maximum temperature of 78-degree Fahrenheit (considered as product storage error) at an unknown dose, orally use for typhoid immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took the first dose of Vivotif which was left unrefrigerated for over a week; The patient took the first dose of Vivotif which was left unrefrigerated for over a week; Case reference number US-BN-2024-002509 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2407) on 17-Sep-2024 and concerns an adult female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the doses of Vivotif were left unrefrigerated for over a week (explicitly coded as 'product storage error').  On 15-Sep-2024, the patient took the affected first dose of Vivotif (batch number: 3004061), at an unknown dose, orally, for an unknown indication (explicitly coded as 'product administration error'). As reported, the patient ordered Vivotif again for the patient's husband and heard that Vivotif vaccine was supposed to be refrigerated.  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif.  No further information was provided.; Reporter's Comments: An adult female patient took the affected first dose of Vivotif which were left unrefrigerated for over a week (considered as product storage error), at an unknown dose, orally, for an unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed ad not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult female patient took the affected first dose of Vivotif which were left unrefrigerated for over a week (considered as product storage error), at an unknown dose, orally, for an unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed ad not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took Vivotif vaccine which did not refrigerate, maximum reached temperature was 77 Fahrenheit degrees; The patient took Vivotif vaccine which did not refrigerate,maximum reached temperature was 77 Fahrenheit degrees; Case reference number US-BN-2024-002523 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2438) on 19-Sep-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as since 14-Sep-2024, the patient did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees (explicitly coded as 'Product storage error').  On 14-Sep-2024, the patient took the first dose of Vivotif vaccine (batch number: 3004062), at unknown dose, route or site of administration, for immunization (explicitly coded as 'Product administration error')  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 female patient of unspecified age, did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees which is considered as product storage error. The patient took the first dose of Vivotif vaccine, at unknown dose, route or site of administration, for immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age, did not refrigerate one box Vivotif vaccine, maximum reached temperature was 77 Fahrenheit degrees which is considered as product storage error. The patient took the first dose of Vivotif vaccine, at unknown dose, route or site of administration, for immunization which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took Vivotif doses which were left at room temperature for a week and the maximum temperature reached 25ºC; Patient took Vivotif doses which were left at room temperature for a week and the maximum temperature reached 25ºC; Case reference number US-BN-2024-002524 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2440) on 19-Sep-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, reported as for a week, the patient left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees (explicitly coded as 'product storage error')    On unspecified dates, the patient took the unspecified number of doses, as reported did the entire course of Vivotif (batch number: 3004062) at an unknown dose, route for unknown indication (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif.  Additional information received from a pharmacist via Med Communication (reference number: USBAV24-2446) on 19-Sep-2024: Information included additional reference number (USBAV24-2446) and gender.; Reporter's Comments: A female patient of unknown age left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees which is considered as product storage error. The patient took the unspecified number of doses, as reported did the entire course of Vivotif, at an unknown dose, route for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees which is considered as product storage error. The patient took the unspecified number of doses, as reported did the entire course of Vivotif, at an unknown dose, route for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Patient missed to take third dose of Vivotif yesterday; Case reference number US-BN-2024-002547 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2514) on 25-Sep-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.   On unspecified dates, the patient took the first and second dose of Vivotif (batch numbers: unknown) at an unknown dose, orally for unknown indication. As reported the patient missed to take third dose of Vivotif yesterday (explicitly coded as 'missed dose')  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported the patient missed to take the third dose of Vivotif on time, which is considered as missed dose. It was unknown if the patient experienced any adverse events due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported the patient missed to take the third dose of Vivotif on time, which is considered as missed dose. It was unknown if the patient experienced any adverse events due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took the Vivotif vaccine 20 min after eating; Case reference number US-BN-2024-002546 is a spontaneous case initially received from healthcare professional via Med Communications (reference number: USBAV24-2511) on 25-Sep-2024 and concerns a 42-year-old female patient.  The patient's medical history and concomitant medication details were not provided.   On an unspecified date, as reported the patient ate and after 20 min took a dose of Vivotif (batch number: unknown) at an unknown dose or route of administration, for unknown indication (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif.  No further information was provided.; Reporter's Comments: A 42-year-old female patient ate and after 20 min took a dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 42-year-old female patient ate and after 20 min took a dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Vivotif was kept at the temperature that got up to 60 degrees (unit not provided), and one capsule was administered after excursion; Vivotif was kept at the temperature that got up to 60 degrees (unit not provided), and one capsule was administered after excursion; Case reference number US-BN-2024-002570 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2558) on 30-Sep-2024 and concerns one male and one female patient (MULTI2) of unspecified age.  The patients' medical history and concomitant medication details were not provided.   On an unspecified date, as reported, Vivotif vaccine was stored in a cooler, but it got up to 60 degrees (unit not provided) (explicitly coded as 'product storage error').  On an unspecified date, after temperature excursion, the patients took the first dose of Vivotif (batch number: unknown), at an unknown dose, route, for a trip (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patients experienced any adverse events due to the Vivotif vaccination.  Additional information received from the consumer via Med Communications on 30-Sep-2024 included an additional reference number (USBAV24-2559), the case is crosslinked by same reporter.  Additional information received from Bavarian Nordic on 01-Oct-2024 included additional reference number (BN_2024_02995).; Reporter's Comments: One male and one female patient of unspecified age took the first dose of Vivotif, which was stored in a cooler, but it got up to 60 degrees, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: One male and one female patient of unspecified age took the first dose of Vivotif, which was stored in a cooler, but it got up to 60 degrees, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Incorrect dose administered
Clinical narrative: Patient took three doses of Vivotif as prescribed, but did not take fourth dose as scheduled; Last dose of Vivotif left out of the refrigerator at room temperature for days or a week; Case reference number US-BN-2024-002628 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2635) on 07-Oct-2024 and concerns a 31-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, reported as per prescribed, the patient took the first, second and third dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally for an unknown indication.  On unspecified date, the patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week (explicitly coded as 'product storage error').  On 01-Oct-2024, as reported was due date for the last dose, but the patient never took the fourth dose of Vivotif on that day (explicitly coded as 'Inappropriate schedule of product administration').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  Additional information received from pharmacist on 09-Oct-2024 included: information about reporter and conformation that the patient did not take fourth dose of Vivotif on 10-Oct-2024.; Reporter's Comments: A 31-year-old female patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week which is considered as product storage error. Reportedly, the patient never took the fourth dose of Vivotif the scheduled day which is considered as inappropriate schedule of product administration. Inappropriate schedule of product administration and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 31-year-old female patient left out of the fridge one capsule of Vivotif vaccine at room temperature for days or maybe a week which is considered as product storage error. Reportedly, the patient never took the fourth dose of Vivotif the scheduled day which is considered as inappropriate schedule of product administration. Inappropriate schedule of product administration and product storage error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product storage error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took oral typhoid vaccine not in recommended way (two doses 25 hours apart instead of skipping the day in between); Case reference number US-BN-2024-002626 is a spontaneous case initially received from other healthcare professional via Med Communications (reference number: USBAV24-2655) on 08-Oct-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication.  On unspecified date, reported as 25 hours apart instead of skipping the day in between the doses, patient took the next dose of Vivotif (batch number: unknown), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administration').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination.  No further information was provided.; Reporter's Comments: A female patient of unspecified age took the next dose of Vivotif, at an unknown dose, orally, 25 hours apart instead of skipping the day in between the doses which is considered as inappropriate schedule of vaccine administration. 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 the Vivotif vaccination. 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 female patient of unspecified age took the next dose of Vivotif, at an unknown dose, orally, 25 hours apart instead of skipping the day in between the doses which is considered as inappropriate schedule of vaccine administration. 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 the Vivotif vaccination. 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: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took the first dose of Vivotif vaccine which was out of refrigerator for less than 48 hours; The patient took the first dose of Vivotif vaccine which was out of refrigerator for less than 48 hours; Case reference number US-BN-2024-002667 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2782) on 21-Oct-2024 and concerns a female patient of unspecified age.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as on Friday night, the patient picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours (explicitly coded as 'product storage error').  On 20-Oct-2024, reported as on Sunday morning, the patient took the first dose of affected Vivotif (batch number: 3004045), at a dose of one capsule, orally, for indication reported as pretravel November (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination.  No further information was provided.; Reporter's Comments: A female patient of unspecified age picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours which is considered as product storage error. The patient took the first dose of affected Vivotif, at a dose of one capsule, orally, for indication reported as pretravel in November which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours which is considered as product storage error. The patient took the first dose of affected Vivotif, at a dose of one capsule, orally, for indication reported as pretravel in November which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient administered Vivotif with cold water and five minutes after started eating a meal; Case reference number US-BN-2024-002686 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2819) on 24-Oct-2024 and concerns a female patient of unknown age.  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, orally, for indication reported as pre travel. As reported the patient administered Vivotif with cold water and five minutes after started eating a meal (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unknown age took the first dose of Vivotif, at unknown dose, orally, for indication reported as pre travel. Reportedly the patient administered Vivotif with cold water and five minutes after started eating a meal which is considered as product administration error. Product administration error is considered listed per company convention. At this point it was unknown if the patient experienced any adverse event due to Vivotif. 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 female patient of unknown age took the first dose of Vivotif, at unknown dose, orally, for indication reported as pre travel. Reportedly the patient administered Vivotif with cold water and five minutes after started eating a meal which is considered as product administration error. Product administration error is considered listed per company convention. At this point it was unknown if the patient experienced any adverse event due to Vivotif. 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: F
Vaccine: TYP
Symptoms: Nausea, Vomiting
Clinical narrative: The patient experienced nausea and vomiting about 12 hours after taking Vivotif, and it has been consistent since the first pill.; The patient experienced nausea and vomiting about 12 hours after taking Vivotif, and it has been consistent since the first pill.; Case reference number US-BN-2024-002734 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-2923) on 05-Nov-2024 and concerns a female patient of unspecified age, reported as around 14 to 15 years old.  The patient's medical history and concomitant medication details were not provided.  On 31-Oct-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid Immunization.  On 02-Nov-2024, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally.   On 04-Nov-2024, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, orally.   Since the first dose of Vivotif, about 12 hours after taking Vivotif, the patient experienced nausea and vomiting, and it has been consistent since the first pill. The healthcare professional stated the patient was definitely ingesting the pill, and it was working. The HCP would like to know if the fourth dose could be postponed until finals are done, which would be on 06-Nov-2024, Saturday.   At the time of the initial report, the patient was not recovered from the events of vomiting and nausea, reported as consistent since the first pill.  The reporter assessed the events of vomiting and nausea as non-serious, and causality for the events of vomiting and nausea was reported as possible.  No further information was provided.; Reporter's Comments: A female patient of unspecified age reported as around 14 to 15 years old experienced non-serious events of nausea and vomiting as reported about 12 hours after taking Vivotif for typhoid Immunization. Vomiting and nausea are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events. Considering suggestive temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age reported as around 14 to 15 years old experienced non-serious events of nausea and vomiting as reported about 12 hours after taking Vivotif for typhoid Immunization. Vomiting and nausea are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events. Considering suggestive temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: The patient received first dose of Vivotif on 01-Nov-2024, second dose on 03-Nov-2024, and third dose was missed; Case reference number US-BN-2024-002740 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-2924) on 06-Nov-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On 01-Nov-2024, at 7 pm, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication.  On 03-Nov-2024, two days after the first dose, at 7 pm, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally.  On unspecified date, reported as last night at 7 pm, the patient missed the third dose of Vivotif vaccine (explicitly coded as 'missed dose').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender missed the third dose of Vivotif vaccine which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. 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 missed the third dose of Vivotif vaccine which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. 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: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took first dose of  Vivotif vaccine which had temperature excursion for seven hours, maximum temperature was 74 Fahrenheit degrees; The patient took first dose of  Vivotif vaccine which had temperature excursion for seven hours, maximum temperature was 74 Fahrenheit degrees; Case reference number US-BN-2024-002753 is a spontaneous case initially received from a other health care professional via Med Communications (reference number: USBAV24-2940) on 07-Nov-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, reported as yesterday, one box (four doses) of the Viviotif vaccine was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, as reported was not instructed to put in refrigerator (explicitly coded as 'product storage error').  On 06-Nov-2024, the patient took the first dose of the affected Vivotif vaccine (batch number: unknown) at one dose, orally for typhoid prophylaxis (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unknown age took the first dose of the affected Vivotif vaccine for typhoid prophylaxis, which was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the first dose of the affected Vivotif vaccine for typhoid prophylaxis, which was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient had taken one out of four Vivotif capsule, and her daughter had taken three out of four Vivotif capsule after the meals, instead of one hour before the meals; Case reference number US-BN-2024-002758 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-2942) on 07-Nov-2024 and concerns two female patients of unknown age (mother and daughter).  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patients took doses of Vivotif (batch number: unknown), at a dose of one capsule, orally, for indication reported as travel. As reported, the patient (mother) had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals (explicitly coded as 'drug administration error').  At the time of the initial report, the patients did not experience any adverse event due to Vivotif, reported as did not feel anything bad.  This case is linked to case US-BN-2024-002760 (same reporter).  The reporter did not want to be contacted for a follow-up.  Additional information received from consumer via Med Communications (reference number: USBAV24-2955) on 07-Nov-2024: included additional reference number.; Reporter's Comments: Two female patients of unknown age took doses of Vivotif for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals, which is considered as drug administration error. The patients did not experience any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two female patients of unknown age took doses of Vivotif for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals, which is considered as drug administration error. The patients did not experience any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: One patient took three doses of Vivotif with food, other patients took only one dose with food; Case reference number US-BN-2024-002754 is a spontaneous case initially received from other healthcare professional via Med Communications (reference number: USBAV24-2938) on 07-Nov-2024 and concerns three patients of unknown age and gender (MULTI3).  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patients took Vivotif (batch number: unknown), at unknown dose, route, for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals (explicitly coded as drug administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.   Additional information received from other healthcare professional via Med Communications (reference USBAV24-2948) on 07-Nov-2024: included reference number.; Reporter's Comments: Three patients of unknown age and gender took Vivotif for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals, which is considered as drug administration error. It was unknown if the patients experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Three patients of unknown age and gender took Vivotif for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals, which is considered as drug administration error. It was unknown if the patients experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient took three doses of Vivotif with food; Case reference number US-BN-2024-002756 is a spontaneous case initially received from a physician via Med Communications (reference number: USBAV24-2943) on 07-Nov-2024 and concerns an 18-years-old female patient.  The patient's medical history and concomitant medications were not provided.  On 31-Oct-2024, the patient took first dose of Vivotif, (batch number: unknown; expiration date: unknown) unknown dose (capsule), orally for pre-travel.  On 02-Nov-2024, the patient took second dose of Vivotif, (batch number: unknown; expiration date: unknown) unknown dose (capsule), orally.  On 04-Nov-2024, the patient took third dose of Vivotif, (batch number: unknown; expiration date: unknown) unknown dose (capsule), orally.  The patient took three doses of Vivotif with food and had one left (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: An 18-year-old female patient took three doses of Vivotif for pre-travel with food, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An 18-year-old female patient took three doses of Vivotif for pre-travel with food, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took two doses of Vivotif capsules at the same time instead of one dose; The patient took two doses of Vivotif capsules at the same time instead of one dose; Case reference number US-BN-2024-002757 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-2945) on 07-Nov-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 07-Nov-2024, reported as today, the patient took the first and second of Vivotif capsule at the same time instead of one dose (batch number: unknown), at a dose of one capsule, via unknown route and for unknown indication (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A male patient of unknown age took the first and the second of Vivotif capsule at the same time instead of one dose for unknown indication, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Overdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Overdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first and the second of Vivotif capsule at the same time instead of one dose for unknown indication, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Overdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Overdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient accidentally took doses of Vivotif with food; Case reference number US-BN-2024-002763 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2967) on 08-Nov-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the patient accidently took with food the doses of Vivotif (batch number: unknown and expiration date: unknown) at unknown dose, orally for protection against typhoid fever (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unknown age accidently took the doses of Vivotif for protection against typhoid fever with food, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age accidently took the doses of Vivotif for protection against typhoid fever with food, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.