chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Incorrect dose administered
Clinical narrative: The reporter took first dose of Vivotif which was three days in the counter, maximum temperature reached 70 Fahrenheit; The reporter took first dose of Vivotif which was three days in the counter, maximum temperature reached 70 Fahrenheit; Case reference number US-BN-2024-000665 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0547) on 21-Mar-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  As reported, the reporter took Vivotif from pharmacy which prescribed by doctor, nobody said anything that needed to be refrigerated, so for first three days Vivotif was sitting on the counter. Maximum temperature reached 70 Fahrenheit.  On 20-Mar-2024, the patient took the first dose of Vivotif (batch number: 3003907), at an unknown dose, orally, for typhoid immunization (explicitly coded as 'Product administration error' and 'Product storage error')  At the time of the 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 male patient of unspecified age took the first dose of Vivotif, which was for first three days sitting on the counter (maximum temperature reached 70 Fahrenheit), for typhoid immunization, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as 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 unspecified age took the first dose of Vivotif, which was for first three days sitting on the counter (maximum temperature reached 70 Fahrenheit), for typhoid immunization, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient took first two capsules on two consecutive days; Case reference number US-BN-2024-000675 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0560) on 25-Mar-2024 and concerns a female patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  It was reported that patient did not read the instructions and patient took first two capsules of Vivotif (batch number: Unknown), on two consecutive days, orally, for unknown indication (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A female patient of unspecified age did not read the instructions and took first two capsules of Vivotif, on two consecutive days, for unknown indication, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age did not read the instructions and took first two capsules of Vivotif, on two consecutive days, for unknown indication, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took one dose of Vivotif vaccine which was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit; The patient took one dose of Vivotif vaccine which was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit; Case reference number US-BN-2024-001725 is a spontaneous case report initially received from a physician via Med Communications (reference number USBAV24-0574) on 27-Mar-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 was left one box of Vivotif vaccine at ambient temperature for six hours, maximum temperature was 68 Fahrenheit.  On an unspecified date the patient took dose of Vivotif (batch number: 3004041), at unknown dose, reported as one pill, route or site administration for indication reported as immunization (explicitly coded as 'Product administration error' and 'Product storage error').  At the time of the 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 took a dose of Vivotif, that was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit, for indication reported as immunization, which is considered as product administration error and product storage error. No associated adverse events were reported. Product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took a dose of Vivotif, that was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit, for indication reported as immunization, which is considered as product administration error and product storage error. No associated adverse events were reported. Product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Four patients did not take the fourth dose of Vivotif as the box of pills was lost; Case reference number US-BN-2024-001737 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0596) on 29-Mar-2024 and concerns four patients of unspecified age or gender.  The patients' medical history and concomitant medication details were not provided.  On an unspecified dates, the patients took first, second and third doses of Vivotif (batch number: unknown) at an unknown dose, orally, for unknown indication.  As reported, the patients were supposed to take the fourth dose of Vivotif on 29-Mar-2024, however the four patients did not take the fourth dose as the box of pills was lost (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown whether the patients experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: Four patients of unspecified age or gender were supposed to take the fourth dose of Vivotif on 29-Mar-2024, however the patients did not take the fourth dose as the box of pills was lost, which is considered as inappropriate schedule of vaccine administered. It was unknown whether the patients experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Four patients of unspecified age or gender were supposed to take the fourth dose of Vivotif on 29-Mar-2024, however the patients did not take the fourth dose as the box of pills was lost, which is considered as inappropriate schedule of vaccine administered. It was unknown whether the patients experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Drug intolerance, Nausea, Vomiting
Clinical narrative: Patient could not tolerate the Vivotif, vomited and was nauseated all day; Patient could not tolerate the Vivotif, vomited and was nauseated all day; Patient could not tolerate the Vivotif, vomited and was nauseated all day; Case reference number US-BN-2024-001740 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0614) on 01-Apr-2024 and concerns a *16-year-old* male patient.  *The patient had no medical history*.  The patient's concomitant medication details were not provided.  *On 03-Sep-2024, the patient took a first dose of Vivotif (batch number: 3003901, expiry date: 30-Jun-2024) orally, at an unknown dose, for typhoid. As reported the patient had not taken any other medications at the time of the events and no laboratory tests were performed*.  *On the same day, eight hours from the first dose, the patient severely could not tolerate the Vivotif. Additionally, the patient severely vomited and felt moderately nauseated all day*.  *On the same day, the patient recovered from the events drug intolerance, nauseated and vomited*.  The reporter assessed the events drug intolerance, nauseated and vomited as non-serious and causality was assessed for the events drug intolerance, nauseated and vomited as possible.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up report received from a nurse via manufacturer on 23-Apr-2024: New information included added patient demographic details (initials, age and date of birth), dosage details of Vivotif, events start date, stop date, outcome, intensity and confirmation on the medical history, laboratory tests and other medications administered at the time of Vivotif.; Reporter's Comments: A 16-year-old male patient could not tolerate the Vivotif (eight hours from the first dose), vomited and was nauseated all day. Nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst drug intolerance is listed per company convention as a non-specific event. The outcome was resolved. The patient had no medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality for all reported events is assessed as related to Vivotif. The case is non-serious.; Sender's Comments: A 16-year-old male patient could not tolerate the Vivotif (eight hours from the first dose), vomited and was nauseated all day. Nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst drug intolerance is listed per company convention as a non-specific event. The outcome was resolved. The patient had no medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality for all reported events is assessed as related to Vivotif. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient took the second dose of Vivotif one day after the first dose; Case reference number US-BN-2024-001741 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0608) on 01-Apr-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 30-Mar-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization.  On 31-Mar-2024, one day after the first dose of Vivotif, as reported the patient woke up on Sunday morning super sleepy and thought it was Monday and the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as '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 vaccine.  No further information was provided.; Reporter's Comments: A female patient of unspecified age took a second dose of Vivotif one day after the first dose for typhoid immunization, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took a second dose of Vivotif one day after the first dose for typhoid immunization, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient left Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit; The patient left Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit; Case reference number US-BN-2024-001746 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0616) on 01-Apr-2024 and concerns a 43-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit.  On 01-Apr-2024, the patient took the first dose of Vivotif (batch number: unknown), orally, at unknown dose or site administration for unknown indication (explicitly coded as 'Product administration error' and 'Product storage error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  Additional information received from health care professional via Med Communications on 02-Apr-2024 included clarification about the age of patient.; Reporter's Comments: A 43-year-old female patient took the first dose of Vivotif, after the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit, for unknown indication, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 43-year-old female patient took the first dose of Vivotif, after the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit, for unknown indication, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient took dose of Vivotif vaccine one consecutive days; Case reference number US-BN-2024-001747 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0615) on 01-Apr-2024 and concerns a patient of unspecified gender or age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took unknown number of doses of Vivotif vaccine (batch number: unknown) orally, at unknown dose for unknown indication, as reported on consecutive days (explicitly coded as '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 vaccine.  No further information was provided.; Reporter's Comments: A patient of unspecified gender or age took unknown number of doses of Vivotif vaccine for unknown indication, as reported on consecutive days, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified gender or age took unknown number of doses of Vivotif vaccine for unknown indication, as reported on consecutive days, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as 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 first and second dose of Vivotif and went out of town for four days and wanted to know if the vaccination can be resumed; Case reference number US-BN-2024-001748 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0625) on 02-Apr-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication was not provided.  On unspecified date, reported as last week, the patient took first and second doses of Vivotif (batch number: unknown), orally, at an unknown dose, for typhoid prophylaxis. As reported, the patient went out of town for four days and the patient wanted to know if the vaccination should be resumed (explicitly coded as '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 vaccine.  No further information was provided.; Reporter's Comments: A male patient of unspecified age took first and second doses of Vivotif for typhoid prophylaxis. As reported, the patient went out of town for four days and the patient wanted to know if the vaccination should be resumed, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication was not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age took first and second doses of Vivotif for typhoid prophylaxis. As reported, the patient went out of town for four days and the patient wanted to know if the vaccination should be resumed, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication was not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took two doses of Vivotif vaccine which left at room temperature for over 72 hours, maximum temperature reached was room temperature 70 Fahrenheit; The patient took two doses of Vivotif vaccine which left at room temperature for over 72 hours, maximum temperature reached was room temperature 70 Fahrenheit; Case reference number US-BN-2024-001756 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0632) on 03-Apr-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, as reported on Saturday, the patient left one box of Vivotif vaccine at room temperature for 72 hours, maximum temperature was 70 Fahrenheit.  On an unspecified dates, as reported the patient took two doses of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization (explicitly coded as 'Product administration error' and 'Product storage error').  At the time of the 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 male patient of unknown age took two doses of Vivotif left at room temperature for 72 hours (maximum temperature was 70 Fahrenheit), which is considered product administration error and product storage error. Product administration error and product storage error are listed by convention. No associated adverse events were reported. Product administration error and product storage error are not related to the suspect product, but to a human action.; Sender's Comments: A male patient of unknown age took two doses of Vivotif left at room temperature for 72 hours (maximum temperature was 70 Fahrenheit), which is considered product administration error and product storage error. Product administration error and product storage error are listed by convention. No associated adverse events were reported. Product administration error and product storage error are not related to the suspect product, but to a human action.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took two capsules of Vivotif which were left at room temperature for almost three weeks; The patient took two capsules of Vivotif which were left at room temperature for almost three weeks; Case reference number US-BN-2024-001762 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0651) on 04-Apr-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 18-Mar-2024, the patient left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks (explicitly coded as and 'product storage error').  On unspecified dates, the patient took first and second dose of affected Vivotif (batch number: unknown), at unknown dose, orally 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 event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A male patient of unspecified age left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks which is considered as product storage error. reportedly, the patient took first and second dose of affected Vivotif, at unknown dose, orally 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 event due to Vivotif vaccine. 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 unspecified age left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks which is considered as product storage error. reportedly, the patient took first and second dose of affected Vivotif, at unknown dose, orally 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 event due to Vivotif vaccine. 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: M
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: The patient experienced some abdominal pain with cramping; Case reference number US-BN-2024-001773 is a spontaneous case report initially received from other health care professional via Med Communications (reference number USBAV24-0671) on 05-Apr-2024 and concerns a 14-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 01-Apr-2024, the patient took first dose of Vivotif (batch number: unknown) at unknown dose, orally, for immunization against disease caused by Salmonella typhi.  On 03-Apr-2024, two days after the first dose of Vivotif, the patient took second dose of Vivotif (batch number: unknown) at unknown dose, orally.  On 05-Apr-2024, two days after the second dose of Vivotif, the patient took third dose of Vivotif (batch number: unknown) at unknown dose, orally.  On unspecified date, the patient experienced some abdominal pain with cramping.  The patient's treatment for abdominal pain with cramping included Tylenol.  At the time of initial report, the outcome for the event of abdominal pain with cramping was unknown.   The reporter assessed the abdominal pain with cramping as non-serious and possibly related to the product of Vivotif.   No further information was provided.; Reporter's Comments: A 14-year-old male patient took three doses of Vivotif vaccine, for immunization against disease caused by Salmonella typhi. On unspecified date, the patient experienced some abdominal pain with cramping. Abdominal pain is listed/expected for Vivotif according to CCDS version 8.0 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome for the event of abdominal pain with cramping was unknown. Due to implied temporal relationship, product known safety profile and lack of alternative etiology at the moment, the causality for reported event is assessed as related to Vivotif. The case is non-serious.; Sender's Comments: A 14-year-old male patient took three doses of Vivotif vaccine, for immunization against disease caused by Salmonella typhi. On unspecified date, the patient experienced some abdominal pain with cramping. Abdominal pain is listed/expected for Vivotif according to CCDS version 8.0 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome for the event of abdominal pain with cramping was unknown. Due to implied temporal relationship, product known safety profile and lack of alternative etiology at the moment, the causality for reported event is assessed as related to Vivotif. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient ate five minutes after took Vivotif; Case reference number US-BN-2024-001774 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0686) on 08-Apr-2024 and concerns a 53-years-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 07-Apr-2024, as reported the patient ate and after five minutes took first dose of Vivotif (batch number: 3004007), at unknown dose, orally, site administration was unknown, for indication reported as immunization against disease caused by salmonella typhi (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 vaccine.  No further information was provided.; Reporter's Comments: A 53-year-old male patient ate and after five minutes took the first dose of Vivotif for indication reported as immunization against disease caused by salmonella typhi, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 53-year-old male patient ate and after five minutes took the first dose of Vivotif for indication reported as immunization against disease caused by salmonella typhi, 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 has been considered as 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: Vivotif vaccine was stored at approximately 70 Fahrenheit degrees for at least 24 hours and the patient already started treatment; Vivotif vaccine was stored at approximately 70 Fahrenheit degrees for at least 24 hours and the patient already started treatment; Case reference number US-BN-2024-001777 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0668) on 05-Apr-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, as reported, the patient left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. As reported, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated (explicitly coded as 'product storage error').  On an unspecified date, the patient took the first dose of Vivotif (batch number: 3003852), at unknown dose, orally 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 event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A female patient of unspecified age left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. Reportedly, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated which is considered as product storage error. The patient took the first dose of Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. 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. Product storage error and product administration error are both considered listed per company conventions. 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 left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. Reportedly, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated which is considered as product storage error. The patient took the first dose of Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. 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. Product storage error and product administration error are both considered listed per company conventions. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: COVID-19, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Patient had tested positive to COVID and had some mild congestion, cough and no other symptoms; Case reference number US-BN-2024-001786 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0707) on 10-Apr-2024 and concerns a 54-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 05-Apr-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for immunization against disease caused by salmonella typhi.  On 07-Apr-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose, via oral use.  On 09-Apr-2024, four days after the first dose, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose, via oral use. As reported, patient was taking the medication and got sick with COVID, had third dose yesterday morning, already feeling feverish at that time, but the patient didn't know whether to take the dose or not, so the patient took his dose yesterday, feeling much better, patient says hasn't had a fever since last night.  On an unspecified date, the patient tested positive to Covid-19 and the patient had some mild congestion, cough and no other symptoms.  At the time of the initial report, the outcome of the event COVID-19 was unknown.  The reporter assessed the event COVID-19 as non-serious and causality as possible for the event COVID-19.; Reporter's Comments: A 54-year-old male patient tested positive to Covid-19 after the patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi. COVID-19 is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering the nature of the event, COVID-19 has been considered as not related to the suspect vaccine, but to an infection. This case is considered as non-serious.; Sender's Comments: A 54-year-old male patient tested positive to Covid-19 after the patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi. COVID-19 is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering the nature of the event, COVID-19 has been considered as not related to the suspect vaccine, but to an infection. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received the second dose of Vivotif vaccine on 11-Apr-2024 and forgot the third and fourth dose; Case reference number US-BN-2024-001806 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0765) on 16-Apr-2024 and concerns an 18-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 09-Apr-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally, for immunization against disease caused by Salmonella typhi.  On 11-Apr-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally.  As reported, the patient forgot the third and the fourth dose of Vivotif vaccine and it has been four or five days (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 vaccine.  No further information was provided.; Reporter's Comments: An 18-year-old male patient forgot the third and the fourth dose of Vivotif vaccine after the patient took the first and the second dose of Vivotif vaccine for immunization against disease caused by Salmonella typhi, and it has been four or five days, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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 has been considered as 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 male patient forgot the third and the fourth dose of Vivotif vaccine after the patient took the first and the second dose of Vivotif vaccine for immunization against disease caused by Salmonella typhi, and it has been four or five days, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: The patient took first dose and second of Vivotif vaccine on two consecutive days; The patient took the first dose of Vivotif vaccine with food; Case reference number US-BN-2024-001817 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number: USBAV24-0773) on 18-Apr-2024 and concerns an elderly female patient.  The patient's medical history and concomitant medications were not provided.  On 16-Apr-2024, reported as on Tuesday, the patient took the first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally, for unknown indication. As reported, the patient took the first dose of Vivotif with food (explicitly coded as 'product administration error').  On 17-Apr-2024, reported as on Wednesday, one day after the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  Additional information received from Med Communications on 18-Apr-2024 included additional reference number, dates and route of Vivotif administration.; Reporter's Comments: An elderly female patient took the first dose of Vivotif with food, which is considered as product administration error. Reportedly, the patient took the second dose of Vivotif vaccine on the day 1 after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An elderly female patient took the first dose of Vivotif with food, which is considered as product administration error. Reportedly, the patient took the second dose of Vivotif vaccine on the day 1 after the first dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, No adverse event
Clinical narrative: Both patients took all four capsules of the Vivotif at one time; Both patients took all four capsules of the Vivotif at one time; Case reference number US-BN-2024-001825 is a spontaneous case report initially received from pharmacist via Med Communication (reference number: USBAV24-0755) on 16-Apr-2024 and concerns *64-year-old female patient and 65-year-old male patient (multi 2).*  The patients relevant medical history and concomitant medications were not provided.  *On 12-Apr-2024, two patients were vaccinated with all four doses of Vivotif (batch number: 3004009, expiry date: Oct-2024), at a dose of four capsules*, orally, for typhoid immunization (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered').  *At the time of follow up report, the patients did not experience any adverse event due to Vivotif vaccine*.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up report received from a pharmacist on 16-May-2024: New information included patients demographic details (age, gender and initials), Vivotif dosage information, confirmation that the patients did not experience any adverse events.; Reporter's Comments: This case concerns 64-year-old female patient and 65-year-old male patient who were vaccinated with all four doses of Vivotif for typhoid immunization, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Overdose and inappropriate schedule of vaccine administered are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: This case concerns 64-year-old female patient and 65-year-old male patient who were vaccinated with all four doses of Vivotif for typhoid immunization, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Overdose and inappropriate schedule of vaccine administered are not related to Vivotif, but to a human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Gastrointestinal disorder, Vomiting
Clinical narrative: The patient had gastrointestinal illness; The patient vomited and saw Vivotif capsule in vomit; Case reference number US-BN-2024-001826 is a spontaneous case report initially received from nurse via Med Communications (reference number: USBAV24-0825) on 23-Apr-2024 and concerns a female patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication.  On unspecified date, for unknow amount of time after first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: unknown), at an unknown dose, orally.  On unspecified date, reported as eight hours after the last dose of Vivotif, the patient developed gastrointestinal illnesses, vomited and saw the capsule of Vivotif in vomit.  At the time of initial repot it was unknown if the patient recovered form events of gastrointestinal illnesses and 'vomiting'.  The reporter assessed the events of gastrointestinal illnesses and ' vomiting' as non-serious and possible related to the product of Vivotif.  No further information was provided.; Reporter's Comments: A female patient developed non-serious events of gastrointestinal illnesses and vomiting reported as eight hours after the last dose of Vivotif for unknown indication. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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 developed non-serious events of gastrointestinal illnesses and vomiting reported as eight hours after the last dose of Vivotif for unknown indication. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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.