chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: A patient took two doses of Vivotif, two days in a row instead of alternated days.; Case reference number US-BN-2024-002104 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1494) on 26-Jun-2024 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, reported as two days in a row instead of alternated days, the patient took the first and the second dose of Vivotif (batch number: unknown), at an unknown dose, orally, for an unknown indication (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 vaccination.  No further information was provided.; Reporter's Comments: A patient of unknown demographics took the first and the second dose of Vivotif, at an unknown dose, orally, for an unknown indication which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif 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 patient of unknown demographics took the first and the second dose of Vivotif, at an unknown dose, orally, for an unknown indication which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif 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.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: One box of Vivotif was at 76 degrees Fahrenheit for eight hours; patient took one pill; One box of Vivotif was at 76 degrees Fahrenheit for eight hours; patient took one pill; Case reference number US-BN-2024-002111 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1511) on 27-Jun-2024 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as yesterday, the patient picked up Vivotif., but the pharmacist did not tell the patient that Vivotif needed to be refrigerated. One box of Vivotif was at 76 degrees Fahrenheit for eight hours (explicitly coded as 'Product storage error').  On 27-Jun-2024, the patient took the first dose of Vivotif (batch number: 3004045), at an unknown dose, orally, for an 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 the Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown demographics picked up Vivotif, but the pharmacist did not tell the patient that Vivotif needed to be refrigerated. One box of Vivotif was at 76 degrees Fahrenheit for eight hours, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the 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 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 patient of unknown demographics picked up Vivotif, but the pharmacist did not tell the patient that Vivotif needed to be refrigerated. One box of Vivotif was at 76 degrees Fahrenheit for eight hours, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1511:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took the first dose of Vivotif on 24-Jun-2024, and the second dose on 27-Jun-2024; Case reference number US-BN-2024-002114 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1514) on 27-Jun-2024 and concerns a 17-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 24-Jun-2024, the patient took the first dose of Vivotif (batch number: 3004008, exp. date: 31-Oct-2024), at an unknown dose, orally, for indication reported as prior to travel.  On 27-Jun-2024, three days after the first dose, the patient took the second dose of Vivotif (batch number: 3004008, exp. date: 31-Oct-2024), at an unknown dose, orally. As reported, the patient forgot to take yesterday's dose so was advised to take it as long as it was on an empty stomach and could wait to eat (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the third dose was scheduled for 29-Jun-2024, and the fourth dose for 01-Jul-2024.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccine.  No further information was provided.; Reporter's Comments: A 17-year-old male patient forgot to take yesterday's third dose of Vivotif on scheduled day, so was advised to take it as long as it was on an empty stomach and could wait to eat, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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 17-year-old male patient forgot to take yesterday's third dose of Vivotif on scheduled day, so was advised to take it as long as it was on an empty stomach and could wait to eat, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took dose of Vivotif which one box had temperature excursion for five hours, maximum temperature was 70 Fahrenheit; The patient took dose of Vivotif which one box had temperature excursion for five hours, maximum temperature was 70 Fahrenheit; Case reference number US-BN-2024-002120 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1528) on 01-Jul-2024 and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, one box of Vivotif vaccine had temperature excursion for five hours, as reported, maximum temperature was 70 degrees Fahrenheit (explicitly coded 'Product storage error').  On 29-Jun-2024, the patient took first dose of Vivotif vaccine (batch number: unknown), at unknown dose, route or site 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 event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unspecified age and gender took first dose of Vivotif vaccine, which had temperature excursion for five hours, as reported, maximum temperature was 70 degrees Fahrenheit (considered as product storage error) at unknown dose, route or site of administration for unknown indication which is considered as product administration error. Product administration error and product storage error are both considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medications 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 unspecified age and gender took first dose of Vivotif vaccine, which had temperature excursion for five hours, as reported, maximum temperature was 70 degrees Fahrenheit (considered as product storage error) at unknown dose, route or site of administration for unknown indication which is considered as product administration error. Product administration error and product storage error are both considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1528:
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: The patient experienced vomiting within first few hours after the first dose of Vivotif; Case reference number US-BN-2024-002119 is a spontaneous case initially received from other health professional via Med Communications (reference number USBAV24-1539) on 01-Jul-2024 and concerns a female patient of unspecified age, reported as 65+.  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 typhoid Immunization.  On the same day, reported as within first few hours, the patient experienced vomiting.  At the time of the initial report, it was unknown if the patient recovered from the event of vomiting.  The reporter assessed the event of vomiting as non-serious, and causality for the event of vomiting was reported as possible.  No further information was provided.; Reporter's Comments: A female patient of unspecified age, reported as 65+, experienced vomiting, on the same day she took the first dose of Vivotif, at unknown dose, orally, for typhoid Immunization. Vomiting is listed and expected according to CCDS v8 and USPI. At this point, it was unknown if the patient recovered from the event of vomiting. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to plausible temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A female patient of unspecified age, reported as 65+, experienced vomiting, on the same day she took the first dose of Vivotif, at unknown dose, orally, for typhoid Immunization. Vomiting is listed and expected according to CCDS v8 and USPI. At this point, it was unknown if the patient recovered from the event of vomiting. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to plausible temporal relationship, known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious. USBAV24-1539:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took first and second dose of Vivotif vaccine in two consecutive days instead of skipping day; Case reference number US-BN-2024-002164 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1593) on 08-Jul-2024 and concerns a 21-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 06-Jul-2024, the patient took the first dose of Vivotif vaccine (batch number: 3004043), at an unknown dose, orally for typhoid immunization.  On 07-Jul-2024, one day after first dose of Vivotif vaccine, the patient took the second dose of Vivotif vaccine (batch number: 3004043), at an unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). As reported, the patient knew that doses were every other day, but mistakenly took one of the doses in two consecutive days, instead of skipping day.  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 21-year-old female patient took the second dose of Vivotif vaccine one day after first dose of Vivotif which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications 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 21-year-old female patient took the second dose of Vivotif vaccine one day after first dose of Vivotif which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1593:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took first dose of Vivotif and forgot to take second dose, its been about a week from the first dose; Case reference number US-BN-2024-002159 is a spontaneous case initially received from physician via Med Communication (reference number: USBAV24-1588) on 08-Jul-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose and route for unknown indication. As reported, the patient forgot to take second dose and it has been about a week from the first dose (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.  No further information was provided.  Non-significant case correction performed after internal review for information received on 08-Jul-2024 included company comment correction.; Reporter's Comments: A female patient of unknown age forgot to take second dose and it has been about a week from the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications 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 forgot to take second dose and it has been about a week from the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medications 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 administration error
Clinical narrative: Patient took the first dose of Vivotif according to the schedule, but patient took a cup of coffee, ten minutes later after the dose; Case reference number US-BN-2024-002165 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV24-1590) on 08-Jul-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, the patient took Vivotif according to the schedule, but the patient took a cup of coffee ten minutes later after the dose (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.  No further information was provided.; Reporter's Comments: A female patient of unknown age took a cup of coffee ten minutes later after the dose of Vivotif 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 medications 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 a cup of coffee ten minutes later after the dose of Vivotif 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 medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The patient received fourth dose of Vivotif on day 12; Case reference number US-BN-2024-002175 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1609) on 09-Jul-2024 and concerns a 57-year-old male patient.  The patient's medical history and concomitant medication were not provided.  On 03-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule orally, for immunization against disease caused by salmonella typhi.  On 05-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule, orally.  On 07-Jul-2024, four days after the first dose, the patient took the third dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule, orally.  On 15-Jul-2024, 12 days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004044, expiry date: Nov-2024) one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered').  *At the time of follow up report, the patient did not experience any adverse event due to Vivotif*.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a nurse on 20-Aug-2024: New information included added patient demographic details (initials), Vivotif dosage information and updated event verbatim.  Follow up information received from a nurse on 04-Sep-2024: New information included confirmation on the adverse events during the administration of Vivotif.; Reporter's Comments: A 57-year-old male patient took fourth dose of Vivotif, one capsule, orally, 12 days after the first dose which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 57-year-old male patient took fourth dose of Vivotif, one capsule, orally, 12 days after the first dose which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Patient received last dose of Vivotif two weeks after the expiry date 30-Jun-2024; Case reference number US-BN-2024-002185 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1634) on 12-Jul-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient took the last dose of Vivotif (batch number: unknown, expiry date: 30-Jun-2024) two weeks after the expiry date, at an unknown dose or route, for unknown indication (explicitly coded as 'expired vaccine used').  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 took the last dose of Vivotif (expiry date: 30-Jun-2024) two weeks after the expiry date, for unknown indication, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to Vivotif. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Expired product administered 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 last dose of Vivotif (expiry date: 30-Jun-2024) two weeks after the expiry date, for unknown indication, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to Vivotif. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Expired product administered is 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
Clinical narrative: The patient took the first and the second dose of Vivotif correctly and then took a five to six days vacation and has not finished the other two doses; Case reference number US-BN-2024-002194 is a spontaneous case initially received from other health care professional via Med Communications (reference number USBAV24-1665) on 15-Jul-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, reported as correctly, the patient took the first and the second dose of Vivotif (batch number: unknown), the dose was unknown, orally for unknown indication. As reported, then patient took a five to six days of vacation and has not finished the other two doses (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.  No further information was provided.; Reporter's Comments: A female patient of unspecified age took the first and the second dose of Vivotif for unknown indication. As reported, then patient took a five to six days of vacation and has not finished the other two doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. 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 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 unspecified age took the first and the second dose of Vivotif for unknown indication. As reported, then patient took a five to six days of vacation and has not finished the other two doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Headache, Malaise, Pain, Pyrexia, Vomiting
Clinical narrative: Body pain; Vomited once; The patient had three doses of Vivotif that felt sick from them; Fever; Headache; Case reference number US-BN-2024-002208 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1685) on 17-Jul-2024 and concerns a patient of an unspecified demographics.  The patient's medical history and concomitant medication details are not provided.  On 11-Jul-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for an unknown indication.  On 13-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally.  On 15-Jul-2024, two days after the second dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, orally.  On an unspecified date, as reported the patient had three doses and felt sick from them. The patient felt body pain, fever, and headache, and vomited once. As reported, the patient vomited the day after taking Vivotif so no capsule was vomited intact.  At the time of the initial report, the outcome for the events of feeling sick, body pain, fever, headaches, and vomiting was unknown.  The reporter assessed the events of feeling sick, body pain, fever, headaches, and vomiting as not serious, and possibly related to the Vivotif.  No further information was provided.; Reporter's Comments: A patient of an unspecified demographics felt body pain, fever, and headache, and vomited once, within approximately two days after three doses of Vivotif were administered, at an unknown dose, orally, for an unknown indication. Pain is unlisted and unexpected while vomiting, malaise, pyrexia and headache are all listed and expected according to CCDS v8 and USPI. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details are not provided. Causal relationship is assessed as related due to plausible temporal relationship, known product safety profile (for vomiting, malaise, pyrexia and headache), lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of an unspecified demographics felt body pain, fever, and headache, and vomited once, within approximately two days after three doses of Vivotif were administered, at an unknown dose, orally, for an unknown indication. Pain is unlisted and unexpected while vomiting, malaise, pyrexia and headache are all listed and expected according to CCDS v8 and USPI. The outcome of all reported events was unknown. The patient's medical history and concomitant medication details are not provided. Causal relationship is assessed as related due to plausible temporal relationship, known product safety profile (for vomiting, malaise, pyrexia and headache), lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took two doses of Vivotif vaccine which were left out of the refrigerator for 48 hours; The patient took two doses of Vivotif vaccine which were left out of the refrigerator for 48 hours; Case reference number US-BN-2024-002268 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-1792) on 26-Jul-2024 and concerns a female patient of unknown age.  The patient had no relevant medical history, reported as no health issues, and the patient was not pregnant.  The patient's concomitant medication details were not provided.  On unspecified date, the doses of Vivotif were left out of the refrigerator for 48 hours (explicitly coded as 'product storage error').  On 24-Jul-2024, the patient took the affected first dose of Vivotif (batch number: 33004009), at an unknown dose, orally, for indication reported as pre travel.  On 26-Jul-2024, two days after first dose of Vivotif, the patient took the affected second dose of Vivotif (batch number: unknown), at an unknown dose, orally (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 vaccine.  No further information was provided.; Reporter's Comments: A female patient received her second Vivotif dose, after the capsule had been stored for 48 hours outside of the refrigerator, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage and administration error are considered listed per company convention. The patient had no relevant medical history. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A female patient received her second Vivotif dose, after the capsule had been stored for 48 hours outside of the refrigerator, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage and administration error are considered listed per company convention. The patient had no relevant medical history. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took the third dose of Vivotif three days after the second dose; Case reference number US-BN-2024-002253 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-1791) on 26-Jul-2024 and concerns an 18-year-old male patient.  The patient's medical history and concomitant medication were not provided.  On 21-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004009), at an unknown dose or route, for immunization against disease caused by salmonella typhi.  On 23-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004009), at an unknown dose or route.  On 26-Jul-2024, three days after the second dose, the patient took the third dose of Vivotif (batch number: 3004009), at an unknown dose or route (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.  No further information was provided.; Reporter's Comments: An 18-year-old male patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 3 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration 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 male patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi, on the day 3 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is 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
Clinical narrative: The patient took two capsules of Vivotif at the same time on the first day; The patient took two capsules of Vivotif at the same time on the first day; Case reference number US-BN-2024-002262 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-1800) on 29-Jul-2024 and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took the two capsules of Vivotif on the first day at the same time (batch number: unknown), 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 patient of unknown demographics took two capsules of Vivotif on the same day, which is considered overdose and inappropriate schedule of product administration. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patient's medical history and concomitant medication details were not provided. The events are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics took two capsules of Vivotif on the same day, which is considered overdose and inappropriate schedule of product administration. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patient's medical history and concomitant medication details were not provided. The events are not related to Vivotif, but to human error. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient lost the fourth dose of Vivotif vaccine and was able to take only first three doses; Case reference number US-BN-2024-002271 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-1817) on 30-Jul-2024 and concerns a 19-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 15-Jul-2024, the patient took the first dose of Vivotif vaccine (batch number: 3004008, *expiry date: 31-Oct-2024*), at a dose of a pill, orally, for indication reported as prior to travel.  On 17-Jul-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: 3004008, *expiry date: 31-Oct-2024*), at a dose of a pill, orally.  On 19-Jul-2024, four days after the first dose of Vivotif, the patient took the third dose of Vivotif vaccine (batch number: 3004008, *expiry date: 31-Oct-2024*), at a dose of a pill, orally.  On unspecified date, an unknown amount of time after the first dose of Vivotif, as reported the *patient lost the fourth dose of Vivotif* and was only able to take three pills (explicitly coded as 'incomplete course of vaccination').  At the time of *follow up report*, it was unknown if the patient experienced any adverse events due to Vivotif vaccine.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up information received from a nurse on 23-Aug-2024: New information included patient initials, Vivotif dosage information and event verbatim was updated.; Reporter's Comments: A 19-year-old male patient lost the fourth dose of Vivotif and was only able to take three pills which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient lost the fourth dose of Vivotif and was only able to take three pills which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first two doses of Vivotif on consecutive days; Case reference number US-BN-2024-002269 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1813) on 30-Jul-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 28-Jul-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally for unknown indication.  On 29-Jul-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), as reported, two doses out of four capsules, 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.  No further information was provided.; Reporter's Comments: A female patient of unknown age took the second dose of Vivotif for unknown indication, as reported one day after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration 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 took the second dose of Vivotif for unknown indication, as reported one day after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: COVID-19
Clinical narrative: COVID-19; Case reference number US-BN-2024-002264 is a spontaneous case initially received from nurse care professional via Med Communications (reference number USBAV24-1809) on 30-Jul-2024 and concerns a patient of unspecified gender or age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, as reported recently the patient completed Vivotif vaccination (batch number: unknown), the dose was unknown, orally, for typhoid fever prophylaxis.  On unspecified date, as reported of the middle of Vivotif series the patient experienced COVID-19.  It was reported that, provider would now like to prescribe an antibiotic to the patient, but they were unsure if it will interact with Vivotif.  At the time of initial report, the patient did not recover from event of COVID-19.  The reporter assessed the event of COVID-19 as non-serious. The reporter did not provide causality assessment for event of COVID-19.  No further information.; Reporter's Comments: A patient of unknown demographics contracted COVID-19, an unknown amount of time after completing Vivotif vaccination. COVID-19 is unlisted and unlabeled per the CCDS v8.0 and USPI for Vivotif. Medical history and concomitant medications were unknown. Considering the highly contagious nature of the SARS-CoV-2 strain, its known human-to-human airborne mechanism of spreading, as well as the lack of biological plausibility, this event is assessed as not related to Vivotif. The case is non-serious.; Sender's Comments: A patient of unknown demographics contracted COVID-19, an unknown amount of time after completing Vivotif vaccination. COVID-19 is unlisted and unlabeled per the CCDS v8.0 and USPI for Vivotif. Medical history and concomitant medications were unknown. Considering the highly contagious nature of the SARS-CoV-2 strain, its known human-to-human airborne mechanism of spreading, as well as the lack of biological plausibility, this event is assessed as not related to Vivotif. The case is non-serious. USBAV24-1809:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received third dose of Vivotif on day four; Case reference number US-BN-2024-002284 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-1848) on 01-Aug-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 an unknown dose, via oral use for unknown indication.  On an unspecified date, three days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, via oral use.  On an unspecified date, four days after the first dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, via oral use (explicitly coded as 'inappropriate schedule of drug administered').  At the time of the initial report, it was unknown it the patient experienced any adverse event due to Vivotif.  Additional information received from nurse via Med Communication (reference number: USBAV24-1864) on 02-Aug-2024: information included additional reference number (USBAV24-1864) and reporter details.  Non-significant case correction received from other health care professional via Med Communication on 05-Aug-2024 included an additional reference number.(za med comm); Reporter's Comments: A female patient of unknown age took the third dose of Vivotif, four days after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of drug administered. Inappropriate schedule of product administration is considered listed per company convention.  At this point, it was unknown it 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 third dose of Vivotif, four days after the first dose, at an unknown dose, via oral use which is considered as inappropriate schedule of drug administered. Inappropriate schedule of product administration is considered listed per company convention.  At this point, it was unknown it 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: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose of Vivotif on 02-Aug-2024 and second dose on 03-Aug-2024, consecutively in two days; Case reference number US-BN-2024-002310 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1871) on 05-Aug-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 02-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), one capsule, via orally, as reported for travel.  On 03-Aug-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), one capsule, via 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.  No further information was provided.; Reporter's Comments: A female patient of unknown age took the second dose of Vivotif (one day after the first dose), one capsule, via orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. 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 second dose of Vivotif (one day after the first dose), one capsule, via orally which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. 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.