chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: The patient missed the fourth dose of Vivotif; Case reference number US-BN-2024-002311 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-1882) on 05-Aug-2024 and concerns patient of unspecified age or gender.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took three doses of Vivotif (batch number: unknown), at an unknown dose, route or site of administration, for unknown indication.  As reported, only a day or longer than a week since (to be confirmed) the patient missed the fourth dose of Vivotif (explicitly coded as 'missed dose').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unspecified age or gender missed the fourth dose of Vivotif which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age or gender missed the fourth dose of Vivotif which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took four doses of Vivotif every day instead every other day; Case reference number US-BN-2024-002323 is a spontaneous case initially received from physician via Med Communications (reference number USBAV24-1918) on 08-Aug-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 05-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication.  On 06-Aug-2024, one day after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered')  On 07-Aug-2024, one day after the second dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered')  On 08-Aug-2024, one day after the third dose of Vivotif, the patient took the fourth 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 received four doses of Vivotif, given every day one after another, instead of every other day. This is considered inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is considered listed per company convention. Medical history and concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human factors. The case is non-serious.; Sender's Comments: A female patient received four doses of Vivotif, given every day one after another, instead of every other day. This is considered inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is considered listed per company convention. Medical history and concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human factors. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took first two doses of Vivotif two days in a row; Case reference number US-BN-2024-002328 is a spontaneous case initially received from nurse via Med Communications (reference number USBAV24-1927) on 09-Aug-2024 and concerns a *61-year-old* female patient.  The patient's medical history and concomitant medication details were not provided.  *On 18-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004044, expiry date: 30-Nov-2024), four capsules, via oral use, as reported for travel vaccine*  On an unspecified date, *reported as one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, via unknown route (explicitly coded as 'Inappropriate schedule of vaccine administered').*  At the time of the *follow up report*, the patient *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 information received from a nurse on 23-Aug-2024: New information included added patient age, Vivotif dosage information and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 61-year-old female patient received her first Vivotif doses, two days in a row, which is considered inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. 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 error. The case is non-serious.; Sender's Comments: A 61-year-old female patient received her first Vivotif doses, two days in a row, which is considered inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. 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 error. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient left Vivotif vaccine at room temperature for about a week and took second and third dose; The patient left Vivotif vaccine at room temperature for about a week and took second and third dose; Case reference number US-BN-2024-002327 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1925) on 09-Aug-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, reported as four to six days ago, the patient took the first dose of Vivotif vaccine (batch number: unknown), at a dose of capsule, orally for an unknown indication.  As reported, the first dose of Vivotif was refrigerated but then the patient left it at room temperature for about a week (explicitly coded as 'Product storage error').  On unspecified date, unknown amount of time after first dose of Vivotif, the patient took the second dose of Vivotif vaccine batch number: unknown), at a dose of capsule, orally (explicitly coded as 'Product administration error').  On unspecified date, unknown amount of time after second dose of Vivotif, the patient took the third dose of Vivotif vaccine batch number: unknown), at a dose of capsule, orally. As reported, the patient realized that Vivotif vaccine should have been refrigerated (explicitly coded as 'Product administration error').  As reported, the patient has not taken fourth dose yet.  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 stored Vivotif at room temperature for about a week, and then received her second and third doses. This is considered product storage error and product administration error, which are listed special situations per convention. No associated adverse events were reported. Patient's medical history details were not available. Product storage and administration error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A female patient stored Vivotif at room temperature for about a week, and then received her second and third doses. This is considered product storage error and product administration error, which are listed special situations per convention. No associated adverse events were reported. Patient's medical history details were not available. Product storage and administration error are not related to Vivotif, but to human error. The case is non-serious. USBAV24-1925:
Sex: M
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient missed last dose of Vivotif that was due on 11-Aug-2024; Case reference number US-BN-2024-002334 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-1932) on 11-Aug-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took the first, second and third doses of Vivotif (batch numbers: unknown), one capsule, via oral use for unknown indication. As reported, the patient received three doses of Vivotif and the fourth dose of Vivotif was missed that was due which was left out of the refrigerator for 30 minutes to one hour, reached a maximum temperature of 95 degrees Fahrenheit (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.  Additional information received from a consumer via Med Communication (reference number: USBAV24-1943) on 12-Aug-2024: included additional reference number (USBAV24-1943), additional reporter, gender of the patient and confirmation that last dose of Vivotif was not administred.; Reporter's Comments: A male patient did not receive his fourth dose of Vivotif on time, which is considered Inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. Medical history or concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A male patient did not receive his fourth dose of Vivotif on time, which is considered Inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. Medical history or concomitant medications were not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human error. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took three doses of Vivotif regularly and did not take the fourth dose due to temperature excursion; Case reference number US-BN-2024-002341 is a spontaneous case initially received from nurse via Med Communications (reference number USBAV24-1960) on 13-Aug-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 05-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, or site of administration, orally, for unknown indication.  On 07-Aug-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, or site of administration, orally.  On 09-Aug-2024, two days after the second dose, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, or site of administration, orally.  On an unspecified date, as reported, after the third dose, Vivotif vaccine was out of the fridge for one hour, maximum temperature reached around 80-90 Fahrenheit. As reported, the patient did not receive the fourth dose of Vivotif on 11-Aug-2024 (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 did not receive his fourth dose of Vivotif, as it underwent a temperature excursion. This is considered inappropriate schedule of vaccine administered. No associated adverse events were report. Inappropriate schedule of vaccine administered is listed per company convention. Medical history was not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A male patient did not receive his fourth dose of Vivotif, as it underwent a temperature excursion. This is considered inappropriate schedule of vaccine administered. No associated adverse events were report. Inappropriate schedule of vaccine administered is listed per company convention. Medical history was not reported. Inappropriate schedule of vaccine administered is not related to Vivotif, but to human error. The case is non-serious. USBAV24-1960:
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Patient took Vivotif vaccine with alcohol; Case reference number US-BN-2024-002339 is a spontaneous case initially received from nurse via Med Communications (reference number USBAV24-1955) on 13-Aug-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), the dose, and site of administration were unknown, orally, for unknown indication. As reported, the patient took a dose with alcohol (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 consumed alcohol while taking Vivotif, which is considered a product administration error. No associated adverse events were reported. Product administration error is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A female patient consumed alcohol while taking Vivotif, which is considered a product administration error. No associated adverse events were reported. Product administration error is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to Vivotif, but to a human error. The case is non-serious. USBAV24-1955:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took three doses of Vivotif three days in a row and one dose left; Case reference number US-BN-2024-002351 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1977) on 15-Aug-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 12-Aug-2024, the patient took the first dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally, for unknown indication.  On 13-Aug-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally (explicitly coded as 'Inappropriate schedule of vaccine administered').  On 14-Aug-2024, one day after the second dose, the patient took the third dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally. The patient did not take the fourth dose, reported as the one dose left (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 the second dose of Vivotif for unknown indication one day after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, one day after the second dose, the patient took the third dose of Vivotif and the patient did not take the fourth dose, reported as the one dose left, 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 was 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 male patient of unspecified age took the second dose of Vivotif for unknown indication one day after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, one day after the second dose, the patient took the third dose of Vivotif and the patient did not take the fourth dose, reported as the one dose left, 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 was 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. USBAV24-1977:
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Abdominal pain upper, Malaise, Nausea
Clinical narrative: Patient had severe stomach cramps; Patient felt very sick; Very nauseated; Case reference number US-BN-2024-002382 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2087) on 22-Aug-2024 and concerns a 46-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 21-Aug-2024 at 05:30 PM, as reported an hour before the meal, the patient took the first dose of Vivotif (batch number: 3004044), at an unknown dose, via oral use for immunization against disease caused by salmonella typhi.  On the same day, as reported two to three hours after the dose, the patient experienced severe stomach cramps, felt very nauseated, felt very sick and did not receive any treatment for the events.  At the time of the initial report, it was unknown if the patient recovered from the events 'stomach cramps', 'nausea' and 'feeling sick'.  The reporter assessed the events 'stomach cramps', 'nausea' and 'feeling sick' as non-serious and causality was assessed as possible for the events 'stomach cramps', 'nausea' and 'feeling sick'.  No further information was provided.; Reporter's Comments: A 46-year-old female patient experienced non-serious events of stomach cramps, felt very nauseated and very sick on the day 0 after the patient took the first dose of Vivotif for immunization against disease caused by salmonella typhi. Malaise is listed for Vivotif per CCDS v8 and unexpected per USPI, nausea is listed per both CCDS v8 and USPI, whilst abdominal pain upper is considered as listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A 46-year-old female patient experienced non-serious events of stomach cramps, felt very nauseated and very sick on the day 0 after the patient took the first dose of Vivotif for immunization against disease caused by salmonella typhi. Malaise is listed for Vivotif per CCDS v8 and unexpected per USPI, nausea is listed per both CCDS v8 and USPI, whilst abdominal pain upper is considered as listed and expected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient received four doses of Vivotif in consecutive days, instead of every other day; Case reference number US-BN-2024-002380 is a spontaneous case initially received from physician via Med Communication (reference number: USBAV24-2068) on 22-Aug-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took four doses of Vivotif (batch number: unknown), four capsules, via oral use for unknown indication. As reported, the patient received Vivotif doses in consecutive days, instead of every other day (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif.  No further information was provided.; Reporter's Comments: A male patient of unknown age took four doses of Vivotif for unknown indication. As reported, the patient received Vivotif doses in consecutive days, instead of every other day, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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 male patient of unknown age took four doses of Vivotif for unknown indication. As reported, the patient received Vivotif doses in consecutive days, instead of every other day, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient received four doses of Vivotif, three of those doses being taken were unrefrigerated; The patient received four doses of Vivotif, three of those doses being taken were unrefrigerated; Case reference number US-BN-2024-002391 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2092) on 23-Aug-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 16-Aug-2024, the patient took the first dose of Vivotif (batch number: unknown), one capsule, via oral use for unknown indication.  On 18-Aug-2024, two days after the first dose, the patient was vaccinated with the second dose of Vivotif (batch number: unknown), one capsule, via oral use (explicitly coded as 'product storage error' and 'product administration error').  On 20-Aug-2024, four days after the first dose, the patient was vaccinated with the third dose of Vivotif (batch number: unknown), one capsule, via oral use (explicitly coded as 'product storage error' and 'product administration error').  On 22-Aug-2024, six days after the first dose, the patient was vaccinated with the fourth dose of Vivotif (batch number: unknown), one capsule, via oral use. As reported, three of those doses were taken unrefrigerated (explicitly coded as 'product storage error' and 'product administration error').  As reported, patient had no adverse reactions from administration of Vivotif vaccine.  No further information was provided.; Reporter's Comments: A female patient of unknown age took the first, second, third and the fourth dose of Vivotif for unknown indication. As reported, three of those doses were taken unrefrigerated, which is considered as product storage error and product administration error. The patient had no adverse reactions from administration of Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the first, second, third and the fourth dose of Vivotif for unknown indication. As reported, three of those doses were taken unrefrigerated, which is considered as product storage error and product administration error. The patient had no adverse reactions from administration of Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient received one dose of Vivotif capsule which was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degrees Fahrenheit; Patient received one dose of Vivotif capsule which was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degrees Fahrenheit; Case reference number US-BN-2024-002406 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2114) on 26-Aug-2024 and concerns a 48-year-old female patient.  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, orally, for unknown indication. As reported, the administered Vivotif dose was out of the refrigerator for 22 hours and the maximum temperature reached was 80 degree Fahrenheit (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A 48-year-old female patient took a dose of Vivotif, which had been out of the refrigerator for 22 hours, reaching a maximum surrounding temperature of 80 deg F (equivalent to 26 deg C). This is considered product storage error and product administration error - listed as per company convention. No associated adverse events were reported. Medical history information was unavailable. The product storage and administration error are not related to Vivotif, but to human factors. The case is non-serious.; Sender's Comments: A 48-year-old female patient took a dose of Vivotif, which had been out of the refrigerator for 22 hours, reaching a maximum surrounding temperature of 80 deg F (equivalent to 26 deg C). This is considered product storage error and product administration error - listed as per company convention. No associated adverse events were reported. Medical history information was unavailable. The product storage and administration error are not related to Vivotif, but to human factors. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received second dose of Vivotif on 25-Aug-2024 and third dose on 26-Aug-2024; Case reference number US-BN-2024-002401 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2117) on 26-Aug-2024 and concerns a 48-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 23-Aug-2024, the patient took the first dose of Vivotif (batch number: 3004045), at an unknown dose, orally, for indication reported as protection against typhoid fever.  On 25-Aug-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004045), at an unknown dose, orally.  On 26-Aug-2024, three days after the first dose, the patient took the third dose of Vivotif (batch number: 3004045), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient took the Vivotif vaccine two days in a row thinking that the previous dose was administered on Saturday instead of Sunday.  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 48-year-old female patient took the third dose of Vivotif for indication reported as protection against typhoid fever, on the day 1 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 48-year-old female patient took the third dose of Vivotif for indication reported as protection against typhoid fever, on the day 1 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took Vivotif, but did not refrigerate it; The patient took Vivotif, but did not refrigerate it; Case reference number US-BN-2024-002405 is a spontaneous case initially received from a healthcare professional via Med Communications (reference number: USBAV24-2137) on 27-Aug-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 believed that the entire course was done, the patient took doses of Vivotif (batch number: unknown), at an unknown dose or route of administration, for an unknown indication. As reported, the patient took Vivotif but did not refrigerate it while taking it (explicitly coded as 'product storage error' and '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 female patient of unspecified age did not refrigerate Vivotif while taking it which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age did not refrigerate Vivotif while taking it which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2137:
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient took all four doses of Vivotif vaccine with food and not on empty stomach; Case reference number US-BN-2024-002413 is a spontaneous case initially received from other health professional via Med Communication (reference number USBAV24-2168) on 29-Aug-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On unspecified dates, the patient took the first, second, third and fourth dose of Vivotif vaccine (batch number: unknown), at a dose of a capsule, orally, for typhoid immunization. As reported, the patient took all four Vivotif tablets with food and not on empty stomach (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.  Additional information received from Med Communications on 29-Aug-2024, included additional reference number, dosage, and patient's and reporter's details.  Additional information received from Med Communications on 29-Aug-2024, included additional reference number.  Additional information received from Med Communications on 03-Sep-2024, included additional reference number, reporter's detail and confirmation that patient took all four doses of Vivotif with food and not on empty stomach.; Reporter's Comments: A female patient of unknown age took all four Vivotif tablets with food and not on empty stomach 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 vaccine. The patient's medical history and concomitant medication 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 all four Vivotif tablets with food and not on empty stomach 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 vaccine. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2168:
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient reports that it has been 1.5 weeks since taking the first dose of Vivotif and no further doses taken; Case reference number US-BN-2024-002457 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-2323) on 10-Sep-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as a week and a half ago, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for protection against typhoid fever. As reported, the patient took the first dose of Vivotif, but a road trip came up and since the vaccine needed to be refrigerated, the patient did not bring it on the trip and was wondering if to continue with the remaining doses on alternate days or to do the series over (explicitly coded as 'incomplete course of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif for protection against typhoid fever, but a road trip came up and since the vaccine needed to be refrigerated, the patient did not bring it on the trip and was wondering if to continue with the remaining doses on alternate days or to do the series over, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif for protection against typhoid fever, but a road trip came up and since the vaccine needed to be refrigerated, the patient did not bring it on the trip and was wondering if to continue with the remaining doses on alternate days or to do the series over, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received first dose of Vivotif and did not take the remaining three doses for couple of weeks; Case reference number US-BN-2024-002456 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2319) on 10-Sep-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at a dose of capsule, orally, for typhoid Immunization.   As reported, the patient did not resume taking the rest three doses and the reporter believed that it had been a couple of weeks since the patient took the first dose of Vivotif (explicitly coded as 'incomplete course of vaccination').  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 did not resume taking the rest three doses, and the reporter believed that it had been a couple of weeks since the patient took the first dose of Vivotif for typhoid Immunization, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination 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 did not resume taking the rest three doses, and the reporter believed that it had been a couple of weeks since the patient took the first dose of Vivotif for typhoid Immunization, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took a dose of Vivotif vaccine which was left out of fridge on temperature more or less 70 degrees Fahrenheit for 20 to 23 hours; The patient took a dose of Vivotif vaccine which was left out of fridge on temperature more or less 70 degrees Fahrenheit for 20 to 23 hours; Case reference number US-BN-2024-002482 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-2345) on 12-Sep-2024 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the doses of Vivotif were left out of the refrigerator for a temperature of more or less 70 degrees Fahrenheit for 20 to 23 hours (explicitly coded as 'product storage error').  On 11-Sep-2024, the patient took the affected first dose of Vivotif (batch number: unknown), at an unknown dose and route, for unknown indication (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown demographics took the affected first dose of Vivotif for unknown indication, which was left out of the refrigerator for a temperature of more or less 70 degrees Fahrenheit for 20 to 23 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serous; Sender's Comments: A patient of unknown demographics took the affected first dose of Vivotif for unknown indication, which was left out of the refrigerator for a temperature of more or less 70 degrees Fahrenheit for 20 to 23 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serous
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient took one or two doses of Vivotif vaccine together with Vitamin gummies at the same time; Case reference number US-BN-2024-002481 is a spontaneous case initially received from a consumer via Med Communications (reference number USBAV24-2347) on 12-Sep-2024 and concerns a female patient of unspecified age.  The patient's medical history details was not provided.  The patient's concomitant medications included vitamin gummies (brand name unknown).   On unspecified dates, the patient took the first, second, third, and fourth dose of Vivotif (batch number: unknown), at a dose of a capsule, orally, for typhoid Immunization. As reported, the patient took one or two Vivotif capsules with vitamin gummies at the same time, because normally the patient took all medications at the same time (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unspecified age took one or two Vivotif capsules for typhoid Immunization with vitamin gummies at the same time, because normally the patient took all medications at the same time, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history was not provided, and concomitant medications included vitamin gummies. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age took one or two Vivotif capsules for typhoid Immunization with vitamin gummies at the same time, because normally the patient took all medications at the same time, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history was not provided, and concomitant medications included vitamin gummies. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.