chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took third dose of Vivotif the next day after the second dose; Case reference number US-BN-2024-002766 is a spontaneous case initially received from a physician via Med Communication (reference number: USBAV24-2971) on 11-Nov-2024 and concerns 27-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient received the first dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally, for indication typhoid immunization.  On an unspecified date, as reported, one day off from the first dose, the patient took the second dose of Vivotif vaccine (batch number: unknown) at unknown dose, orally.  On an unspecified date, as reported one day after the second dose, the patient took the third dose of Vivotif vaccine (batch number: unknown) at unknown dose, orally (explicitly coded as 'Inappropriate schedule of product administration').  On an unspecified date, reported as a day off from the third dose, the patient took the fourth dose of Vivotif vaccine (batch number: unknown) at unknown dose, orally.   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.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient stored Vivotif vaccine at room temperature while was taking; The patient stored Vivotif vaccine at room temperature while taking it; Case reference number US-BN-2024-002772 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2994) on 12-Nov-2024 and concerns a patient of unknown gender and unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the patient stored Vivotif vaccine at room temperature (explicitly coded as 'product storage error').  On an unspecified date, the patient took a dose of affected Vivotif, (batch number: unknown) unknown dose, unknows site of administration, unknown 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 event due to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unknown gender and age took a dose of affected Vivotif which was stored at room temperature, for unknown indication, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif. 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 patient of unknown gender and age took a dose of affected Vivotif which was stored at room temperature, for unknown indication, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif. 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: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took one dose and put it back in refrigerator, the maximum temperature was 70 degrees Fahrenheit for maximum 24 hours; The patient took one dose and put it back in refrigerator, the maximum temperature was 70 degrees Fahrenheit for maximum 24 hours; Case reference number US-BN-2024-002774 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2995) on 12-Nov-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the patient took the first dose dose of Vivotif (batch number: unknown), at a dose of one capsule, taken orally for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator (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 male patient of unknown age took the first dose dose of Vivotif for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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 male patient of unknown age took the first dose dose of Vivotif for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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: Inappropriate schedule of product administration
Clinical narrative: The patient took the third dose of Vivotif a day later and the fourth dose took 30 hours after the third dose.; Case reference number US-BN-2024-002800 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-3068) on 20-Nov-2024 and concerns an adult 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 unknown dose, orally, for unknown indication.  On an unspecified date, unknown amount of time after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally.  On an unspecified date, unknown amount of time after the first dose of Vivotif, reported as a day later, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered').   On an unspecified date, unknown amount of time after first dose of Vivotif, as reported, 30 hours after the third dose of Vivotif the patient took the fourth dose of Vivotif (batch number: unknown), at unknown doe, 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: An adult female patient took the third dose of Vivotif for unknown indication, reported as a day later, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, as reported, 30 hours after the third dose of Vivotif, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. 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: An adult female patient took the third dose of Vivotif for unknown indication, reported as a day later, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, as reported, 30 hours after the third dose of Vivotif, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. 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. USBAV24-3068:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took the second dose of the Vivotif vaccine day after the first dose; Case reference number US-BN-2024-002820 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3133) on 26-Nov-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 24-Nov-2024, the patient took the first dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for unknown indication.   On 25-Nov-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at a dose of one capsule 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 events due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unspecified age took the second dose of Vivotif (at a dose of one capsule orally) one day after 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 the 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 unspecified age took the second dose of Vivotif (at a dose of one capsule orally) one day after 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 the 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: M
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient had eaten before taking the first dose of Vivotif; Case reference number US-BN-2024-002816 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-3125) on 26-Nov-2024 and concerns a 34-year-old male patient.  The patient had no medical history.   The patient's concomitant medications were not provided.  On 26-Nov-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown; expiration date: unknown) at a dose of one capsule, orally, for indication reported as pre travel. As reported, the patient had eaten before taking first dose of Vivotif (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 34-year-old male patient took the first dose of Vivotif vaccine for indication reported as pre travel. As reported, the patient had eaten before taking the first dose of Vivotif, 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 had no medical history, and concomitant medications were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 34-year-old male patient took the first dose of Vivotif vaccine for indication reported as pre travel. As reported, the patient had eaten before taking the first dose of Vivotif, 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 had no medical history, and concomitant medications were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Constipation
Clinical narrative: Patient experienced constipation; Case reference number US-BN-2024-002825 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-3166) on 02-Dec-2024 and concerns a 39-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  The patient's current medical condition included pork allergy.  On 30-Nov-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for typhoid immunization.  On unspecified date, unknown amount of time after taking the first dose, the patient experienced constipation. As reported, the pork constipated him, and it had the effect on him. The reporter would like to check the composition of the gelatin capsules and if there was any ingredient originated from beef.   On 02-Dec-2024, reported as tonight, the patient was due for another dose of Vivotif.   At the time of the initial report, it was unknown if the patient recovered from event of the constipation.   The reporter assessed the event of constipation as non-serious, and causality for the event was reported as possible.  No further information was provided.; Reporter's Comments: A 39-year-old male patient experienced constipation within approximately one month after taking the first dose of Vivotif (administered at an unknown dose, orally, for typhoid immunization). Constipation is listed according to CCDS v8 however unexpected according to USPI. The outcome was unknown. The patient's medical history and concomitant medication details were not provided while current medical condition included pork allergy. Causality is assessed as related due to 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 39-year-old male patient experienced constipation within approximately one month after taking the first dose of Vivotif (administered at an unknown dose, orally, for typhoid immunization). Constipation is listed according to CCDS v8 however unexpected according to USPI. The outcome was unknown. The patient's medical history and concomitant medication details were not provided while current medical condition included pork allergy. Causality is assessed as related due to known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took the second dose of Vivotif 72 hours later; The patient did not wait until one hour for eat food, five minutes later of taking Vivotif patient ate food; Case reference number US-BN-2024-002831 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3183) on 03-Dec-2024 and concerns a 72-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 29-Nov-2024, the patient took first dose of Vivotif (batch number: unknown), at unknown dose, orally, for indication typhoid immunization.  On an unspecified date, reported as 72 hours later, the patient took the second dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported the patient did not wait until one hour for eating food, five minutes later of taking Vivotif patient ate food (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 72-years-old female patient took first dose of Vivotif on 29-Nov-2024, at unknown dose, orally, for indication typhoid immunization. Reportedly, five minutes after taking Vivotif patient ate food which is considered as product administration error. Inappropriate schedule of product administration and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration 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 72-years-old female patient took first dose of Vivotif on 29-Nov-2024, at unknown dose, orally, for indication typhoid immunization. Reportedly, five minutes after taking Vivotif patient ate food which is considered as product administration error. Inappropriate schedule of product administration and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-3183:
Sex: F
Vaccine: TYP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours.; Case reference number US-BN-2024-002865 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3251) on 09-Dec-2024 and concerns a 78-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified dates, the patient received first, second and third dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for typhoid immunization.  On an unknown date, the patient received fourth dose of Vivotif (batch number: unknown), at a dose of one capsule, orally. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours (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 vaccine.  No further information was provided.; Reporter's Comments: A 78-year-old female patient received the first, second and the third dose of Vivotif for typhoid immunization. On an unknown date, the patient received the fourth dose of Vivotif. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours, 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 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 78-year-old female patient received the first, second and the third dose of Vivotif for typhoid immunization. On an unknown date, the patient received the fourth dose of Vivotif. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours, 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 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: Contraindicated product administered, Labelled drug-drug interaction issue, Product storage error
Clinical narrative: The patient took two doses on Vivotif which were not refrigerated; The patient took two doses on Vivotif which were not refrigerated; The patient took Vivotif and was on unspecified antibiotics; Case reference number US-BN-2024-002893 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3306) on 16-Dec-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 13-Dec-2024 Friday, the patient took the first dose of Vivotif (batch number: unknown), at a dose of one capsule, via unknown route for indication reported as travel.  On 15-Dec-2024 Sunday, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at a dose of one capsule, via unknown route.  As reported, the patient took two doses on Vivotif which were not refrigerated and the patient was on unspecified antibiotics (explicitly coded as 'product storage error', 'product administration error' and 'labeled drug-drug interaction medication error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unknown age took two doses on Vivotif for indication reported as travel, which were not refrigerated, and the patient was on unspecified antibiotics, which is considered as product storage error, product administration error and labelled drug-drug interaction medication error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and labelled drug-drug interaction medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and labelled drug-drug interaction medication 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 two doses on Vivotif for indication reported as travel, which were not refrigerated, and the patient was on unspecified antibiotics, which is considered as product storage error, product administration error and labelled drug-drug interaction medication error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and labelled drug-drug interaction medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and labelled drug-drug interaction medication error are 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 the first dose of Vivotif which was kept on 75 degrees Fahrenheit for five days; The patient took the first dose of Vivotif which was kept on 75 degrees Fahrenheit for five days; Case reference number US-BN-2024-002900 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3313) on 17-Dec-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On 16-Dec-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, route, site of administration for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days (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 patient of unknown age and gender took the first dose of Vivotif for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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 patient of unknown age and gender took the first dose of Vivotif for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. 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: Cough, Influenza, Pain, Pyrexia
Clinical narrative: The patient had a cough and felt achy; The patient had a cough and felt achy; The patient had the flu and a fever; The patient had the flu and a fever; Case reference number US-BN-2024-002901 is a spontaneous case initially received from nurse via Med Communications (reference number: EUBAV24-3314) on 17-Dec-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 13-Dec-2024, reported as on day zero, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose reported as two out of four capsules, orally for unknown indication.  On 15-Dec-2024, reported as on day two, the patient was vaccinated with the second dose of Vivotif (batch number: unknown) at unknown dose reported as two out of four capsules, orally.   On 16-Dec-2024, reported as last night, one day after vaccination with second dose of Vivotif, the patient had the flu and a fever, as reported the patient also had a cough and felt achy since yesterday.  At the time of the initial report, it was unknown if the patient recovered from the events of 'cough', 'pain', 'flu' and 'fever'.  The reporter did not provide seriousness for events of 'cough', 'pain', 'flu' and 'fever'. The reporter did not provide causality assessment for the events of 'cough', 'pain', 'flu' and 'fever'.  No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of flu and a fever, as reported also cough and felt achy one day after vaccination with second dose of Vivotif for unknown indication. Pyrexia is listed and expected for Vivotif per CCDS v8 and USPI, whilst cough, pain and influenza are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible 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 female patient of unspecified age experienced non-serious events of flu and a fever, as reported also cough and felt achy one day after vaccination with second dose of Vivotif for unknown indication. Pyrexia is listed and expected for Vivotif per CCDS v8 and USPI, whilst cough, pain and influenza are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible 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: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took first dose of unrefrigerated Vivotif vaccine; Patient took first dose of unrefrigerated Vivotif vaccine; Patient took first dose of unrefrigerated Vivotif vaccine; Case reference number US-BN-2024-002902 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3324) on 17-Dec-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 on Friday, patient picked up Vivotif vaccine.  On an unspecified date, the patient took first dose of Vivotif (batch number: 3004085; expiration date: Mar-2025), at unknown dose, orally for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate. (explicitly coded as 'product storage error', 'product administration error' and 'product temperature excursion issue').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient of unknown age took the first dose of Vivotif for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate, which is considered as product storage error, product administration error and product temperature excursion issue. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the first dose of Vivotif for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate, which is considered as product storage error, product administration error and product temperature excursion issue. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are 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 three doses of Vivotif and had no time to pick up the last dose; Case reference number US-BN-2024-002906 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3339) on 30-Dec-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, the patient took first and second dose of Vivotif (batch number: unknown), at unknown dose, route for unknown indication.  On 15-Dec-2024, unknown time after first dose of Viviotif, the patient took third dose of Vivotif (batch number: unknown), at unknown dose, route and site of administration. As reported, the patient had not time to pick up the last dose of Vivotif (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 had not time to pick up the last dose of Vivotif for unknown indication, after the patient took three 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 unknown age had not time to pick up the last dose of Vivotif for unknown indication, after the patient took three 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: Inappropriate schedule of product administration
Clinical narrative: The patient took first three doses of the Vivotif vaccine correctly and did not take the last one for three days; Case reference number US-BN-2024-002914 is a spontaneous case initially received from other healthcare professional via Med Communication (reference number: USBAV24-3360) on 19-Dec-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 dates, the patient took first, second and third dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for an unknown indication.  As reported, the patient took first three doses of the Vivotif vaccine correctly and did not take the last one for three days (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender did not take the last dose of Vivotif for three days 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 events due to Rabipur. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender did not take the last dose of Vivotif for three days 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 events due to Rabipur. 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: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: The patient did not receive dose of Vivotif about 48 hours after the last dose; Case reference number US-BN-2024-000004 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV24-0008) on 02-Jan-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 29-Dec-2023, the patient received a dose of Vivotif (batch number), at an unknown dose or route of administration, for unknown indication.  As reported, the patient was scheduled to receive the next dose of Vivotif on On 31-Dec-2023, however the patient did not receive dose of Vivotif about 48 hours after the last dose (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.  Additional information received from Emergent BioSolutions on 03-Jan-2024 and included local case reference ID and confirmation of patient's gender.; Reporter's Comments: A male patient of unspecified age was scheduled to receive the next dose of Vivotif, however the patient did not receive dose of Vivotif about 48 hours after the last dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue 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 male patient of unspecified age was scheduled to receive the next dose of Vivotif, however the patient did not receive dose of Vivotif about 48 hours after the last dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue 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 dose omission issue
Clinical narrative: The patient missed the fourth dose of Vivotif.; Case reference number US-BN-2024-000013 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0020) on 04-Jan-2024 and concerns a 20-year-old patient of unspecified gender.   The patient's relevant medical history and concomitant medications were not provided.  On 25-Dec-2023, the patient was vaccinated with the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for immunization against typhoid fever.  On 27-Dec-2023, two days after the first dose of Vivotif, the patient was vaccinated with the second dose of Vivotif (batch number: unknown), at an unknown dose, orally.  On 29-Dec-2023, four days after the first dose of Vivotif , the patient was vaccinated with the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. As reported, 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 20-year-old patient of unspecified gender missed the fourth dose of Vivotif, after the patient was vaccinated with the first, second and the third dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 20-year-old patient of unspecified gender missed the fourth dose of Vivotif, after the patient was vaccinated with the first, second and the third dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient took two doses of Vivotif on schedule and forgot next two doses due to busy schedule; Case reference number US-BN-2024-000014 is a spontaneous case report initially received from other health care professional via Med Communication (reference number: USBAV24-0021) on 04-Jan-2024 and concerns a 34-year-old female patient.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient was vaccinated with the first dose of Vivotif (batch number: 3003831), at unknown dose and route of administration for unknown indication.  On unspecified date, an unknown amount of time after the first dose of Vivotif, the patient was vaccinated with second dose of Vivotif vaccine (batch number: 3003831), at unknown dose and route of administration. As reported, the patient received two doses of Vivotif on schedule and forgot next two doses of Vivotif due to busy schedule (explicitly coded as 'incomplete course of vaccination').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A 34-year-old female patient received two doses of Vivotif on schedule and forgot next two doses of Vivotif due to busy schedule, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A 34-year-old female patient received two doses of Vivotif on schedule and forgot next two doses of Vivotif due to busy schedule, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to Vivotif, but to a human factor. The case is non-serious.
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patient had cup of coffee about 15 minutes after administrating a dose of Vivotif on an empty stomach with cold water; Case reference number US-BN-2024-000016 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0024) on 04-Jan-2024 and concerns a patient of unspecified age or gender.  The patient's medical history and concomitant medications were not provided.  On unspecified date, the patient received a dose of Vivotif (batch number: unknown), at an unknown dose and route of administration, for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee (explicitly coded as 'product administration error').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  Additional information received from Emergent BioSolutions on 05-Jan-2024 included additional reference number.; Reporter's Comments: A patient of unspecified age or gender received a dose of Vivotif for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company conventions. The patient's medical history and concomitant medications were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age or gender received a dose of Vivotif for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company conventions. The patient's medical history and concomitant medications were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.