chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took doses of Vivotif at room temperature, did not store in the refrigerator; The patient took doses of Vivotif at room temperature, did not store in the refrigerator; Case reference number US-BN-2024-001948 is a spontaneous case initially received from a health care professional via Med Communications (reference number: USBAV24-1145) on 24-May-2024 and concerns female patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified dates, the patient took doses of Vivotif (batch numbers: unknown), without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi (explicitly coded as 'product storage error' and 'product administration error').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A female patient of unspecified age took doses of Vivotif, without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi 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 Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took doses of Vivotif, without refrigerating, at room temperature, at unknown doses, routes, or sites of administration, for immunization against disease caused by Salmonella typhi 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 Vivotif vaccine. The patient's relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took first dose of Vivotif this morning but says the package that was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour; Patient took first dose of Vivotif this morning but says the package that was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour; Case reference number US-BN-2024-001965 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-1173) on 29-May-2024 and concerns a 31-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 29-May-2024, the patient took the first dose of Vivotif (batch number: 3003908, expiry date: Jun-2024) at an unknown dose, via oral use, for typhoid prophylaxis. As reported, patient took first dose of Vivotif this morning but says the package was left in a hot car for ten minutes prior to bringing into house and leaving on the counter for another hour (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 31-year-old male patient took the first dose of Vivotif, after storing it in a hot car and then for an hour indoors (which is considered product storage error and product administration error). No associated adverse events were reported. Product storage error and administration error are listed as per company conventions. No medical information was available. The events are considered not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A 31-year-old male patient took the first dose of Vivotif, after storing it in a hot car and then for an hour indoors (which is considered product storage error and product administration error). No associated adverse events were reported. Product storage error and administration error are listed as per company conventions. No medical information was available. The events are considered not related to Vivotif, but to human error. The case is non-serious.
Vaccine: TYP
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had reaction after first dose of Vivotif and patient will not complete vaccination; Patient had reaction after first dose of Vivotif and patient will not complete vaccination; Case reference number US-BN-2024-001969 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1154) on 28-May-2024 and concerns a patient of unspecified age and gender.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally for unknown indication.  On unspecified date, unknown amount of time after taking the first dose of Vivotif, the patient experienced unspecified adverse reaction, and as reported the patient will not complete the vaccination (explicitly coded as 'incomplete course of vaccination').  At the time of the initial report, the outcome of the adverse reaction was unknown.  The reporter assessed the adverse reaction as non-serious and related to Vivotif.  No further information was provided.; Reporter's Comments: A patient of unspecified age and gender experienced unspecified adverse reaction, unknown time after taking the first dose of Vivotif and as reported the patient will not complete the vaccination which is considered as incomplete course of vaccination. Adverse reaction and incomplete course of vaccination are both considered listed per company conventions. The outcome of the adverse reaction was unknown. The patient's relevant medical history and concomitant medications were not provided. Adverse reaction is conservatively assessed as related due to lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender experienced unspecified adverse reaction, unknown time after taking the first dose of Vivotif and as reported the patient will not complete the vaccination which is considered as incomplete course of vaccination. Adverse reaction and incomplete course of vaccination are both considered listed per company conventions. The outcome of the adverse reaction was unknown. The patient's relevant medical history and concomitant medications were not provided. Adverse reaction is conservatively assessed as related due to lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.
Vaccine: TYP
Symptoms: Rash
Clinical narrative: Rash; Case reference number US-BN-2024-001970 is a spontaneous case report initially received from a pharmacist via Emergent BioSolutions (reference number: EMG2024-621) on 26-May-2024 and concerns a patient of unspecified gender or age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patent took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication.  On an unspecified date, the patient developed rash.  At the time of initial report, it was unknown if the patient recovered from the event of rash.  The reporter did not provide seriousness and causality assessment for event of rash.  No further information was provided.; Reporter's Comments: A patient of unspecified gender or age developed rash, unknown time after taking the first dose of Vivotif, at unknown dose, orally, for unknown indication. Rash is listed and expected according to CCDS v8 and USPI for Vivotif. At this point, it was unknown if the patient recovered from the event of rash. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A patient of unspecified gender or age developed rash, unknown time after taking the first dose of Vivotif, at unknown dose, orally, for unknown indication. Rash is listed and expected according to CCDS v8 and USPI for Vivotif. At this point, it was unknown if the patient recovered from the event of rash. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Nausea, Product storage error
Clinical narrative: Patient received one dose of Vivotif and felt very nauseated; Patient received first dose of Vivotif which was left out of the fridge for about a week; Patient received first dose of Vivotif which was left out of the fridge for about a week; Case reference number US-BN-2024-002109 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1448) on 24-Jun-2024 and concerns an 18-year-old male patient.  The patient's medical history and concomitant medication were not provided.  On 23-Jun-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid immunization. As reported, patient received first dose of Vivotif which was left out of the fridge for about a week (explicitly coded as 'product storage error' and 'product administration error').  On an unspecified date, the patient felt very nauseated.  At the time of the initial report, it was unknown if the patient recovered from nauseated.  The reporter assessed the event nauseated as non-serious and causality as possible for the event nauseated.  No further information was provided.; Reporter's Comments: An 18-year-old male patient felt nauseated within one day after he took the first dose of Vivotif, at an unknown dose, orally for typhoid immunization. Reportedly, the patient received first dose of Vivotif which was left out of the fridge for about a week, and that is considered as product storage error and product administration error. Nausea is listed and expected according to CCDS v8 and USPI while product storage error and product administration error are both considered listed per company conventions. The outcome of event nausea was unknown. The patient's medical history and concomitant medication were not provided. Nausea is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. 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: An 18-year-old male patient felt nauseated within one day after he took the first dose of Vivotif, at an unknown dose, orally for typhoid immunization. Reportedly, the patient received first dose of Vivotif which was left out of the fridge for about a week, and that is considered as product storage error and product administration error. Nausea is listed and expected according to CCDS v8 and USPI while product storage error and product administration error are both considered listed per company conventions. The outcome of event nausea was unknown. The patient's medical history and concomitant medication were not provided. Nausea is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took the first dose of Vivotif vaccine which was kept out of the refrigerator for about one week; The patient took the first dose of Vivotif vaccine which was kept out of the refrigerator for about one week; Case reference number US-BN-2024-002133 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1448) on 24-Jun-2024 and concerns a 14-year-old male patient.  The patient's medical history and concomitant medication were not provided.  On 23-Jun-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown) at dose of one capsule, orally for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge for five days, from 17-Jun-2024 (explicitly coded as 'product storage error' and 'product administration error').   At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A 14-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and the vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge 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 the Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 14-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient forgot to place vaccine in the fridge and the vaccine was out of the fridge for about one week, the reporter assumed that vaccine was out of the fridge 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 the Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had inadvertently taken the first two doses of Vivotif 24 hours apart, instead of 48 hours; Case reference number US-BN-2024-002168 is a spontaneous case initially received from phycisian via Emergent (reference number: EMG2024-757) on 06-Jul-2024 and concerns a 15-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 or route for unknown indication.  On an unspecified date, 24 hours after the first dose, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose or route (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A 15-year-old female patient took the second dose of Vivotif, 24 hours after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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 15-year-old female patient took the second dose of Vivotif, 24 hours after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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: M
Vaccine: TYP
Symptoms: Drug intolerance, Inappropriate schedule of product administration
Clinical narrative: Patient could not tolerate the oral typhoid; The patient took three doses and sent back a partial pack; Case reference number US-BN-2024-002169 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-1589) on 08-Jul-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication were not provided.  On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack (explicitly coded as 'Inappropriate schedule of vaccine administered').  On an unspecified date, the patient could not tolerate the oral typhoid.  At the time of the initial report, it was unknown if the patient recovered from the event 'drug intolerance'.  The reporter assessed the seriousness of the event 'drug intolerance' as non-serious, and causality for the event 'drug intolerance' was provided as possible.  Additional information received from a health care professional on 10-Jul-2024: included confirmation how many doses of Vivotif patient took.  Additional information received from a health care professional via Med Communication (reference number: USBAV24-1616) on 10-Jul-2024: included additional reference number (USBAV24-1616).; Reporter's Comments: A male patient of unknown age took the first, second and the third dose of Vivotif for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack, which is considered as inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, the patient could not tolerate the oral typhoid. Drug intolerance and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The causality for drug intolerance is considered as possibly related to Vivotif. 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 the first, second and the third dose of Vivotif for typhoid Immunization. As reported, the patient took three doses and has sent back partial pack, which is considered as inappropriate schedule of vaccine administered. Reportedly, on an unspecified date, the patient could not tolerate the oral typhoid. Drug intolerance and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The causality for drug intolerance is considered as possibly related to Vivotif. 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 received the first and second doses of Vivotif every other day, however, the patient took the third dose on sunday instead of saturday; Case reference number US-BN-2024-002230 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV24-1728) on 22-Jul-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 an unknown dose, orally, for typhoid immunization.  On an unspecified date, reported as every other day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally.  On 21-Jul-2024, reported as on Sunday, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. As reported, the patient took the third dose on Sunday instead of Saturday (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 patient of unknown age and gender took the third dose of Vivotif for typhoid immunization. As reported, the patient took the third dose on Sunday instead of Saturday, 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 patient of unknown age and gender took the third dose of Vivotif for typhoid immunization. As reported, the patient took the third dose on Sunday instead of Saturday, 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.
Vaccine: TYP
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received one dose of Vivotif, which was left out of the refrigerator for two hours, reached a maximum temperature of 70 degrees Fahrenheit; The patient received one dose of Vivotif, which was left out of the refrigerator for two hours, reached a maximum temperature of 70 degrees Fahrenheit; Case reference number US-BN-2024-002309 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1868) on 05-Aug-2024 and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, route for unknown indication. As reported the patient took one dose of Vivotif, which was left out of the refrigerator for two hours and reached a maximum temperature of 70 degrees 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 patient of unknown demographics received a dose of Vivotif, which had been stored outside of a fridge for two hours, reaching a maximum temperature of 70 deg F (equivalent to 21 deg C). This is considered product storage error and product administration error, which are listed situations as per company convention. No associated adverse events were reported at this time. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics received a dose of Vivotif, which had been stored outside of a fridge for two hours, reaching a maximum temperature of 70 deg F (equivalent to 21 deg C). This is considered product storage error and product administration error, which are listed situations as per company convention. No associated adverse events were reported at this time. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to Vivotif, but to human error. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took the first, second and third dose of Vivotif vaccine and realized that did not refrigerated vaccines; The patient took the first, second and third dose of Vivotif vaccine and realized that did not refrigerated vaccines; Case reference number US-BN-2024-002344 is a spontaneous case initially received from a consumer via Emergent BioSolutions (reference number: EMG2024-874) 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 unspecified date, the doses of Vivotif were not refrigerated (explicitly coded as 'product storage error').  On an unspecified date, the patent took the first dose of Vivotif (batch number: unknown), at a dose of pill, orally, for typhoid immunization (explicitly coded as 'product administration error').  On an unspecified date, unknown amount of time after first dose of Vivotif, the patent took the second dose of Vivotif (batch number: unknown), at a dose of pill, orally (explicitly coded as 'product administration error').  On an unspecified date, unknown amount of time after second dose of Vivotif, the patent took the third dose of Vivotif (batch number: unknown), at a dose of pill, orally (explicitly coded as 'product administration error'). As reported, the patient took three pills of Vivotif out of the four pills due to travel and realised that did not refrigerate Vivotif.  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine.  Additional information received from consumer via Med Communication (reference number: USBAV24-1970) on 14-Aug-2024: Information included patient details and Vivotif dosing information.  Non-significant case correction received from Emergent on 27-Aug-2024 included confirmation of initial receipt date.; Reporter's Comments: A female patient received three doses of Vivotif, after not refrigerating them, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are 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 Vivotif, but to a human error. The case is non-serious.; Sender's Comments: A female patient received three doses of Vivotif, after not refrigerating them, which is considered product storage error and product administration error. No associated adverse events were reported. Product storage error and product administration error are 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 Vivotif, but to a human error. The case is non-serious.
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: The patients took Vivotif every other day with food instead of taking it on empty stomach; Case reference number US-BN-2024-002412 is a spontaneous case report initially received from a consumer via Emergent BioSolutions (reference number: EMG2024-928) on 29-Aug-2024 and concerns two patients unspecified age, husband and wife.  The patients' medical history and concomitant medication details were not provided.  On an unspecified date, reported as every other day, the patients took the first, second, third and fourth dose of Vivotif vaccine (batch number: unknown), at a dose of capsule, orally, for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach (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 Med Communications on 29-Aug-2024, at 09:04, included additional reference number, route of Vivotif administration, dosage, and patients' details.  Additional information received from Med Communications on 29-Aug-2024, at 09:05 included additional reference number.; Reporter's Comments: Two patients of unspecified age, husband and wife took the first, second, third and the fourth dose of Vivotif vaccine for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two patients of unspecified age, husband and wife took the first, second, third and the fourth dose of Vivotif vaccine for an unknown indication. As reported, the patients took all four doses every other day but not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain, Faeces discoloured
Clinical narrative: Clay colored stools; Discomfort from stomach; Abdominal pain; Case reference number US-BN-2024-002542 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2024_02980) on 24-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 a dose of typhoid vaccine (brand name: unknown, batch number: unknown), at dose of one capsule, via unknown route and for unknown indication.  On an unspecified date, unknown amount of time after taking the typhoid vaccine, the patient experienced abdominal pain, clay colored stools and discomfort from stomach.  At the time of the initial report, the outcome for the events of abdominal pain, clay colored stools and discomfort from stomach was unknown.  The reporter did not provide seriousness and causality assessment for the events of abdominal pain, clay colored stools and discomfort from stomach.  Additional information received from Bavarian Nordic on 25-Sep-2024 included confirmation of county of occurrence.; Reporter's Comments: A patient of unknown age and gender experienced non-serious events of abdominal pain, clay colored stools and discomfort from stomach on an unspecified date, unknown amount of time after the patient took a dose of typhoid vaccine for unknown indication. Abdominal pain is listed and expected for Typhoid vaccine per CCDS v8 and USPI, whilst faeces discoloured and abdominal discomfort are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Typhoid vaccine. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender experienced non-serious events of abdominal pain, clay colored stools and discomfort from stomach on an unspecified date, unknown amount of time after the patient took a dose of typhoid vaccine for unknown indication. Abdominal pain is listed and expected for Typhoid vaccine per CCDS v8 and USPI, whilst faeces discoloured and abdominal discomfort are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Typhoid vaccine. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: The patient missed a day to take a dose of Vivotif; Case reference number US-BN-2024-002636 is a spontaneous case initially received from pharmacist via Med Communications (reference number: USBAV24-2672) on 10-Oct-2024 and concerns a patient of unknown age or gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), at an unknown dose, orally, for indication Typhoid immunization. As reported the patient missed a day of took of Vivotif vaccine (explicitly coded as 'missed dose').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  Additional information received from pharmacist via Med Communications (reference number: USBAV24-2674) on 10-Oct-2024 and included additional reference number.; Reporter's Comments: A patient of unknown age or gender missed a day while taking Vivotif vaccine which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age or gender missed a day while taking Vivotif vaccine which is considered as missed dose. Product dose omission issue is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Contraindication to vaccination, Labelled drug-disease interaction medication error, No adverse event
Clinical narrative: The patient with lactose intolerance received dose of Vivotif; The patient with lactose intolerance received dose of Vivotif; Case reference number US-BN-2024-002698 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2751) on 17-Oct-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication were not provided.  The patient's current condition included lactose intolerance.  On unspecified date, the patient took a dose of Vivotif (batch number: unknown) at unknown dose, or route of administration for unknown indication. As reported, the patient was lactose intolerant (explicitly coded as 'contraindicated product administered' and 'labelled drug-disease interaction error').  At the time of the initial report, the patient did not experience any adverse events due to Vivotif, since it was reported that patient did not have any incidence.  The case is linked with the case US-BN-2024-002661, containing the same reporter.  No further information was provided.; Reporter's Comments: A male patient of unknown age took a dose of Vivotif, at unknown dose, route of administration for unknown indication. Reportedly, the patient was lactose intolerant which is considered as contraindicated product administered and labelled drug-disease interaction medication error. Contraindicated product administered and labelled drug-disease interaction medication error are both considered listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif. The patient's medical history and concomitant medication information was not provided while current condition included lactose intolerance. Contraindicated product administered and labelled drug-disease interaction error are not related to Vivotif, but to human error. The case is non-serious.; Sender's Comments: A male patient of unknown age took a dose of Vivotif, at unknown dose, route of administration for unknown indication. Reportedly, the patient was lactose intolerant which is considered as contraindicated product administered and labelled drug-disease interaction medication error. Contraindicated product administered and labelled drug-disease interaction medication error are both considered listed per company conventions. At this point, the patient did not experience any adverse events due to Vivotif. The patient's medical history and concomitant medication information was not provided while current condition included lactose intolerance. Contraindicated product administered and labelled drug-disease interaction error are not related to Vivotif, but to human error. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: The patient had rash on the neck and trunk; Case reference number US-BN-2024-002739 is a spontaneous case initially received from other health care professional via Bavarian Nordic (reference number: BN_2024_03049) on 04-Nov-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication.   On an unspecified date, unknown amount of time after vaccination with Vivotif, the patient had rash on neck and trunk.  At the time of initial report, it was unknown if the patient recovered from event of 'rash'.  The reporter did not provide seriousness and causality assessment for event of 'rash'.  No further information was provided.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of rash on neck and trunk an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Rash is listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of rash on neck and trunk an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Rash is listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Heart rate increased, Oral pruritus, Pruritus
Clinical narrative: Increased heart rate (could feel heartbeat in her teeth); Itching on the roof of mouth; Itching on the top of head; Case reference number US-BN-2024-002771 is a spontaneous case initially received from other health care professional via Bavarian Nordic (reference number: BN_2024_03074) on 11-Nov-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient took the first dose of Vivotif vaccine (batch number: unknown) at unknown dose, route or site of administration, for unknown indication.   On unspecified date, for unknown amount of time from a first dose of Vitotif vaccine, the patient experienced adverse events of itching on the roof of mouth, itching on the top of head, and increased heart rate (could feel heartbeat in teeth).  At the time of the initial report, it was unknown if the patient recovered from the events of 'heart rate increased', 'oral pruritus', and 'itchy scalp'.  The reporter did not provide a seriousness and causality assessment for events of 'heart rate increased', 'oral pruritus', and 'itchy scalp'.   No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of itching on the roof of mouth, itching on the top of head, and increased heart rate an unknown amount of time after the patient took the first dose of Vivotif vaccine for unknown indication. Heart rate increased and oral pruritus are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst pruritus is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, 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 itching on the roof of mouth, itching on the top of head, and increased heart rate an unknown amount of time after the patient took the first dose of Vivotif vaccine for unknown indication. Heart rate increased and oral pruritus are unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst pruritus is listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to Vivotif. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Underdose
Clinical narrative: Jynneos vaccines were administered at dose of 0.1 ml intradermally; Jynneos vaccines were administered at dose of 0.1 ml intradermally; Case reference number US-BN-2024-002867 is a spontaneous case initially received from other health care professional via Med Communications (reference number: USBAV24-2977) on 11-Nov-2024 and concerns a *31-year-old, male* patient.  The patient's medical history and concomitant medication details were not provided.  On *02-November-2024*, the patient received dose of Jynneos vaccine (batch number: *96867; expiration date: 30-Apr-2026*) at dose 0.1 ml, intradermally *in the left forearm*, for unknown indication (explicitly coded as 'Intradermal injection' and 'vaccine underdose').  *The patient did not received any further doses of Jynneos vaccine. *  At the time of the *follow-up*, it was unknown if the patients experienced any adverse events due to Jynneos.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from health care professional on 17-Jan-2025: New information included dosing information, demografic information of the patient.; Reporter's Comments: This case report concerns an unspecified number of patients of unspecified gender or age. The patients received doses of Jynneos vaccines, at dose 0.1 ml, intradermally, at unknown site of administration for unknown indication which is considered as intradermal injection and vaccine underdose. Injection and underdose are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. 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.Based on the follow-up information received, there is no change in the Company's assessment.; Sender's Comments: This case report concerns an unspecified number of patients of unspecified gender or age. The patients received doses of Jynneos vaccines, at dose 0.1 ml, intradermally, at unknown site of administration for unknown indication which is considered as intradermal injection and vaccine underdose. Injection and underdose are both considered listed per company conventions. At this point, it was unknown if the patients experienced any adverse events due to Jynneos. 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.Based on the follow-up information received, there is no change in the Company's assessment.