chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took one capsule of Vivotif, and Vivotif left out of fridge for 48 hours at max temperature of 68 degrees Fahrenheit and then patient took second dose; Patient took one capsule of Vivotif, and Vivotif left out of fridge for 48 hours at max temperature of 68 degrees Fahrenheit and then patient took second dose; Case reference number US-BN-2024-001828 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0824) on 23-Apr-2023 and concerns female patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, as reported patient came back home from pharmacy and patient took first dose of Vivotif vaccine (batch number: 3004007), at unknown dose (capsule), orally, for indication reported taken prior to travel. Patient left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit (explicitly coded as 'product storage error temperature too high).  On unspecified date, as reported two days after first dose, patient took second dose of Vivotif vaccine (batch number: 3004007), at unknown dose (capsule), orally (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.  No further information was provided.; Reporter's Comments: A female patient of unspecified age left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit, which is considered as product storage error temperature too high. On unspecified date, as reported two days after first dose, the patient took the second dose of Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications 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 female patient of unspecified age left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit, which is considered as product storage error temperature too high. On unspecified date, as reported two days after first dose, the patient took the second dose of Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications 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: The patient received the second dose of Vivotif three days after the first dose; Case reference number US-BN-2024-001845 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0859) on 29-Apr-2024 and concerns a *22-year-old female patient.*  The patient *had no relevant medical history and was not taking any concomitant medication.*  On 26-Apr-2024, the patient took the first dose of Vivotif *(batch number: 3004009, expiration date: 31-Oct-2024)*, one capsule, orally, for typhoid immunization. As reported, patient was due to take the other dose on the 28th but forgot (explicitly coded as 'inappropriate schedule of vaccine administered').  *On 29-Apr-2024, three days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004009, expiration date: 31-Oct-2024), one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). The patient was advised it is safe to continue the rest of the doses every other day. The reporter did not continue to follow-up if the patient took the last two doses on schedule and assumed that the patient did.*  At the time of the *follow-up* report, it was unknown if the patient experienced any adverse event due to Vivotif.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*)  Follow up information received from the reporter on 10-Jun-2024, new information included: patient details, Vivotif dosing information, medical history and concomitant medications information.  Non-significant case correction performed for information received form the reporter on 24-Jun-2024 included confirmation that patient did not report anything back to the clinic.; Reporter's Comments: A 22-year-old female patient took the second dose of Vivotif on the day 3 after the patient took the first dose of Vivotif for typhoid immunization, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 22-year-old female patient took the second dose of Vivotif on the day 3 after the patient took the first dose of Vivotif for typhoid immunization, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient had no relevant medical history and was not taking any concomitant medication. 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: The patient took second and third dose of Vivotif which were not refrigerated; The patient took second and third dose of Vivotif which were not refrigerated and did not take first three doses on an empty stomach; Case reference number US-BN-2024-001853 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0894) on 01-May-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 18-Apr-2024, the patient took first dose of Vivotif (batch number: unknown), orally, at unknown dose, for unknown indication. As reported, the patient did not take vaccine on empty stomach (explicitly coded as 'Product administration error').  On an unspecified date, the patient did not refrigerate Vivotif vaccine.  On unspecified dates, unknown amount of time after first dose of Vivotif, the patient took second and third dose of Vivotif (batch number: unknown), orally, at unknown dose, as reported the patient did not take vaccine on empty stomach. As reported the product of Vivotif was out of refrigerator over a week (explicitly coded as 'Product administration error' and 'Product storage error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A male patient of unspecified age took all three doses of Vivotif on an empty stomach, which is considered as product administration error. Additionally it was reported that the product of Vivotif was out of refrigerator over a week, which is considered as product storage error. No associated adverse events were reported. Product administration error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product administration error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age took all three doses of Vivotif on an empty stomach, which is considered as product administration error. Additionally it was reported that the product of Vivotif was out of refrigerator over a week, which is considered as product storage error. No associated adverse events were reported. Product administration error and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product administration error are not related to Vivotif, but to a human factor. The case is non-serious.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took Vivotif accidentally every day instead of every other day; Case reference number US-BN-2024-001861 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0913) on 02-May-2024 and concerns male patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified dates, the patient took Vivotif (batch number: unknown), orally, at unknown dose for unknown indication. As reported, the patient took Vivotif vaccine accidentally every day instead of every other day (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A male patient of unspecified age took Vivotif, orally every day instead of every other day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is 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 male patient of unspecified age took Vivotif, orally every day instead of every other day which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is 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: F
Vaccine: TYP
Symptoms: Headache, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Body ache; Sore throat; After two doses of Vivotif, patient was not feeling well; Headache; Case reference number US-BN-2024-001869 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0919) on 03-May-2024 and concerns female patient of unspecified age (teenager).  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient was vaccinated with first and second dose of Vivotif vaccine (batch number: Unknown), at unknown dose, route, or site of administration for unknown indication.  On unspecified date, unknown amount of time after administration of Vivotif vaccine patient was not feeling well and patient experienced headache, body ache and sore throat.  At the time of initial report, it was unknown if the patient recovered from the events 'feeling unwell', 'headache', 'ache' and 'sore throat'.  The reporter assessed the events as non-serious. Causality assessment was reported as not related to Vivotif vaccine.  No further information provided.; Reporter's Comments: A female patient of unspecified age (teenager) was not feeling well and experienced non-serious events of headache, body ache and sore throat on unspecified date, unknown amount of time after the patient was vaccinated with first and the second dose of Vivotif vaccine for unknown indication. Malaise and headache are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst pain and oropharyngeal pain are unlisted and unexpected. The patient's relevant medical history and concomitant medications 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 (teenager) was not feeling well and experienced non-serious events of headache, body ache and sore throat on unspecified date, unknown amount of time after the patient was vaccinated with first and the second dose of Vivotif vaccine for unknown indication. Malaise and headache are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst pain and oropharyngeal pain are unlisted and unexpected. The patient's relevant medical history and concomitant medications 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: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took one dose of Vivotif vaccine which left at room temperature for nine hours time frame, maximum temperature reached was temperature 62 Fahrenheit; The patient took one dose of Vivotif vaccine which left at room temperature for nine hours time frame, maximum temperature reached was temperature 62 Fahrenheit; Case reference number US-BN-2024-001870 is a spontaneous case report initially received from a physician via Med Communications (reference number USBAV24-0928) on 06-May-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit. (explicitly coded as 'Product administration error' and 'Product storage error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A female patient of unspecified age took a dose of Vivotif for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error 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 female patient of unspecified age took a dose of Vivotif for typhoid immunization. As reported, the patient mistakenly left one pill of the four of Vivotif vaccine, at room temperature for nine hours time frame, maximum temperature was 62 Fahrenheit, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took seven days course of Vivotif which did not refrigerate; The patient took seven days course of Vivotif which did not refrigerate; Case reference number US-BN-2024-001892 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0988) on 09-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, as reported the patient did not know Vivotif vaccine was supposed to be kept refrigerated (explicitly coded as 'Product storage error').  On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif (batch number: unknown), at unknown dose, route, or site administration, for unknown indication (explicitly coded as 'Product administration error')  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A patient of unspecified gender or age did not know Vivotif vaccine was supposed to be kept refrigerated, which is considered as product storage error. On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified gender or age did not know Vivotif vaccine was supposed to be kept refrigerated, which is considered as product storage error. On unspecified dates, as reported the patient took seven days course of vaccination of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took two doses of Vivotif correctly, but third dose patient took 12 hours later; Case reference number US-BN-2024-001896 is a spontaneous case report initially received from nurse via Med Communications (reference number: USBAV24-0993) on 09-May-2024 and concerns patient of unspecified age and gender.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified dates, the patient took two doses of Vivotif (batch number: unknown) at unknown doses, orally, for typhoid immunization, due to trip.  On unspecified date, reported as 12 hours later than Vivotif should be taken, patient took third dose of Vivotif, at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A patient of unspecified age and gender took third dose of Vivotif, 12 hours later than Vivotif should have been taken which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif 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 patient of unspecified age and gender took third dose of Vivotif, 12 hours later than Vivotif should have been taken which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif 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.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient started immunization course with unrefrigerated Vivotif vaccine, maximum temperature was below 77 degrees of Fahrenheit for 24 hours; Patient started immunization course with unrefrigerated Vivotif vaccine, maximum temperature was below 77 degrees of Fahrenheit for 24 hours; Case reference number US-BN-2024-001897 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV24-0985) on 09-May-2024 and concerns a patient of unspecified age or gender.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient started immunization course with unknown number of doses of Vivotif (batch number: unknown), at an unknown dose or route of administration, for unknown indication. As reported, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours (explicitly coded as 'product storage error temperature too high' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A patient of unspecified age or gender started immunization course with unknown number of doses of Vivotif, at an unknown dose or route of administration, for unknown indication. Reportedly, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours which is considered as product storage error temperature too high 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. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age or gender started immunization course with unknown number of doses of Vivotif, at an unknown dose or route of administration, for unknown indication. Reportedly, the administered doses were not refrigerated, with maximum temperature reaching 77 degrees of Fahrenheit for 24 hours which is considered as product storage error temperature too high 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. 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 administration error
Clinical narrative: The patient drank alcohol with dinner and after that took the first dose of Vivotif vaccine; Case reference number US-BN-2024-001905 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-1008) on 10-May-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 09-May-2024, as reported, the patient drank alcohol with dinner and after dinner the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for an unknown indication (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A male patient of unspecified age drank alcohol with dinner and after dinner the patient took the first dose of Vivotif, at unknown dose, orally, for an unknown indication which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication 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 male patient of unspecified age drank alcohol with dinner and after dinner the patient took the first dose of Vivotif, at unknown dose, orally, for an unknown indication which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Patient took the second dose of Vivotif vaccine four hours after meal; Case reference number US-BN-2024-001907 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number: USBAV24-1029) on 14-May-2024 and concerns a patient of unspecified age or gender.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, patient took the first dose of Vivotif (batch number: unknown), at unknown dose or route of administration, for unknown indication.  On unspecified date, reported as on alternate day, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose or route of administration. As reported, the patient took the second dose of Vivotif four hours after meal (explicitly coded as 'product administration error')  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A patient of unspecified age or gender took the second dose of Vivotif for unknown indication four hours after the meal, 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 relevant 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 took the second dose of Vivotif for unknown indication four hours after the meal, 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 relevant 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.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours; Patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours; Case reference number US-BN-2024-001913 is a spontaneous case report initially received from a health care professional via Med Communications (reference number: USBAV24-1045) on 14-May-2024 and concerns a patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown) at an unknown dose, via an unknown route for unknown indication. As reported, the patient took third dose of Vivotif which was exposed to 55-60 degree Fahrenheit for 16 hours (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, second and the third dose of Vivotif for unknown indication. As reported, the patient took the third dose of Vivotif which was exposed to 5560-degree Fahrenheit for 16 hours, 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 administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first, second and the third dose of Vivotif for unknown indication. As reported, the patient took the third dose of Vivotif which was exposed to 5560-degree Fahrenheit for 16 hours, 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 administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: TYP
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: The patient did not take the fourth dose of Vivotif as the dog ate it; Case reference number US-BN-2024-001915 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-1039) on 14-May-2024 and concerns a *64-year-old female patient.*  The patient's medical history and concomitant medication details were not provided.  *On 09-May-2024,* the patient took the first dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule,* orally, for typhoid immunization.  *On 11-May-2024, three days after the first dose of Vivotif,* the patient took the second dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule, orally.*  *On 13-May-2024, five days after the first dose of Vivotif,* the patient took the third dose of Vivotif (batch number: *3004009, expiry date: 31-Oct-2024) one capsule, orally.* As reported, the patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it (explicitly coded as 'missed dose').  *As reported, the patient did not experience any adverse event due to Vivotif.*  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Additional information received from a nurse on 15-May-2024: New information included confirmation that the patient did not take the fourth dose of Vivotif.  Follow up information received from a nurse on 28-May-2024: New information included added patient demographic details, Vivotif dosage information and confirmation on the fourth dose of Vivotif, and confirmation that the patient did not experience any adverse event.; Reporter's Comments: A 64-year-old female patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it, which is considered as missed dose. Reportedly, the patient did not experience 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 64-year-old female patient took the first three doses as directed, every other day, however the patient did not take the fourth dose of Vivotif as the dog ate it, which is considered as missed dose. Reportedly, the patient did not experience 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.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took the third dose of Vivotif vaccine was stored at 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours; The patient took the third dose of Vivotif vaccine was stored at 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours; Case reference number US-BN-2024-001918 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-1046) on 14-May-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took the first and second dose of Vivotif (batch number: unknown), at an unknown, dose, orally, for unknown indication.  On an unspecified date, the third dose of Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours (explicitly coded as 'Product storage error').   On unspecified date, an unknown amount of time after second dose of Vivotif, the patient took the affected third dose of Vivotif (batch number: unknown), at an unknown dose, orally (explicitly coded as 'Product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A male patient of unknown age took the affected third dose of Vivotif for unknown indication after Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the affected third dose of Vivotif for unknown indication after Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 60 degrees Fahrenheit for at least 12 hours but not greater than 16 hours, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took first and second dose of Vivotif, and forgot to take third dose; Case reference number US-BN-2024-001922 is a spontaneous case report initially received from pharmacist via Med Communication (reference number: USBAV24-1064) on 16-May-2024 and concerns male patient.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient was vaccinated with first dose of Vivotif vaccine (batch number: unknown), at unknown dose, reported as four capsules, at an unknown route of administration, for unknown indication.   On unspecified date, the patient was vaccinated with second dose of Vivotif vaccine (batch number: unknown), at unknown dose, reported as four capsules, at an unknown route of administration.  As reported, the patient took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: This case concerns a male patient who took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif 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: This case concerns a male patient who took doses one and two and skipped day three, and called pharmacy the next day, 23 hours later which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif 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.
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient left Vivotif in the car for one hour and 40 minutes, the maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened; The patient left Vivotif in the car for one hour and 40 minutes, the maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened; Case reference number US-BN-2024-001926 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-1073) on 17-May-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 left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened (explicitly coded as 'product storage error').  On an unspecified date, the patient took a first dose of Vivotif (batch number: 3004008) at an unknown dose, orally, for typhoid immunization (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 age and gender took the first dose of Vivotif for typhoid immunization, after the patient left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened, 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first dose of Vivotif for typhoid immunization, after the patient left Vivotif in the car for one hour and 40 minutes, as reported while driving the car. The maximum temperature reached was 72 Fahrenheit degrees and the patient took one capsule after the excursion happened, 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 have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: The patient took third dose of Vivotif which left in his envelope in car overnight about 26 hours; The patient took third dose of Vivotif which left in his envelope in car overnight about 26 hours; Case reference number US-BN-2024-001941 is a spontaneous case report initially received from other health care professional via Med Communications (reference number USBAV24-1122) on 22-May-2024 and concerns a 19-years-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 18-May-2024, the patient took the first dose of Vivotif (batch number: 3004008), at unknown dose, orally, for unknown indication reported as pre travel.  On 20-May-2024, two days after first dose of Vivoitf, the patient took the second dose of Vivotif (batch number: 3004008), at unknown dose, orally.  On an unspecified date, as reported, the patient left in car Vivotif with his envelope overnight for about 26 hours, the temperature was cool but was not at a normal refrigerated temperature (explicitly coded 'Product storage error').  On 22-May-2024, two days after second dose of Vivoitf, the patient took the third dose of Vivotif (batch number: 3004008), at unknown dose, orally (explicitly coded as 'Product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information was provided.; Reporter's Comments: A 19-year-old male patient left in car Vivotif with his envelope overnight for about 26 hours (the temperature was cool but was not at a normal refrigerated temperature) which is considered as product storage error. Two days after second dose of Vivoitf, the patient took the third dose of Vivotif, at unknown dose, orally which is considered as product administration error. Product storage error and product administration error are both considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient left in car Vivotif with his envelope overnight for about 26 hours (the temperature was cool but was not at a normal refrigerated temperature) which is considered as product storage error. Two days after second dose of Vivoitf, the patient took the third dose of Vivotif, at unknown dose, orally which is considered as product administration error. Product storage error and product administration error are both considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Product administration error
Clinical narrative: Two doses of Vivotif were taken with food and two on an empty stomach; Case reference number US-BN-2024-001947 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-1143) on 24-May-2024 and concerns a female patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, the patient took four doses of Vivotif (batch number: unknown) orally, at an unknown dose, for unknown indication. As reported, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an empty stomach (explicitly coded as 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif.  No further information was provided.; Reporter's Comments: A female patient, took four doses of Vivotif orally, at an unknown dose, for unknown indication. Reportedly, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. 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, took four doses of Vivotif orally, at an unknown dose, for unknown indication. Reportedly, the patient took already four doses, but didn't know it had to take it on an empty stomach, two of the doses were taken with food and two on an empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. 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.