🏥 VAERS Vaccine Data Browser

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Data Interpretation

The presence of a report does not mean the vaccine caused the adverse event.
Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
Serious adverse events must be reported by law, even if unrelated to the vaccine.
The database is useful for detecting safety signals that require further investigation.

📖 Help & Search Guide

Column Icons Legend

💀 Death

🏥 Hospitalized

🚑 Emergency Room

♿ Disability

⚠️ Life Threatening

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Understanding the Data

Reports are unverified: VAERS accepts all reports without medical verification
Not proof of causation: A report does not mean the vaccine caused the event
Anyone can report: Healthcare providers, patients, and family members can submit reports
Multiple vaccines: One report may list multiple vaccines given at the same time
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Using the Table

Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
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⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.

34,052

Total Reports (2025)

500

Deaths Reported

1,634

Hospitalizations

ER Visits

1,191

Disabilities

570

Life Threatening

Year: VAERS ID: Age: Sex: State: Vaccine Type: Manufacturer: Lot Number: Site: Symptom: Death: Hospitalized:

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Showing 27,401 to 27,450 of 34,052 reports (Page 549 of 682)

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ID	Sex	State	Date ▼	Vaccine	Manufacturer	Lot #	Symptoms	Narrative
2829415	F	WI	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took oral typhoid vaccine not in recommended way (two doses 25 hours apart instead of sk... The patient took oral typhoid vaccine not in recommended way (two doses 25 hours apart instead of skipping the day in between); Case reference number US-BN-2024-002626 is a spontaneous case initially received from other healthcare professional via Med Communications (reference number: USBAV24-2655) on 08-Oct-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 an unknown dose, orally, for unknown indication. On unspecified date, reported as 25 hours apart instead of skipping the day in between the doses, patient took the next dose of Vivotif (batch number: unknown), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administration'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. No further information was provided.; Reporter's Comments: A female patient of unspecified age took the next dose of Vivotif, at an unknown dose, orally, 25 hours apart instead of skipping the day in between the doses which is considered as inappropriate schedule of vaccine administration. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took the next dose of Vivotif, at an unknown dose, orally, 25 hours apart instead of skipping the day in between the doses which is considered as inappropriate schedule of vaccine administration. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829416	F	PA	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004045	Product storage error Product storage error	The patient took the first dose of Vivotif vaccine which was out of refrigerator for less than 48 ho... The patient took the first dose of Vivotif vaccine which was out of refrigerator for less than 48 hours; The patient took the first dose of Vivotif vaccine which was out of refrigerator for less than 48 hours; Case reference number US-BN-2024-002667 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2782) on 21-Oct-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, reported as on Friday night, the patient picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours (explicitly coded as 'product storage error'). On 20-Oct-2024, reported as on Sunday morning, the patient took the first dose of affected Vivotif (batch number: 3004045), at a dose of one capsule, orally, for indication reported as pretravel November (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. No further information was provided.; Reporter's Comments: A female patient of unspecified age picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours which is considered as product storage error. The patient took the first dose of affected Vivotif, at a dose of one capsule, orally, for indication reported as pretravel in November which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age picked the Vivotif up and missed that it needed to be refrigerated, it was out less than 48 hours which is considered as product storage error. The patient took the first dose of affected Vivotif, at a dose of one capsule, orally, for indication reported as pretravel in November which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif vaccination. 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. More
2829417	F	NJ	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	The patient administered Vivotif with cold water and five minutes after started eating a meal; Case ... The patient administered Vivotif with cold water and five minutes after started eating a meal; Case reference number US-BN-2024-002686 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2819) on 24-Oct-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for indication reported as pre travel. As reported the patient administered Vivotif with cold water and five minutes after started eating a 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. No further information was provided.; Reporter's Comments: A female patient of unknown age took the first dose of Vivotif, at unknown dose, orally, for indication reported as pre travel. Reportedly the patient administered Vivotif with cold water and five minutes after started eating a meal 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 of unknown age took the first dose of Vivotif, at unknown dose, orally, for indication reported as pre travel. Reportedly the patient administered Vivotif with cold water and five minutes after started eating a meal 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. More
2829418	F	SC	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004043	Inappropriate schedule of product administration, Product storage error Inappropriate schedule of product administration, Product storage error	Patient left Vivotif out of refrigeration (maximum temperature was unknown) on 28-Oct-2024 and took ... Patient left Vivotif out of refrigeration (maximum temperature was unknown) on 28-Oct-2024 and took two affected doses; Patient left Vivotif out of refrigeration (maximum temperature was unknown) on 28-Oct-2024 and took two affected doses; Case reference number US-BN-2024-002702 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2864) on 30-Oct-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medications were not provided. On 28-Oct-2024, at 09:40 am on Monday, the patient left Vivotif out of refrigeration, maximum temperature was unknown, and as reported Vivotif was inside the house. On the same day, the patient took first dose of affected Vivotif, (batch number: 3004043) one capsule, orally for unknown indication (explicitly coded as 'product storage error' and 'product administration error'). On 30-Oct-2024, two days after administration of the first dose of Vivotif, reported as today, the patient took the second dose of Vivotif (batch number: 3004043), one capsule, orally (explicitly coded as 'product administration error'). As reported, the patient wanted to know if they could take Augmentin antibiotics prescribed by the otolaryngologist (ENT) and then resume Vivotif afterwards or if the patient had to retake it. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age left Vivotif out of refrigeration (maximum temperature was unknown) and Vivotif was inside the house. On the same day, the patient took first dose of affected Vivotif, one capsule, orally for unknown indication which is considered as product storage error and product administration error. Two days after administration of the first dose of Vivotif, the patient took the second dose of Vivotif, one capsule, orally which is considered as 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. The patient's 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 female patient of unknown age left Vivotif out of refrigeration (maximum temperature was unknown) and Vivotif was inside the house. On the same day, the patient took first dose of affected Vivotif, one capsule, orally for unknown indication which is considered as product storage error and product administration error. Two days after administration of the first dose of Vivotif, the patient took the second dose of Vivotif, one capsule, orally which is considered as 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. The patient's 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. More
2829419	F	WI	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Dizziness, Dyspnoea, Muscular weakness, Myalgia, Nausea Dizziness, Dyspnoea, Muscular weakness, Myalgia, Nausea	Patient experienced mild nausea after first, second and one hour after third dose of Vivotif.; Patie... Patient experienced mild nausea after first, second and one hour after third dose of Vivotif.; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Patient took third dose of Vivotif and after one hour experienced short of breath, dizziness, muscle pain, muscle ache and generally weak; Case reference number US-BN-2024-002703 is a spontaneous case initially received from a physician via Med Communications (reference number: USBAV24-2858) on 30-Oct-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 (batch number: unknown) one capsule, orally for travelling. On unspecified date, reported as after the first dose of Vivotif, patient experienced mild nausea. On unspecified date, unknown amount of time after the first dose, the patient took the second of Vivotif (batch number: unknown) one capsule, orally. On an unspecified date, reported as after second dose of Vivotif, the patient again experienced mild nausea. On 29-Oct-2024, unknown amount of time after the first dose, reported as yesterday, the patient took the third dose of Vivotif (batch number: unknown) one capsule, orally. On the same day, one hour after the third dose, the patient experienced nausea, short of breath, dizziness, muscle pain, muscle ache and patient was generally weak. As reported the patient did not seek or take any treatment. On an unspecified date, reported as today at 09:00 am, the patient recovered from the events nausea, short of breath, dizziness, muscle pain, muscle ache and weakness generalized, since it was reported that patient was completely back to normal. The reporter assessed the events of nausea, short of breath, dizziness, muscle pain and weakness generalized as non-serious and as possibly related to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced two episodes of a non-serious event of nausea on unspecified dates, reported as after the patient took the first and the second dose of Vivotif for travelling. Reportedly, on the day 0 after the third dose, the patient experienced non-serious events of nausea, short of breath, dizziness, muscle pain, muscle ache and the patient was generally weak. Nausea is listed and expected for Vivotif per CCDS v8 and USPI, whilst dyspnoea is unlisted and unexpected. Dizziness, myalgia and asthenia are listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age experienced two episodes of a non-serious event of nausea on unspecified dates, reported as after the patient took the first and the second dose of Vivotif for travelling. Reportedly, on the day 0 after the third dose, the patient experienced non-serious events of nausea, short of breath, dizziness, muscle pain, muscle ache and the patient was generally weak. Nausea is listed and expected for Vivotif per CCDS v8 and USPI, whilst dyspnoea is unlisted and unexpected. Dizziness, myalgia and asthenia are listed per CCDS v8 and unexpected per USPI. The patient's medical history and concomitant medication details were not provided. The patient recovered. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious. More
2829420	F	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Nausea, Vomiting Nausea, Vomiting	The patient experienced nausea and vomiting about 12 hours after taking Vivotif, and it has been con... The patient experienced nausea and vomiting about 12 hours after taking Vivotif, and it has been consistent since the first pill.; The patient experienced nausea and vomiting about 12 hours after taking Vivotif, and it has been consistent since the first pill.; Case reference number US-BN-2024-002734 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-2923) on 05-Nov-2024 and concerns a female patient of unspecified age, reported as around 14 to 15 years old. The patient's medical history and concomitant medication details were not provided. On 31-Oct-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid Immunization. On 02-Nov-2024, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally. On 04-Nov-2024, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, orally. Since the first dose of Vivotif, about 12 hours after taking Vivotif, the patient experienced nausea and vomiting, and it has been consistent since the first pill. The healthcare professional stated the patient was definitely ingesting the pill, and it was working. The HCP would like to know if the fourth dose could be postponed until finals are done, which would be on 06-Nov-2024, Saturday. At the time of the initial report, the patient was not recovered from the events of vomiting and nausea, reported as consistent since the first pill. The reporter assessed the events of vomiting and nausea as non-serious, and causality for the events of vomiting and nausea was reported as possible. No further information was provided.; Reporter's Comments: A female patient of unspecified age reported as around 14 to 15 years old experienced non-serious events of nausea and vomiting as reported about 12 hours after taking Vivotif for typhoid Immunization. Vomiting and nausea are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events. Considering suggestive temporal relationship and known vaccine safety profile, 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 reported as around 14 to 15 years old experienced non-serious events of nausea and vomiting as reported about 12 hours after taking Vivotif for typhoid Immunization. Vomiting and nausea are listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events. Considering suggestive temporal relationship and known vaccine safety profile, the reported events have been considered as related to Vivotif. This case is considered as non-serious. More
2829421		MD	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product dose omission issue Product dose omission issue	The patient received first dose of Vivotif on 01-Nov-2024, second dose on 03-Nov-2024, and third dos... The patient received first dose of Vivotif on 01-Nov-2024, second dose on 03-Nov-2024, and third dose was missed; Case reference number US-BN-2024-002740 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV24-2924) on 06-Nov-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On 01-Nov-2024, at 7 pm, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication. On 03-Nov-2024, two days after the first dose, at 7 pm, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally. On unspecified date, reported as last night at 7 pm, the patient missed the third dose 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. No further information was provided.; Reporter's Comments: A patient of unknown age and gender missed the third dose of 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. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender missed the third dose of 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. 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. More
2829422	F	LA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took first dose of Vivotif vaccine which had temperature excursion for seven hours, max... The patient took first dose of Vivotif vaccine which had temperature excursion for seven hours, maximum temperature was 74 Fahrenheit degrees; The patient took first dose of Vivotif vaccine which had temperature excursion for seven hours, maximum temperature was 74 Fahrenheit degrees; Case reference number US-BN-2024-002753 is a spontaneous case initially received from a other health care professional via Med Communications (reference number: USBAV24-2940) on 07-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date, reported as yesterday, one box (four doses) of the Viviotif vaccine was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, as reported was not instructed to put in refrigerator (explicitly coded as 'product storage error'). On 06-Nov-2024, the patient took the first dose of the affected Vivotif vaccine (batch number: unknown) at one dose, orally for typhoid prophylaxis (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age took the first dose of the affected Vivotif vaccine for typhoid prophylaxis, which was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, which is considered as product storage error and 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 are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the first dose of the affected Vivotif vaccine for typhoid prophylaxis, which was left in the bathroom for seven hours at maximum 74 Fahrenheit degree, which is considered as product storage error and 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 are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829423	F		03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	The patient had taken one out of four Vivotif capsule, and her daughter had taken three out of four ... The patient had taken one out of four Vivotif capsule, and her daughter had taken three out of four Vivotif capsule after the meals, instead of one hour before the meals; Case reference number US-BN-2024-002758 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-2942) on 07-Nov-2024 and concerns two female patients of unknown age (mother and daughter). The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patients took doses of Vivotif (batch number: unknown), at a dose of one capsule, orally, for indication reported as travel. As reported, the patient (mother) had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals (explicitly coded as 'drug administration error'). At the time of the initial report, the patients did not experience any adverse event due to Vivotif, reported as did not feel anything bad. This case is linked to case US-BN-2024-002760 (same reporter). The reporter did not want to be contacted for a follow-up. Additional information received from consumer via Med Communications (reference number: USBAV24-2955) on 07-Nov-2024: included additional reference number.; Reporter's Comments: Two female patients of unknown age took doses of Vivotif for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals, which is considered as drug administration error. The patients did not experience any adverse event due to Vivotif. 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 female patients of unknown age took doses of Vivotif for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule and her daughter had taken three out of four Vivotif capsules after the meals, instead of one hour before the meals, which is considered as drug administration error. The patients did not experience any adverse event due to Vivotif. 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. More
2829424	M		03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Abdominal discomfort, Product administration error Abdominal discomfort, Product administration error	Felt a little bit of upset stomach; The patient had taken one out of four Vivotif capsule after the ... Felt a little bit of upset stomach; The patient had taken one out of four Vivotif capsule after the meals, instead of one hour before the meals; Case reference number US-BN-2024-002760 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-2956) on 07-Nov-2024 and concerns a male patient of unknown age (reporter's husband). The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule after the meals instead of one hour before the meals (explicitly coded as 'drug administration error'). On specified date, unknown amount of time after taking Vivotif, the patient felt a little bit of upset stomach but nothing much. At the time of the initial report, the outcome of the event upset stomach was unknown. The reporter assessed the event of upset stomach as non-serious, while the causality assessment for the same event was not provided. This case is linked to case US-BN-2024-002758 (same reporter). No further information was provided.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule after the meals instead of one hour before the meals, which is considered as drug administration error. An unknown amount of time after taking Vivotif, the patient felt a little bit of upset stomach. Abdominal discomfort is unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event upset stomach was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication reported as travel. As reported, the patient had taken one out of four Vivotif capsule after the meals instead of one hour before the meals, which is considered as drug administration error. An unknown amount of time after taking Vivotif, the patient felt a little bit of upset stomach. Abdominal discomfort is unlisted and unexpected for Vivotif per CCDS v8 and USPI, whilst product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of the event upset stomach was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829427			03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	One patient took three doses of Vivotif with food, other patients took only one dose with food; Case... One patient took three doses of Vivotif with food, other patients took only one dose with food; Case reference number US-BN-2024-002754 is a spontaneous case initially received from other healthcare professional via Med Communications (reference number: USBAV24-2938) on 07-Nov-2024 and concerns three patients of unknown age and gender (MULTI3). The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patients took Vivotif (batch number: unknown), at unknown dose, route, for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals (explicitly coded as drug administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from other healthcare professional via Med Communications (reference USBAV24-2948) on 07-Nov-2024: included reference number.; Reporter's Comments: Three patients of unknown age and gender took Vivotif for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals, which is considered as drug administration error. It was unknown if the patients experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patients' 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: Three patients of unknown age and gender took Vivotif for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals, which is considered as drug administration error. It was unknown if the patients experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patients' 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. More
2829428	F	NY	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	The patient took three doses of Vivotif with food; Case reference number US-BN-2024-002756 is a spon... The patient took three doses of Vivotif with food; Case reference number US-BN-2024-002756 is a spontaneous case initially received from a physician via Med Communications (reference number: USBAV24-2943) on 07-Nov-2024 and concerns an 18-years-old female patient. The patient's medical history and concomitant medications were not provided. On 31-Oct-2024, the patient took first dose of Vivotif, (batch number: unknown; expiration date: unknown) unknown dose (capsule), orally for pre-travel. On 02-Nov-2024, the patient took second dose of Vivotif, (batch number: unknown; expiration date: unknown) unknown dose (capsule), orally. On 04-Nov-2024, the patient took third dose of Vivotif, (batch number: unknown; expiration date: unknown) unknown dose (capsule), orally. The patient took three doses of Vivotif with food and had one left (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: An 18-year-old female patient took three doses of Vivotif for pre-travel with food, 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: An 18-year-old female patient took three doses of Vivotif for pre-travel with food, 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. More
2829429	M		03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took two doses of Vivotif capsules at the same time instead of one dose; The patient too... The patient took two doses of Vivotif capsules at the same time instead of one dose; The patient took two doses of Vivotif capsules at the same time instead of one dose; Case reference number US-BN-2024-002757 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-2945) on 07-Nov-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 07-Nov-2024, reported as today, the patient took the first and second of Vivotif capsule at the same time instead of one dose (batch number: unknown), at a dose of one capsule, via unknown route and for unknown indication (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A male patient of unknown age took the first and the second of Vivotif capsule at the same time instead of one dose for unknown indication, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Overdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Overdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first and the second of Vivotif capsule at the same time instead of one dose for unknown indication, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Overdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Overdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829430	F		03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	The patient accidentally took doses of Vivotif with food; Case reference number US-BN-2024-002763 is... The patient accidentally took doses of Vivotif with food; Case reference number US-BN-2024-002763 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2967) on 08-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date, the patient accidently took with food the doses of Vivotif (batch number: unknown and expiration date: unknown) at unknown dose, orally for protection against typhoid fever (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age accidently took the doses of Vivotif for protection against typhoid fever with food, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history 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: A female patient of unknown age accidently took the doses of Vivotif for protection against typhoid fever with food, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient's medical history 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. More
2829431	M	NY	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took third dose of Vivotif the next day after the second dose; Case reference number US-... The patient took third dose of Vivotif the next day after the second dose; Case reference number US-BN-2024-002766 is a spontaneous case initially received from a physician via Med Communication (reference number: USBAV24-2971) on 11-Nov-2024 and concerns 27-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received the first dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally, for indication typhoid immunization. On an unspecified date, as reported, one day off from the first dose, the patient took the second dose of Vivotif vaccine (batch number: unknown) at unknown dose, orally. On an unspecified date, as reported one day after the second dose, the patient took the third dose of Vivotif vaccine (batch number: unknown) at unknown dose, orally (explicitly coded as 'Inappropriate schedule of product administration'). On an unspecified date, reported as a day off from the third dose, the patient took the fourth dose of Vivotif vaccine (batch number: unknown) at unknown dose, orally. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided. More
2829432			03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient stored Vivotif vaccine at room temperature while was taking; The patient stored Vivotif ... The patient stored Vivotif vaccine at room temperature while was taking; The patient stored Vivotif vaccine at room temperature while taking it; Case reference number US-BN-2024-002772 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2994) on 12-Nov-2024 and concerns a patient of unknown gender and unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date, the patient stored Vivotif vaccine at room temperature (explicitly coded as 'product storage error'). On an unspecified date, the patient took a dose of affected Vivotif, (batch number: unknown) unknown dose, unknows site of administration, unknown route for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown gender and age took a dose of affected Vivotif which was stored at room temperature, for unknown indication, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown gender and age took a dose of affected Vivotif which was stored at room temperature, for unknown indication, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829433	M	TX	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took one dose and put it back in refrigerator, the maximum temperature was 70 degrees Fa... The patient took one dose and put it back in refrigerator, the maximum temperature was 70 degrees Fahrenheit for maximum 24 hours; The patient took one dose and put it back in refrigerator, the maximum temperature was 70 degrees Fahrenheit for maximum 24 hours; Case reference number US-BN-2024-002774 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2995) on 12-Nov-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medications were not provided. On an unspecified date, the patient took the first dose dose of Vivotif (batch number: unknown), at a dose of one capsule, taken orally for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A male patient of unknown age took the first dose dose of Vivotif for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first dose dose of Vivotif for unknown indication. As reported, Vivotif was kept out of refrigerator for 24 hours, at a maximum temperature of 70 Fahrenheit and after administration the remaining doses were put in the refrigerator, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829434	M	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004081	Product storage error Product storage error	The patient took the first dose of Vivotif vaccine which was left out of the fridge for six to seven... The patient took the first dose of Vivotif vaccine which was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit; The patient took the first dose of Vivotif vaccine which was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit; Case reference number US-BN-2024-002795 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-3063) on 19-Nov-2024 and concerns a 26-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 18-Nov-2024, reported as yesterday, the patient picked up Vivotif and forgot to put in the fridge. The Vivotif vaccine was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit and the vaccines were placed back in the fridge (explicitly coded as a 'product storage error'). On the same day, the patient took the first dose of the defected Vivotif capsule (batch number: 3004081) at dose of one capsule, orally, for indication 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 the Vivotif vaccine. No further information was provided.; Reporter's Comments: A 26-year-old male patient picked up Vivotif and forgot to put in the fridge. The Vivotif vaccine was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit, and the vaccines were placed back in the fridge, which is considered as product storage error. On the same day, the patient took the first dose of the defected Vivotif capsule for indication typhoid immunization, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 26-year-old male patient picked up Vivotif and forgot to put in the fridge. The Vivotif vaccine was left out of the fridge for six to seven hours, maximum temperature reached 65 degrees Fahrenheit to 67 degrees Fahrenheit, and the vaccines were placed back in the fridge, which is considered as product storage error. On the same day, the patient took the first dose of the defected Vivotif capsule for indication typhoid immunization, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to the Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829435	F	VA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took the third dose of Vivotif a day later and the fourth dose took 30 hours after the t... The patient took the third dose of Vivotif a day later and the fourth dose took 30 hours after the third dose.; Case reference number US-BN-2024-002800 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-3068) on 20-Nov-2024 and concerns an adult female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for unknown indication. On an unspecified date, unknown amount of time after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally. On an unspecified date, unknown amount of time after the first dose of Vivotif, reported as a day later, the patient took the third dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On an unspecified date, unknown amount of time after first dose of Vivotif, as reported, 30 hours after the third dose of Vivotif the patient took the fourth dose of Vivotif (batch number: unknown), at unknown doe, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: An adult female patient took the third dose of Vivotif for unknown indication, reported as a day later, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, as reported, 30 hours after the third dose of Vivotif, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult female patient took the third dose of Vivotif for unknown indication, reported as a day later, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, as reported, 30 hours after the third dose of Vivotif, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-3068: More
2829436	F		03/04/2025	TYP	BERNA BIOTECH, LTD.	3004063	Incomplete course of vaccination, Product storage error Incomplete course of vaccination, Product storage error	The patient took the pill of Vivotif vaccine which had temperature excursion for three days, maximum... The patient took the pill of Vivotif vaccine which had temperature excursion for three days, maximum temperature reached 65 Fahrenheit; The patient took the pill of Vivotif vaccine which had temperature excursion for three days, maximum temperature reached 65 Fahrenheit; The patient took the pill of Vivotif vaccine which had temperature excursion for three days, maximum temperature reached 65 Fahrenheit; The patient received only first dose of Vivotf vaccine; Case reference number US-BN-2024-002815 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3124) on 26-Nov-2024 and concerns a 75-years-old female patient. The patient's medical history and concomitant medication details were not provided. On 22-Nov-2024, on Friday, as reported the Vivotif vaccine was put on the shelf for three days, the maximum temperature reached 65 Fahrenheit (explicitly coded as 'product storage error' and 'product temperature excursion issue'). As reported, the patient was not counselled that the medication should be stored in the refrigerator. On 25-Nov-2024, the patient took the first dose of the affected Vivotif vaccine, (batch number: 3004063), at a dose of one pill, orally. As reported, the patient took only first dose of Vivotif (explicitly coded as 'product administration error' and 'Incomplete course of vaccination'). At the time of the follow-up report, the patient did not experience any adverse event due to Vivotif.. Additional information received from consumer via Med Communication (reference number: USBAV24-3136) on 26-Nov-2024 included: additional reference number, lot number for Vivotif vaccine, information about temperature and total length of excursion, and conformation that the patient took affected vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a consumer on 12-Jan-2025: New information included added patient age, information on Vivotif additional doses, and confirmed that patient did not experience any adverse event due to Vivotif and was not counselled that the medication should be stored in the refrigerator. Follow up information received from a consumer on 29-Jan-2025: New information included Vivotif dosing information.; Reporter's Comments: A 75-year-old female patient took the affected dose of the Vivotif vaccine for indication Typhoid immunization four days after the first dose, which was put on the shelf for three days, the maximum temperature reached 65 Fahrenheit, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of the affected Vivotif vaccine, at a dose of one pill, orally and took only first dose of Vivotif which is considered as product administration error and incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration, product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination, product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 75-year-old female patient took the affected dose of the Vivotif vaccine for indication Typhoid immunization four days after the first dose, which was put on the shelf for three days, the maximum temperature reached 65 Fahrenheit, which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of the affected Vivotif vaccine, at a dose of one pill, orally and took only first dose of Vivotif which is considered as product administration error and incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration, product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination, product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829437	F	CO	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took the second dose of the Vivotif vaccine day after the first dose; Case reference num... The patient took the second dose of the Vivotif vaccine day after the first dose; Case reference number US-BN-2024-002820 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3133) on 26-Nov-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 24-Nov-2024, the patient took the first dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for unknown indication. On 25-Nov-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at a dose of one capsule orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age took the second dose of Vivotif (at a dose of one capsule orally) one day after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took the second dose of Vivotif (at a dose of one capsule orally) one day after the first dose which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Vivotif. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829438	M	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	The patient had eaten before taking the first dose of Vivotif; Case reference number US-BN-2024-0028... The patient had eaten before taking the first dose of Vivotif; Case reference number US-BN-2024-002816 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-3125) on 26-Nov-2024 and concerns a 34-year-old male patient. The patient had no medical history. The patient's concomitant medications were not provided. On 26-Nov-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown; expiration date: unknown) at a dose of one capsule, orally, for indication reported as pre travel. As reported, the patient had eaten before taking first dose of Vivotif (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A 34-year-old male patient took the first dose of Vivotif vaccine for indication reported as pre travel. As reported, the patient had eaten before taking the first dose of Vivotif, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient had no medical history, and concomitant medications were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 34-year-old male patient took the first dose of Vivotif vaccine for indication reported as pre travel. As reported, the patient had eaten before taking the first dose of Vivotif, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patient had no medical history, and concomitant medications were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829439	M	SC	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Constipation Constipation	Patient experienced constipation; Case reference number US-BN-2024-002825 is a spontaneous case init... Patient experienced constipation; Case reference number US-BN-2024-002825 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV24-3166) on 02-Dec-2024 and concerns a 39-year-old male patient. The patient's medical history and concomitant medication details were not provided. The patient's current medical condition included pork allergy. On 30-Nov-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for typhoid immunization. On unspecified date, unknown amount of time after taking the first dose, the patient experienced constipation. As reported, the pork constipated him, and it had the effect on him. The reporter would like to check the composition of the gelatin capsules and if there was any ingredient originated from beef. On 02-Dec-2024, reported as tonight, the patient was due for another dose of Vivotif. At the time of the initial report, it was unknown if the patient recovered from event of the constipation. The reporter assessed the event of constipation as non-serious, and causality for the event was reported as possible. No further information was provided.; Reporter's Comments: A 39-year-old male patient experienced constipation within approximately one month after taking the first dose of Vivotif (administered at an unknown dose, orally, for typhoid immunization). Constipation is listed according to CCDS v8 however unexpected according to USPI. The outcome was unknown. The patient's medical history and concomitant medication details were not provided while current medical condition included pork allergy. Causality is assessed as related due to known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A 39-year-old male patient experienced constipation within approximately one month after taking the first dose of Vivotif (administered at an unknown dose, orally, for typhoid immunization). Constipation is listed according to CCDS v8 however unexpected according to USPI. The outcome was unknown. The patient's medical history and concomitant medication details were not provided while current medical condition included pork allergy. Causality is assessed as related due to known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. The case is non-serious. More
2829440	F	MN	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took the second dose of Vivotif 72 hours later; The patient did not wait until one hour ... The patient took the second dose of Vivotif 72 hours later; The patient did not wait until one hour for eat food, five minutes later of taking Vivotif patient ate food; Case reference number US-BN-2024-002831 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3183) on 03-Dec-2024 and concerns a 72-years-old female patient. The patient's medical history and concomitant medication details were not provided. On 29-Nov-2024, the patient took first dose of Vivotif (batch number: unknown), at unknown dose, orally, for indication typhoid immunization. On an unspecified date, reported as 72 hours later, the patient took the second dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported the patient did not wait until one hour for eating food, five minutes later of taking Vivotif patient ate food (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A 72-years-old female patient took first dose of Vivotif on 29-Nov-2024, at unknown dose, orally, for indication typhoid immunization. Reportedly, five minutes after taking Vivotif patient ate food which is considered as product administration error. Inappropriate schedule of product administration and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 72-years-old female patient took first dose of Vivotif on 29-Nov-2024, at unknown dose, orally, for indication typhoid immunization. Reportedly, five minutes after taking Vivotif patient ate food which is considered as product administration error. Inappropriate schedule of product administration and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-3183: More
2829441	F	ID	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The female patient took the third dose nine days after the first dose of VIviotif, and the male pati... The female patient took the third dose nine days after the first dose of VIviotif, and the male patient took the second dose three days after first dose, the fourth dose five days after first dose and the fourth dose nine days after first dose; Case reference number US-BN-2024-002832 is a spontaneous case report initially received from nurse via Med Communication (reference number: USBAV24-3188) on 03-Dec-2024 concerns a female patient and male patient. The patients relevant medical history and concomitant medications were not provided. On 22-Nov-2024, both the patients took first dose of Vivotif (batch number: unknown) at an unknown dose, orally, for an unknown indication. On 24-Nov-2024, two days after the first dose, the female patient took second dose of Vivotif (batch number: unknown) at an unknown dose, orally. On 25-Nov-2024, three days after the first dose, the male patient took second dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 27-Nov-2024, five days after the first dose, the male patient took third dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 01-Dec-2024, nine days after the first dose, the female patient took the third dose and male patient took the fourth dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patients messed up their schedule because of the holidays. At the time of initial report, it was unknown if the patients experienced any adverse events due to Vivotif vaccine. Additional information received from a nurse via Med Communications on 03-Dec-2024 included: reference number (EUBAV24-3190) and demographic information for male patient.; Reporter's Comments: This case concerns a female patient and male patient. Three days after the first dose, the male patient took second dose of Vivotif, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose, the male patient took third dose of Vivotif, at an unknown dose, orally which is also considered as inappropriate schedule of vaccine administered. Nine days after the first dose, the female patient took the third dose and male patient took the fourth dose of Vivotif which is also 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 patients experienced any adverse events due to Vivotif vaccine. The patients 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 female patient and male patient. Three days after the first dose, the male patient took second dose of Vivotif, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose, the male patient took third dose of Vivotif, at an unknown dose, orally which is also considered as inappropriate schedule of vaccine administered. Nine days after the first dose, the female patient took the third dose and male patient took the fourth dose of Vivotif which is also 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 patients experienced any adverse events due to Vivotif vaccine. The patients 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. More
2829442	M	GA	03/04/2025	TYP	BERNA BIOTECH, LTD.	3003851	Expired product administered, Product lot number issue Expired product administered, Product lot number issue	The patient took one dose of Vivotif vaccine with two different batch numbers and expiration dates o... The patient took one dose of Vivotif vaccine with two different batch numbers and expiration dates on the box and on blister packaging; The patient took one dose of Vivotif vaccine with two different batch numbers and expiration dates on the box and on blister packaging; The patient took the Vivotif vaccine with expired date on Mar-2024 on the blister; Case reference number US-BN-2024-002835 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3193) on 03-Dec-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 03-Dec-2024, the patient took the first dose of Vivotif (batch number (box): 3004085, Expiration date (box): Mar-2024; batch number (blister pack): 3003851; Expiration date: Mar-2024), at a dose of one capsule, orally, for indication typhoid fever prophylaxis. As reported, Vivotif vaccine was with two different batch numbers and expiration dates on the box and on blister packaging (explicitly coded as 'product administration error', 'product lot number issue' and 'expired vaccine used'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from Bavarian Nordic on 04-Dec-2024 included product complaint reference number (QE-013912) and added one more reporter.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication typhoid fever prophylaxis. Reportedly, Vivotif vaccine was with two different batch numbers and expiration dates on the box and on blister packaging which is considered as product administration error, product lot number issue and expired vaccine used. Product administration error, product lot number issue and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error, product lot number issue and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication typhoid fever prophylaxis. Reportedly, Vivotif vaccine was with two different batch numbers and expiration dates on the box and on blister packaging which is considered as product administration error, product lot number issue and expired vaccine used. Product administration error, product lot number issue and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error, product lot number issue and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious. More
2829443	F	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administered to patient of inappropriate age Product administered to patient of inappropriate age	The patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours.; C... The patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours.; Case reference number US-BN-2024-002865 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3251) on 09-Dec-2024 and concerns a 78-year-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified dates, the patient received first, second and third dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for typhoid immunization. On an unknown date, the patient received fourth dose of Vivotif (batch number: unknown), at a dose of one capsule, orally. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 78-year-old female patient received the first, second and the third dose of Vivotif for typhoid immunization. On an unknown date, the patient received the fourth dose of Vivotif. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 78-year-old female patient received the first, second and the third dose of Vivotif for typhoid immunization. On an unknown date, the patient received the fourth dose of Vivotif. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829444	M	MO	03/04/2025	TYP	BERNA BIOTECH, LTD.	3004085	Incomplete course of vaccination, Product storage error Incomplete course of vaccination, Product storage error	The patient took one dose of Vivotif vaccine which package was left out of the fridge for less than ... The patient took one dose of Vivotif vaccine which package was left out of the fridge for less than 12 hours; The patient took one dose of Vivotif vaccine which package was left out of the fridge for less than 12 hours; The patient took one dose of Vivotif vaccine which package was left out of the fridge for less than 12 hours; The patient took one dose of Vivotif vaccine and had not taken other doses yet; Case reference number US-BN-2024-002917 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-3297) on 13-Dec-2024 and concerns a 71-years-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left package of Vivotif vaccine out of the fridge for less than 12 hours and once realized, put back in the fridge (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 06-Dec-2024, the patient took first dose of defected Vivotif vaccine (batch number: 3004085 and expiration date: 31-Mar-2025), at a dose of one capsule, orally for indication reported as travel Immunization and patient had not taken the other doses yet.* As reported, the patient took one pill as instructed on the package leaflet and did not take the other three pills in the package* (explicitly coded as 'incomplete course of vaccination' and 'product administration error'). At the time of the follow-up report, patient did not experience any adverse event due to Vivotif. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 27-Dec-2024: New information included added patient initials, Vivotif dosing details and confirmed that patient did not experience any adverse effects. Follow up information received from a nurse on 07-Jan-2025: New information included Vivotif dosing details.; Reporter's Comments: A 71-year-old male patient left package of Vivotif vaccine out of the fridge for less than 12 hours and once realized, put back in the fridge which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine, at unknown dose, orally for indication typhoid immunization and had not taken the other doses yet which is considered as incomplete course of vaccination and product administration error. Product temperature excursion issue, product storage error, product administration error and incomplete course of vaccination are all considered listed according to company conventions. The patient did not experience any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error, product administration and incomplete course of vaccination are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 71-year-old male patient left package of Vivotif vaccine out of the fridge for less than 12 hours and once realized, put back in the fridge which is considered as product storage error and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine, at unknown dose, orally for indication typhoid immunization and had not taken the other doses yet which is considered as incomplete course of vaccination and product administration error. Product temperature excursion issue, product storage error, product administration error and incomplete course of vaccination are all considered listed according to company conventions. The patient did not experience any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error, product administration and incomplete course of vaccination are all assessed as not related to suspect product but to human factor. The case is non-serious. More
2829445	F	VA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took two doses of Vivotif capsules which was left out at room temperature whole the time... The patient took two doses of Vivotif capsules which was left out at room temperature whole the time for almost a month; The patient took two doses of Vivotif capsules which was left out at room temperature whole the time for almost a month; The patient took two doses of Vivotif capsules which was left out at room temperature whole the time for almost a month; Case reference number US-BN-2024-002894 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3307) on 16-Dec-2024 and concerns a 21-year-old female patient. The patient's past medical history and concomitant medication details were not provided. The patient's current conditions included anxiety. On unspecified date, the patient left out the Vivotif vaccine at room temperature whole the time for almost a month (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On 13-Dec-2024, patient took the first dose of defected Vivotif vaccine (batch number: unknown), at a dose of one capsule, orally, for indication reported as pre travel (explicitly coded as 'product administration error'). On 15-Dec-2024, two days after the first dose, the patient took the second dose of defected Vivotif vaccine (batch number: unknown), at a dose of one 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 21-year-old female patient left out the Vivotif vaccine at room temperature whole the time for almost a month, which is considered as product storage error temperature too high and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine for indication reported as pre travel, which is considered as product administration error. Two days after the first dose, the patient took the second dose of defected 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, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's past medical history and concomitant medication details were not provided, and current conditions included anxiety. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 21-year-old female patient left out the Vivotif vaccine at room temperature whole the time for almost a month, which is considered as product storage error temperature too high and product temperature excursion issue. Reportedly, the patient took the first dose of defected Vivotif vaccine for indication reported as pre travel, which is considered as product administration error. Two days after the first dose, the patient took the second dose of defected 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, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's past medical history and concomitant medication details were not provided, and current conditions included anxiety. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829446	F		03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Contraindicated product administered, Labelled drug-drug interaction issue, Prod... Contraindicated product administered, Labelled drug-drug interaction issue, Product storage error More	The patient took two doses on Vivotif which were not refrigerated; The patient took two doses on Viv... The patient took two doses on Vivotif which were not refrigerated; The patient took two doses on Vivotif which were not refrigerated; The patient took Vivotif and was on unspecified antibiotics; Case reference number US-BN-2024-002893 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-3306) on 16-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 13-Dec-2024 Friday, the patient took the first dose of Vivotif (batch number: unknown), at a dose of one capsule, via unknown route for indication reported as travel. On 15-Dec-2024 Sunday, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at a dose of one capsule, via unknown route. As reported, the patient took two doses on Vivotif which were not refrigerated and the patient was on unspecified antibiotics (explicitly coded as 'product storage error', 'product administration error' and 'labeled drug-drug interaction medication error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age took two doses on Vivotif for indication reported as travel, which were not refrigerated, and the patient was on unspecified antibiotics, which is considered as product storage error, product administration error and labelled drug-drug interaction medication error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and labelled drug-drug interaction medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and labelled drug-drug interaction medication error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took two doses on Vivotif for indication reported as travel, which were not refrigerated, and the patient was on unspecified antibiotics, which is considered as product storage error, product administration error and labelled drug-drug interaction medication error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and labelled drug-drug interaction medication error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and labelled drug-drug interaction medication error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829447	M	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took two doses of Vivotif capsules which was kept at room temperature; The patient took ... The patient took two doses of Vivotif capsules which was kept at room temperature; The patient took two doses of Vivotif capsules which was kept at room temperature; The patient took two doses of Vivotif capsules which was kept at room temperature; Case reference number US-BN-2024-002889 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3309) on 16-Dec-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient didn't know they were supposed to refrigerate four capsules of Vivotif vaccine and was kept at room temperature (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On unspecified date, patient received first and second doses of defected Vivotif vaccine (batch number: unknown), at a dose of one capsule, orally, for unknown indication (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 male patient of unknown age didn't know they were supposed to refrigerate four capsules of Vivotif vaccine and was kept at room temperature which is considered as product storage error temperature too high and product temperature excursion issue. On unspecified date, patient received first and second doses of defected Vivotif vaccine, at a dose of one capsule, orally, for unknown indication which is considered as product administration error. Product temperature excursion issue, product storage error and product administration error are all 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 medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age didn't know they were supposed to refrigerate four capsules of Vivotif vaccine and was kept at room temperature which is considered as product storage error temperature too high and product temperature excursion issue. On unspecified date, patient received first and second doses of defected Vivotif vaccine, at a dose of one capsule, orally, for unknown indication which is considered as product administration error. Product temperature excursion issue, product storage error and product administration error are all 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 medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious. More
2829448			03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took the first dose of Vivotif which was kept on 75 degrees Fahrenheit for five days; Th... The patient took the first dose of Vivotif which was kept on 75 degrees Fahrenheit for five days; The patient took the first dose of Vivotif which was kept on 75 degrees Fahrenheit for five days; Case reference number US-BN-2024-002900 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3313) on 17-Dec-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On 16-Dec-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, route, site of administration for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A patient of unknown age and gender took the first dose of Vivotif for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first dose of Vivotif for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829449	F	PA	03/04/2025	TYP	BERNA BIOTECH, LTD.		Cough, Influenza, Pain, Pyrexia Cough, Influenza, Pain, Pyrexia	The patient had a cough and felt achy; The patient had a cough and felt achy; The patient had the fl... The patient had a cough and felt achy; The patient had a cough and felt achy; The patient had the flu and a fever; The patient had the flu and a fever; Case reference number US-BN-2024-002901 is a spontaneous case initially received from nurse via Med Communications (reference number: EUBAV24-3314) on 17-Dec-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 13-Dec-2024, reported as on day zero, the patient took the first dose of Vivotif (batch number: unknown) at unknown dose reported as two out of four capsules, orally for unknown indication. On 15-Dec-2024, reported as on day two, the patient was vaccinated with the second dose of Vivotif (batch number: unknown) at unknown dose reported as two out of four capsules, orally. On 16-Dec-2024, reported as last night, one day after vaccination with second dose of Vivotif, the patient had the flu and a fever, as reported the patient also had a cough and felt achy since yesterday. At the time of the initial report, it was unknown if the patient recovered from the events of 'cough', 'pain', 'flu' and 'fever'. The reporter did not provide seriousness for events of 'cough', 'pain', 'flu' and 'fever'. The reporter did not provide causality assessment for the events of 'cough', 'pain', 'flu' and 'fever'. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of flu and a fever, as reported also cough and felt achy one day after vaccination with second dose of Vivotif for unknown indication. Pyrexia is listed and expected for Vivotif per CCDS v8 and USPI, whilst cough, pain and influenza are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age experienced non-serious events of flu and a fever, as reported also cough and felt achy one day after vaccination with second dose of Vivotif for unknown indication. Pyrexia is listed and expected for Vivotif per CCDS v8 and USPI, whilst cough, pain and influenza are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Vivotif. This case is considered as non-serious. More
2829450	F		03/04/2025	TYP	BERNA BIOTECH, LTD.	3004085	Product storage error Product storage error	Patient took first dose of unrefrigerated Vivotif vaccine; Patient took first dose of unrefrigerated... Patient took first dose of unrefrigerated Vivotif vaccine; Patient took first dose of unrefrigerated Vivotif vaccine; Patient took first dose of unrefrigerated Vivotif vaccine; Case reference number US-BN-2024-002902 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3324) on 17-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as on Friday, patient picked up Vivotif vaccine. On an unspecified date, the patient took first dose of Vivotif (batch number: 3004085; expiration date: Mar-2025), at unknown dose, orally for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate. (explicitly coded as 'product storage error', 'product administration error' and 'product temperature excursion issue'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age took the first dose of Vivotif for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate, which is considered as product storage error, product administration error and product temperature excursion issue. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the first dose of Vivotif for pre travel. The patient did not refrigerate the typhoid vaccine even though it said on the package to refrigerate, which is considered as product storage error, product administration error and product temperature excursion issue. It was unknown if the patient experienced any adverse event due to Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829451	F	VA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took three doses of Vivotif and had no time to pick up the last dose; Case reference num... The patient took three doses of Vivotif and had no time to pick up the last dose; Case reference number US-BN-2024-002906 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3339) on 30-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient, the patient took first and second dose of Vivotif (batch number: unknown), at unknown dose, route for unknown indication. On 15-Dec-2024, unknown time after first dose of Viviotif, the patient took third dose of Vivotif (batch number: unknown), at unknown dose, route and site of administration. As reported, the patient had not time to pick up the last dose of Vivotif (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of unknown age had not time to pick up the last dose of Vivotif for unknown indication, after the patient took three doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age had not time to pick up the last dose of Vivotif for unknown indication, after the patient took three doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829452		WI	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took first three doses of the Vivotif vaccine correctly and did not take the last one fo... The patient took first three doses of the Vivotif vaccine correctly and did not take the last one for three days; Case reference number US-BN-2024-002914 is a spontaneous case initially received from other healthcare professional via Med Communication (reference number: USBAV24-3360) on 19-Dec-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified dates, the patient took first, second and third dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for an unknown indication. As reported, the patient took first three doses of the Vivotif vaccine correctly and did not take the last one for three days (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unknown age and gender did not take the last dose of Vivotif for three days which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Rabipur. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender did not take the last dose of Vivotif for three days which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due to Rabipur. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829453	M	CA	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product dose omission issue Product dose omission issue	The patient did not receive dose of Vivotif about 48 hours after the last dose; Case reference numbe... The patient did not receive dose of Vivotif about 48 hours after the last dose; Case reference number US-BN-2024-000004 is a spontaneous case report initially received from pharmacist via Med Communications (reference number: USBAV24-0008) on 02-Jan-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 29-Dec-2023, the patient received a dose of Vivotif (batch number), at an unknown dose or route of administration, for unknown indication. As reported, the patient was scheduled to receive the next dose of Vivotif on On 31-Dec-2023, however the patient did not receive dose of Vivotif about 48 hours after the last dose (explicitly coded as 'missed dose'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from Emergent BioSolutions on 03-Jan-2024 and included local case reference ID and confirmation of patient's gender.; Reporter's Comments: A male patient of unspecified age was scheduled to receive the next dose of Vivotif, however the patient did not receive dose of Vivotif about 48 hours after the last dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age was scheduled to receive the next dose of Vivotif, however the patient did not receive dose of Vivotif about 48 hours after the last dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829454		NY	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product dose omission issue Product dose omission issue	The patient missed the fourth dose of Vivotif.; Case reference number US-BN-2024-000013 is a spontan... The patient missed the fourth dose of Vivotif.; Case reference number US-BN-2024-000013 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0020) on 04-Jan-2024 and concerns a 20-year-old patient of unspecified gender. The patient's relevant medical history and concomitant medications were not provided. On 25-Dec-2023, the patient was vaccinated with the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for immunization against typhoid fever. On 27-Dec-2023, two days after the first dose of Vivotif, the patient was vaccinated with the second dose of Vivotif (batch number: unknown), at an unknown dose, orally. On 29-Dec-2023, four days after the first dose of Vivotif , the patient was vaccinated with the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. As reported, the patient missed the fourth dose of Vivotif (explicitly coded as 'missed dose'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A 20-year-old patient of unspecified gender missed the fourth dose of Vivotif, after the patient was vaccinated with the first, second and the third dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 20-year-old patient of unspecified gender missed the fourth dose of Vivotif, after the patient was vaccinated with the first, second and the third dose, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif. Product dose omission issue is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product dose omission issue has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829455	F	KS	03/04/2025	TYP	BERNA BIOTECH, LTD.	3003831	Incomplete course of vaccination Incomplete course of vaccination	The patient took two doses of Vivotif on schedule and forgot next two doses due to busy schedule; Ca... The patient took two doses of Vivotif on schedule and forgot next two doses due to busy schedule; Case reference number US-BN-2024-000014 is a spontaneous case report initially received from other health care professional via Med Communication (reference number: USBAV24-0021) on 04-Jan-2024 and concerns a 34-year-old female patient. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient was vaccinated with the first dose of Vivotif (batch number: 3003831), at unknown dose and route of administration for unknown indication. On unspecified date, an unknown amount of time after the first dose of Vivotif, the patient was vaccinated with second dose of Vivotif vaccine (batch number: 3003831), at unknown dose and route of administration. As reported, the patient received two doses of Vivotif on schedule and forgot next two doses of Vivotif due to busy schedule (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A 34-year-old female patient received two doses of Vivotif on schedule and forgot next two doses of Vivotif due to busy schedule, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A 34-year-old female patient received two doses of Vivotif on schedule and forgot next two doses of Vivotif due to busy schedule, which is considered as incomplete course of vaccination. No associated adverse events were reported. Incomplete course of vaccination is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to Vivotif, but to a human factor. The case is non-serious. More
2829456		MT	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product administration error Product administration error	The patient had cup of coffee about 15 minutes after administrating a dose of Vivotif on an empty st... The patient had cup of coffee about 15 minutes after administrating a dose of Vivotif on an empty stomach with cold water; Case reference number US-BN-2024-000016 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0024) on 04-Jan-2024 and concerns a patient of unspecified age or gender. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient received a dose of Vivotif (batch number: unknown), at an unknown dose and route of administration, for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from Emergent BioSolutions on 05-Jan-2024 included additional reference number.; Reporter's Comments: A patient of unspecified age or gender received a dose of Vivotif for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company conventions. The patient's medical history and concomitant medications were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unspecified age or gender received a dose of Vivotif for unknown indication. As reported, the patient administrated a dose of Vivotif on empty stomach with cold water and about 15 minutes later had a cup of coffee, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company conventions. The patient's medical history and concomitant medications were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829457	F	UT	03/04/2025	TYP	BERNA BIOTECH, LTD.	3003830	Product storage error Product storage error	The patient left Vivotif out of the refrigerator and took the second dose of Vivotif after the tempe... The patient left Vivotif out of the refrigerator and took the second dose of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two hours; The patient left Vivotif out of the refrigerator and took the second dose of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two hours; Case reference number US-BN-2024-000036 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0034) on 08-Jan-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 the first dose of Vivotif (batch number: 3003830 expiration date: 29-Feb-2024) at an unknown dose, orally for unknown indication. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003830 expiration date: 29-Feb-2024) at an unknown dose, orally. As reported, the patient left Vivotif out of the refrigerator and took the second dose (day three capsule) of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit, and it was left for two 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 vaccine. No further information provided.; Reporter's Comments: A female patient of unspecified age took the second dose of Vivotif. As reported, the patient left Vivotif out of the refrigerator and took the second dose (day three capsule) of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two 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 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 the second dose of Vivotif. As reported, the patient left Vivotif out of the refrigerator and took the second dose (day three capsule) of Vivotif after the temperature excursion, maximum temperature was 70 degrees of Fahrenheit and it was left for two 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 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. More
2829458	F	MN	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient completed the whole series of Vivotif and then realized it should had been refrigerated ... The patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 hours; The patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 hours; Case reference number US-BN-2024-000037 is a spontaneous case report initially received from a physician via Med Communication (reference number: USBAV24-0042) on 08-Jan-2024 and concerns female patient. The patient's relevant medical history and concomitant medications were not provided. The patient was not pregnant. On unspecified dates, the patient received the first, the second, the third and the fourth dose of Vivotif vaccine (batch number: unknown), all at unknown dose, orally, for indication reported as typhoid prophylaxis. As reported, the patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 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 vaccine. No further information provided.; Reporter's Comments: A female patient received the first, the second, the third and the fourth dose of Vivotif vaccine for indication reported as typhoid prophylaxis. As reported, the patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 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 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. The patient was not pregnant. 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 received the first, the second, the third and the fourth dose of Vivotif vaccine for indication reported as typhoid prophylaxis. As reported, the patient completed the whole series of Vivotif and then realized it should had been refrigerated after the patient left Vivotif capsules at room temperature for up to 48 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 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. The patient was not pregnant. 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. More
2829459	F	MO	03/04/2025	TYP	BERNA BIOTECH, LTD.	3003851	Fatigue, Inappropriate schedule of product administration, Nausea, Product stora... Fatigue, Inappropriate schedule of product administration, Nausea, Product storage error More	The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahre... The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahrenheit) for three weeks; The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahrenheit) for three weeks; The patient experienced fatigue after the first dose of Vivotif; The patient experienced fatigue after the second dose of Vivotif; Nausea after the first dose of Vivotif; Nausea after the second dose of Vivotif; Case reference number US-BN-2024-000042 is a spontaneous case report initially received from a physician via Med Communications (reference number: USBAV24-0054) on 09-Jan-2024 and concerns a 66-years-old female patient. The patient's current conditions included depression, hypercholerolemia , and hypertension. The patient's concomitant medications included Wellbutrin XL (bupropion hydrochloride), escitalopram (brand name: unknown), ezetimibe (brand name: unknown) and losartan (brand name: unknown). As reported, the Vivotif mistakenly was left at room temperature for three weeks (maximum temperature reached 68 Fahrenheit degrees), and the patient took the first and second doses (explicitly coded as 'product storage error'). As reported Prescriber did not instruct to refrigerate. The pharmacy did not provide verbal instruction to refrigerate, holiday travel plans to grandchildren warranted delaying the start and added to organizational disruption of routines, written instructions were buried in the pamphlet of fine print. On 06-Jan-2024, the patient took the first dose of Vivotif (batch number: 3003851, expiry date: Mar-2024), at an unknown dose, orally, as reported one capsule, for typhoid fever (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the first dose of Vivotif the patient experienced mild nausea and fatigue. On an unspecified date, after 48 hours the patient recovered from the events of nausea and fatigue. On 08-Jan-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003851, expiry date: Mar-2024), at an unknown dose, orally, as reported one capsule (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the second dose of Vivotif the patient experienced mild nausea and fatigue. On an unspecified date, after 48 hours the patient recovered from the events of nausea and fatigue. The reporter assessed the events of nausea and fatigue as non-serious and possibly related to Vivotif. This case is linked with US-BN-2024-000043, concerning the same reporter. Additional information received from Emergent BioSolutions on 09-Jan-2024 and included additional information about the reporter, information on how long the vaccine was at room temperature, additional events, and additional reference (EMG2024-042). Additional information received from Med Communications on 10-Jan-2024 and included additional reference (USBAV24-0057). 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 13-Feb-2024: New information included patient's details, current conditions, concomitant products, Vivotif dosage information, intensity for the event fatigue, event gastrointestinal symptom was recoded to nausea, outcome, and event duration for the events fatigue, nausea, and confirmation on contributing factors that led to the event. Additional information received from the reporter on 20-Feb-2024: New information included confirmation on the start date of Vivotif for the first two doses.; Reporter's Comments: A 66-year-old female patient took the first and the second dose of Vivotif for Typhoid fever, after Vivotif was mistakenly left at room temperature for three weeks, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. On the day 2 after the first dose of Vivotif, the patient took the second dose of affected Vivotif, which is considered as product administration error. Also, as reported on an unspecified date, an unknown amount of time after the second dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue is listed per CCDS v8 and unexpected per USPI. Product storage error and product administration error are considered as listed per company convention. The patient's current conditions included depression, hypercholerolemia , and hypertension, and concomitant medications included Wellbutrin XL, escitalopram, ezetimibe and losartan. The patient recovered from the events. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of nausea and fatigue have been considered as related to Vivotif. 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 66-year-old female patient took the first and the second dose of Vivotif for Typhoid fever, after Vivotif was mistakenly left at room temperature for three weeks, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. On the day 2 after the first dose of Vivotif, the patient took the second dose of affected Vivotif, which is considered as product administration error. Also, as reported on an unspecified date, an unknown amount of time after the second dose of Vivotif, the patient experienced non-serious events of nausea and fatigue. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue is listed per CCDS v8 and unexpected per USPI. Product storage error and product administration error are considered as listed per company convention. The patient's current conditions included depression, hypercholerolemia , and hypertension, and concomitant medications included Wellbutrin XL, escitalopram, ezetimibe and losartan. The patient recovered from the events. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events of nausea and fatigue have been considered as related to Vivotif. 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. More
2829460	M	MO	03/04/2025	TYP	BERNA BIOTECH, LTD.	3003851	Decreased appetite, Diarrhoea, Fatigue, Nausea, Product storage error Decreased appetite, Diarrhoea, Fatigue, Nausea, Product storage error	The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahre... The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahrenheit) for three weeks; The patient took the first and second doses of Vivotif vaccine at room temperature (reached 68 Fahrenheit) for three weeks; Anorrexia, after the second dose of Vivotif; Fatigue, after the first dose of Vivotif; Fatigue, after the second dose of Vivotif; Nausea, after the first dose of Vivotif; Nausea, after the second dose of Vivotif; Loose stools, after the first dose of Vivotif; Loose stools, after the second dose of Vivotif; Case reference number US-BN-2024-000043 is a spontaneous case report initially received from a physician via Med Communications (reference number: USBAV24-0053) on 09-Jan-2024 and concerns a 64-years-old male patient. The patient's current condition included hypercholererolemia, hypogonadism, rheumatoid arthritis, and seasonal allergy. The patient's concomitant medication included Pravachol (pravastatin sodium) and ezetimibe (brand name: unknown), testosterone cypionate (brand name: unknown), prednisone (brand name: unknown), and Wal zyr (cetirizine hydrochloride). As reported, the Vivotif mistakenly was left at room temperature for three weeks (maximum temperature of 68 Fahrenheit degrees), and the patient took the first and second doses (explicitly coded as 'product storage error'). As reported, the prescriber did not instruct to refrigerate. The pharmacy did not provide verbal instruction to refrigerate. Holiday travel plans to grandchildren warranted delaying the start and added to organizational disruption of routines. Written instructions were buried in the pamphlet of fine print. On 06-Jan-2024, the patient took the first dose of Vivotif (batch number: 3003851, expiration date: Mar-2024), at a dose of 2.0-10.0x10^9 Colony-forming unit (CFU), orally, for typhoid fever (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the first dose of Vivotif the patient experienced mild fatigue. On an unspecified date, also reported 01-May-2024 (to be confirmed), an unknown amount of time after the first dose of Vivotif the patient experienced mild loose stools, nausea.* On an unspecified date, after 48 hours the patient recovered from the events of fatigue. On an unspecified date, also reported 01-Jul-2024 (to be confirmed), after 48 hours the patient recovered from the events of nausea, and loose stools. On 08-Jan-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003851, expiration date: Mar-2024), at a dose of 2.0-10.0x10^9 CFU, orally, (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the second dose of Vivotif the patient experienced mild fatigue. On an unspecified date also reported as 05-Jan-2024 (to be confirmed), an unknown amount of time after the second dose of Vivotif the patient experienced mild loose stools, anorexia and mild fatigue. On an unspecified date, after 48 hours the patient recovered from the event of fatigue. On an unspecified date, also reported 07-Jan-2024 (to be confirmed), after 48 hours the patient recovered from the events of nausea, loose stools, and anorexia.* The reporter assessed the events of all instances of nausea, loose stools, fatigue, and anorexia as non-serious and possibly related to Vivotif. This case is linked with US-BN-2024-000042, concerning the same reporter. Additional information received from Emergent BioSolutions on 09-Jan-2024 and included additional information about the reporter, information on how long the vaccine was at room temperature, additional events, and additional reference (EMG2024-042). Additional information received from Med Communications on 10-Jan-2024 and included additional reference (USBAV24-0056). 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 13-Feb-2024: New information included patient's details, concomitant products, Vivotif dosage information, intensity for the event fatigue, event gastrointestinal symptom was recoded to nausea, stoole loose, anorexia, outcome, start dates and stop dates for events, and event duration for the events fatigue, nausea, and confirmation on contributing factors that led to the event. Additional information received from the reporter on 20-Feb-2024: New information included confirmation on the start date of Vivotif for the first two doses.; Reporter's Comments: A 64-year-old male patient took the first and the second dose of Vivotif for Typhoid fever, after Vivotif was mistakenly left at room temperature for three weeks, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced non-serious events of fatigue, loose stools and nausea. Also, as reported on an unspecified date, an unknown amount of time after the second dose of Vivotif, the patient experienced non-serious events of fatigue, loose stools, anorexia and nausea. Diarrhoea and nausea are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue and decreased appetite are listed per CCDS v8 and unexpected per USPI. Product storage error and product administration error are considered as listed per company convention. The patient's current condition included hypercholererolemia, hypogonadism, rheumatoid arthritis, and seasonal allergy, and concomitant medication included Pravachol and ezetimibe, testosterone cypionate, prednisone, and Wal zyr. The patient recovered. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, all the reported events have been considered as related to Vivotif. 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 64-year-old male patient took the first and the second dose of Vivotif for Typhoid fever, after Vivotif was mistakenly left at room temperature for three weeks, which is considered as product storage error and product administration error. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced non-serious events of fatigue, loose stools and nausea. Also, as reported on an unspecified date, an unknown amount of time after the second dose of Vivotif, the patient experienced non-serious events of fatigue, loose stools, anorexia and nausea. Diarrhoea and nausea are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst fatigue and decreased appetite are listed per CCDS v8 and unexpected per USPI. Product storage error and product administration error are considered as listed per company convention. The patient's current condition included hypercholererolemia, hypogonadism, rheumatoid arthritis, and seasonal allergy, and concomitant medication included Pravachol and ezetimibe, testosterone cypionate, prednisone, and Wal zyr. The patient recovered. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, all the reported events have been considered as related to Vivotif. 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. More
2829461	F	VI	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took the third dose of Vivotif three days after the first dose and the fourth dose of Vi... The patient took the third dose of Vivotif three days after the first dose and the fourth dose of Vivotif six days after the first dose; Case reference number US-BN-2024-000051 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0071) on 11-Jan-2024 and concerns a 37-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 05-Jan-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid fever prophylaxis. On 07-Jan-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose, orally. On 08-Jan-2024, three days after the first dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 11-Jan-2024, six days after the first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: unknown) at an 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 was provided.; Reporter's Comments: A 37-year-old female patient took the third dose of Vivotif on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, on the day 6 after the first dose, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration 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 37-year-old female patient took the third dose of Vivotif on the day 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, on the day 6 after the first dose, the patient took the fourth dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829462	M	AL	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took Vivotif capsules two days in a row instead of every other day.; Case reference numb... The patient took Vivotif capsules two days in a row instead of every other day.; Case reference number US-BN-2024-000052 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0075) on 11-Jan-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took a dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid prophylaxis. On an unspecified date, reported as two days in a row instead of every other day, the patient took another dose of Vivotif (batch number: unknown) at an 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 was provided.; Reporter's Comments: A male patient of unspecified age took a dose of Vivotif for typhoid prophylaxis. Reportedly, on an unspecified date, reported as two days in a row instead of every other day, the patient took another dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age took a dose of Vivotif for typhoid prophylaxis. Reportedly, on an unspecified date, reported as two days in a row instead of every other day, the patient took another dose of Vivotif, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829463	F	WI	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Expired product administered, Extra dose administered Expired product administered, Extra dose administered	The patient took one capsule of Vivotif on Jan-2024, which was expired on Dec-2023; The patient took... The patient took one capsule of Vivotif on Jan-2024, which was expired on Dec-2023; The patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired; Case reference number US-BN-2024-000056 is a spontaneous case report initially received from a physician via Med Communication (reference number: USBAV24-0081) on 12-Jan-2024 and concerns female patient. The patient's relevant medical history and concomitant medication details were not provided. On unspecified date in Jan-2024, the patient took the first dose of Vivotif vaccine (batch number: 3003824; expiration date: Dec-2023), at a dose reported as one capsule, administered orally, for an unknown indication (explicitly coded as 'expired vaccine used'). The patient was given a replacement that was not expired. On unspecified date, (reported as yesterday), an unknown amount of time after receiving the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown; expiration date: unknown), at a dose reported as one capsule, via unknown route of administration. As reported, the patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired (explicitly coded as 'extra dose administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient took the first dose of Vivotif vaccine (expiration date: Dec-2023), at a dose reported as one capsule, administered orally, for an unknown indication on unspecified date in Jan-2024, which is considered as expired vaccine used. Reportedly, the patient took the second dose of Vivotif vaccine, at a dose reported as one capsule. As reported, the patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired, which is considered as extra dose administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Expired product administered and extra dose administered are considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and extra dose administered 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 took the first dose of Vivotif vaccine (expiration date: Dec-2023), at a dose reported as one capsule, administered orally, for an unknown indication on unspecified date in Jan-2024, which is considered as expired vaccine used. Reportedly, the patient took the second dose of Vivotif vaccine, at a dose reported as one capsule. As reported, the patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired, which is considered as extra dose administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Expired product administered and extra dose administered are considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and extra dose administered have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829464	M	WI	03/04/2025	TYP	BERNA BIOTECH, LTD.	3003851	Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event	The patient took four doses of Vivotif vaccine every day instead of every other day; Case reference ... The patient took four doses of Vivotif vaccine every day instead of every other day; Case reference number US-BN-2024-000057 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0082) on 12-Jan-2024 and concerns an adult male patient. The patient's medical history and concomitant medication details were not provided. On 09-Jan-2024, the patient took the first dose of Vivotif vaccine (batch number: 3003851, expiry date: 31-Mar-2024), orally for typhoid vaccine. On 10-Jan-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: 3003851, expiry date: 31-Mar-2024), orally. As reported, the patient was instructed to take 1 capsule every other day, but the patient reported they took 1 capsule every day instead (explicitly coded as 'inappropriate schedule of vaccine administered'). On 11-Jan-2024, two days after the first dose, the patient took the third dose of Vivotif # (batch number: 3003851, expiry date: 31-Mar-2024), orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 12-Jan-2024, three days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3003851, expiry date: 31-Mar-2024), orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the follow up report, the patient did not experience any adverse event due to Vivotif vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Additional information received on 15-Jan-2024 from a pharmacist included confirmation of patient's date of birth. Follow-up information received from a pharmacist on 29-Jan-2024: New information included information about Vivotif dosing information, dates of administration, expiration date and indication, and confirmation that medical history was not available.; Reporter's Comments: An adult male patient took the first dose of Vivotif vaccine reportedly for typhoid vaccine. Reportedly, the patient received the second, the third and the fourth dose of Vivotif on the days 1, 2, and 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult male patient took the first dose of Vivotif vaccine reportedly for typhoid vaccine. Reportedly, the patient received the second, the third and the fourth dose of Vivotif on the days 1, 2, and 3 after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829465	F	CO	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Product storage error Product storage error	The patient took one capsule of Vivotif and the reporter was not sure if the product already suffere... The patient took one capsule of Vivotif and the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius; The patient took one capsule of Vivotif and the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius; Case reference number US-BN-2024-000079 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0114) on 18-Jan-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient took a dose of Vivotif (batch number: unknown), at a dose reported as one capsule, orally, for unknown indication. As reported, the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius (explicitly coded as 'product storage error' and 'product administration error'). At the time of this report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided. Non-significant case correction was received on 14-Feb-2024 from the reporter, included confirmation that they have no further information regarding this case.; Reporter's Comments: A female patient of unspecified age took a dose of Vivotif for unknown indication. As reported, the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius, which is considered as product storage error and 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 took a dose of Vivotif for unknown indication. As reported, the reporter was not sure if the product already suffered temperature excursion, which was two to ten days stood at max temperature of 20 degrees of Celsius, which is considered as product storage error and 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. More
2829466	F	NJ	03/04/2025	TYP	BERNA BIOTECH, LTD.	Unknown	Inappropriate schedule of product administration Inappropriate schedule of product administration	The patient took the second and the third dose of Vivotif two days in a row; Case reference number U... The patient took the second and the third dose of Vivotif two days in a row; Case reference number US-BN-2024-000084 is a spontaneous case report initially received from nurse via Med Communications (reference number: USBAV24-0120) on 19-Jan-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On 15-Jan-2024, the patient took the first dose of Vivotif (batch number: unknown), at an unknown dose or route of administration, for unknown indication. On 17-Jan-2024, two days after first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose or route of administration. On 18-Jan-2024, three days after first dose of Vivotif, as reported two days in a row with the second dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose or route of administration, for unknown indication (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient took the second and third dose of Vivotif, two days in a row for an unknown indication, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient took the second and third dose of Vivotif, two days in a row for an unknown indication, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious. More

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