๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

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.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

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
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

  • โœ… Early warning system for potential safety signals
  • โœ… Open and transparent - publicly accessible
  • โœ… Accepts all reports regardless of likelihood of causation
  • โœ… Monitored by CDC/FDA experts who investigate concerning patterns

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

โš ๏ธ 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
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2829467 F NY 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Blister, Rash Blister, Rash
Blisters on eyelids; The patient developed a rash eight-ten years ago on face after taking Vivotif; ... Blisters on eyelids; The patient developed a rash eight-ten years ago on face after taking Vivotif; Case reference number US-BN-2024-000085 is a spontaneous case report initially received from a healthcare professional via Med Communications (reference number: USBAV24-0121) on 19-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 a dose of Vivotif (batch number: unknown), at an unknown dose, orally, for an unknown indication. On an unspecified date, an unknown amount of time after the vaccination with the Vivotif vaccine, as reported the patient developed a rash eight-ten years ago, on the face. The patient went to the emergency room, and they concluded that it was possibly related to the oral typhoid vaccine. The reporter added that the patient had blisters on eyelids, and the patient had nothing else implicated at the time like creams. The reporter asked if the crossover could be done between the oral vaccine and the injectable, if some had a reaction to the oral vaccine, they had the injectable and vice versa. As healthcare professional their preference would not be to repeat the oral vaccine because they did not know for sure if it was the vaccine, gelatin, or something else. At the time of the initial report, it was unknown if the patient recovered from the events of blisters on eyelids and a rash face. The reporter assessed the events of blisters on eyelids and rash face as non-serious. The reporter assessed causality assessment as related for the events of blisters and rash face to the Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of blister and rash on an unspecified date, an unknown amount of time after the patient took a dose of Vivotif for an unknown indication. Rash is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst blister is unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the 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 blister and rash on an unspecified date, an unknown amount of time after the patient took a dose of Vivotif for an unknown indication. Rash is listed and expected for Vivotif according to the CCDS v8 and USPI, whilst blister is unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the events have been considered as related to Vivotif. This case is considered as non-serious. More
2829468 M CO 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003851
Product dose omission issue Product dose omission issue
The patient forgot to take the fourth dose of Vivotif vaccine on day seven.; Case reference number U... The patient forgot to take the fourth dose of Vivotif vaccine on day seven.; Case reference number US-BN-2024-000089 is a spontaneous case report initially received from other healthcare professional via Med Communication (reference number: USBAV24-0139) on 22-Jan-2024 and concerns a 19-year-old male 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 capsule (batch number: 3003851) at an unknown dose, orally, for typhoid fever prophylaxis. As reported the patient had started the seven day series. On 17-Jan-2024, two days after receiving the first dose of Vivotif, the patient took the second dose of Vivotif capsule (batch number: 3003851) at an unknown dose, orally. On 19-Jan-2024, four days after receiving the first dose of Vivotif, the patient took the third dose of Vivotif capsule (batch number: 3003851) at an unknown dose, orally. As reported, the patient forgot to take the fourth dose of Vivotif since the patient was going on different trip and before leaving the country (explicitly coded as 'missed dose'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 19-year-old male patient took three doses of Vivotif for typhoid fever prophylaxis, and reportedly forgot to take the fourth dose, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient took three doses of Vivotif for typhoid fever prophylaxis, and reportedly forgot to take the fourth dose, which is considered as product dose omission issue. No associated adverse events were reported. Product dose omission issue is listed per company convention. The patient's medical history and concomitant medication details were not provided. Product dose omission issue is not related to Vivotif, but to a human factor. The case is non-serious. More
2829469 M OH 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient took second dose of Vivotif, five days after the first dose; Case reference number US-BN... The patient took second dose of Vivotif, five days after the first dose; Case reference number US-BN-2024-00092 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0141) on 22-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 the first dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication. On unspecified date, as reported five days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On an unspecified dates, as reported every other day, the patient took the third and the fourth dose of Vivotif (batch number: unknown), at an unknown dose, orally. At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age took the second dose of Vivotif five days after the first dose 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 male patient of unspecified age took the second dose of Vivotif five days after the first dose 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
2829470 F ID 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product storage error Product storage error
Patient took three doses of Vivotif vaccine that was exposed to minimum temperature of 65 degrees Fa... Patient took three doses of Vivotif vaccine that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days; Patient took three doses of Vivotif vaccine that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days; Case reference number US-BN-2024-000096 is a spontaneous case report initially received from a physician via Med Communication (reference number: USBAV24-0151) on 23-Jan-2024 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took first, second and third dose of Vivotif (batch number: unknown), at a dose reported as one capsule, orally, for unknown indication. It was reported that patient took three capsules of Vivotif vaccine from the box that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven days (explicitly coded as 'product storage error' and 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided. Non-significant case correction performed on 09-Feb-2024 for the information received on 24-Jan-2024 included: additional reference numbers.; Reporter's Comments: A female patient of unspecified age took three capsules of Vivotif vaccine for unknown indication, from the box that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven 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 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 three capsules of Vivotif vaccine for unknown indication, from the box that was exposed to minimum temperature of 65 degrees Fahrenheit and maximum temperature of 72 degrees Fahrenheit for seven 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 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
2829471 M KS 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003852
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient took Vivotif day one dose and day three dose two days in a row, as reported the first do... The patient took Vivotif day one dose and day three dose two days in a row, as reported the first dose was yesterday and the second dose as today; Case reference number US-BN-2024-000100 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0156) on 24-Jan-2024 and concerns a *68-year-old* male patient. *The patient had no relevant medical history.* The patient's concomitant medication details were not provided. On 23-Jan-2024, reported as yesterday, the patient took the first dose of Vivotif *(batch number: 3003852; expiration date: 31-Mar-2024) at a dose of one capsule,* orally, *for indication reported as travel.* On 24-Jan-2024, one day after the first dose of Vivotif, the patient took the second dose of Vivotif * (batch number: 3003852; expiration date: 31-Mar-2024) at a dose of one capsule,* orally. As reported, the patient took Vivotif day one dose and day three dose two days in a row (explicitly coded as 'inappropriate schedule of vaccine administered'). *As reported, the patient did not experience any adverse event due to Vivotif.* Additional information received from Bavarian Nordic on 24-Jan-2024 included local BN case ID. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from nurse on 28-Feb-2024: New information included patient demographic details, confirmation of no relevant medical history, Vivotif administration details for first and second dose and confirmation that the patient did not experience any adverse event due to Vivotif.; Reporter's Comments: A male patient of unspecified age took the second dose of Vivotif one day after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of vaccine administered is listed per company convention. The patient had no 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 male patient of unspecified age took the second dose of Vivotif one day after the first dose, which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of vaccine administered is listed per company convention. The patient had no 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
2829472 F IL 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003908
No adverse event, Product storage error No adverse event, Product storage error
Patient took a dose of Vivotif stored for 12 hours at maximum temperature of 55 degrees Fahrenheit; ... Patient took a dose of Vivotif stored for 12 hours at maximum temperature of 55 degrees Fahrenheit; Patient took a dose of Vivotif stored for 12 hours at maximum temperature of 55 degrees Fahrenheit; Case reference number US-BN-2024-000144 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0252) on 05-Feb-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On 03-Feb-2024, reported as on Saturday night at 09:00 pm, the patient took the first dose of Vivotif (batch number: 3003908), at an unknown dose, orally, for typhoid immunization. After administration of first dose, the patient put Vivotif on a calendar outside of the refrigerator for 12 hours, at maximum temperature of 55 degrees Fahrenheit (explicitly coded as 'product storage error'). As reported, on the next morning the patient put Vivotif to the refrigerator and this was the first temperature excursion. On 05-Feb-2024, two days after taking the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003908), at unknown dose, orally (explicitly coded as 'product administration error'). As reported that patient did not have any effects due to excursion. No further information provided.; Reporter's Comments: A female patient of unspecified age put Vivotif outside of the refrigerator for 12 hours, at maximum temperature of 55 degrees Fahrenheit, which is considered as product storage error. As reported, on the next morning the patient put Vivotif to the refrigerator and this was the first temperature excursion. Reportedly, two days after taking the first dose of Vivotif, the patient took the second dose of Vivotif which had temperature excursion, which is considered as product administration error. The patient did not have any effects due to excursion. 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 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 female patient of unspecified age put Vivotif outside of the refrigerator for 12 hours, at maximum temperature of 55 degrees Fahrenheit, which is considered as product storage error. As reported, on the next morning the patient put Vivotif to the refrigerator and this was the first temperature excursion. Reportedly, two days after taking the first dose of Vivotif, the patient took the second dose of Vivotif which had temperature excursion, which is considered as product administration error. The patient did not have any effects due to excursion. 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829473 UT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product administration error Product administration error
Patient took the first dose of Vivotif with a full breakfast; Case reference number US-BN-2024-00015... Patient took the first dose of Vivotif with a full breakfast; Case reference number US-BN-2024-000158 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0283) on 07-Feb-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On 06-Feb-2024, but reported as health care professional not certain, the patient took the first dose of Vivotif (batch number: not reported) orally, at an unknown dose, for typhoid immunization. As reported, the patient took the first dose of Vivotif with a full breakfast, not on an empty stomach (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A patient of unknown demographics took the first dose of Vivotif for typhoid immunization with a full breakfast, not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error 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 unknown demographics took the first dose of Vivotif for typhoid immunization with a full breakfast, not on an empty stomach, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829474 UT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product administration error Product administration error
The patient administrated a dose of Vivotif vaccine with food instead of one-hour prior meal; Case r... The patient administrated a dose of Vivotif vaccine with food instead of one-hour prior meal; Case reference number US-BN-2024-000160 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0284) on 07-Feb-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient took a dose of Vivotif vaccine (batch number: unknown), at an unknown dose and route of administration, for unknown indication. As reported, the patient administrated a dose of Vivotif vaccine with food instead of one-hour prior meal (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 provided.; Reporter's Comments: A patient of unknown demographics administrated a dose of Vivotif vaccine for unknown indication with food instead of one-hour prior meal, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details 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 unknown demographics administrated a dose of Vivotif vaccine for unknown indication with food instead of one-hour prior meal, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error is considered as listed per company convention. The patient's medical history and concomitant medication details 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
2829475 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003908
Product storage error Product storage error
Patient took Vivotif capsules stored at room temperature with maximum temperature reached for 67 deg... Patient took Vivotif capsules stored at room temperature with maximum temperature reached for 67 degree farhenheit and the time out of range was one month; Patient took Vivotif capsules stored at room temperature with maximum temperature reached for 67 degree farhenheit and the time out of range was one month; Case reference number US-BN-2024-000161 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0262) on 07-Feb-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, Vivotif doses were stored out of the refrigerator. The patient did not refrigerate the Vivotif and received it on the beginning of January, but the patient leaves on Friday, patient took Vivotif for every 48 hours and started refrigerating the vaccine a couple days ago but it wasn't in the sun, it was 67 degrees in the bedroom (explicitly coded as 'product storage error') On an unspecified date, the patient took the first affected dose of Vivotif (batch number: unknown) at unknown dose, via oral use for unknown indication (explicitly codes as 'product administration error'). On an unspecified date, an unknown amount of time after the first dose of Vivotif reported as every 48 hours, the patient took the second dose of Vivotif (batch number: 3003908) at unknown dose, via unknown route (explicitly codes 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 patient of unknown age and gender took the first affected dose of Vivotif, although Vivotif doses were stored out of the refrigerator. The patient did not refrigerate the Vivotif and received it on the beginning of January, but as the patient planned to leave, the patient took Vivotif for every 48 hours and started refrigerating the vaccine a couple days before, but it wasn't in the sun, it was 67 degrees in the bedroom, 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 reported as every 48 hours, the patient took the second dose of Vivotif, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first affected dose of Vivotif, although Vivotif doses were stored out of the refrigerator. The patient did not refrigerate the Vivotif and received it on the beginning of January, but as the patient planned to leave, the patient took Vivotif for every 48 hours and started refrigerating the vaccine a couple days before, but it wasn't in the sun, it was 67 degrees in the bedroom, 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 reported as every 48 hours, the patient took the second dose of Vivotif, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829476 M OH 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient forgot to take final dose of Vivotif and could not take additionally because of travelin... The patient forgot to take final dose of Vivotif and could not take additionally because of traveling out of country; Case reference number US-BN-2024-000162 is a spontaneous case report initially received from other health care professional via Med Communications (reference number: USBAV24-0278) on 07-Feb-2024 and concerns 56-years-old male patient. The patient's medical history and concomitant medications were not provided. On unspecified dates, the patient received the first, the second and third dose of Vivotif (batch number: unknown) at an unknown dose and route of administration, for immunization against disease caused by Salmonella typhi. As reported, the patient forgot to take final dose of Vivotif and was travelling out of country and did not have pills. The patient would not be able to return home until 24th February and then will immediately depart for another country on the 27th (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 56-year-old male patient forgot to take the final dose of Vivotif for immunization against disease caused by Salmonella typhi after the patient received the first, the second and third dose of Vivotif, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Incomplete course of vaccination 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 56-year-old male patient forgot to take the final dose of Vivotif for immunization against disease caused by Salmonella typhi after the patient received the first, the second and third dose of Vivotif, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829477 CA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient took one capsule of Vivotif vaccine once daily for four days instead of every other day;... The patient took one capsule of Vivotif vaccine once daily for four days instead of every other day; Case reference number US-BN-2024-000174, initially received from Med Communications on 09-Feb-2024 (reference number USBAV24-0291), is a spontaneous case received from a pharmacist and concerns a patient of unknown demographics. The patient's medical history and concomitant medications were not provided. On unspecified dates, the patient received the first, second, third and fourth dose of Vivotif vaccine (batch number: unknown), at an unknown dose, administered orally for typhoid immunization. As reported, the patient took Vivotif once daily for four days instead of every other day and taken four doses (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 patient of unknown demographics received the first, second, third and the fourth dose of Vivotif vaccine for typhoid immunization. As reported, the patient took Vivotif once daily for four days instead of every other day and taken four doses, 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 medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics received the first, second, third and the fourth dose of Vivotif vaccine for typhoid immunization. As reported, the patient took Vivotif once daily for four days instead of every other day and taken four doses, 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 medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect, but to a human factor. This case is considered as non-serious. More
2829478 M UT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
The patient took four capsules of Vivotif every day rather than every other day.; Case reference num... The patient took four capsules of Vivotif every day rather than every other day.; Case reference number US-BN-2024-000175 is a spontaneous case report initially received from other health care professional via Med Communications (reference number: USBAV24-0292) on 09-Feb-2024 and concerns 18-years-old male. The patient's medical history and concomitant medications were not provided. On 01-Jan-2024, the patient took the first dose of Vivotif (batch number: unknown) *one capsule*, orally, as reported for Immunization against disease caused by salmonella typhi indication. On 02-Jan-2024, one day after first dose of Vivotif, the patient took the second dose of Vivotif (batch number: unknown) *one capsule*, orally (explicitly codded as 'Inappropriate schedule of vaccine administered'). On 03-Jan-2024, two days after first dose of Vivotif, the patient took the third dose of Vivotif (batch number: unknown) *one capsule*, orally (explicitly codded as 'Inappropriate schedule of vaccine administered'). On 04-Jan-2024, three days after first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: unknown) *one capsule*, orally (explicitly codded as 'Inappropriate schedule of vaccine administered'). *At the time of the initial report, the patient did not experience any adverse event due to Vivotif vaccine. * All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from nurse on 20-Feb-2024: volume for four doses of Vivotif updated, patient initials added and confirmation that patient did not experience any adverse event.; Reporter's Comments: An 18-year-old male patient took the second, third and the fourth dose of Vivotif vaccine for immunization against disease caused by salmonella typhi indication, on the days 1, 2 and 3 after the patient took the first dose of Vivotif, which is considered as inappropriate schedule of product administration. 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 medications 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 18-year-old male patient took the second, third and the fourth dose of Vivotif vaccine for immunization against disease caused by salmonella typhi indication, on the days 1, 2 and 3 after the patient took the first dose of Vivotif, which is considered as inappropriate schedule of product administration. 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 medications 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
2829479 M GA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003852
Nausea, Product administration error Nausea, Product administration error
The patient took first dose of Vivotif vaccine with food; The patient received five doses of Vivotif... The patient took first dose of Vivotif vaccine with food; The patient received five doses of Vivotif; Patient experienced nausea after first dose of Vivotif; Case reference number US-BN-2024-000178 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0311) on 13-Feb-2024 and concerns a 62-years old male patient. The patient had no medical history and concomitant medications. On 13-Feb-2024, the patient took the first dose of Vivotif vaccine (batch number: 3003852, expiration date: 31-Mar-2024), one capsule, administered orally, for typhoid immunization. As reported, the patient took a dose of Vivotif vaccine with *meal* (explicitly coded as 'product administration error'). On the same day, as reported immediately after the eating, the patient experienced mild nausea. *On 13-Feb-2024, as reported within a few hours after taking Vivotif,* the patient recovered from the event of nausea. On 15-Feb-2024, three days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally. On 17-Feb-2024, five days after the first dose of Vivotif, the patient took the third dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally. On 19-Feb-2024, seven days after the first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally. On 21-Feb-2024, nine days after the first dose of Vivotif, the patient took the fifth dose of Vivotif (batch number: 3003852, also reported 3004009, expiration date: 31-Mar-2024, also reported 31-Oct-2024 (to be confirmed)), one capsule, orally (explicitly coded as 'vaccine overdose'). It was reported that the patient completed the series and there were no adverse event reactions with subsequent doses taken one hour before meal. *As reported, the reporter was not aware of the sequence of lot numbers as the medication was self-administered and only dose lot number which with certainty taken was the first dose.* The reporter assessed the event of nausea as non-serious, and probably related to Vivotif. Additional information received from a nurse via Med Communications (reference number: USBAV24-0315) on 14-Feb-2024 included additional reporter, indication, expiration date, batch number of Vivotif vaccine, and additional reference number. Additional information received from a nurse on 15-Feb-2024 included confirmation of patient details and event details. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from nurse on 22-Feb-2024: New information included volume of the dose, patient initials and date of birth, confirmation that patient had no medical history and concomitant medication and that the patient experienced nausea. Follow-up received from the reporter on 04-Mar-2024: New information included details about additional doses of Vivotif, duration, seriousness, severity, and causality assessment for the event of nausea, and additional 'vaccine overdose'. Follow-up received from the reporter on 21-Mar-2024: New information included details about duration of the event of nausea, confirmation that reporter was not aware of the sequence of lot numbers for each dose separately and confirmation of batch number for the first dose of Vivotif.; Reporter's Comments: A 62-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient took a dose of Vivotif vaccine with food, which is considered as product administration error. On the same day, as reported immediately after the eating, the patient experienced mild nausea (non-serious event) which was resolved after couple of hours. Nine days after the first dose of Vivotif, the patient took the fifth dose of Vivotif, one capsule, orally which is considered as vaccine overdose. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI. Product administration error and overdose are both considered as listed per company convention. The patient had no medical history and concomitant medications. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the event of nausea has been considered as related to Vivotif. Product administration error and overdose are both assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 62-year-old male patient took the first dose of Vivotif vaccine for typhoid immunization. As reported, the patient took a dose of Vivotif vaccine with food, which is considered as product administration error. On the same day, as reported immediately after the eating, the patient experienced mild nausea (non-serious event) which was resolved after couple of hours. Nine days after the first dose of Vivotif, the patient took the fifth dose of Vivotif, one capsule, orally which is considered as vaccine overdose. Nausea is listed and expected for Vivotif according to the CCDS v8 and USPI. Product administration error and overdose are both considered as listed per company convention. The patient had no medical history and concomitant medications. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the event of nausea has been considered as related to Vivotif. Product administration error and overdose are both assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829480 F MI 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003908
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
The patient received third Vivotif capsule on day 7 and fourth capsule on day 12; Case reference num... The patient received third Vivotif capsule on day 7 and fourth capsule on day 12; Case reference number US-BN-2024-000194 is a spontaneous case report initially received from a nurse via Med Communication on 19-Feb-2024 and concerns a *17-years-old* female patient. The patient's medical history and concomitant medication details were not provided. On 27-Jan-2024, the patient took a first dose of Vivotif (batch number: 3003908; *expiration date: Jun-2024), at a dose of one capsule* via oral route, for typhoid immunization. On 29-Jan-2024, two days after the first dose, the patient took a second dose of Vivotif (batch number: 3003908, *expiration date: Jun-2024), at a dose of one capsule* via oral route. On 02-Feb-2024, on day seven instead on day five, the patient took a third dose of Vivotif (batch number: 3003908; *expiration date: Jun-2024), at a dose of one capsule* via oral route (explicitly coded as ๏ฟฝinappropriate schedule of vaccine administered'). On 07-Feb-2024, on day 12 instead on day seven, the patient took a fourth dose of Vivotif (batch number: 3003908; *expiration date: Jun-2024), at a dose of one capsule* via oral route (explicitly coded as ๏ฟฝinappropriate schedule of vaccine administered'). *At the time of follow up report, the patient did not experience any adverse event due to Vivotif vaccine.* Additional information received from a nurse via Med Communication on 21-Feb-2024: New information included additional reporter (nurse) and additional reference number. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from nurse on 05-Apr-2024: New information included patient's demographic information, expiration date and dose for four doses of Vivotif vaccines and conformation that the patient did not experience any adverse event due to Vivotif.; Reporter's Comments: A 17-year-old female patient of unknown age took the third (one capsule) and the fourth (one capsule) dose of Vivotif on the days 7 and 12, which is considered as inappropriate schedule of vaccine administered. It was confirmed that 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: A 17-year-old female patient of unknown age took the third (one capsule) and the fourth (one capsule) dose of Vivotif on the days 7 and 12, which is considered as inappropriate schedule of vaccine administered. It was confirmed that 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
2829481 M UT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient took Vivotif every day, instead of every other day; Case reference number US-BN-2024-000... The patient took Vivotif every day, instead of every other day; Case reference number US-BN-2024-000198 is a spontaneous case report initially received from a healthcare professional via Med Communications (reference number: USBAV24-0348) on 20-Feb-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 took a dose of Vivotif (batch number: not provided) at an unknown dose, orally, for an unknown indication. As reported, instead of every other day, the patient took Vivotif every day (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccination. No further information was provided.; Reporter's Comments: A male patient of unknown age took a dose of Vivotif for an unknown indication. As reported, instead of every other day, the patient took Vivotif every day, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccination. 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 unknown age took a dose of Vivotif for an unknown indication. As reported, instead of every other day, the patient took Vivotif every day, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccination. 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
2829482 M CA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product administration error Product administration error
Patient ate 15 minutes after taking the first dose of Vivoitf; Case reference number US-BN-2024-0001... Patient ate 15 minutes after taking the first dose of Vivoitf; Case reference number US-BN-2024-000199 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0346) on 20-Feb-2024 and concerns a 64-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 18-Feb-2024, the patient took a first dose of Vivotif (batch number: unknown) at an unknown dose via oral route, for immunisation against disease caused by salmonella typhi. As reported, the patient ate 15 minutes after taking the dose (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 64-year-old male patient took the first dose of Vivotif for immunisation against disease caused by salmonella typhi. As reported, the patient ate 15 minutes after taking the dose, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 64-year-old male patient took the first dose of Vivotif for immunisation against disease caused by salmonella typhi. As reported, the patient ate 15 minutes after taking the dose, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829483 F TN 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Gastrointestinal disorder, Inappropriate schedule of product administration, Vom... Gastrointestinal disorder, Inappropriate schedule of product administration, Vomiting More
Patient was due to take second dose of Vivotif at 2PM, patient was approximately 3 hours overdue, se... Patient was due to take second dose of Vivotif at 2PM, patient was approximately 3 hours overdue, second dose not yet taken; Patient had gastrointestinal (GI) side effects; Vomited; Case reference number US-BN-2024-000200 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0352) on 20-Feb-2024 and concerns a 28-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 18-Feb-2024, at 02:00 pm. the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose via oral route, for unknown indication. On 19-Feb-2024, around 09:30 am, one day after the first dose, the patient had gastrointestinal side effects and vomited. As reported no fever occurred. On 20-Feb-2024, two days after the first dose of Vivotif, the patient was supposed to take the second dose of Vivotif at 2 pm, however the patient was approximately 3 hours overdue, and the reporter asked should the schedule be continued if the patient decides to continue with Vivotif series as the second dose was not yet taken (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, the outcome for the events of gastrointestinal side effects and vomited was unknown. The reporter did not provide seriousness or causality assessment for the events gastrointestinal side effects and vomited. No further information was provided.; Reporter's Comments: A 28-year-old female patient had gastrointestinal side effects and vomited on the day 1 after the patient took the first dose of Vivotif for unknown indication. On the day 2 after the first dose, the patient was supposed to take the second dose of Vivotif at 2 pm, however the patient was approximately 3 hours overdue, and the reporter asked should the schedule be continued if the patient decides to continue with Vivotif series as the second dose was not yet taken, which is considered as inappropriate schedule of vaccine administered. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and known vaccine safety profile, the events of gastrointestinal disorder and vomiting have been considered as related to Vivotif. 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 28-year-old female patient had gastrointestinal side effects and vomited on the day 1 after the patient took the first dose of Vivotif for unknown indication. On the day 2 after the first dose, the patient was supposed to take the second dose of Vivotif at 2 pm, however the patient was approximately 3 hours overdue, and the reporter asked should the schedule be continued if the patient decides to continue with Vivotif series as the second dose was not yet taken, which is considered as inappropriate schedule of vaccine administered. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering plausible temporal relationship and known vaccine safety profile, the events of gastrointestinal disorder and vomiting have been considered as related to Vivotif. 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
2829484 CA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient took Vivotif once a day, instead of every other day; Case reference number US-BN-2024-000221... Patient took Vivotif once a day, instead of every other day; Case reference number US-BN-2024-000221 is a spontaneous case report initially received from a health care professional via Med Communications (reference number: USBAV24-0378) on 23-Feb-2024 and concerns a patient of unspecified age and gender. The patient's relevant medical history and concomitant medications were not provided. On unspecified dates, the patient took doses of Vivotif (batch number: unknown), at unknown doses, orally, for typhoid immunization. The patient took Vivotif once a day, instead of every other day (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unspecified age and gender took doses of Vivotif, at unknown doses, orally, for typhoid immunization. The patient took Vivotif once a day, instead of every other day, 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 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 and gender took doses of Vivotif, at unknown doses, orally, for typhoid immunization. The patient took Vivotif once a day, instead of every other day, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829485 M MA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Incomplete course of vaccination, Vomiting Incomplete course of vaccination, Vomiting
The patient received three doses of Vivotif vaccine instead of four; The patient vomited the full ca... The patient received three doses of Vivotif vaccine instead of four; The patient vomited the full capsule three hours after the ingestion of the first dose; Case reference number US-BN-2024-000566 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0415) on 29-Feb-2024 and concerns a 17-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 28-Feb-2024, the patient took the first dose of Vivotif (batch number: not provided), at an unknown dose, orally, for unknown indication. On the same day, *three* hours after taking the first dose, the patient vomited the full capsule. As reported, patient most likely adsorbed the first dose of Vivotif vaccine even though vomited capsule three hours later. On unspecified date, unknown amount of time after the first dose, the patient took the second dose of Vivotif (batch number: not provided), at an unknown dose and route, for unknown indication. On unspecified date, unknown amount of time after the second dose, the patient took the third dose of Vivotif (batch number: not provided), at an unknown dose, and route, for unknown indication. As reported, the patient received three doses of Vivotif instead of four doses and *no issues were reported* (explicitly coded as 'incomplete course of vaccination'). At the time of the follow up, the outcome for the event of vomiting of medication was unknown. The reporter did not provide seriousness or causality assessment for the event of vomiting of medication. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from the pharmacist on 10-Mar-2024: New information included confirmation that the patient took three doses of Vivotif vaccine instead of four, and time interval between vaccination and event of vomiting. Follow-up information received from the pharmacist on 22-Mar-2024: New information included confirmation that the patient used three caps of the four dose pack of Vivotif, no issues were reported.; Reporter's Comments: A 17-year-old male patient took the first dose of Vivotif for unknown indication and on the same day (four hours after taking the dose) vomited the full capsule. Reportedly, patient most likely adsorbed the first dose of Vivotif vaccine due to the time lapse of vomiting. As reported, the patient received three doses of Vivotif instead of four doses, which is considered as incomplete course of vaccination. Vomiting is listed and expected for Viviotif according to CCDS version 8.0 and USPI. Incomplete course of vaccination is considered s listed per company convention. The outcome of vomiting was unknown. The patient's medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality is assessed as related to Vivotif for the event of vomiting. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 17-year-old male patient took the first dose of Vivotif for unknown indication and on the same day (four hours after taking the dose) vomited the full capsule. Reportedly, patient most likely adsorbed the first dose of Vivotif vaccine due to the time lapse of vomiting. As reported, the patient received three doses of Vivotif instead of four doses, which is considered as incomplete course of vaccination. Vomiting is listed and expected for Viviotif according to CCDS version 8.0 and USPI. Incomplete course of vaccination is considered s listed per company convention. The outcome of vomiting was unknown. The patient's medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality is assessed as related to Vivotif for the event of vomiting. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829486 M MT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient took a partial dosage of Vivotif; took one or two pills of Vivotif which were prescribed... The patient took a partial dosage of Vivotif; took one or two pills of Vivotif which were prescribed three weeks ago; Case reference number US-BN-2024-000606 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0448) on 05-Mar-2024 and concerns a 16-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unknown date, the patient took a dose of Vivotif (batch number: unknown), orally, at an unknown dose, for typhoid prophylaxis. As reported, the patient was seen in the clinic three weeks ago (on the 14th), when they were prescribed with Vivotif and the patient took one or two pills (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from the reporter via Med Communications on 06-Mar-2024: included confirmation of patient's gender and that patient took one or two pills.; Reporter's Comments: A 16-year-old male patient took a dose of Vivotif orally, at an unknown dose, for typhoid prophylaxis. Reportedly, the patient was seen in the clinic three weeks ago, when they were prescribed with Vivotif and the patient took one or two pills which is currently considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient'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 16-year-old male patient took a dose of Vivotif orally, at an unknown dose, for typhoid prophylaxis. Reportedly, the patient was seen in the clinic three weeks ago, when they were prescribed with Vivotif and the patient took one or two pills which is currently considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient'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
2829487 NC 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product storage error Product storage error
Vivotif vaccine was stored at 72 Fahrenheit degrees for one week; The patients did the entire course... Vivotif vaccine was stored at 72 Fahrenheit degrees for one week; The patients did the entire course of vaccination after temperature excursion; Vivotif vaccine was stored at 72 Fahrenheit degrees for one week; The patients did the entire course of vaccination after temperature excursion; Case reference number US-BN-2024-000617 is a spontaneous case received from a pharmacist initially received from Med Communications (reference number: USBAV24-0485) on 11-Mar-2024 and concerns two child patients. The patients' medical history and concomitant medications were not provided. On an unspecified date, the Vivotif vaccine was exposed to the first temperature excursion reaching a temperature of 72 Fahrenheit degrees for one week (explicitly coded as 'product storage error'). As reported, mother of patients did not put vaccine in refrigerator. On an unspecified date, an unknown amount of time after the first temperature excursion, patients were vaccinated with Vivotif vaccine (batch number: unknown), at an unknown dose and route of administration for an unknown indication (explicitly coded as 'product administration error'). As reported, patients did the entire course of vaccination. At the time of the initial report, it was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Additional information received on 11-Mar-2024 from a pharmacist via Med Communications: included confirmation about initials and date of birth for second patient and additional reference number (USBAV24-0484).; Reporter's Comments: Two child patients were vaccinated with Vivotif vaccine for an unknown indication, which was exposed to the first temperature excursion reaching a temperature of 72 Fahrenheit degrees for one week, which is considered as product storage error and product administration error. It was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' 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: Two child patients were vaccinated with Vivotif vaccine for an unknown indication, which was exposed to the first temperature excursion reaching a temperature of 72 Fahrenheit degrees for one week, which is considered as product storage error and product administration error. It was unknown if any of the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' 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
2829488 F 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Incomplete course of vaccination, Rash Incomplete course of vaccination, Rash
The patient develop rash after receiving two of four doses of the Vivotif vaccine; The patient recei... The patient develop rash after receiving two of four doses of the Vivotif vaccine; The patient received two of the four doses of the Vivotif vaccine; Case reference number US-BN-2024-000625 is a spontaneous case initially received from other health professional via Communications (reference number: USBAV24-0480) on 10-Mar-2024, received and concerns female patient of unknown age. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient took first dose of Vivotif vaccine (batch number: unknown), administered orally, at an unknown dose, for typhoid immunization. On unspecified date, unknown amount of time after first dose, the patient took second dose of Vivotif vaccine (batch number: unknown), administered orally, at an unknown dose. As reported, the patient was told to stop Vivotif vaccination (explicitly coded as 'inappropriate schedule of vaccine administered'). On unspecified date, unknown amount of time after second dose of Vivotif vaccine, as reported, the patient developed severe rash and was sent to the hospital, for unspecified duration. The patient was treated with high dose steroids for twelve days. On unspecified date, the patient recovered from the event of rash. As reported, it took twelve days of high dose steroids for the rash to resolve. The reporter assessed the event of rash as serious. Causality assessment was reported as possibly related. No further information was provided.; Reporter's Comments: A female patient of unknown age was told to stop Vivotif vaccination after she took the second dose (administered unknown time after the first dose) which is considered as inappropriate schedule of vaccine administered. The patient developed serious event of severe rash and was sent to the hospital, unknown time after the second dose of Vivotif vaccine. Reportedly, the patient was treated with high dose steroids for twelve days. Rash is listed and expected according to CCDS v8 and USPI for Vivotif while inappropriate schedule of product administration is considered listed per company convention. The outcome of rash was resolved. The patient's medical history and concomitant medications were not provided. Rash is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is serious due to seriousness criteria of hospitalization.; Sender's Comments: A female patient of unknown age was told to stop Vivotif vaccination after she took the second dose (administered unknown time after the first dose) which is considered as inappropriate schedule of vaccine administered. The patient developed serious event of severe rash and was sent to the hospital, unknown time after the second dose of Vivotif vaccine. Reportedly, the patient was treated with high dose steroids for twelve days. Rash is listed and expected according to CCDS v8 and USPI for Vivotif while inappropriate schedule of product administration is considered listed per company convention. The outcome of rash was resolved. The patient's medical history and concomitant medications were not provided. Rash is assessed as related due to known product safety profile, lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is serious due to seriousness criteria of hospitalization. More
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2829489 F CA 03/04/2025 TYP
TYP
 BERNA BIOTECH, LTD.
BERNA BIOTECH, LTD.
 Unknown
Unknown
Abdominal pain upper, Diarrhoea, Fatigue, Headache, Incomplete course of vaccina... Abdominal pain upper, Diarrhoea, Fatigue, Headache, Incomplete course of vaccination; Vomiting More
The patient felt completely down for the day after taking Vivotif; The patient was not able to conti... The patient felt completely down for the day after taking Vivotif; The patient was not able to continue with Vivotif administration; Stomach cramps and pain in the belly; Diarrhea (ten to 15 times); Vomiting (ten to 15 times); Headache; Fatigue, Completely drained out; Case reference number US-BN-2024-000628 is a spontaneous case report initially received from other health care professional via Med Communications (reference number: USBAV24-0502) on 12-Mar-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medications were not provided. On 10-Mar-2024, the patient took first dose of Vivotif (batch number: unknown), orally, at unknown dose, for typhoid immunization indication. On 11-Mar-2024, one day after taking Vivotif vaccine, the patient experienced pain in the belly, stomach cramps, diarrhea (ten to 15 times), vomiting (ten to 15 times), headache, fatigue. As reported, the patient was completely down for the day after taking Vivotif and completely drained out. As reported, the patient was not able to continue with Vivotif administration (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, the patient was recovering from pain in the belly, stomach cramps, diarrhea, vomiting, headache, fatigue and completely down. As reported, the patient felt much better on the following day. The reporter assessed the events of pain in the belly, stomach cramps, diarrhea, vomiting, headache, fatigue and completely down as non-serious and possibly related to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age experienced non-serious events of pain in the belly, stomach cramps, diarrhea (ten to 15 times), vomiting (ten to 15 times), headache, fatigue, was completely down for the day and was completely drained out on the day 1 after the patient took first dose of Vivotif for typhoid immunization indication. Reportedly, the patient was not able to continue with Vivotif administration, which is considered as incomplete course of vaccination. Abdominal pain upper, diarrhoea, vomiting, headache and fatigue are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst depressed mood is unlisted and unexpected. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. The patient was recovering from the events. Considering plausible temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the events have been considered as related to Vivotif. Incomplete course of vaccination 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 female patient of unspecified age experienced non-serious events of pain in the belly, stomach cramps, diarrhea (ten to 15 times), vomiting (ten to 15 times), headache, fatigue, was completely down for the day and was completely drained out on the day 1 after the patient took first dose of Vivotif for typhoid immunization indication. Reportedly, the patient was not able to continue with Vivotif administration, which is considered as incomplete course of vaccination. Abdominal pain upper, diarrhoea, vomiting, headache and fatigue are listed and expected for Vivotif according to the CCDS v8 and USPI, whilst depressed mood is unlisted and unexpected. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. The patient was recovering from the events. Considering plausible temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the events have been considered as related to Vivotif. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829490 F NH 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product dose omission issue Product dose omission issue
The patient only took three out of four doses of Vivotif before the medication was lost; Case refere... The patient only took three out of four doses of Vivotif before the medication was lost; Case reference number US-BN-2024-000644 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0532) on 18-Mar-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first, second, and third dose of Vivotif (batch number: unknown), at an unknown dose or route of administration, for unknown indication. As reported, the patient only took three out of four doses before the medication was lost (explicitly coded as 'missed dose'). The patient wanted to know if the vaccination needed to be restarted. 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, second, and third dose of Vivotif for unknown indication. As reported, the patient only took three out of four doses before the medication was lost, 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 female patient of unknown age took the first, second, and third dose of Vivotif for unknown indication. As reported, the patient only took three out of four doses before the medication was lost, 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
2829491 M CA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003907
Incorrect dose administered Incorrect dose administered
The reporter took first dose of Vivotif which was three days in the counter, maximum temperature rea... The reporter took first dose of Vivotif which was three days in the counter, maximum temperature reached 70 Fahrenheit; The reporter took first dose of Vivotif which was three days in the counter, maximum temperature reached 70 Fahrenheit; Case reference number US-BN-2024-000665 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0547) on 21-Mar-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. As reported, the reporter took Vivotif from pharmacy which prescribed by doctor, nobody said anything that needed to be refrigerated, so for first three days Vivotif was sitting on the counter. Maximum temperature reached 70 Fahrenheit. On 20-Mar-2024, the patient took the first dose of Vivotif (batch number: 3003907), at an unknown dose, orally, for typhoid immunization (explicitly coded as 'Product administration error' and 'Product storage error') At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age took the first dose of Vivotif, which was for first three days sitting on the counter (maximum temperature reached 70 Fahrenheit), for typhoid immunization, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age took the first dose of Vivotif, which was for first three days sitting on the counter (maximum temperature reached 70 Fahrenheit), for typhoid immunization, which is considered as product administration error and product storage error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829492 F WA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004009
Inappropriate schedule of product administration, No adverse event, Product stor... Inappropriate schedule of product administration, No adverse event, Product storage error More
The patient took first and the second dose of Vivotif which was left at room temperature at 65 Fahre... The patient took first and the second dose of Vivotif which was left at room temperature at 65 Fahrenheit about four of five days; The patient took first and the second dose of Vivotif which was left at room temperature at 65 Fahrenheit about four of five days; The patient took second dose of Vivotif four days after the first dose; Case reference number US-BN-2024-000674 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0568) on 25-Mar-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. As reported, the product of Vivotif was left at room temperature at 65 Fahrenheit for about four of five days. On 21-Mar-2024, the patient took first dose of Vivotif (batch number: 3004009) at unknown dose, orally, for indication reported as immunization against disease caused by Salmonella typhi (explicitly coded as 'Product administration error' and 'Product storage error'). On 25-Mar-2024, four days after fist dose of Vivotif the patient received second dose of Vivotif (batch number: 3004009) at unknown dose, orally (explicitly coded as 'Product administration error', 'Product storage error' 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 vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age took first dose of Vivotif that was left at room temperature at 65 Fahrenheit, at unknown dose, orally, for indication reported as immunization against disease caused by Salmonella typhi, which is considered as product administration error and product storage error. Four days later, the patient received second dose of Vivotif , which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered, product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took first dose of Vivotif that was left at room temperature at 65 Fahrenheit, at unknown dose, orally, for indication reported as immunization against disease caused by Salmonella typhi, which is considered as product administration error and product storage error. Four days later, the patient received second dose of Vivotif , which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered, product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious. More
2829493 F MN 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient took first two capsules on two consecutive days; Case reference number US-BN-2024-000675 is ... Patient took first two capsules on two consecutive days; Case reference number US-BN-2024-000675 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-0560) on 25-Mar-2024 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. It was reported that patient did not read the instructions and patient took first two capsules of Vivotif (batch number: Unknown), on two consecutive days, orally, for unknown indication (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information provided.; Reporter's Comments: A female patient of unspecified age did not read the instructions and took first two capsules of Vivotif, on two consecutive days, for 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 relevant medical history and concomitant medications 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 of unspecified age did not read the instructions and took first two capsules of Vivotif, on two consecutive days, for 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 relevant medical history and concomitant medications were not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious. More
2829494 F MN 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004041
Product storage error Product storage error
The patient took one dose of Vivotif vaccine which was left at ambient temperature for six hours, ma... The patient took one dose of Vivotif vaccine which was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit; The patient took one dose of Vivotif vaccine which was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit; Case reference number US-BN-2024-001725 is a spontaneous case report initially received from a physician via Med Communications (reference number USBAV24-0574) on 27-Mar-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 was left one box of Vivotif vaccine at ambient temperature for six hours, maximum temperature was 68 Fahrenheit. On an unspecified date the patient took dose of Vivotif (batch number: 3004041), at unknown dose, reported as one pill, route or site administration for indication reported as immunization (explicitly coded as 'Product administration error' and 'Product storage error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age took a dose of Vivotif, that was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit, for indication reported as immunization, which is considered as product administration error and product storage error. No associated adverse events were reported. Product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took a dose of Vivotif, that was left at ambient temperature for six hours, maximum temperature was 68 Fahrenheit, for indication reported as immunization, which is considered as product administration error and product storage error. No associated adverse events were reported. Product administration error and product storage error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error are not related to Vivotif, but to a human factor. The case is non-serious. More
2829495 UT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
Four patients did not take the fourth dose of Vivotif as the box of pills was lost; Case reference n... Four patients did not take the fourth dose of Vivotif as the box of pills was lost; Case reference number US-BN-2024-001737 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0596) on 29-Mar-2024 and concerns four patients of unspecified age or gender. The patients' medical history and concomitant medication details were not provided. On an unspecified dates, the patients took first, second and third doses of Vivotif (batch number: unknown) at an unknown dose, orally, for unknown indication. As reported, the patients were supposed to take the fourth dose of Vivotif on 29-Mar-2024, however the four patients did not take the fourth dose as the box of pills was lost (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown whether the patients experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: Four patients of unspecified age or gender were supposed to take the fourth dose of Vivotif on 29-Mar-2024, however the patients did not take the fourth dose as the box of pills was lost, which is considered as inappropriate schedule of vaccine administered. It was unknown whether the patients experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patients' 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: Four patients of unspecified age or gender were supposed to take the fourth dose of Vivotif on 29-Mar-2024, however the patients did not take the fourth dose as the box of pills was lost, which is considered as inappropriate schedule of vaccine administered. It was unknown whether the patients experienced any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patients' 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
2829496 M TN 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003901
Drug intolerance, Nausea, Vomiting Drug intolerance, Nausea, Vomiting
Patient could not tolerate the Vivotif, vomited and was nauseated all day; Patient could not tolerat... Patient could not tolerate the Vivotif, vomited and was nauseated all day; Patient could not tolerate the Vivotif, vomited and was nauseated all day; Patient could not tolerate the Vivotif, vomited and was nauseated all day; Case reference number US-BN-2024-001740 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0614) on 01-Apr-2024 and concerns a *16-year-old* male patient. *The patient had no medical history*. The patient's concomitant medication details were not provided. *On 03-Sep-2024, the patient took a first dose of Vivotif (batch number: 3003901, expiry date: 30-Jun-2024) orally, at an unknown dose, for typhoid. As reported the patient had not taken any other medications at the time of the events and no laboratory tests were performed*. *On the same day, eight hours from the first dose, the patient severely could not tolerate the Vivotif. Additionally, the patient severely vomited and felt moderately nauseated all day*. *On the same day, the patient recovered from the events drug intolerance, nauseated and vomited*. The reporter assessed the events drug intolerance, nauseated and vomited as non-serious and causality was assessed for the events drug intolerance, nauseated and vomited as possible. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from a nurse via manufacturer on 23-Apr-2024: New information included added patient demographic details (initials, age and date of birth), dosage details of Vivotif, events start date, stop date, outcome, intensity and confirmation on the medical history, laboratory tests and other medications administered at the time of Vivotif.; Reporter's Comments: A 16-year-old male patient could not tolerate the Vivotif (eight hours from the first dose), vomited and was nauseated all day. Nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst drug intolerance is listed per company convention as a non-specific event. The outcome was resolved. The patient had no medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality for all reported events is assessed as related to Vivotif. The case is non-serious.; Sender's Comments: A 16-year-old male patient could not tolerate the Vivotif (eight hours from the first dose), vomited and was nauseated all day. Nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst drug intolerance is listed per company convention as a non-specific event. The outcome was resolved. The patient had no medical history and concomitant medication details were not provided. Due to plausible temporal relationship and product known safety profile, the causality for all reported events is assessed as related to Vivotif. The case is non-serious. More
2829497 F OR 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
The patient took the second dose of Vivotif one day after the first dose; Case reference number US-B... The patient took the second dose of Vivotif one day after the first dose; Case reference number US-BN-2024-001741 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0608) on 01-Apr-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 30-Mar-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization. On 31-Mar-2024, one day after the first dose of Vivotif, as reported the patient woke up on Sunday morning super sleepy and thought it was Monday and the patient took the second dose of Vivotif (batch number: unknown), at unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age took a second dose of Vivotif one day after the first dose for typhoid immunization, 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 of unspecified age took a second dose of Vivotif one day after the first dose for typhoid immunization, 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
2829498 F CA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product storage error Product storage error
The patient left Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahre... The patient left Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit; The patient left Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit; Case reference number US-BN-2024-001746 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0616) on 01-Apr-2024 and concerns a 43-years-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit. On 01-Apr-2024, the patient took the first dose of Vivotif (batch number: unknown), orally, at unknown dose or site administration for unknown indication (explicitly coded as 'Product administration error' and 'Product storage error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from health care professional via Med Communications on 02-Apr-2024 included clarification about the age of patient.; Reporter's Comments: A 43-year-old female patient took the first dose of Vivotif, after the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit, 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 vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 43-year-old female patient took the first dose of Vivotif, after the patient left one box of Vivotif vaccine at room temperature for four days, maximum temperature was 65 Fahrenheit, 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 vaccine. Product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administration error and product storage error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829499 OR 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
The patient took dose of Vivotif vaccine one consecutive days; Case reference number US-BN-2024-0017... The patient took dose of Vivotif vaccine one consecutive days; Case reference number US-BN-2024-001747 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0615) on 01-Apr-2024 and concerns a patient of unspecified gender or age. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took unknown number of doses of Vivotif vaccine (batch number: unknown) orally, at unknown dose for unknown indication, as reported on consecutive 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 event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unspecified gender or age took unknown number of doses of Vivotif vaccine for unknown indication, as reported on consecutive days, 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 patient of unspecified gender or age took unknown number of doses of Vivotif vaccine for unknown indication, as reported on consecutive days, 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
2829500 M UT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient took first and second dose of Vivotif and went out of town for four days and wanted to k... The patient took first and second dose of Vivotif and went out of town for four days and wanted to know if the vaccination can be resumed; Case reference number US-BN-2024-001748 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0625) on 02-Apr-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication was not provided. On unspecified date, reported as last week, the patient took first and second doses of Vivotif (batch number: unknown), orally, at an unknown dose, for typhoid prophylaxis. As reported, the patient went out of town for four days and the patient wanted to know if the vaccination should be resumed (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age took first and second doses of Vivotif for typhoid prophylaxis. As reported, the patient went out of town for four days and the patient wanted to know if the vaccination should be resumed, 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 was 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 male patient of unspecified age took first and second doses of Vivotif for typhoid prophylaxis. As reported, the patient went out of town for four days and the patient wanted to know if the vaccination should be resumed, 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 was not provided. Inappropriate schedule of vaccine administered is not related to Vivotif, but to a human factor. The case is non-serious. More
2829501 M GA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product storage error Product storage error
The patient took two doses of Vivotif vaccine which left at room temperature for over 72 hours, maxi... The patient took two doses of Vivotif vaccine which left at room temperature for over 72 hours, maximum temperature reached was room temperature 70 Fahrenheit; The patient took two doses of Vivotif vaccine which left at room temperature for over 72 hours, maximum temperature reached was room temperature 70 Fahrenheit; Case reference number US-BN-2024-001756 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0632) on 03-Apr-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported on Saturday, the patient left one box of Vivotif vaccine at room temperature for 72 hours, maximum temperature was 70 Fahrenheit. On an unspecified dates, as reported the patient took two doses of Vivotif (batch number: unknown), at unknown dose, orally, for typhoid immunization (explicitly coded as 'Product administration error' and 'Product storage error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unknown age took two doses of Vivotif left at room temperature for 72 hours (maximum temperature was 70 Fahrenheit), which is considered product administration error and product storage error. Product administration error and product storage error are listed by convention. No associated adverse events were reported. Product administration error and product storage error are not related to the suspect product, but to a human action.; Sender's Comments: A male patient of unknown age took two doses of Vivotif left at room temperature for 72 hours (maximum temperature was 70 Fahrenheit), which is considered product administration error and product storage error. Product administration error and product storage error are listed by convention. No associated adverse events were reported. Product administration error and product storage error are not related to the suspect product, but to a human action. More
2829502 F MA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Diarrhoea, Incomplete course of vaccination Diarrhoea, Incomplete course of vaccination
The patient had diarrhea after first two doses of Vivotif vaccine; The patient received three doses ... The patient had diarrhea after first two doses of Vivotif vaccine; The patient received three doses of Vivotif vaccine and did not want to take the fourth dose; Case reference number US-BN-2024-001760 is a spontaneous case report initially received from other health professional via Med Communications (reference number: USBAV24-0653) on 04-Apr-2024 and concerns an elderly female patient. 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), at an unknown dose, orally, for unknown indication. On unspecified date, unknown amount of time after the first dose, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication. On unspecified date, unknown amount of time after the second dose of Vivotif, the patient experienced diarrhea. On unspecified date, the patient recovered from the event of diarrhea. On unspecified date, unknown amount of time after the second dose, the patient took the third dose of Vivotif (batch number: unknown), at an unknown dose, orally. As reported, when the patient took third dose of Vivotif, the patient did not experience diarrhea but did not want to take the fourth dose as the fourth dose was close to travel (explicitly coded as 'incomplete course of vaccination'). The reporter assessed the event of diarrhea as non-serious and possibly related to Vivotif. No further information provided.; Reporter's Comments: An elderly female patient experienced diarrhea, unknown time after the second dose of Vivotif. Unknown time after the second dose, the patient took the third dose of Vivotif, at an unknown dose, orally. Reportedly, when the patient took third dose of Vivotif, the patient did not experience diarrhea but did not want to take the fourth dose as the fourth dose was close to travel which is considered as incomplete course of vaccination. Diarrhea is listed according to the CCDS v8 for Vivotif while incomplete course of vaccination is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of diarrhea was resolved. Causality assessment for diarrhea is related due to known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An elderly female patient experienced diarrhea, unknown time after the second dose of Vivotif. Unknown time after the second dose, the patient took the third dose of Vivotif, at an unknown dose, orally. Reportedly, when the patient took third dose of Vivotif, the patient did not experience diarrhea but did not want to take the fourth dose as the fourth dose was close to travel which is considered as incomplete course of vaccination. Diarrhea is listed according to the CCDS v8 for Vivotif while incomplete course of vaccination is considered listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of diarrhea was resolved. Causality assessment for diarrhea is related due to known product safety profile, lack of alternative explanation and since contributory role of suspect product cannot be excluded. Incomplete course of vaccination is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829503 M TN 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Product storage error Product storage error
The patient took two capsules of Vivotif which were left at room temperature for almost three weeks;... The patient took two capsules of Vivotif which were left at room temperature for almost three weeks; The patient took two capsules of Vivotif which were left at room temperature for almost three weeks; Case reference number US-BN-2024-001762 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0651) on 04-Apr-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 18-Mar-2024, the patient left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks (explicitly coded as and 'product storage error'). On unspecified dates, the patient took first and second dose of affected Vivotif (batch number: unknown), at unknown dose, orally for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks which is considered as product storage error. reportedly, the patient took first and second dose of affected Vivotif, at unknown dose, orally for unknown indication 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 vaccine. 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 male patient of unspecified age left Vivotif vaccine out of the refrigerator at room temperature for almost three weeks which is considered as product storage error. reportedly, the patient took first and second dose of affected Vivotif, at unknown dose, orally for unknown indication 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 vaccine. 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
2829504 M CO 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Abdominal pain Abdominal pain
The patient experienced some abdominal pain with cramping; Case reference number US-BN-2024-001773 i... The patient experienced some abdominal pain with cramping; Case reference number US-BN-2024-001773 is a spontaneous case report initially received from other health care professional via Med Communications (reference number USBAV24-0671) on 05-Apr-2024 and concerns a 14-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 01-Apr-2024, the patient took first dose of Vivotif (batch number: unknown) at unknown dose, orally, for immunization against disease caused by Salmonella typhi. On 03-Apr-2024, two days after the first dose of Vivotif, the patient took second dose of Vivotif (batch number: unknown) at unknown dose, orally. On 05-Apr-2024, two days after the second dose of Vivotif, the patient took third dose of Vivotif (batch number: unknown) at unknown dose, orally. On unspecified date, the patient experienced some abdominal pain with cramping. The patient's treatment for abdominal pain with cramping included Tylenol. At the time of initial report, the outcome for the event of abdominal pain with cramping was unknown. The reporter assessed the abdominal pain with cramping as non-serious and possibly related to the product of Vivotif. No further information was provided.; Reporter's Comments: A 14-year-old male patient took three doses of Vivotif vaccine, for immunization against disease caused by Salmonella typhi. On unspecified date, the patient experienced some abdominal pain with cramping. Abdominal pain is listed/expected for Vivotif according to CCDS version 8.0 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome for the event of abdominal pain with cramping was unknown. Due to implied temporal relationship, product known safety profile and lack of alternative etiology at the moment, the causality for reported event is assessed as related to Vivotif. The case is non-serious.; Sender's Comments: A 14-year-old male patient took three doses of Vivotif vaccine, for immunization against disease caused by Salmonella typhi. On unspecified date, the patient experienced some abdominal pain with cramping. Abdominal pain is listed/expected for Vivotif according to CCDS version 8.0 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome for the event of abdominal pain with cramping was unknown. Due to implied temporal relationship, product known safety profile and lack of alternative etiology at the moment, the causality for reported event is assessed as related to Vivotif. The case is non-serious. More
2829505 M WA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004007
Product administration error Product administration error
The patient ate five minutes after took Vivotif; Case reference number US-BN-2024-001774 is a sponta... The patient ate five minutes after took Vivotif; Case reference number US-BN-2024-001774 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number USBAV24-0686) on 08-Apr-2024 and concerns a 53-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 07-Apr-2024, as reported the patient ate and after five minutes took first dose of Vivotif (batch number: 3004007), at unknown dose, orally, site administration was unknown, for indication reported as immunization against disease caused by salmonella typhi (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A 53-year-old male patient ate and after five minutes took the first dose of Vivotif for indication reported as immunization against disease caused by salmonella typhi, 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 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 53-year-old male patient ate and after five minutes took the first dose of Vivotif for indication reported as immunization against disease caused by salmonella typhi, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829506 M CA 03/04/2025 TYP
TYP
 BERNA BIOTECH, LTD.
UNKNOWN MANUFACTURER
 3004009
Unknown
Incomplete course of vaccination, Interchange of vaccine products, Malaise, Naus... Incomplete course of vaccination, Interchange of vaccine products, Malaise, Nausea, Vomiting; Incomplete course of vaccination, Interchange of vaccine products, Malaise, Nausea, Vomiting More
The patient was unable to take the scheduled fourth dose of Vivotif; The patient received Vivotif an... The patient was unable to take the scheduled fourth dose of Vivotif; The patient received Vivotif and killed Typhoid vaccine; The patient felt mildly unwell after first dose of Vivotif; The patient become extremely nauseous and vomited after second dose of Vivotif; The patient become extremely nauseous and vomited after second dose of Vivotif; The patient vomited after third dose of Vivotif; The patient had severe nausea after third dose of Vivotif; Case reference number US-BN-2024-001776 is a spontaneous case report initially received from a physician (self-report) via Emergent BioSolutions (reference number: EMG2024-430) on 04-Apr-2024 and concerns a male 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: 3004009; expiration date: Oct-2024), at an unknown dose, orally, for unknown indication. On an unspecified date, for unknown amount of time after the first dose of Vivotif the patient felt mildly unwell. On an unspecified date, for unknown amount of time after first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004009; expiration date: Oct-2024), at an unknown dose, orally. On an unspecified date, as reported about 12 hours after the second dose of Vivotif, the patient become extremely nauseous and vomited. On an unspecified date, for unknown amount of time after second dose of Vivotif, the patient took the third dose of Vivotif (batch number: 3004009; expiration date: Oct-2024), at an unknown dose, orally. On an unspecified date, as reported within 20 minutes, the patient vomited and for the next total of five days had severe nausea. As reported, the patient was unable to take the scheduled fourth dose of Vivotif (explicitly coded as 'inappropriate schedule of vaccine administered'), however received as reported co-suspect killed typhoid vaccine (brand name unknown; batch number unknown), at an unknown dose, route or site of administration, for unknown indication (explicitly coded as 'interchange of vaccine products'). At the time of the initial report, the outcome for the events of mildly unwell, an both instances of vomiting and nausea was unknown. The reporter did not provide seriousness assessment for the events of mildly unwell and both instances of vomiting and nausea, while the causality was assessed as possibly related to Vivotif, reported as adverse reaction. Additional information received from Med Communications on 05-Apr-2024, included additional reference number (USBAV24-0673).; Reporter's Comments: A male patient of unspecified age felt mildly unwell unknown amount of time after the first dose of Vivotif was administered for an unknown indication. Reportedly, 12 hours after the second dose of Vivotif, the patient become extremely nauseous and vomited. Within 20 minutes of receiving the third dose, the patient vomited and for the next total of five days had severe nausea. Additionally, the patient was unable to take the scheduled fourth dose of Vivotif, however received as reported co-suspect killed typhoid vaccine, which is considered as inappropriate schedule of vaccine administered and interchange of vaccine products. Malaise, nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst inappropriate schedule of vaccine administered and interchange of vaccine products are listed per company convention. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, the outcome for the events of mildly unwell, an both instances of vomiting and nausea was unknown. Due to plausible temporal relationship and product known safety profile, the causality for reported malaise, nause and vomiting is assessed as related to Vivotif. Inappropriate schedule of vaccine administered and interchange of vaccine products are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: A male patient of unspecified age felt mildly unwell unknown amount of time after the first dose of Vivotif was administered for an unknown indication. Reportedly, 12 hours after the second dose of Vivotif, the patient become extremely nauseous and vomited. Within 20 minutes of receiving the third dose, the patient vomited and for the next total of five days had severe nausea. Additionally, the patient was unable to take the scheduled fourth dose of Vivotif, however received as reported co-suspect killed typhoid vaccine, which is considered as inappropriate schedule of vaccine administered and interchange of vaccine products. Malaise, nausea and vomiting are listed/expected for Vivotif according to CCDS version 8.0 and USPI, whilst inappropriate schedule of vaccine administered and interchange of vaccine products are listed per company convention. The patient's medical history and concomitant medication details were not provided. At the time of the initial report, the outcome for the events of mildly unwell, an both instances of vomiting and nausea was unknown. Due to plausible temporal relationship and product known safety profile, the causality for reported malaise, nause and vomiting is assessed as related to Vivotif. Inappropriate schedule of vaccine administered and interchange of vaccine products are not related to Vivotif, but to a human factor. The case is non-serious. More
2829507 F CA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3003852
Product storage error Product storage error
Vivotif vaccine was stored at approximately 70 Fahrenheit degrees for at least 24 hours and the pati... Vivotif vaccine was stored at approximately 70 Fahrenheit degrees for at least 24 hours and the patient already started treatment; Vivotif vaccine was stored at approximately 70 Fahrenheit degrees for at least 24 hours and the patient already started treatment; Case reference number US-BN-2024-001777 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-0668) on 05-Apr-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, as reported, the patient left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. As reported, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated (explicitly coded as 'product storage error'). On an unspecified date, the patient took the first dose of Vivotif (batch number: 3003852), at unknown dose, orally for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. Reportedly, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated which is considered as product storage error. The patient took the first dose of Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both considered listed per company conventions. 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 left Vivotif vaccine for at least 24 hours, but maybe more, out of the refrigerator, maximum temperature was approximately 70 Fahrenheit degrees. Reportedly, the patient's grandfather was not told at the pharmacy that vaccine had to be refrigerated which is considered as product storage error. The patient took the first dose of Vivotif, at unknown dose, orally for unknown indication which is considered as product administration error. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both considered listed per company conventions. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2829508 M NC 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
COVID-19, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive COVID-19, Cough, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test positive
Patient had tested positive to COVID and had some mild congestion, cough and no other symptoms; Case... Patient had tested positive to COVID and had some mild congestion, cough and no other symptoms; Case reference number US-BN-2024-001786 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0707) on 10-Apr-2024 and concerns a 54-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 05-Apr-2024, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for immunization against disease caused by salmonella typhi. On 07-Apr-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose, via oral use. On 09-Apr-2024, four days after the first dose, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose, via oral use. As reported, patient was taking the medication and got sick with COVID, had third dose yesterday morning, already feeling feverish at that time, but the patient didn't know whether to take the dose or not, so the patient took his dose yesterday, feeling much better, patient says hasn't had a fever since last night. On an unspecified date, the patient tested positive to Covid-19 and the patient had some mild congestion, cough and no other symptoms. At the time of the initial report, the outcome of the event COVID-19 was unknown. The reporter assessed the event COVID-19 as non-serious and causality as possible for the event COVID-19.; Reporter's Comments: A 54-year-old male patient tested positive to Covid-19 after the patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi. COVID-19 is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering the nature of the event, COVID-19 has been considered as not related to the suspect vaccine, but to an infection. This case is considered as non-serious.; Sender's Comments: A 54-year-old male patient tested positive to Covid-19 after the patient took the third dose of Vivotif for immunization against disease caused by salmonella typhi. COVID-19 is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering the nature of the event, COVID-19 has been considered as not related to the suspect vaccine, but to an infection. This case is considered as non-serious. More
2829509 M ID 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient received the second dose of Vivotif vaccine on 11-Apr-2024 and forgot the third and four... The patient received the second dose of Vivotif vaccine on 11-Apr-2024 and forgot the third and fourth dose; Case reference number US-BN-2024-001806 is a spontaneous case report initially received from a nurse via Med Communications (reference number: USBAV24-0765) on 16-Apr-2024 and concerns an 18-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 09-Apr-2024, the patient took the first dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally, for immunization against disease caused by Salmonella typhi. On 11-Apr-2024, two days after the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown), at unknown dose, orally. As reported, the patient forgot the third and the fourth dose of Vivotif vaccine and it has been four or five days (explicitly coded as 'missed dose'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: An 18-year-old male patient forgot the third and the fourth dose of Vivotif vaccine after the patient took the first and the second dose of Vivotif vaccine for immunization against disease caused by Salmonella typhi, and it has been four or five days, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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: An 18-year-old male patient forgot the third and the fourth dose of Vivotif vaccine after the patient took the first and the second dose of Vivotif vaccine for immunization against disease caused by Salmonella typhi, and it has been four or five days, which is considered as missed dose. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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
2829510 F NY 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Inappropriate schedule of product administration, Product administration error Inappropriate schedule of product administration, Product administration error
The patient took first dose and second of Vivotif vaccine on two consecutive days; The patient took ... The patient took first dose and second of Vivotif vaccine on two consecutive days; The patient took the first dose of Vivotif vaccine with food; Case reference number US-BN-2024-001817 is a spontaneous case report initially received from a consumer (self-report) via Med Communications (reference number: USBAV24-0773) on 18-Apr-2024 and concerns an elderly female patient. The patient's medical history and concomitant medications were not provided. On 16-Apr-2024, reported as on Tuesday, the patient took the first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, orally, for unknown indication. As reported, the patient took the first dose of Vivotif with food (explicitly coded as 'product administration error'). On 17-Apr-2024, reported as on Wednesday, one day after the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (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. Additional information received from Med Communications on 18-Apr-2024 included additional reference number, dates and route of Vivotif administration.; Reporter's Comments: An elderly female patient took the first dose of Vivotif with food, which is considered as product administration error. Reportedly, the patient took the second dose of Vivotif vaccine on the day 1 after the first 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 and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration 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: An elderly female patient took the first dose of Vivotif with food, which is considered as product administration error. Reportedly, the patient took the second dose of Vivotif vaccine on the day 1 after the first 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 and product administration error are considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration 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
2829511 KY 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004009
Inappropriate schedule of product administration, Incorrect dose administered, N... Inappropriate schedule of product administration, Incorrect dose administered, No adverse event More
Both patients took all four capsules of the Vivotif at one time; Both patients took all four capsule... Both patients took all four capsules of the Vivotif at one time; Both patients took all four capsules of the Vivotif at one time; Case reference number US-BN-2024-001825 is a spontaneous case report initially received from pharmacist via Med Communication (reference number: USBAV24-0755) on 16-Apr-2024 and concerns *64-year-old female patient and 65-year-old male patient (multi 2).* The patients relevant medical history and concomitant medications were not provided. *On 12-Apr-2024, two patients were vaccinated with all four doses of Vivotif (batch number: 3004009, expiry date: Oct-2024), at a dose of four capsules*, orally, for typhoid immunization (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered'). *At the time of follow up report, the patients did not experience any adverse event due to Vivotif vaccine*. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from a pharmacist on 16-May-2024: New information included patients demographic details (age, gender and initials), Vivotif dosage information, confirmation that the patients did not experience any adverse events.; Reporter's Comments: This case concerns 64-year-old female patient and 65-year-old male patient who were vaccinated with all four doses of Vivotif for typhoid immunization, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Overdose and inappropriate schedule of vaccine administered are not related to Vivotif, but to a human factor. The case is non-serious.; Sender's Comments: This case concerns 64-year-old female patient and 65-year-old male patient who were vaccinated with all four doses of Vivotif for typhoid immunization, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. No associated adverse events were reported. Overdose and inappropriate schedule of product administration are listed per company convention. The patients' relevant medical history and concomitant medications were not provided. Overdose and inappropriate schedule of vaccine administered are not related to Vivotif, but to a human factor. The case is non-serious. More
2829512 F MI 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 Unknown
Gastrointestinal disorder, Vomiting Gastrointestinal disorder, Vomiting
The patient had gastrointestinal illness; The patient vomited and saw Vivotif capsule in vomit; Case... The patient had gastrointestinal illness; The patient vomited and saw Vivotif capsule in vomit; Case reference number US-BN-2024-001826 is a spontaneous case report initially received from nurse via Med Communications (reference number: USBAV24-0825) on 23-Apr-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On unspecified dates, the patient took the first, second and third dose of Vivotif (batch number: unknown), at an unknown dose, orally, for unknown indication. On unspecified date, for unknow amount of time after first dose of Vivotif, the patient took the fourth dose of Vivotif (batch number: unknown), at an unknown dose, orally. On unspecified date, reported as eight hours after the last dose of Vivotif, the patient developed gastrointestinal illnesses, vomited and saw the capsule of Vivotif in vomit. At the time of initial repot it was unknown if the patient recovered form events of gastrointestinal illnesses and 'vomiting'. The reporter assessed the events of gastrointestinal illnesses and ' vomiting' as non-serious and possible related to the product of Vivotif. No further information was provided.; Reporter's Comments: A female patient developed non-serious events of gastrointestinal illnesses and vomiting reported as eight hours after the last dose of Vivotif for unknown indication. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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 developed non-serious events of gastrointestinal illnesses and vomiting reported as eight hours after the last dose of Vivotif for unknown indication. Gastrointestinal disorder and vomiting are considered as listed and expected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. 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
2829513 F 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004007
Product storage error Product storage error
Patient took one capsule of Vivotif, and Vivotif left out of fridge for 48 hours at max temperature ... Patient took one capsule of Vivotif, and Vivotif left out of fridge for 48 hours at max temperature of 68 degrees Fahrenheit and then patient took second dose; Patient took one capsule of Vivotif, and Vivotif left out of fridge for 48 hours at max temperature of 68 degrees Fahrenheit and then patient took second dose; Case reference number US-BN-2024-001828 is a spontaneous case report initially received from a consumer via Med Communication (reference number: USBAV24-0824) on 23-Apr-2023 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, as reported patient came back home from pharmacy and patient took first dose of Vivotif vaccine (batch number: 3004007), at unknown dose (capsule), orally, for indication reported taken prior to travel. Patient left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit (explicitly coded as 'product storage error temperature too high). On unspecified date, as reported two days after first dose, patient took second dose of Vivotif vaccine (batch number: 3004007), at unknown dose (capsule), orally (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit, which is considered as product storage error temperature too high. On unspecified date, as reported two days after first dose, the patient took the second dose of Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unspecified age left Vivotif package for 48 hours on max temperature of 68 degrees of Fahrenheit, which is considered as product storage error temperature too high. On unspecified date, as reported two days after first dose, the patient took the second dose of Vivotif vaccine, which is considered as product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2829514 M GA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004041
Incomplete course of vaccination, No adverse event, Product storage error Incomplete course of vaccination, No adverse event, Product storage error
The patient took three of four doses of Vivotif, which did not refrigerate; The patient took three o... The patient took three of four doses of Vivotif, which did not refrigerate; The patient took three of four doses of Vivotif, which did not refrigerate; The patient did not take fourth dose of Vivotif; Case reference number US-BN-2024-001836 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0843) on 25-Apr-2024 and concerns a *53-years-old* male patient. The patient's medical history and concomitant medication details were not provided. On 17-Apr-2024, the patient picked Vivotif vaccine and did not refrigerate (explicitly coded as and 'product storage error'). On 19-Apr-2024, the patient took the first dose of Vivotif (batch number: 3004041, *expiration date: Oct-2024), at one capsule*, orally, for typhoid immunization (explicitly coded as 'product administration error'). On 21-Apr-2024, three days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004041, *expiration date: Oct-2024), at one capsule*, orally (explicitly coded as 'product administration error'). On 23-Apr-2024, five days after the first dose of Vivotif, the patient took the third dose of Vivotif (batch number: 3004041, *expiration date: Oct-2024), at one capsule*, orally (explicitly coded as 'product administration error'). *As reported, the patient did not take fourth dose of Vivotif, and the patient will be restarting the Vivotif course due to upcoming travel (explicitly coded as ' Incomplete course of vaccination '). * *At the time of follow up, the patient did not experience any adverse event due to Vivotif vaccine. * All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from investigator on 06-May-2024: New information included confirmation that the patient received three doses of Vivotif, dosing information for all doses of Vivotif, patient demographic information and conformation that the patient did not experience any adverse event.; Reporter's Comments: A 53-year-old male patient picked Vivotif vaccine and did not refrigerate, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif, at unknown dose, orally, for typhoid immunization, which is considered as product administration error. Three days after the first dose of Vivotif, the patient took the second dose of Vivotif, at unknown dose, which is also considered as product administration error. It was confirmed that the patient received only three doses of Vivotif, which is considered as incomplete course of vaccination. Product storage error, incomplete course of vaccination and product administration error are listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 53-year-old male patient picked Vivotif vaccine and did not refrigerate, which is considered as product storage error. Reportedly, the patient took the first dose of Vivotif, at unknown dose, orally, for typhoid immunization, which is considered as product administration error. Three days after the first dose of Vivotif, the patient took the second dose of Vivotif, at unknown dose, which is also considered as product administration error. It was confirmed that the patient received only three doses of Vivotif, which is considered as incomplete course of vaccination. Product storage error, incomplete course of vaccination and product administration error are listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. More
2829515 M PA 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 30040009
Inappropriate schedule of product administration, No adverse event, Product stor... Inappropriate schedule of product administration, No adverse event, Product storage error More
The patient took one capsule of Vivotif which was approximately 48 hours at room temperature which r... The patient took one capsule of Vivotif which was approximately 48 hours at room temperature which reached about 70 Fahrenheit; The patient took one capsule of Vivotif which was approximately 48 hours at room temperature which reached about 70 Fahrenheit; Patient took only one dose of Vivotif; Case reference number US-BN-2024-001838 is a spontaneous case report initially received from a nurse via Med Communications (reference number USBAV24-0841) on 25-Apr-2024 and concerns a 19-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 22-Apr-2024, as reported, the typhoid was given to a patient, patient left Vivotif vaccine for approximately 48 hours at room temperature which reached about 70 degrees Fahrenheit (explicitly coded as 'product storage error'). On 24-Apr-2024, the patient took the first dose of affected Vivotif (batch number: 30040009, expiration date: 31-Oct-2024), at a dose reported as one tablet, orally for typhoid immunization (explicitly coded as 'product administration error', 'inappropriate schedule of vaccine'). *As reported, patient received a new Vivotif package and yet to begin with administration from 23-May-2024.* At the time of the follow up report, the patient did not experience any adverse event due to Vivotif vaccine. Non-significant case correction performed on 07-May-2024 for information received on 06-May-2024 included reporters email address. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow-up information received from nurse on 08-May-2024: New information included dosing information for first dose of Vivotif, patient's demographic information and confirmation that the patient did not experience any adverse event. Follow-up information received from nurse on 21-May-2024: included it was confirmed that patient had received a new Vivotif package, and it is yet to administer.; Reporter's Comments: A 19-year-old male patient left Vivotif vaccine for approximately 48 hours at room temperature which reached about 70 degrees Fahrenheit which is considered as product storage error. Reportedly, the patient took the first dose of affected Vivotif, at a dose reported as one tablet, orally for typhoid immunization, which is considered as product administration error and inappropriate schedule of vaccine. Product storage error, inappropriate schedule of vaccine and product administration error are considered listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error, inappropriate schedule of vaccine and product administration error are assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 19-year-old male patient left Vivotif vaccine for approximately 48 hours at room temperature which reached about 70 degrees Fahrenheit which is considered as product storage error. Reportedly, the patient took the first dose of affected Vivotif, at a dose reported as one tablet, orally for typhoid immunization, which is considered as product administration error and inappropriate schedule of vaccine. Product storage error, inappropriate schedule of vaccine and product administration error are considered listed per company conventions. The patient did not experience any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product storage error, inappropriate schedule of vaccine and product administration error are assessed as not related to suspect product but to human factor. The case is non-serious. More
2829516 F MT 03/04/2025 TYP
 BERNA BIOTECH, LTD.
 3004009
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received the second dose of Vivotif three days after the first dose; Case reference numb... The patient received the second dose of Vivotif three days after the first dose; Case reference number US-BN-2024-001845 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-0859) on 29-Apr-2024 and concerns a *22-year-old female patient.* The patient *had no relevant medical history and was not taking any concomitant medication.* On 26-Apr-2024, the patient took the first dose of Vivotif *(batch number: 3004009, expiration date: 31-Oct-2024)*, one capsule, orally, for typhoid immunization. As reported, patient was due to take the other dose on the 28th but forgot (explicitly coded as 'inappropriate schedule of vaccine administered'). *On 29-Apr-2024, three days after the first dose of Vivotif, the patient took the second dose of Vivotif (batch number: 3004009, expiration date: 31-Oct-2024), one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). The patient was advised it is safe to continue the rest of the doses every other day. The reporter did not continue to follow-up if the patient took the last two doses on schedule and assumed that the patient did.* At the time of the *follow-up* report, it was unknown if the patient experienced any adverse event due to Vivotif. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow up information received from the reporter on 10-Jun-2024, new information included: patient details, Vivotif dosing information, medical history and concomitant medications information. Non-significant case correction performed for information received form the reporter on 24-Jun-2024 included confirmation that patient did not report anything back to the clinic.; Reporter's Comments: A 22-year-old female patient took the second dose of Vivotif on the day 3 after the patient took the first dose of Vivotif for typhoid immunization, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 22-year-old female patient took the second dose of Vivotif on the day 3 after the patient took the first dose of Vivotif for typhoid immunization, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient had no relevant medical history and was not taking any concomitant medication. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
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