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
2847600 40 F WY 06/27/2025 COVID19
COVID19
 NOVAVAX
NOVAVAX
 6024MF012
6024MF012
Balance disorder, Central nervous system lesion, Condition aggravated, Gait dist... Balance disorder, Central nervous system lesion, Condition aggravated, Gait disturbance, Magnetic resonance imaging head abnormal; Neurological symptom, Vertigo More
New enhancing brain lesion after vaccination event on 09/24/2024, confirmed by MRI on 11/2/2024. PM... New enhancing brain lesion after vaccination event on 09/24/2024, confirmed by MRI on 11/2/2024. PMRI done prior to vaccination in mid-September 2024 did not show this lesion. Following vaccination, new neurologic symptoms appeared, including vertigo and balance/gait difficulties. More
โœ“
2847601 M MI 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP0052
Anosmia Anosmia
Loss of a sense of smell; Case reference number US-BN-2024-002414 is a spontaneous case initially re... Loss of a sense of smell; Case reference number US-BN-2024-002414 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-2166) on 29-Aug-2024 and concerns a 65-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 21-Aug-2024, the patient was vaccinated with the first dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration for post exposure from a bat bite. On 24-Aug-2024, three days after the first dose, the patient was vaccinated with the second dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration. On the same day, the patient experienced loss of smell. The patient did not receive any treatment for the event loss of smell. On 28-Aug-2024, seven days after the first dose, the patient was vaccinated with the third dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration. On 04-Sep-2024, 14 days after the first dose, the patient was vaccinated with the fourth dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration. On the same day, the patient recovered from the event loss of smell. The reporter assessed the seriousness of the event loss of smell as non-serious and causality was not provided for the event loss of smell. Additional information received from health care professional via Med Communication (reference number: USBAV24-2238) on 04-Sep-2024: Information included reference number (USBAV24-2238), Rabipur dosage information and updated outcome for the event of loss of smell.; Reporter's Comments: A 65-year-old male patient experienced a non-serious event of loss of smell on the day 0 after the patient was vaccinated with the second dose of Rabavert for post exposure from a bat bite. Anosmia is unlisted and unexpected for RabAvert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of anosmia is considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A 65-year-old male patient experienced a non-serious event of loss of smell on the day 0 after the patient was vaccinated with the second dose of Rabavert for post exposure from a bat bite. Anosmia is unlisted and unexpected for RabAvert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of anosmia is considered as related to RabAvert. This case is considered as non-serious. More
2847602 CA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patent received the second dose of RabAvert vaccine on day 10; Case reference number US-BN-2024-... The patent received the second dose of RabAvert vaccine on day 10; Case reference number US-BN-2024-002455 is a spontaneous case initially received from other health care professional via Med Communications (reference number USBAV24-2313) on 10-Sep-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as day zero, the patient received the first dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration, for pre-exposure prophylaxis. On an unspecified date, reported as day ten, the patient received the second dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). On an unspecified date, reported as day 28, the patient received the third dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration. At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. No further information was provided.; Reporter's Comments: A patient of unknown demographics received the second dose of RabAvert for pre-exposure prophylaxis on the day 10 after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown demographics received the second dose of RabAvert for pre-exposure prophylaxis on the day 10 after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847603 M 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient had been exposed to rabies on Friday, and only got the first dose of RabAvert on 12-Sep-2024... Patient had been exposed to rabies on Friday, and only got the first dose of RabAvert on 12-Sep-2024; Case reference number US-BN-2024-002501 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-2351) on 12-Sep-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, reported as on Friday, the patient had rabies exposure. As reported, it was unknown if the animal had rabies. On 12-Sep-2024, unknown amount of time after rabies exposure, the patient received the first dose of RabAvert (batch number: unknown), at an unknown dose, route and site of administration, for rabies post-exposure prophylaxis (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 RabAvert vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age received the first dose of RabAvert for rabies post-exposure prophylaxis on 12-Sep-2024, after the patient had rabies exposure, reported as on Friday, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age received the first dose of RabAvert for rabies post-exposure prophylaxis on 12-Sep-2024, after the patient had rabies exposure, reported as on Friday, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847604 M UT 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
On day 14 the patient was incorrectly given HyperRab (HRIG) instead of fourth RabAvert dose; Case re... On day 14 the patient was incorrectly given HyperRab (HRIG) instead of fourth RabAvert dose; Case reference number US-BN-2024-002522 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2423) on 18-Sep-2024 and concerns a 32-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was exposed to a bat. On an unspecified date, reported as day zero, unknown amount of time after animal exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration for post-exposure. On an unspecified date, reported as day three, unknown amount of time after animal exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration. On an unspecified date, reported as day seven, unknown amount of time after animal exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration. On an unspecified date, reported as day 14, unknown amount of time after animal exposure, the patient was incorrectly given HyperRab (HRIG; immunoglobulin human anti-rabies; batch number: unknown), at an unknown dose, route, or site of administration for post-exposure, instead of fourth dose of RabAvert (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 the RabAvert vaccination. No further information was provided.; Reporter's Comments: A 32-year-old male patient was incorrectly given HyperRab, reported as on the day 14, for post-exposure, instead of the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the RabAvert vaccination. Inappropriate schedule of product administration is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 32-year-old male patient was incorrectly given HyperRab, reported as on the day 14, for post-exposure, instead of the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the RabAvert vaccination. Inappropriate schedule of product administration is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847605 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Needle issue, Underdose Needle issue, Underdose
When the patient received the shot felt like no medicine was administered into arm hardly, patient t... When the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle; When the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle; Case reference number US-BN-2024-002545 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2496) on 24-Sep-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had rabies exposure. On 16-Sep-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at an unknown dose, intramuscularly in unknown site of administration for post exposure. On the same day the patient was vaccinated with the first dose of co-suspect IgG (immunoglobulin G) (brand name: unknown; batch number: unknown) at an unknown dose, intramuscularly, as reported in buttocks instead in leg, for post exposure. On 19-Sep-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, intramuscularly in unknown site of administration. On 23-Sep-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown) at an unknown dose, intramuscularly in unknown site of administration. As reported, when the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle (explicitly coded as 'vaccine underdose' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. No further information was provided.; Reporter's Comments: A female patient of unknown age was vaccinated with the third dose of RabAvert for post exposure, and as reported, when the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle, which is considered as vaccine underdose and product administration error. It was unknown if the patient experienced any adverse events due to RabAvert. Underdose and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the third dose of RabAvert for post exposure, and as reported, when the patient received the shot felt like no medicine was administered into arm hardly, patient thinks a lot of medicine escaped through the aeration of the needle, which is considered as vaccine underdose and product administration error. It was unknown if the patient experienced any adverse events due to RabAvert. Underdose and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Underdose and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847606 M PA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient was vaccinated with three doses of Rabavert at the same time; Patient was vaccinated with th... Patient was vaccinated with three doses of Rabavert at the same time; Patient was vaccinated with three doses of Rabavert at the same time; Case reference number US-BN-2024-002556 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2522) on 26-Sep-2024 and concerns a 7-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient experienced dog bite. On 25-Sep-2024, unknown amount of time after the animal exposure, reported around 10:00 pm, the patient was vaccinated with three doses of Rabavert (batch number: unknown) one milliliter, intramuscularly in unknown site of administration for post exposure prophylaxis (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Rabavert. No further information was provided.; Reporter's Comments: A 7-year-old male patient was vaccinated with three doses of Rabavert for post exposure prophylaxis, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Rabavert. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 7-year-old male patient was vaccinated with three doses of Rabavert for post exposure prophylaxis, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Rabavert. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847607 F FL 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00552
Inappropriate schedule of product administration, Product storage error Inappropriate schedule of product administration, Product storage error
Patient received first dose of RabAvert, however it was mistakenly stored in freezer and the minimum... Patient received first dose of RabAvert, however it was mistakenly stored in freezer and the minimum temperature reached -4.7 Fahrenheit degrees; Patient received first dose of RabAvert, however it was mistakenly stored in freezer and the minimum temperature reached -4.7 Fahrenheit degrees; The patient was scheduled to receive their second dose on 29-Sep-2024, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling; Case reference number US-BN-2024-002567 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2548) on 30-Sep-2024 and concerns a 74-year-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, the RabAvert vaccine was mistakenly stored in freezer and the minimum temperature reached was negative 4.7 degrees Fahrenheit (explicitly coded as 'product storage error'). On 20-Sep-2024, the patient was vaccinated with the affected first dose of RabAvert (batch number: FDP00552) at an unknown dose, route and site of administration for pre-exposure prophylaxis (explicitly coded as 'product administration error'). As reported the second dose of RabAvert was scheduled on 29-Sep-2024 for the patient, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling (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 RabAvert. No further information was provided.; Reporter's Comments: A 74-year-old female patient was vaccinated with the affected first dose of RabAvert for pre-exposure prophylaxis, which was mistakenly stored in freezer and the minimum temperature reached was negative 4.7 degrees Fahrenheit, which is considered as product storage error and product administration error. As reported the second dose of RabAvert was scheduled on 29-Sep-2024 for the patient, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Product storage error, product administration error and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 74-year-old female patient was vaccinated with the affected first dose of RabAvert for pre-exposure prophylaxis, which was mistakenly stored in freezer and the minimum temperature reached was negative 4.7 degrees Fahrenheit, which is considered as product storage error and product administration error. As reported the second dose of RabAvert was scheduled on 29-Sep-2024 for the patient, but ended up not having the vaccine since pharmacist was unsure regarding dose scheduling, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Product storage error, product administration error and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product administration error and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847608 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
No adverse event, Product administered at inappropriate site No adverse event, Product administered at inappropriate site
Patient received the Rabavert vaccine via intramuscular route in the quadricep instead of the deltoi... Patient received the Rabavert vaccine via intramuscular route in the quadricep instead of the deltoid site; Case reference number US-BN-2024-002577 is a spontaneous case initially received from health care professional via Med Communications (reference number: USBAV24-2579) on 01-Oct-2024 and concerns a 66-year-old female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had rabies exposure due to dog bite. On 16-Sep-2024, unknown amount of time after rabies exposure, at hospital, the patient was vaccinated with the first dose of RabAvert (batch number: unknown, NDC number: 50632-010-01), at a dose of one milliliter, intramuscularly in quadricep for indication post exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site'). It was reported that patient has not received any additional doses at hospital, and patient was out of town. At the time of the follow up report, the patient did not experience any adverse events due to RabAvert. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from health care professional on 11-Oct-2024: New information included added patient demographic details (initials and age), RabAvert dosage information and confirmation on the absence of adverse events. Follow up information received from health care professional on 24-Oct-2024: New information included confirmation on the type of rabies exposure and confirmation that patient did not receive any additional doses at hospital.; Reporter's Comments: An adult patient of unknown age and gender was vaccinated with the first dose of RabAvert (at a dose of one milliliter) intramuscularly in quadricep for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. Reportedly, the patient has not received any additional doses at hospital. The patient's medical history and concomitant medication details were not provided. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult patient of unknown age and gender was vaccinated with the first dose of RabAvert (at a dose of one milliliter) intramuscularly in quadricep for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. Reportedly, the patient has not received any additional doses at hospital. The patient's medical history and concomitant medication details were not provided. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847609 M GA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP0052
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
The two patients were vaccinated with second dose of Rabavert, 21 days (first patient) and 24 days (... The two patients were vaccinated with second dose of Rabavert, 21 days (first patient) and 24 days (second patient) after the first dose.; Case reference number US-BN-2024-002637 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-2681) on 10-Oct-2024 and concerns two male patients with *29-year-old (first patient) and 37-year-old (second patient) *. The patients relevant medical history and concomitant medications were not provided. On 17-Sep-2024, the *second patient* was vaccinated with first dose of RabAvert vaccine *(batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid* for pre-exposure prophylaxis. On 19-Sep-2024, the *first patient* was vaccinated with first dose of RabAvert vaccine *(batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid* for pre-exposure prophylaxis. The first patient was due for second dose of RabAvert vaccine on 24-Sep-2024, and second patient was due for second dose of RabAvert on 26-Sep-2024 and as reported, were unable to come on that week due to the tropical storm. *On 10-Oct-2024, 21 days after the first dose, the first patient was vaccinated with second dose of RabAvert vaccine (batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid (explicitly coded as 'Inappropriate schedule of vaccine administered') * *On 11-Oct-2024, 24 days after the first dose, the second patient was vaccinated with second dose of Rabavert vaccine (batch number: FDP0052; expiration date: 30-NOV-2027) at a dose of 1 ml, intramuscularly, in the left deltoid (explicitly coded as 'Inappropriate schedule of vaccine administered') * *At the time of this follow-up report, the patients did not experience* any adverse events due to RabAvert vaccine. Additional information received from a nurse via Med Communications on 10-Oct-2024 included additional reference numbers. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 23-Oct-2024: New information included reporter details, patients age, RabAvert dosing details were added, previously coded event of Incomplete course of vaccination was deleted and new event of Inappropriate schedule of vaccine administered was added, and confirmation that patient did not experience any adverse event due to RabAvert.; Reporter's Comments: Two male patients, a 29-year-old (the first patient) and a 37-year-old (the second patient) were vaccinated with second dose of RabAvert vaccine for pre-exposure prophylaxis, on the days 21 and 24 after the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered as listed per company convention. The patients did not experience any adverse events due to RabAvert vaccine. The patients' relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two male patients, a 29-year-old (the first patient) and a 37-year-old (the second patient) were vaccinated with second dose of RabAvert vaccine for pre-exposure prophylaxis, on the days 21 and 24 after the first dose, which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered as listed per company convention. The patients did not experience any adverse events due to RabAvert vaccine. The patients' relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847610 M 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received first dose of RabAvert four days after exposure and did not receive the second ... The patient received first dose of RabAvert four days after exposure and did not receive the second dose on scheduled date; Case reference number US-BN-2024-002668 is a spontaneous case initially received from a physician via Med Communications (reference number: USBAV24-2780) on 21-Oct-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. The patient's past vaccination included unspecified rabies vaccine. On night of 12-Oct-2024 to 13-Oct-2024, as reported the patient could hear and see bats flying around but never touched the patient. On 17-Oct-2024, four days after bat encounter, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at an unknown dose, route and site of administration for post exposure (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, patient was scheduled to get second dose yesterday but was worried about the risk of getting Creutzfeldt-Jakob disease (CJD) and didn't go to take the dose, patient asked if the low-risk exposure justifies the risk of getting CJD and requested probability of the risk of getting CJD (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 RabAvert. No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert four days after a bat encounter for post exposure, which is considered as inappropriate schedule of vaccine administered. As reported, the patient was scheduled to get second dose but was worried about the risk of getting Creutzfeldt-Jakob disease (CJD) and didn't go to take the dose, which is as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, and past vaccination included unspecified rabies vaccine. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert four days after a bat encounter for post exposure, which is considered as inappropriate schedule of vaccine administered. As reported, the patient was scheduled to get second dose but was worried about the risk of getting Creutzfeldt-Jakob disease (CJD) and didn't go to take the dose, which is as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided, and past vaccination included unspecified rabies vaccine. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847611 M MI 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient got the first dose of RabAvert last year on 03NOV2023 and never came for the second dose... The patient got the first dose of RabAvert last year on 03NOV2023 and never came for the second dose; Case reference number US-BN-2024-002673 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2786) on 22-Oct-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 03-Nov-2023, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration, for pre-exposure treatment. As reported, the patient never came for the second dose of RabAvert (explicitly codes as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. No further information was provided.; Reporter's Comments: A male patient received the first dose of RabAvert for pre-exposure prophylaxis, but never returned for a second dose, which is considered incomplete course of vaccination. This is a listed event as per company convention. No associated adverse events were reported. Medical history was not reported. Incomplete course of vaccination is not related to RabAvert, but to human error. The case is non-serious.; Sender's Comments: A male patient received the first dose of RabAvert for pre-exposure prophylaxis, but never returned for a second dose, which is considered incomplete course of vaccination. This is a listed event as per company convention. No associated adverse events were reported. Medical history was not reported. Incomplete course of vaccination is not related to RabAvert, but to human error. The case is non-serious. More
2847612 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
No adverse event, Product administered at inappropriate site No adverse event, Product administered at inappropriate site
Patient received the first and the second dose of RabAvert in the thigh region; Case reference numbe... Patient received the first and the second dose of RabAvert in the thigh region; Case reference number US-BN-2024-002693 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2830) on 28-Oct-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was near water source and there was fluttering in hair, but the patient was not sure if saw bat or not. On 05-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in right thigh for post exposure (explicitly coded as 'vaccine administered at inappropriate site') and with immunoglobulins (brand name: unknown; batch number: unknown) at an unknown dose and route in the deltoid for unknown indication.. On 08-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the second dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in left thigh (explicitly coded as 'vaccine administered at inappropriate site'). On 12-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the third dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in left deltoid. On 19-Aug-2024, unknown amount of time after exposure with animal, the patient was vaccinated with the fourth dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in right deltoid. On an unspecified date, as reported the patient was in Africa and there was something hopping in room, it was bat, the security come and pick it up out of room, bat was not flying so the patient was very nervous. On 25-Oct-2024, unknown amount of time after second exposure with animal, the patient was vaccinated with the fifth dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscular use in left deltoid . On unspecified dates, the patient was vaccinated with the second dose and third dose of immunoglobulins (brand name: unknown; batch number: unknown) at an unknown dose and route, in the thigh and left deltoid respectively. At the time of the initial report, the patient did not experience any adverse events due to RabAvert, reported as no irritations or side effects whatsoever. No further information was provided.; Reporter's Comments: A female patient of unknown age was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, intramuscular use in right thigh for post exposure, which is considered as vaccine administered at inappropriate site. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, intramuscular use in right thigh for post exposure, which is considered as vaccine administered at inappropriate site. The patient did not experience any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847613 M PA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient had exposure last Saturday, received the first dose of RabAvert on Monday and second dose on... Patient had exposure last Saturday, received the first dose of RabAvert on Monday and second dose on day seven; Case reference number US-BN-2024-002695 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2842) on 28-Oct-2024 and concerns a male patient of unspecified age. The patient had no relevant medical history. The patient's concomitant medication details were not provided. On unspecified dates in 2020, reported as four years ago, the patient was vaccinated with the whole series of RabAvert (batch number: unknown) at an unknown dose, administered intramuscularly in unknown site of administration, for post exposure. On unspecified date, reported as on last Saturday, patient had exposure. On 21-Oct-2024, reported as a week ago on Monday, at emergency room, the patient was vaccinated with the first dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscularly, at unknown site of administration, for post-exposure (explicitly coded as 'inappropriate schedule of vaccine administered'). On 28-Oct-2024, seven days after the previous dose and unspecified amount of time after exposure, reported in urgent care, the patient was vaccinated with the second dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, intramuscularly at unknown site of administration (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 RabAvert. No further information was provided.; Reporter's Comments: A male patient of unspecified age was vaccinated with the first dose of RabAvert for post-exposure, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, reported as a week ago on Monday, after the patient had exposure reported as on the last Saturday, which is considered as inappropriate schedule of vaccine administered. Seven days after the previous dose and unspecified amount of time after the exposure, the patient was vaccinated with the second dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient had no relevant medical history, and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age was vaccinated with the first dose of RabAvert for post-exposure, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, reported as a week ago on Monday, after the patient had exposure reported as on the last Saturday, which is considered as inappropriate schedule of vaccine administered. Seven days after the previous dose and unspecified amount of time after the exposure, the patient was vaccinated with the second dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient had no relevant medical history, and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847614 IL 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product administered at inappropriate site Product administered at inappropriate site
Adult patient received RabAvert dose into the anterolateral thigh instead of deltoid area; Case refe... Adult patient received RabAvert dose into the anterolateral thigh instead of deltoid area; Case reference number US-BN-2024-002768 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2978) on 11-Nov-2024 and concerns an adult patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with the dose of RabAvert (batch number: unknown) along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert. No further information was provided.; Reporter's Comments: An adult patient of unknown age and gender was vaccinated with the dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult patient of unknown age and gender was vaccinated with the dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847615 M 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received first, and second dose of Rabavert and having late for the third dose; Case ref... The patient received first, and second dose of Rabavert and having late for the third dose; Case reference number US-BN-2024-002776 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3013) on 13-Nov-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient was vaccinated with the first and second dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown), at an unknown dose, route, or site of administration for post-exposure prophylaxis. On unspecified date, reported as last Sunday, the patient was supposed to get third dose of RabAvert, however patient came today and administered the third dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown), at an unknown dose, route, or site of administration, which was late for the administration (explicitly coded as ๏ฟฝInappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Rabavert. No further information was provided.; Reporter's Comments: A male patient of unknown age was late for the administration of the third dose of RabAvert, after the patient was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age was late for the administration of the third dose of RabAvert, after the patient was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847616 M NJ 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Adverse reaction, Dizziness, Incomplete course of vaccination Adverse reaction, Dizziness, Incomplete course of vaccination
The patient had side effects that included dizziness, so the patient didn't get second dose of ... The patient had side effects that included dizziness, so the patient didn't get second dose of Rabavert on day seven; The patient had side effects that included dizziness, so the patient didn't get second dose of Rabavert on day seven; The patient had side effects that included dizziness, so the patient didn't get second dose of Rabavert on day seven; Case reference number US-BN-2024-002821 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV24-3137) on 26-Nov-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 19-Nov-2024, the patient received the first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration, for indication pre-exposure prophylaxis. On unspecified date, reported as seven days later from the first dose, the patient had some dizziness and some other symptoms that were not so good, as reported the past two to three days. As reported, the patient had side effects that included dizziness, so the patient didn't get the second dose of RabAvert on day seven (explicitly coded as 'Inappropriate schedule of product administration'). At the time of the initial report, the outcome for the events 'adverse reaction' and 'dizziness' was unknown. The reporter assessed the events of 'adverse reaction' and 'dizziness' as non-serious and possibly related to the product of RabAvert. No further information was provided.; Reporter's Comments: A male patient of unspecified age experienced non-serious events of dizziness and some other symptoms that were not so good reported as seven days after the patient received the first dose of RabAvert vaccine for indication pre-exposure prophylaxis. The patient had side effects, so the patient didn't get the second dose of RabAvert on day seven, which is considered as inappropriate schedule of product administration. Dizziness is listed and expected for RabAvert per CCDS v4 and USPI, whilst adverse reaction and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome for the events was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age experienced non-serious events of dizziness and some other symptoms that were not so good reported as seven days after the patient received the first dose of RabAvert vaccine for indication pre-exposure prophylaxis. The patient had side effects, so the patient didn't get the second dose of RabAvert on day seven, which is considered as inappropriate schedule of product administration. Dizziness is listed and expected for RabAvert per CCDS v4 and USPI, whilst adverse reaction and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome for the events was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-3137: More
2847617 F CO 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product administered at inappropriate site Product administered at inappropriate site
The patient received RabAvert vaccine in the finger where the bite was, instead intramuscularly in t... The patient received RabAvert vaccine in the finger where the bite was, instead intramuscularly in the deltoid; Case reference number US-BN-2024-002818 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3135) on 26-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had rabies exposure, reported as a finger bite. On unspecified date, unknown amount of time after rabies exposure, the patient was vaccinated with the RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, for indication post exposure vaccination. As reported, the patient received RabAvert vaccine in the finger (wound) where the animal was bitten, instead intramuscularly in the deltoid (explicitly coded as 'vaccine administered at inappropriate site'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. No further information was provided.; Reporter's Comments: A female patient of unknown age received RabAvert vaccine in the finger (bite wound), instead intramuscularly in the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age received RabAvert vaccine in the finger (bite wound), instead intramuscularly in the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2847618 F CA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration, Insurance issue Inappropriate schedule of product administration, Insurance issue
The patient received only one dose of RabAvert vaccine, the second dose was delayed due to lack of i... The patient received only one dose of RabAvert vaccine, the second dose was delayed due to lack of insurance coverage; Case reference number US-BN-2024-002827 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3171) on 02-Dec-2024 and concerns a 78-year-old female patient. The patient's current medical condition included diabetes mellitus, thyroid issues, hypertension and hyperlipidemia. The patient's concomitant medication details were not provided. On unspecified date, patient experienced dog exposure. On 27-Nov-2024, the patient received the first dose of RabAvert vaccine (batch number: unknown), at unknown dose, intramuscularly, at unknown site of administration, for post exposure. The patient only had one dose of RabAvert, the second one was delayed due to lack of insurance coverage (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 RabAvert vaccine. No further information was provided.; Reporter's Comments: A 78-year-old female patient received the first dose of RabAvert vaccine, at unknown dose, intramuscularly, at unknown site of administration, for post exposure. The patient only had one dose of RabAvert, since the second one was delayed due to lack of insurance coverage 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 RabAvert vaccine. The patient's current medical condition included diabetes mellitus, thyroid issues, hypertension and hyperlipidemia while concomitant medication details were not provided. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 78-year-old female patient received the first dose of RabAvert vaccine, at unknown dose, intramuscularly, at unknown site of administration, for post exposure. The patient only had one dose of RabAvert, since the second one was delayed due to lack of insurance coverage 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 RabAvert vaccine. The patient's current medical condition included diabetes mellitus, thyroid issues, hypertension and hyperlipidemia while concomitant medication details were not provided. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious. More
2847619 F PA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received first dose of RabAvert on 14-Oct-2024, second dose on 21-Oct-2024, and patient ... The patient received first dose of RabAvert on 14-Oct-2024, second dose on 21-Oct-2024, and patient is about 30 days late for the third dose.; Case reference number US-BN-2024-002876 is a spontaneous case initially received from a pharmacist via Med Communications (reference USBAV24-3259) on 10-Dec-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 14-Oct-2024, the patient was vaccinated with the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route or site of administration for pre-exposure prophylaxis. On 21-Oct-2024, seven days after the first dose, the patient was vaccinated with the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route or site of administration. As reported, the patient is about 30 days late for the third dose (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 RabAvert. No further information was provided.; Reporter's Comments: A female patient of unknown age is about 30 days late for the third dose of RabAvert for pre-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age is about 30 days late for the third dose of RabAvert for pre-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847620 M IL 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient missed second dose of Rabavert vaccine; Case reference number US-BN-2024-002919 is a spo... The patient missed second dose of Rabavert vaccine; Case reference number US-BN-2024-002919 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3348) on 19-Dec-2024 and concerns a 31-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 15-Dec-2024, the patient took first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose and site of administration, intramuscularly, for post exposure prophylaxis. As reported the patient missed second dose of RabAvert which was due on 18-Dec-2024. (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 RabAvert. No further information was provided.; Reporter's Comments: A 31-years-old male patient missed second dose of RabAvert which was due on 18-Dec-2024 and that 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 RabAvert. 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 31-years-old male patient missed second dose of RabAvert which was due on 18-Dec-2024 and that 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 RabAvert. 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
2847621 M ID 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received first dose of RabAvert vaccine, it was due on day seven for the second dose but... The patient received first dose of RabAvert vaccine, it was due on day seven for the second dose but did not receive it; Case reference number US-BN-2025-000015 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0032) on 06-Jan-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 30-Dec-2024, the patient received first dose of RabAvert vaccine (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution intramuscularly, at unknown dose, site of administration for indication pre-exposure for travel. As reported the patient did not receive the second dose of RabAvert vaccine on day seven (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert. No further information was provided.; Reporter's Comments: A male patient of unspecified age received the first dose of RabAvert vaccine for indication pre-exposure for travel. As reported the patient did not receive the second dose of RabAvert vaccine on the day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age received the first dose of RabAvert vaccine for indication pre-exposure for travel. As reported the patient did not receive the second dose of RabAvert vaccine on the day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847622 M CA 06/27/2025 RAB
UNK
 NOVARTIS VACCINES AND DIAGNOSTICS
UNKNOWN MANUFACTURER
 unknown
Unknown
Unevaluable event; Unevaluable event Unevaluable event; Unevaluable event
The patient received Antirabies vaccine and dose of RabAvert vaccine; Case reference number US-BN-20... The patient received Antirabies vaccine and dose of RabAvert vaccine; Case reference number US-BN-2025-000018 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0038) on 06-Jan-2025 and concerns a male patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On unknown date, the patient had unspecified rabies exposure. On 29-Dec-2024, unknown of time after exposure to rabies, the patient received first dose of Rabies Vaccine Inactivated (rabies vaccine inact (human diploid) reported as Antirabies vaccine (batch number: unknown), at unknown dose, route or site of administration for indication post-exposure prophylaxis. On 06-Jan-2024, unknown of time after exposure to rabies, the patient received second dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for post-exposure prophylaxis (explicitly coded as 'Interchange of vaccine products'). At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert. No further information was provided.; Reporter's Comments: A male patient with unspecified age received the first dose of Rabies vaccine inactivated for indication post-exposure prophylaxis. An unknown of time after exposure to rabies, the patient received the second dose of RabAvert vaccine for post-exposure prophylaxis, which is considered as interchange of vaccine products. It was unknown if the patient experienced any adverse events due RabAvert. Interchange of vaccine products is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient with unspecified age received the first dose of Rabies vaccine inactivated for indication post-exposure prophylaxis. An unknown of time after exposure to rabies, the patient received the second dose of RabAvert vaccine for post-exposure prophylaxis, which is considered as interchange of vaccine products. It was unknown if the patient experienced any adverse events due RabAvert. Interchange of vaccine products is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847623 M PA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
Patient received first dose of RabAvert and then got sidetracked and did not come on time for second... Patient received first dose of RabAvert and then got sidetracked and did not come on time for second dose for 13 days; Case reference number US-BN-2024-001914 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-1030) on 14-May-2024 and concerns a male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On unspecified date, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at unknown dose, route, or site of administration for pre-exposure. It was reported that the patient was sidetracked, and the patient did not come on time for second dose of RabAvert. As reported, the patient was 13 days out of the first dose of RabAvert (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 RabAvert vaccine. No further information provided.; Reporter's Comments: A male patient of unspecified age did not come on time for the second dose of RabAvert, after the patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, the patient was 13 days out of the first dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age did not come on time for the second dose of RabAvert, after the patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, the patient was 13 days out of the first dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert 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
2847624 F WA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received RabAvert first dose on day one after exposure and second dose was administered ... The patient received RabAvert first dose on day one after exposure and second dose was administered 36 hours early; RabAvert was administered in the same arm as human rabies immune globulin (HRIG) dose; Case reference number US-BN-2024-001929 is a spontaneous case report initially received from a pharmacist via Med Communication (reference number: USBAV24-1079) on 20-May-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On 14-May-2024, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at an unknown dose, via unknown route and site of administration for post exposure prophylaxis and with human rabies immune globulin (HRIG) dose (brand name: unknown) in the same arm, at an unknown dose, route, for post-exposure. As reported, instead of using day zero, it was used on day one (explicitly coded as 'inappropriate schedule of vaccine administered', 'lack of vaccination site rotation'). On an unspecified date, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, via unknown route and site of administration. As reported, the second dose was administered 36 hours early (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 RabAvert. Additional information received from a pharmacist via Med Communication (reference number: USBAV24-1089) on 21-May-2024: included added co-suspect (HRIG), event (lack of vaccine site rotation) and reference number (USBAV24-1089).; Reporter's Comments: A female patient was vaccinated with the first dose of RabAvert for post exposure prophylaxis and with human rabies immune globulin (HRIG) dose in the same arm, for post-exposure. As reported, instead of using day zero, it was used on day one, which is considered as inappropriate schedule of vaccine administered and lack of vaccination site rotation. The patient was vaccinated with the second dose of RabAvert. As reported, the second dose was administered 36 hours early, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration and lack of vaccination site rotation are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and lack of vaccination site rotation 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 was vaccinated with the first dose of RabAvert for post exposure prophylaxis and with human rabies immune globulin (HRIG) dose in the same arm, for post-exposure. As reported, instead of using day zero, it was used on day one, which is considered as inappropriate schedule of vaccine administered and lack of vaccination site rotation. The patient was vaccinated with the second dose of RabAvert. As reported, the second dose was administered 36 hours early, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration and lack of vaccination site rotation are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and lack of vaccination site rotation have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847625 M SC 06/27/2025 RAB
RAB
RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Unknown
Unknown
Head discomfort, Headache, Insomnia, Lack of vaccination site rotation, Nausea; ... Head discomfort, Headache, Insomnia, Lack of vaccination site rotation, Nausea; Nervousness, Neuralgia, Palpitations, Paraesthesia, Product administered at inappropriate site; Product administration error More
The patient had quick pressure in head, was harder on the left and inside of the skull; Insomnia; Ne... The patient had quick pressure in head, was harder on the left and inside of the skull; Insomnia; Nervous; Nerve shooting and prickling; The patient felt heart racing; Sporadic tingling; Headache; Nausea; Patient had symptoms after his first shot od Rabavert; The patient received third dose of Rabavert eight days after first dose; The patient drunk alcohol after administrated Rabavert; The first shot that was given to patient was actually three shots: 1 in the left arm and two in the buttocks along with the immunoglobulins; The first shot that was given to patient was actually three shots: 1 in the left arm and two in the buttocks along with the immunoglobulins; The patient received second dose of RabAvert in buttocks; Case reference number US-BN-2024-001939 is a spontaneous case report initially received from a consumer via Med Communications (reference number USBAV24-1106) on 22-May-2024 and concerns an adult female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was bitten by batt. On 04-May-2024, unknown amount of time after bat bite, the patient received the first dose of RabAvert (batch number: unknown), at an unknown dose, in left arm, intramuscularly, for postexposure prophylaxis. As reported, the first shot that was given to the patient was actually three shots: one in the left arm and two in the buttocks along with the co-suspect immunoglobulins (brand name: unknown), at an unknown dose (explicitly coded as 'Product administration error', 'Lack of vaccination site rotation', 'Overdose', 'Vaccine administered at inappropriate site'). On an unspecified date, as reported, after first shot the patient had symptoms. On 07-May-2024, three days after first dose of RabAvert, unknown amount of time after bat bite, the patient received the second dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, and route of administration. On 12-May-2024, eight days after first dose of RabAvert, unknown amount of time after bat bite, the patient received the third dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, and route of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 18-May-2024, 14 days after first dose of RabAvert, unknown amount of time after bat bite, the patient received the fourth dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, and route of administration. On an unspecified date, as reported the patient had been lying down going to sleep, try to go to sleep and feeling heart racing, sporadic tingling, nerve shooting and prickling, headache, a quick pressure in head, was harder on the left and inside of the skull, nausea, but it was not bad, no vomiting and obviously insomnia. As reported, the patient was nervous since was bitten by the bat and maybe the patient drunk a little bit too much of alcohol (explicitly coded as 'Product administration error'). At the time of initial report, it was unknown if the patient recovered from the events of 'heart racing', 'tingling', 'neuralgia', 'nervous', 'headache', 'head pressure', 'nausea', 'insomnia' and 'adverse event NOS'. The reporter assessed events of 'heart racing', 'tingling', 'neuralgia', 'nervous', 'headache', 'head pressure', 'nausea', 'insomnia' as non-serious and possibly related to RabAvert. The reporter did not provide seriousness and causality assessment for event of 'adverse event NOS'. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age received the first dose of RabAvert, an unknown amount of time after the bat bite, in left arm, intramuscularly, for postexposure prophylaxis. As reported, the first shot that was given to the patient was actually three shots: one in the left arm and two in the buttocks along with the co-suspect immunoglobulins, which is considered as product administration error, lack of vaccination site rotation, overdose and vaccine administered at inappropriate site. Reportedly, on the days 8 and 14 after the first dose, the patient received the third and the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, the patient had been lying down going to sleep, try to go to sleep and feeling heart racing, sporadic tingling, nerve shooting and prickling, headache, a quick pressure in head, was harder on the left and inside of the skull, nausea, but it was not bad, no vomiting and obviously insomnia. As reported, the patient was nervous since was bitten by the bat and maybe the patient drunk a little bit too much of alcohol, which is considered as product administration error. Paraesthesia, headache and nausea are listed and expected for RabAvert, whilst head discomfort, insomnia, nervousness and neuralgia are unlisted and unexpected. Palpitations is unlisted per authority 1 and expected per authority 2. Product administration error, lack of vaccination site rotation, overdose, product administration error, adverse event and vaccine administered at inappropriate site are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Product administration error, lack of vaccination site rotation, overdose, product administration error and vaccine administered at inappropriate site 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 adult female patient of unspecified age received the first dose of RabAvert, an unknown amount of time after the bat bite, in left arm, intramuscularly, for postexposure prophylaxis. As reported, the first shot that was given to the patient was actually three shots: one in the left arm and two in the buttocks along with the co-suspect immunoglobulins, which is considered as product administration error, lack of vaccination site rotation, overdose and vaccine administered at inappropriate site. Reportedly, on the days 8 and 14 after the first dose, the patient received the third and the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. On an unspecified date, the patient had been lying down going to sleep, try to go to sleep and feeling heart racing, sporadic tingling, nerve shooting and prickling, headache, a quick pressure in head, was harder on the left and inside of the skull, nausea, but it was not bad, no vomiting and obviously insomnia. As reported, the patient was nervous since was bitten by the bat and maybe the patient drunk a little bit too much of alcohol, which is considered as product administration error. Paraesthesia, headache and nausea are listed and expected for RabAvert, whilst head discomfort, insomnia, nervousness and neuralgia are unlisted and unexpected. Palpitations is unlisted per authority 1 and expected per authority 2. Product administration error, lack of vaccination site rotation, overdose, product administration error, adverse event and vaccine administered at inappropriate site are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported events have been considered as related to RabAvert. Product administration error, lack of vaccination site rotation, overdose, product administration error and vaccine administered at inappropriate site have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847626 M MO 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
Patient received only one dose of Rabavert, did not complete the rest of the series; Case reference ... Patient received only one dose of Rabavert, did not complete the rest of the series; Case reference number US-BN-2024-001946 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-1144) on 24-May-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had dog bite. On 17-May-2024, unknown amount of time after the dog bite, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) intramuscularly, at an unknown dose, at unknown site of administration for rabies post exposure prophylaxis in unvaccinated individual. As reported, the patient received only one dose of RabAvert, did not complete the rest of the series (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 Rabavert. No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert, intramuscularly, at an unknown dose, at unknown site of administration for rabies post exposure prophylaxis in unvaccinated individual.Reportedly, the patient received only one dose of RabAvert and did not complete the rest of the series 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 Rabavert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age was vaccinated with the first dose of RabAvert, intramuscularly, at an unknown dose, at unknown site of administration for rabies post exposure prophylaxis in unvaccinated individual.Reportedly, the patient received only one dose of RabAvert and did not complete the rest of the series 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 Rabavert. 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
2847627 F OR 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Nausea Nausea
Nauseous; Case reference number US-BN-2024-001964 is a spontaneous case initially received from a co... Nauseous; Case reference number US-BN-2024-001964 is a spontaneous case initially received from a consumer via Med Communications (reference number USBAV24-1183) on 29-May-2024 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient was bitten by cat. On an unspecified date, reported as on Sunday, for an unknown amount of time after cat bite, the patient was vaccinated with a dose of RabAvert (batch number: unknown), at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins (brand name: unknown, batch number: unknown), at an unknown dose, around the bite, for cat bite. The patient was treated with antibiotics (brand name: unknown, batch number: unknown), at an unknown dose, route or site administration, for an unknown indication. On an unspecified date, the patient felt nauseous and as reported took some medication for nausea. At the time of initial report, it was unknown if the patient recovered from the event of nausea. The reporter assessed the event of nausea as non-serious and possibly related to RabAvert product or, as reported antibiotics. No further information was provided.; Reporter's Comments: A female patient of unspecified age felt nauseous and as reported took some medication for nausea was vaccinated with a dose of RabAvert, at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins, at an unknown dose, around the bite, for cat bite. The patient was also treated with antibiotics. Nausea is listed and expected for RabAvert. At this point it was unknown if the patient recovered from the event of nausea. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Causal relationship is however confounded with co-suspect product and antibiotic treatment. The case is non-serious.; Sender's Comments: A female patient of unspecified age felt nauseous and as reported took some medication for nausea was vaccinated with a dose of RabAvert, at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins, at an unknown dose, around the bite, for cat bite. The patient was also treated with antibiotics. Nausea is listed and expected for RabAvert. At this point it was unknown if the patient recovered from the event of nausea. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Causal relationship is however confounded with co-suspect product and antibiotic treatment. The case is non-serious. More
2847628 F MA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient received first dose of RabAvert on 23-May-2024, for rabies pre-exposure prophylaxis, and... The patient received first dose of RabAvert on 23-May-2024, for rabies pre-exposure prophylaxis, and did not receive the second dose a week later; Case reference number US-BN-2024-001972 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1211) on 31-May-2024 and concerns female patient of unspecified age. The patient's relevant medical history and concomitant medication details were not provided. On 23-May-2024, reported as last Thursday, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, or site of administration for rabies pre-exposure prophylaxis. On an unspecified date, as reported yesterday, a week later, the patient did not receive the second dose of RabAvert (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 RabAvert. No further information was provided.; Reporter's Comments: A female patient of unspecified age did not receive the second dose of RabAvert (week later than the first dose of RabAvert was administered intramuscularly, at an unknown dose, or site of administration for rabies pre-exposure prophylaxis) 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 RabAvert. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age did not receive the second dose of RabAvert (week later than the first dose of RabAvert was administered intramuscularly, at an unknown dose, or site of administration for rabies pre-exposure prophylaxis) 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 RabAvert. The patient's relevant 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
2847629 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FD000502
Menstrual disorder, Pruritus Menstrual disorder, Pruritus
Patient has experienced changes in menstrual cycle after receiving the Rabavert it hasn't been ... Patient has experienced changes in menstrual cycle after receiving the Rabavert it hasn't been regular and the bleeding was brown and spotty; Patient has experienced changes in menstrual cycle after receiving the Rabavert it hasn't been regular and the bleeding was brown and spotty; The patient experienced itching all over the body intermittently after receiving the first dose of Rabavert; The patient recalls that the Rabavert dose appeared clear and colorless; Case reference number US-BN-2024-002191 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV24-1595) on 08-Jul-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. On unspecified date, the patient was vaccinated with the first dose of Rabavert (batch number: FD000502, expiry date: Aug-2027), at an unknown dose, route and site of administration for post exposure and with the first dose of co-suspect HRIG (immunoglobulin human anti-rabies) at an unknown dose, route and site of administration for unknown indication. As reported, the patient recalls that the Rabavert dose appeared clear and colorless (explicitly coded as 'product discoloration'). On unspecified dates, the patient was vaccinated with the second and third dose of Rabavert (batch number: FD000502, expiry date: Aug-2027), at an unknown dose, route and site of administration for post exposure. On an unspecified date, the patient had itching all over the body intermittently after receiving the first dose of Rabavert and had changes in menstrual cycle after receiving the Rabavert, it hasn't been regular, and the bleeding was brown and spotty. At the time of the initial report, it was unknown if the patient recovered from the events itching all over, menstrual irregularity and spotting menstrual. The reporter did not provide seriousness and causality assessment for the events 'itching all over', 'menstrual irregularity' and 'spotting menstrual'. Additional information received from a consumer via Med Communication (reference number: USBAV24-1653) on 15-Jul-2024: included added reference number (USBAV24-1653), patient gender, Rabavert dosage information, suspect (HRIG), additional events (itching all over, menstrual irregularity and spotting menstrual). Additional information received via Bavarian Nordic on 17-Jul-2024: included confirmation on patient's name.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of Rabavert for post exposure and with the first dose of co-suspect HRIG. As reported, the patient recalls that the Rabavert dose appeared clear and colourless, which is considered as product discoloration. The patient had itching all over the body intermittently after receiving the first dose of Rabavert and had changes in menstrual cycle after receiving the Rabavert, it hasn't been regular, and the bleeding was brown and spotty. Menstruation irregular, intermenstrual bleeding and pruritus are unlisted and unexpected for RabAvert, whilst product colour issue is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. Product colour issue is not related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of Rabavert for post exposure and with the first dose of co-suspect HRIG. As reported, the patient recalls that the Rabavert dose appeared clear and colourless, which is considered as product discoloration. The patient had itching all over the body intermittently after receiving the first dose of Rabavert and had changes in menstrual cycle after receiving the Rabavert, it hasn't been regular, and the bleeding was brown and spotty. Menstruation irregular, intermenstrual bleeding and pruritus are unlisted and unexpected for RabAvert, whilst product colour issue is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. The outcome was unknown. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. Product colour issue is not related to the suspect vaccine. This case is considered as non-serious. More
2847630 F TN 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 ARBB091B
Chest pain, Pain Chest pain, Pain
The vaccination with RabAvert interrupted due to event, the third vaccination was held as medical st... The vaccination with RabAvert interrupted due to event, the third vaccination was held as medical staff wanted to be sure that the patient was not have a side effect from vaccine; The patient experienced after second dose of RabAvert gripping and squeezing chest pain that came and went and sometimes radiated to shoulder; The patient experienced after second dose of RabAvert gripping and squeezing chest pain that came and went and sometimes radiated to shoulder; Case reference number US-BN-2024-002200 is a spontaneous case initially received from a nurse via Bavarian Nordic (reference number: BN_2024_02886) on 16-Jul-2024 and concerns a *28-year-old female* patient. The patient's medical history and concomitant medication were not provided. *On 14-Jun-2024, the patient was vaccinated with the first dose of RabAvert (batch number: ARBB091B) at dose of 1 mL, intramuscularly in right deltoid, for indication reported as the patient was animal care technician.* *On 21-Jun-2024, seven days after first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: ARBB091B) at dose of 1 mL, intramuscularly in right deltoid.* *On 22-Jul-2024, one day* after the second dose of RabAvert, the patient experienced *as reported gripping and squeezing chest pain that comes and goes and sometimes radiates to shoulder,* reported as patient believing to be a side effect of the RabAvert vaccine. *As reported the vaccination with RabAvert was interrupted due to events, as medical staff wanted to be sure that the patient was not having a side effect from the vaccine (explicitly coded as 'Inappropriate schedule of vaccine administered').* *At the time of the follow up report, the patient was recovering form events of 'chest pain' and 'shoulder pain', with events lasting for four weeks and as reported continuing.* *The reporter assessed the events of 'pain chest' and 'shoulder discomfort' as non-serious, mild in intensity* and possibly related to the RabAvert, also stated the patient believed it was side effect of the RabAvert vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received form nurse on 26-Jul-2024: New information included patient's demographic information, dosing information for first and second dose of RabAvert, added adverse events, start date, seriousness and causality assessment and interruption of vaccination due to which 'inappropriate schedule of vaccine administered' was coded.; Reporter's Comments: A 28-year-old female patient experienced the non-serious events of chest pain and shoulder pain (described as radiating pain that comes and goes), one day after receiving the second dose of RabAvert. The second dose of RabAvert was given on day 7 after the first one, which is considered inappropriate schedule of vaccine administered. Chest pain is unlisted and unlabeled, whereas arthralgia is listed and labeled for RabAvert. Inappropriate schedule of vaccination is considered listed per company convention. Patient was currently recovering. The patient's medical history and concomitant medication were not provided. The events are considered related due to the suggestive temporal relationship to the vaccine administration. The irradiating nature of the pain, which was resolving, is suggesting that the chest pain was also of musculoskeletal origin. Inappropriate schedule of vaccination is not related to RabAvert, but to human factors.; Sender's Comments: A 28-year-old female patient experienced the non-serious events of chest pain and shoulder pain (described as radiating pain that comes and goes), one day after receiving the second dose of RabAvert. The second dose of RabAvert was given on day 7 after the first one, which is considered inappropriate schedule of vaccine administered. Chest pain is unlisted and unlabeled, whereas arthralgia is listed and labeled for RabAvert. Inappropriate schedule of vaccination is considered listed per company convention. Patient was currently recovering. The patient's medical history and concomitant medication were not provided. The events are considered related due to the suggestive temporal relationship to the vaccine administration. The irradiating nature of the pain, which was resolving, is suggesting that the chest pain was also of musculoskeletal origin. Inappropriate schedule of vaccination is not related to RabAvert, but to human factors. More
2847631 SD 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product barcode issue Product barcode issue
Patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned wh... Patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number; Patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number; Case reference number US-BN-2024-002839 is a spontaneous case report initially received on 20-Nov-2024 from other health care professional via Bavarian Nordic and concerns a patient of unspecified age and gender. The patient's relevant medical history and concomitant medication details were not reported. On unspecified date, the patient was vaccinated with a dose of RabAvert (batch number: unknown) along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution at unknown dose, route or site of administration, for unknown indication. As reported, the patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number (explicitly coded as 'Product barcode readability issue' and 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert. The product quality complaint number was QE-013176. Additional information received from the reporter on 04-Dec-2024: Information included confirmation of country of occurrence and that the patient received affected vaccine.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with a dose of RabAvert along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution at unknown dose, route or site of administration, for unknown indication. Reportedly, the patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number which is considered as product barcode readability issue and product administration error. Product barcode issue and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to RabAvert. Patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender was vaccinated with a dose of RabAvert along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution at unknown dose, route or site of administration, for unknown indication. Reportedly, the patient received RabAvert with the vial which QR code was not scanning, only the bar code scanned which only entered the NDC number which is considered as product barcode readability issue and product administration error. Product barcode issue and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to RabAvert. Patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2847632 F AL 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Condition aggravated, Gastrooesophageal reflux disease, Nausea Condition aggravated, Gastrooesophageal reflux disease, Nausea
Half an hour after the vaccination with second dose of RabAvert the patient got horrible acid reflux... Half an hour after the vaccination with second dose of RabAvert the patient got horrible acid reflux like almost wanted to vomit; Half an hour after the vaccination with first dose of RabAvert the patient got horrible acid reflux like almost wanted to vomit; Case reference number US-BN-2024-002908 is a spontaneous case initially received from other health care professional via Med Communication (reference number: USBAV24-3310) on 16-Dec-2024 and concerns an adult female, patient of unspecified age. The patient's s medical history and concomitant medication details were not provided. The patient was not pregnant. The patient' current condition included polycystic ovarian syndrome (PCOS), Hashimoto's, acid reflux. On unspecified date, patient was bitten by dog that hadn't gotten a rabies shot in ten years. On 12-Dec-2024, unknown of time after dog bite, the patient received first dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) one milliliter, intramuscularly in the left arm for post-exposure and co-suspect vaccine Immunoglobulin (brand name: unknown; batch number: unknown), at unknown dose, route or site of administration for unknown indication. On the same date, half an hour after the first dose the patient experienced extremely bad acid reflux like almost wanted to vomit. On 15-Dec-2024, unknown of time after dog bite, the patient received the second dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) one milliliter, intramuscularly in the left arm. On the same date, half an hour after the first dose the patient experienced that same horrible acid reflux like almost wanted to vomit as it is from the first dose. The patient had been taking famotidine, 40-80 milligrams and it didn't help. At the time of the initial report, the patient didn't recover from the event of 'acid reflux'. The reporter assessed the 'acid reflux' after first and second dose of RabAvert as non-serious and possibly related to the product of RabAvert. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age experienced a non-serious event of extremely bad acid reflux like almost wanted to vomit on the day 0 after the patient received the first dose and after the patient received the second dose of RabAvert vaccine for post-exposure. Gastrooesophageal reflux disease is unlisted and unexpected for RabAvert per CCDS v4 and USPI. The patient's medical history and concomitant medication details were not provided, was not pregnant, and current condition included polycystic ovarian syndrome (PCOS), Hashimoto's, acid reflux. The patient didn't recover. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: An adult female patient of unspecified age experienced a non-serious event of extremely bad acid reflux like almost wanted to vomit on the day 0 after the patient received the first dose and after the patient received the second dose of RabAvert vaccine for post-exposure. Gastrooesophageal reflux disease is unlisted and unexpected for RabAvert per CCDS v4 and USPI. The patient's medical history and concomitant medication details were not provided, was not pregnant, and current condition included polycystic ovarian syndrome (PCOS), Hashimoto's, acid reflux. The patient didn't recover. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious. More
2847633 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product administered at inappropriate site Product administered at inappropriate site
The patient received second dose of RabAvert in the gluteus; Case reference number US-BN-2024-002923... The patient received second dose of RabAvert in the gluteus; Case reference number US-BN-2024-002923 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV24-3371) on 23-Dec-2024 and concerns a female patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient took the first dose of RabAvert (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration, for post exposure prophylaxis. On 23-Dec-2024, for unknown amount of time from the first dose, reported as day three, the patient took the second dose of RabAvert (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, and route of administration in gluteus area (explicitly coded as 'Inappropriate site of vaccine administered'). At the time of the initial report, it was unknown if the patient experiences any adverse events due to RabAvert. No further information was provided.; Reporter's Comments: A female patient with unspecified age took the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, and route of administration in gluteus area which is considered as inappropriate site of vaccine administered. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experiences any adverse events due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient with unspecified age took the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, and route of administration in gluteus area which is considered as inappropriate site of vaccine administered. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experiences any adverse events due to RabAvert. 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
2847634 F NJ 06/27/2025 RAB
RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Unknown
Dizziness, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral, Malaise; Nau... Dizziness, Heart rate increased, Hypoaesthesia, Hypoaesthesia oral, Malaise; Nausea, Paraesthesia, Paraesthesia oral, Tachycardia More
The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy;... The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; Six hours after the patient received the first dose of RabAvert, patient experienced severe tingling and numbness in feet, legs, arms, hands and face upper lip tingling; The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; Six hours after the patient received the first dose of RabAvert, patient experienced severe tingling and numbness in feet, legs, arms, hands, face, cheeks and upper lip; The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; The patient had very elevated and rapid heart rate, was tachycardic and also was nauseous and dizzy; Six hours after the patient received the first dose of RabAvert, patient experienced severe tingling and numbness in feet, legs, arms, hands, face, cheeks and upper lip; The patient felt generally ill; Case reference number US-BN-2025-000023 is a spontaneous case initially received from a physician via Med Communication (reference number: USBAV25-0042) on 07-Jan-2025 and concerns a female patient with unspecified age. The patient's medical history and concomitant medication details were not provided. On 03-Jan-2025, at emergency room, the patient received first dose of RabAvert vaccine (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, intramuscularly, at unknown site of administration for post exposure treatment. On unspecified date, reported as on Friday, within 6 hours of receiving the first dose of RabAvert vaccine, the patient experienced severe tingling and numbness in feet, legs, arms, hands and face. The patient had a very, very elevated heart rate for about 24 hours and patient was nauseous and dizzy. Patient was tachycardic and felt generally ill and by the next day most of it had resolved after about 24 hours except for still some tingly feelings, cheek and lips of face. At the time of initial report, the patient was not recovered from the events of 'tingling lips' and 'tingling', but was recovered from the events of 'numbness', 'tachycardia', 'heart rate increased', 'illness', 'nauseous' and 'dizzy'. The reporter did not provide seriousness assessment for the events 'tingling lips' and 'tingling', 'numbness', 'tachycardia', 'heart rate increased', 'illness', 'nauseous' and 'dizzy'. Causality assessment for events 'tingling lips' and 'tingling', 'numbness', 'tachycardia', 'heart rate increased', 'illness', 'nauseous' and 'dizzy' was reported as related to RabAvert. No further information was provided.; Reporter's Comments: A female patient with unspecified age experienced non-serious events of paraesthesia, nausea, dizziness, tachycardia, paraesthesia oral, heart rate increased, hypoaesthesia and illness within 6 hours after the patient received first dose of RabAvert vaccine for post exposure treatment. Paraesthesia, nausea and dizziness are considered as listed and expected for RabAvert per CCDS v4 and USPI, whilst tachycardia, paraesthesia oral, heart rate increased and hypoaesthesia are unlisted and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events of tingling lips and tingling, but recovered from the events of numbness, tachycardia, heart rate increased, illness, nauseous and dizzy. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A female patient with unspecified age experienced non-serious events of paraesthesia, nausea, dizziness, tachycardia, paraesthesia oral, heart rate increased, hypoaesthesia and illness within 6 hours after the patient received first dose of RabAvert vaccine for post exposure treatment. Paraesthesia, nausea and dizziness are considered as listed and expected for RabAvert per CCDS v4 and USPI, whilst tachycardia, paraesthesia oral, heart rate increased and hypoaesthesia are unlisted and unexpected. Illness is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the events of tingling lips and tingling, but recovered from the events of numbness, tachycardia, heart rate increased, illness, nauseous and dizzy. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to RabAvert. This case is considered as non-serious. More
2847635 M 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product administered at inappropriate site Product administered at inappropriate site
The patient received RabAvert vaccine in tigh; Case reference number US-BN-2025-000118 is a spontane... The patient received RabAvert vaccine in tigh; Case reference number US-BN-2025-000118 is a spontaneous case initially received from nurse via Med Communications (reference number: USBAV25-0093) on 13-Jan-2025 and concerns a 61-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 13-Jan-2025, the patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the RabAvert. No further information provided.; Reporter's Comments: A 61-years-old male patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the RabAvert. 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 61-years-old male patient received first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution, at an unknown dose and route of administration, in thigh, for indication pre-exposure prophylaxis which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the RabAvert. 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
2847636 F TN 06/27/2025 RAB
TTOX
 NOVARTIS VACCINES AND DIAGNOSTICS
UNKNOWN MANUFACTURER
 Unknown
Unknown
Inappropriate schedule of product administration; Inappropriate schedule of prod... Inappropriate schedule of product administration; Inappropriate schedule of product administration More
After got bitten in Sunday, the patient was given a Tetanus shot instead of rabies vaccine, but afte... After got bitten in Sunday, the patient was given a Tetanus shot instead of rabies vaccine, but after some time the patient received the first dose of RabAvert on 14-Jan-2025; Case reference number US-BN-2025-000123 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0112) on 14-Jan-2025 and concerns a 26-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as on Sunday night, the patient got bitten. On an unspecified date, for unknown amount of time from the bite, the patient got Tetanus shot (batch number: unknown), at unknown dose, route or site of administration for post exposure prophylaxis On 14-Jan-2025, for unknown of time from the bite, the patient received the first dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration for post-exposure prophylaxis ( explicitly coded as 'inappropriate schedule vaccine administrated') and received co-suspect vaccine HRIG (immunoglobulin human anti-rabies; batch number: unknown), at unknown dose, route or site of administration for unknown indication. At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert. No further information was provided.; Reporter's Comments: A 26-year-old female patient received the first dose of RabAvert vaccine, unknown time from the bite, along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post-exposure prophylaxis which is considered as inappropriate schedule vaccine administrated. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 26-year-old female patient received the first dose of RabAvert vaccine, unknown time from the bite, along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post-exposure prophylaxis which is considered as inappropriate schedule vaccine administrated. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2847637 06/27/2025 RAB
 UNKNOWN MANUFACTURER
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient was vaccinated with four doses of Rabies vaccine and did not receive the fifth dose for ... The patient was vaccinated with four doses of Rabies vaccine and did not receive the fifth dose for post exposure; Case reference number US-BN-2025-000139 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0131) on 16-Jan-2025 and concern a patient with unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient had exposure to rabies On unspecified date, unknown of time after exposure to the rabies, the patient received the first dose of rabies vaccine (brand name; unknow; batch number: unknown) along with its consitutent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post exposure prophylaxis. On unspecified date, unknown of time after exposure to the rabies, the patient received the second dose of rabies vaccine (brand name; unknow; batch number: unknown) along with its consitutent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration. On unspecified date, unknown of time after exposure to the rabies, the patient received the third dose of rabies vaccine (brand name; unknow; batch number: unknown) along with its consitutent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration. On unspecified year on 14-Nov, unknown of time after exposure to the rabies, the patient received the fourth dose of rabies vaccine (brand name; unknow; batch number: unknown) along with its consitutent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration. As reported, the patient received only four doses of rabies vaccine (explicitly coded as 'incomplete course of vaccination'). On unspecified date, the patient had another exposure after waking up to a bat. On unspecified date, reported as on day zero, for unknown amount of time from the bat bite, the patient received the first dose of rabies vaccine (brand name; unknow; batch number: unknown) along with its consitutent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for post exposure prophylaxis. On unspecified date, reported as on day third, for unknown amount of time from the bat bite, the patient received the second dose of rabies vaccine (brand name; unknow; batch number: unknown) along with its consitutent parts prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration At the time of initial report, it was unknown if the patient experienced any adverse events due Rabes vaccine. No further information was provided.; Reporter's Comments: A patient with unspecified age and gender received only four doses of rabies vaccine for post exposure prophylaxis, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due Rabes vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient with unspecified age and gender received only four doses of rabies vaccine for post exposure prophylaxis, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse events due Rabes vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847638 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient was unable to receive the second dose of RabAvert on day seven; Case reference number US... The patient was unable to receive the second dose of RabAvert on day seven; Case reference number US-BN-2025-000164 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV25-0177) on 23-Jan-2025 and concerns a patient with unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for pre-exposure. As reported, reported as on day seven was unable to receive second dose of RabAvert vaccine (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert. No further information was provided.; Reporter's Comments: A patient with unspecified age and gender received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for pre-exposure. Reportedly, the patient was unable to receive second dose of RabAvert vaccine on day seven which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient with unspecified age and gender received first dose of RabAvert vaccine along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution, at unknown dose, route or site of administration for pre-exposure. Reportedly, the patient was unable to receive second dose of RabAvert vaccine on day seven which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse events due RabAvert. 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
2847639 M TN 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product storage error Product storage error
The patient received three doses of RabAvert that were stored at 48 Fahrenheit, the earliest dose ha... The patient received three doses of RabAvert that were stored at 48 Fahrenheit, the earliest dose had been stored at same temperature for three days; The patient received three doses of RabAvert that were stored at 48 Fahrenheit, the earliest dose had been stored at same temperature for three days; The patient received three doses of RabAvert that were stored at 48 Fahrenheit, the earliest dose had been stored at same temperature for three days; Case reference number US-BN-2025-000215 is a spontaneous case initially received from a physician via Med Communication (reference number: USBAV25-0321) on 24-Feb-2025 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 had an encounter with a dog. On an unspecified date, the RabAvert vaccine was stored at 48 Fahrenheit, the earliest dose was stored at same temperature for three days (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue' ) On 30-Jan-2025, unknown time of encounter with the dog, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration for indication post exposure (explicitly coded as 'product administration error'). On 03-Feb-2025, unknown time of encounter with the dog the patient received the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration (explicitly coded as 'product administration error'). On 06-Feb-2025, unknown time of encounter with the dog the patient took the third dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due RabAvert. No further information was provided.; Reporter's Comments: A male patient of unspecified age received the first, second and the third dose of RabAvert for indication post exposure, after the RabAvert vaccine was stored at 48 Fahrenheit, the earliest dose was stored at same temperature for three days, which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any of adverse events due RabAvert. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age received the first, second and the third dose of RabAvert for indication post exposure, after the RabAvert vaccine was stored at 48 Fahrenheit, the earliest dose was stored at same temperature for three days, which is considered as product storage error temperature too high, product temperature excursion issue and product administration error. It was unknown if the patient experienced any of adverse events due RabAvert. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847640 F OH 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00595
Circumstance or information capable of leading to medication error Circumstance or information capable of leading to medication error
The RabAvert reconstituted, was not able to get the whole vaccine out of the vial (got more than 90%... The RabAvert reconstituted, was not able to get the whole vaccine out of the vial (got more than 90%).The vaccine was pushed and back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full; The RabAvert reconstituted, was not able to get the whole vaccine out of the vial (got more than 90%).The vaccine was pushed and back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full; Case reference number US-BN-2025-00300 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV25-0470) on 28-Feb-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 28-Feb-2025, the RabAvert dose was reconstituted, and nurse was unable to get the whole vaccine out of the vial (got more than 90%). The vaccine was pushed back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full amount, as reported the patient received the whole dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00595; expiration date: Dec-2027) intramuscularly, at unknown dose, route or site of administration, for pre indication exposure vaccination (explicitly coded as 'product preparation error' and 'product administration error'). As reported, nurse used one inch needle for administration for the patient that had above 200 pounds. At the time of the initial report, it was unknown if the patient experienced any of adverse events due RabAvert. No further information was provided.; Reporter's Comments: This case report concerns a female patient of unspecified age. Reportedly, the RabAvert dose was reconstituted, and nurse was unable to get the whole vaccine out of the vial (got more than 90%). The vaccine was pushed back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full amount, as reported the patient received the whole dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, intramuscularly, at unknown dose, route or site of administration, for pre indication exposure vaccination which is considered as product preparation error and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Product preparation 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: This case report concerns a female patient of unspecified age. Reportedly, the RabAvert dose was reconstituted, and nurse was unable to get the whole vaccine out of the vial (got more than 90%). The vaccine was pushed back in the vial, pulled the whole syringe out, pulled it back to insert some air and then was able to withdraw the full amount, as reported the patient received the whole dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution, intramuscularly, at unknown dose, route or site of administration, for pre indication exposure vaccination which is considered as product preparation error and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due RabAvert. The patient's medical history and concomitant medication details were not provided. Product preparation error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious. More
2847641 F IL 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received the second dose of RabAvert, 18 days after the first dose; Case reference numbe... The patient received the second dose of RabAvert, 18 days after the first dose; Case reference number US-BN-2025-000372 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0585) on 14-Mar-2025 and concerns a 26-year-old, female patient. The patient's medical history and concomitant medication details were not provided. On 20-Feb-2025, the patient took the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for indication pre-exposure prophylaxis. On 10-Mar-2025, 18 days after the patient took first dose, the patient took second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due to RabAvert. Additional information received from pharmacist via Med Communication (reference number: USBAV25-0586) on 14-Mar-2025: New information included patient information, new reporter information.; Reporter's Comments: A 26-year-old female patient who received RabAvert for pre-exposure prophylaxis. The first dose was administered on 20-Feb-2025, and the second dose on 10-Mar-2025, with an inappropriate schedule. The patient's medical history and concomitant medications were not provided. At the time of the initial report, it was unknown if the patient experienced any adverse events. The Inappropriate schedule of product administration is considered listed as per company conventions. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert ,as it is related to human factors, therefore the causality is assessed as not related.; Sender's Comments: A 26-year-old female patient who received RabAvert for pre-exposure prophylaxis. The first dose was administered on 20-Feb-2025, and the second dose on 10-Mar-2025, with an inappropriate schedule. The patient's medical history and concomitant medications were not provided. At the time of the initial report, it was unknown if the patient experienced any adverse events. The Inappropriate schedule of product administration is considered listed as per company conventions. The evaluation did not find enough evidence to suggest a reasonable possibility of a causal relationship between the reported events and RabAvert ,as it is related to human factors, therefore the causality is assessed as not related. More
2847642 F CA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Injection site cellulitis, Injection site pain, Injection site pruritus, Injecti... Injection site cellulitis, Injection site pain, Injection site pruritus, Injection site swelling, Local reaction More
Cellulitis; Intense pain after fourth dose of RabAvert; Itching fourth dose of RabAvert; Injection s... Cellulitis; Intense pain after fourth dose of RabAvert; Itching fourth dose of RabAvert; Injection site swelling; Case reference number US-BN-2025-000382 is a spontaneous case initially received from consumer via Med Communications (reference number: USBAV25-0608) on 18-Mar-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as on day zero, the patient received the first dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration for unknown indication. On an unspecified date, unspecified time after first dose, the patient received the second dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unspecified time after second dose, as reported, after second dose, the patient had a pretty big, localized reaction and the health care professional who was on duty had check the reaction in the emergency room and maybe was an allergic reaction or maybe was cellulitis. The patient had been given dexamethasone (as per reporter"dexamethalone"), the steroid orally and couple of other things for allergy as treatment drugs. On an unspecified date, unspecified time after second dose the patient experienced injection site swelling. On an unspecified date, 30 hours after second dose, the patient received the third dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unknown of time after third dose of Rabavert, the patient had very minimal reaction to, the patient still had injection site swelling, as reported it was much more minor than second dose. On an unspecified date, the patient recovered from the events of injection site swelling and cellulitis On an unspecified date, the patient took the fourth dose of Rabavert along with prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route and site of administration. On an unspecified date, unknown of time after fourth dose, the patient had the pretty large reaction again with the intense pain and itching. It was asked a couple of times, because all the information online about needing a fifth dose because immunosuppression seems to be about a serious immunosuppression not a onetime dose of dexamethasone (as per reporter dexamethalone). With diminished reaction on third vaccine, 30 hours after receiving dexamethasone (as per reporter dexamethalone), there was a concerned about if the patient had full protection. On an unspecified date, the patient recovered from events of 'pain' and 'itching'. The reporter assessed seriousness for events of cellulitis, injection site swelling, 'pain' and 'itching' as non-serious. The reporter assessed the events of cellulitis, injection site swelling, 'pain' and 'itching' as possibly related to the Rabavert vaccine. No further information was provided.; Reporter's Comments: This case is concerned a female patient of unknown age/age group who experienced non-serious events of cellulitis and injection site swelling (after the second dose), pain and pruritus after the fourth dose of RabAvert vaccine for unknown indication. Cellulitis and pain are not listed per CCDS V4 and not expected per USPI. Injection site swelling is listed per CCDS V4 and expected per USPI. Pruritus is unlisted per CCDS v4 and expected per USPI. Patient's medical history and concomitant medications was not reported. All the events were resolved by the time of recipient of this case. Based on the limited information provided regarding this case, along with the latency of same day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events cellulitis, injection site swelling, pain and pruritus are considered related to the suspect vaccine. However, lack of information regarding patient's medical history, detailed event information, treatment received, precludes the comprehensive assessment of the case. This case is considered as non-serious.; Sender's Comments: This case is concerned a female patient of unknown age/age group who experienced non-serious events of cellulitis and injection site swelling (after the second dose), pain and pruritus after the fourth dose of RabAvert vaccine for unknown indication. Cellulitis and pain are not listed per CCDS V4 and not expected per USPI. Injection site swelling is listed per CCDS V4 and expected per USPI. Pruritus is unlisted per CCDS v4 and expected per USPI. Patient's medical history and concomitant medications was not reported. All the events were resolved by the time of recipient of this case. Based on the limited information provided regarding this case, along with the latency of same day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events cellulitis, injection site swelling, pain and pruritus are considered related to the suspect vaccine. However, lack of information regarding patient's medical history, detailed event information, treatment received, precludes the comprehensive assessment of the case. This case is considered as non-serious. More
2847643 F PA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP005553
Incorrect route of product administration, Product administered at inappropriate... Incorrect route of product administration, Product administered at inappropriate site More
The patient received Rabavert subcutaneously instead of intramuscularly with 1 inch needle to back o... The patient received Rabavert subcutaneously instead of intramuscularly with 1 inch needle to back of the upper arm and not the deltoid; The patient received Rabavert subcutaneously instead of intramuscularly with 1 inch needle to back of the upper arm and not the deltoid; The patient received only one dose of Rabavert; Case reference number US-BN-2025-000393 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV25-0639) on 20-Mar-2025 and concerns a 60-years-old female patient. The patient's medical history and concomitant medication detail was not provided. The patient's current medical history included hyperlipidemia. On 20-Mar-2025, the patient was vaccinated with RabAvert (batch number: FDP005553; expiration date: Dec-2027), at a dose of 1 ml, subcutaneously instead of intramuscularly with 1 inch needle to back of the *upper* arm and not the deltoid, for indication pre-exposure *prophylaxis* (explicitly coded as 'inappropriate route of vaccination' and 'vaccine administered at inappropriate site'). *As reported, the patient received only one dose of RabAvert (explicitly coded as 'incomplete course of vaccination'). * At the time of the *follow-up* report, the patient *did not* experience any adverse events due to RabAvert vaccine. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a pharmacist on 24-Apr-2025: New information included indication term and site of administration updated, and confirmation that patient received only one dose of RabAvert and did not experience any adverse events due to RabAvert vaccine.; Reporter's Comments: A 60-year-old female patient was vaccinated with RabAvert at a dose of 1 ml, subcutaneously instead of intramuscularly with 1 inch needle to back of the arm and not the deltoid, for indication pre-exposure prophylaxis, which is considered as inappropriate route of vaccination and vaccine administered at inappropriate site. Reportedly, the patient received only one dose of RabAvert, which is considered as incomplete course of vaccination. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are considered listed per company conventions. The patient did not experience any adverse events due to RabAvert vaccine. The patient's medical history and concomitant medication detail was not provided while current medical history included hyperlipidemia. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 60-year-old female patient was vaccinated with RabAvert at a dose of 1 ml, subcutaneously instead of intramuscularly with 1 inch needle to back of the arm and not the deltoid, for indication pre-exposure prophylaxis, which is considered as inappropriate route of vaccination and vaccine administered at inappropriate site. Reportedly, the patient received only one dose of RabAvert, which is considered as incomplete course of vaccination. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are considered listed per company conventions. The patient did not experience any adverse events due to RabAvert vaccine. The patient's medical history and concomitant medication detail was not provided while current medical history included hyperlipidemia. Incorrect route of product administration, incomplete course of vaccination and product administered at inappropriate site are assessed as not related to suspect product but to human factor. The case is non-serious. More
2847644 F CA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00555
Incomplete course of vaccination Incomplete course of vaccination
The patient received only one dose of RabAvert on 14-Nov-2024; Case reference number US-BN-2025-0004... The patient received only one dose of RabAvert on 14-Nov-2024; Case reference number US-BN-2025-000422 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0738) on 02-Apr-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 14-Nov-2024 (also reported as 14-Nov-2025), the patient took first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00555; expiration date: 01-Sep-2027) at an unknown dose, intramuscularly at unknown site of administration for indication pre-exposure for school. As reported, the patient received only one dose of RabAvert and now she wanted to see if she can finish the series or if she needs to start over (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. No further information was provided.; Reporter's Comments: A female patient of unknown age/age group had received RabAvert vaccine for pre-exposure for school. As reported, patient had received only the first dose of RabAvert vaccine which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to RabAvert vaccine. Incomplete course of vaccination is considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Event incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age/age group had received RabAvert vaccine for pre-exposure for school. As reported, patient had received only the first dose of RabAvert vaccine which is considered as incomplete course of vaccination. It was unknown if patient experienced any adverse events due to RabAvert vaccine. Incomplete course of vaccination is considered as listed as per company convention. The patient's medical history and concomitant medication details were not provided. Event incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847645 F CA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient received two doses of Rabavert and did not come back for the third; Case reference numbe... The patient received two doses of Rabavert and did not come back for the third; Case reference number US-BN-2025-000388 is a spontaneous case report initially received from a nurse via MisCommunication (reference number: USBAV25-0789) on 08-Apr-2025 and concerns a female patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, the patient took first dose of Rabavert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration for unknown indication. On an unspecified date, the patient took second dose of Rabavert vaccine along with prefilled syringe, needle for injection and injection for reconstitution (batch number: unknown) at an unknown dose, route and site of administration. As reported, an animal control person that had two doses but didn't come back for the third (explicitly coded as 'incomplete course of vaccination'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age had two doses but didn't come back for the third which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert vaccine. 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 had two doses but didn't come back for the third which is considered as incomplete course of vaccination. Incomplete course of vaccination is considered listed per company convention. At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert vaccine. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2847646 F TX 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration, Incomplete course of vaccinati... Inappropriate schedule of product administration, Incomplete course of vaccination More
The patient was getting the second dose of RabAvert one day late (on April 15th), three days after f... The patient was getting the second dose of RabAvert one day late (on April 15th), three days after first dose; The patient received only two doses of RabAvert; Case reference number US-BN-2025-000837 is a spontaneous case initially received from nurse via Med Communication (reference number: USBAV25-0834) on 15-Apr-2025 and concerns a *22-years-old* female patient. The patient's medical history and concomitant medication details were not provided. On 11-Apr-2025, the patient was bitten by dog. On the same day, the patient received the first dose of RabAvert (reported as rabies vaccine) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for indication post-exposure. As reported, the patient started treatment at the emergency room (ER). On 15-Apr-2025, four days after the exposure to dog bite, as reported one day late, the patient received the second dose of RabAvert (reported as rabies vaccine) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00530 and expiration date: 30-Dec-2027), at a dose of 1 ml, intramuscularly in the left deltoid (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient did not show for the scheduled follow-up appointments and received only two doses of RabAvert (explicitly coded as 'incomplete course of vaccination'). At the time of the follow-up report, the patient did not experience any of adverse events due to RabAvert. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 01-May-2025: New information included RabAvert dosing details, post-exposure details, and confirmation that the patient did not show for the scheduled follow-up appointments, received only two doses of RabAvert and patient did not experience any of adverse events due to RabAvert. Follow up information received from a nurse on 13-May-2025: New information included patient demographics.; Reporter's Comments: This case concerned a 22-years-old female patient, who had received the first dose of RabAvert vaccine, on the same day for an indication of post-exposure. Reportedly, four days after first dose (one day late), the patient received the second dose of RabAvert which is considered as inappropriate schedule of product administration. Reportedly, the patient did not show for the scheduled follow-up appointments and received only two doses of RabAvert which is considered as incomplete course of vaccination. At this point the patient did not experience any of adverse events due to RabAvert. Inappropriate schedule of product administration and incomplete course of vaccination are both considered listed as per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and incomplete course of vaccination 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: This case concerned a 22-years-old female patient, who had received the first dose of RabAvert vaccine, on the same day for an indication of post-exposure. Reportedly, four days after first dose (one day late), the patient received the second dose of RabAvert which is considered as inappropriate schedule of product administration. Reportedly, the patient did not show for the scheduled follow-up appointments and received only two doses of RabAvert which is considered as incomplete course of vaccination. At this point the patient did not experience any of adverse events due to RabAvert. Inappropriate schedule of product administration and incomplete course of vaccination are both considered listed as per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration and incomplete course of vaccination are both assessed as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847647 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 unknown
Lymphadenopathy, Pyrexia Lymphadenopathy, Pyrexia
The patient received the second dose of RabAvert and experienced fever and right groin lymph node wa... The patient received the second dose of RabAvert and experienced fever and right groin lymph node was swollen; The patient received the second dose of RabAvert and experienced fever and right groin lymph node was swollen; Case reference number US-BN-2025-000884 is a spontaneous case initially received from consumer via Med Communication (reference number: USBAV25-0957) on 28-Apr-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient received first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration for unknown indication. On 26-Apr-2025 also reported as three-day series, unknown amount of time from the first dose, the patient received second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at unknown dose, route or site of administration. On 27-Apr-2025, one day after the vaccination with second dose of RabAvert, the patient experienced a fever and right groin lymph node was swollen. At the time of the initial report, the patient did not recover from the events 'swollen lymph nodes' and 'fever', as reported ongoing. The reporter assessed the events 'swollen lymph nodes' and 'fever' as non-serious and did not provide causality assessment. No further information was provided.; Reporter's Comments: This case concerns a female patient of unknown age/age group who experienced non-serious events of lymphadenopathy and pyrexia, one day after the vaccination with second dose of RabAvert for unknown indication. Lymphadenopathy and pyrexia are listed per CCDS V4 and expected per USPI. Patient's medical history and concomitant medications was not reported. Outcome of these events was not recovered/not resolved. Based on the limited information provided regarding this case, along with the latency of 1 day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. This case is considered as non-serious.; Sender's Comments: This case concerns a female patient of unknown age/age group who experienced non-serious events of lymphadenopathy and pyrexia, one day after the vaccination with second dose of RabAvert for unknown indication. Lymphadenopathy and pyrexia are listed per CCDS V4 and expected per USPI. Patient's medical history and concomitant medications was not reported. Outcome of these events was not recovered/not resolved. Based on the limited information provided regarding this case, along with the latency of 1 day, the causal role of the suspect vaccine cannot be excluded in the occurrence of the events, hence the events are considered related to the suspect vaccine. This case is considered as non-serious. More
2847648 F KS 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient was supposed to get her second dose of RABAVERT on April 23rd, but she never got it.; Ca... The patient was supposed to get her second dose of RABAVERT on April 23rd, but she never got it.; Case reference number US-BN-2025-000886 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0963) on 29-Apr-2025 and concerns an adult female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for indication post-exposure vaccination. As reported, the patient was supposed to get her second dose of RabAvert on April 23rd, but she never got it (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due to RabAvert. No further information was provided.; Reporter's Comments: An adult female patient of unspecified age received the first dose of RabAvert for indication post-exposure vaccination. As reported, the patient was supposed to get her second dose of RabAvert on April 23rd, but she never got it, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult female patient of unspecified age received the first dose of RabAvert for indication post-exposure vaccination. As reported, the patient was supposed to get her second dose of RabAvert on April 23rd, but she never got it, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any of adverse events due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847649 M UT 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00595
Incomplete course of vaccination Incomplete course of vaccination
The patient took first dose of RabAvert in February and didn't receive second dose yet; Case re... The patient took first dose of RabAvert in February and didn't receive second dose yet; Case reference number US-BN-2025-000898 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV25-1009) on 02-May-2025 and concerns a 19-year-old, male patient. The patient's medical history and concomitant medication details were not provided. On 24-Feb-2025, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00595) at unknown dose and site of administration, intramuscularly, for indication pre-exposure prophylaxis. The patient hadn't received the second dose yet (explicitly coded as 'incomplete course of vaccination'). At the time of initial report, it was unknown if the patient experienced any of adverse events due to RabaVert. No further information was provided.; Reporter's Comments: A 19-year-old male patient received the first dose of RabAvert in Feb 2025 for indication pre-exposure prophylaxis. The patient hadn't received the second dose yet, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any of adverse events due to RabaVert. Incomplete course of vaccination is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 19-year-old male patient received the first dose of RabAvert in Feb 2025 for indication pre-exposure prophylaxis. The patient hadn't received the second dose yet, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any of adverse events due to RabaVert. Incomplete course of vaccination is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Incomplete course of vaccination is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
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