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
2847734 40 F 06/29/2025 TDAP
 SANOFI PASTEUR
 U8122AA
Nodule Nodule
Patient states they have had "knot" in arm since administration with no other symptoms. A... Patient states they have had "knot" in arm since administration with no other symptoms. Advised patient to keep watch if no improvement continues to follow-up with PCP. Knot is not interfering with QOL currently More
2847751 52 F PA 06/29/2025 HEP
HEP
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
 945657
945657
Arthralgia, Asthenia, Fatigue, Headache, Joint swelling; Malaise, Myalgia, Nause... Arthralgia, Asthenia, Fatigue, Headache, Joint swelling; Malaise, Myalgia, Nausea, Pain More
arthralgia, myalgia, chronic fatique, headaches, nausea, and very swollen and painful left middle fi... arthralgia, myalgia, chronic fatique, headaches, nausea, and very swollen and painful left middle finger knuckle. I could not lift anything with my left hand for several days due to the pain and driving was even painful. It has since gone away, however, I still feel mild pain in the knuckle. It has never felt the same since the vaccination. I really felt extremely unwell and had very little energy to do my exercise. It lasted about 6 weeks. I do feel better now. More
2847692 F NJ 06/28/2025 HEP
 MERCK & CO. INC.
 Unknown
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HBP reports RECOMBIVAX HB was inadvertently administered to a patient following a ... No additional AE; HBP reports RECOMBIVAX HB was inadvertently administered to a patient following a TE.; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 25-Jun-2025, the patient was vaccinated with an improperly stored dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB), (lot #Unknown), dose number 1, (expiration date was not reported) for prophylaxis (product storage error). No adverse event was reported. More
2847704 28 F NY 06/28/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
 007J212A
045B21A
021B21A
Gestational diabetes, Maternal exposure before pregnancy, Neonatal disorder, Pol... Gestational diabetes, Maternal exposure before pregnancy, Neonatal disorder, Polyhydramnios; Gestational diabetes, Maternal exposure before pregnancy, Neonatal disorder, Polyhydramnios; Gestational diabetes, Maternal exposure before pregnancy, Neonatal disorder, Polyhydramnios More
Patient was vaccinated three times for covid 19. Her last vaccine was in 2022. She gave birth to he... Patient was vaccinated three times for covid 19. Her last vaccine was in 2022. She gave birth to her first child on 12/28/2024 who was discovered to have a congenital birth defect- severe coarctation of the aorta on 1/13/2025 when he presented to our office with tachypnea and retractions and grunting. Maternal prenatal care was adequate. More
2847705 66 F GA 06/28/2025 PNC20
 PFIZER\WYETH
Bell's palsy, Blood test, Cerebrovascular accident, Magnetic resonance imag... Bell's palsy, Blood test, Cerebrovascular accident, Magnetic resonance imaging head abnormal, Scan More
Bells Palsy on right side of face presenting itself on 6/10 and still prevalent. Evidence of stroke ... Bells Palsy on right side of face presenting itself on 6/10 and still prevalent. Evidence of stroke from MRI findings in emergency room. Bells Palsy is not believed to be stroke related. More
โœ“
2847706 1.67 F MN 06/28/2025 VARCEL
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.

Computerised tomogram head, Electroencephalogram, Injection site erythema, Injec... Computerised tomogram head, Electroencephalogram, Injection site erythema, Injection site mass, Laboratory test; Seizure, Vomiting More
5/1: redness, lump (delayed from when vaccine given on 4/20). 5/4: vomit 1x 5/7: 2 seizures 5/1: redness, lump (delayed from when vaccine given on 4/20). 5/4: vomit 1x 5/7: 2 seizures
โœ“
2847707 26 M IL 06/28/2025 CHIK
CHIK
CHIK
TYP
TYP
TYP
 VALNEVA USA, INC.
VALNEVA USA, INC.
VALNEVA USA, INC.
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 Unknown
Unknown
Unknown
Unknown
Unknown
Unknown
Arthritis, Chills, Feeling abnormal, Headache, Influenza like illness; Joint sti... Arthritis, Chills, Feeling abnormal, Headache, Influenza like illness; Joint stiffness, Musculoskeletal discomfort, Musculoskeletal stiffness, Oropharyngeal pain, Pain; Pyrexia, Skin warm; Arthritis, Chills, Feeling abnormal, Headache, Influenza like illness; Joint stiffness, Musculoskeletal discomfort, Musculoskeletal stiffness, Oropharyngeal pain, Pain; Pyrexia, Skin warm More
Tuesday morning started feeling joint inflammation / stiffness / discomfort. Primarily knees, feet, ... Tuesday morning started feeling joint inflammation / stiffness / discomfort. Primarily knees, feet, ankles, and back. Continued on Wednesday. Thursday I felt really bad when I woke up. I was feverish with my head feeling warm and chills in my body. Join discomfort continued. And developed a moderate headache with full pain. I took some advil around 8am and that helped alleviate most symptoms. Also developed a sore throat that has lasted 3 days. It is now Saturday, June 28th and I still have joint discomfort, a headache, and feverish symptoms. This is significantly longer than the 2 day median in their informational pamphlet. I?ve never had a bad vaccine reaction before. I feel like I have the flu More
2847708 4 M NC 06/28/2025 DTAPIPV
DTAPIPV
DTAPIPV
MMR
MMR
MMR
VARCEL
VARCEL
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 4L454
4L454
4L454
Y018703
Y018703
Y018703
Z003767
Z003767
Z003767
Crying, Emotional distress, Eye pruritus, Injection site rash, Ocular hyperaemia... Crying, Emotional distress, Eye pruritus, Injection site rash, Ocular hyperaemia; Periorbital swelling, Rash, Rash erythematous, Skin irritation, Somnolence; Vomiting; Crying, Emotional distress, Eye pruritus, Injection site rash, Ocular hyperaemia; Periorbital swelling, Rash, Rash erythematous, Skin irritation, Somnolence; Vomiting; Crying, Emotional distress, Eye pruritus, Injection site rash, Ocular hyperaemia; Periorbital swelling, Rash, Rash erythematous, Skin irritation, Somnolence; Vomiting More
Within about 15 minutes of receiving the vaccine, as he was in the parking lot leaving clinic, the p... Within about 15 minutes of receiving the vaccine, as he was in the parking lot leaving clinic, the patient had an episode of vomiting, which was originally thought to be related to crying and emotional distress about the vaccinations. He then fell asleep in the car on the way home, which is very atypical for him. When he got home about 30 minutes later (45 minutes after receiving the vaccine) his parent noted scattered large areas of confluent erythematous rash involving the extremities, torso, and face. He also developed periorbital swelling, eye redness, and itchy eyes. A dose of Benadryl was given, and rash resolved. He was able to eat a normal dinner that night and slept well. In the morning he still had residual periorbital swelling and eyes were still injected. He never had any respiratory symptoms, and his physical exam at 10am the morning after the episode was notable only for periorbital swelling, conjunctival injection, and a few excoriations on the lower abdomen. More
2847709 91 F CO 06/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 3J2S2
Asthenia, Dehydration, Diarrhoea, Malaise, Vomiting Asthenia, Dehydration, Diarrhoea, Malaise, Vomiting
Patient states that 2 hours after 2ne shingles dose, she felt sick. She had vomiting and diarrhea wh... Patient states that 2 hours after 2ne shingles dose, she felt sick. She had vomiting and diarrhea which resulted in dehydration. Patient is 93 and frail. She ended up going to ER for dehydration. Patient is fine today. No further side effects reported. Patient does not seek any monetary damages. She reported incident to us 3 days ago(06/25/2025). More
2847710 69 M FL 06/28/2025 COVID19
 MODERNA
Blindness, Eye pain, Gastric cancer, Headache, Visual impairment Blindness, Eye pain, Gastric cancer, Headache, Visual impairment
I took the Moderna on 02/11/2021 2-4 days later I was getting headaches, small amount of lower visio... I took the Moderna on 02/11/2021 2-4 days later I was getting headaches, small amount of lower vision of both eyes, and I put in my glaucoma eye drops to relieve the aching feeling. I took the second Moderna shot on 03/11/2021 at (redacted) Pharmacy and 3 or 4 days later, the symptoms came back, I thought maybe it?s my glasses. So I went to look at my prescriptions on my glasses to see if there was a problem. So I ordered new glasses on May 8th at (eye doctor), and asked for the doctor, I needed them to check my eyes and renew a prescription called (redacted). I had been diagnosed with cancer of the stomach and I had an operation date of May 13th 2021 I went to a cancer center in (redacted) for the operation and stayed in the hospital for several days. I was still complaining about my eyes at the time, and I was using three different eyedrops at the time. And they told me when I get released from the hospital to contact my eye doctor, which at the time was Dr. (redacted) at (redacted) and she checked my eyes and said I was going blind, I could not understand it, everything was going fine. My pressure was maintained and I was on eyedrops, my left eye had problems, but my right eye was 20/20 and was working fine, after being total discouraged with my Doctor. I changed to Dr. (redacted). And she performed several different operations. When i mentioned about the Moderna vaccine to Dr. (redacted), she discarded it, after all operations were complete, my left eye was totally blind and I can only see white clouds and blindness out of my right eye. And every time I mentioned anything about the vaccine, it was always discarded, no matter anyone I talk to, then I heard about some people having problems with their eyes after receiving the Moderna shot and I realized that I could be one of the individuals that could have been affected. More
โœ“ โœ“
2847711 2 M KY 06/28/2025 DTPPVHBHPB
DTPPVHBHPB
 MSP VACCINE COMPANY
MSP VACCINE COMPANY

Cellulitis, Decreased appetite, Fatigue, Injection site erythema, Injection site... Cellulitis, Decreased appetite, Fatigue, Injection site erythema, Injection site swelling; Pyrexia More
Swollen leg, red, fever 103, loss of appetite, fatigue, Swollen leg, red, fever 103, loss of appetite, fatigue,
2847712 65 M OH 06/28/2025 COVID19
 PFIZER\BIONTECH
 md3414
Tinnitus Tinnitus
Persistent tinnitus Persistent tinnitus
2847713 77 F IL 06/28/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Biopsy skin abnormal, Condition aggravated, Diarrhoea, Drug hypersensitivity, Fa... Biopsy skin abnormal, Condition aggravated, Diarrhoea, Drug hypersensitivity, Fatigue; Irritable bowel syndrome, Squamous cell carcinoma More
Multiple Skin disorders, 6 SSQ skin cancers, Accelerated drug sensitivity, Accute IBS-D - Treatment... Multiple Skin disorders, 6 SSQ skin cancers, Accelerated drug sensitivity, Accute IBS-D - Treatments are ongoing for skin disorders and SSQ skin cancers. Daily issues and occasional Flares with intestinal flares. Additionally, Fatigue for past years since vaccine. More
2847714 79 M IA 06/28/2025 PNC21
 MERCK & CO. INC.
 Y019158
Pain, Pain in extremity Pain, Pain in extremity
Patient received vaccine. Next day, wife stopped into the pharmacy to state that patient was stating... Patient received vaccine. Next day, wife stopped into the pharmacy to state that patient was stating his arm was "more sore" than usual and that it was painful to raise. Suggested to ice the location, take some anti-inflammatories, and reach out to medical provider if not better in 3 days. More
2847715 84 M MI 06/28/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 p2443
Injection site bruising, Injection site mass Injection site bruising, Injection site mass
Patient reported to the pharmacy on 6/28/25 stating a couple days after injection on 6/19/25 that p... Patient reported to the pharmacy on 6/28/25 stating a couple days after injection on 6/19/25 that patient developed a bruise and has only gotten worse , upon visual inspection there is a decent size bruise at the injection site with a purple center and yellowing around the outside, told patient that the yellowing bruise is signs of healing. patient also mentioned that there is a tiny bump at the injection side itself. patient mentioned if it does not get better this week he is going to the doctors office to get it looked at. More
2847716 27 F AZ 06/28/2025 COVID19
 PFIZER\BIONTECH
 me6072
Injection site erythema, Injection site induration, Injection site swelling Injection site erythema, Injection site induration, Injection site swelling
swelling to left deltoid injection site with induration. induration approx 3mm thick, size of indura... swelling to left deltoid injection site with induration. induration approx 3mm thick, size of induration 30x20 oval shaped with redness surrounding the induration approx 5mm all around More
2847717 53 F AL 06/28/2025 COVID19
 PFIZER\BIONTECH
 P220395-00122
Biopsy skin abnormal, Malignant melanoma stage I, Skin neoplasm excision Biopsy skin abnormal, Malignant melanoma stage I, Skin neoplasm excision
I don't know if this is related to the COVID vaccine, but I wanted to report this. I was diagn... I don't know if this is related to the COVID vaccine, but I wanted to report this. I was diagnosed with Melanoma Stage 1 following a skin biopsy. The cancer was removed via excision and the margins were clear. There is no history of skin cancer in my family prior to me being diagnosed. More
2847718 81 M OH 06/28/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Product administered at inappropriate site Arthralgia, Product administered at inappropriate site
The patient reported to the pharmacy on 6/28 that his vaccine given by the pharmacist on duty on 5/2... The patient reported to the pharmacy on 6/28 that his vaccine given by the pharmacist on duty on 5/29 was given too high up his shoulder resulting with shoulder pain lingering till today. He has had pain since the injection was given and it has not improved. I recommended the patient to take OTC pain relievers and contact his prescriber or doctor to check his shoulder for any damage. I recommended movement and possible physical therapy depending on his doctor's recommendation. More
2847719 33 F CA 06/28/2025 HEPAB
MMR
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 m4b34
Y013172
Diarrhoea, Fatigue, Headache; Diarrhoea, Fatigue, Headache Diarrhoea, Fatigue, Headache; Diarrhoea, Fatigue, Headache
Fatigue, diarrhea, headache Fatigue, diarrhea, headache
2847720 72 F VA 06/28/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Asthenia, Influenza like illness, Myalgia, Pyrexia, Somnolence Asthenia, Influenza like illness, Myalgia, Pyrexia, Somnolence
Within four hours I was having flu-like symptoms with chills, muscle aches, low fever, weakness, and... Within four hours I was having flu-like symptoms with chills, muscle aches, low fever, weakness, and sleepiness. This continued for 36 hours. All symptoms went away after 36 hours except weakness. I am now on day 4 after the injection and am still feeing considerable weakness. More
2847721 17 M NE 06/28/2025 UNK
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 Cd44A
Cd44A
Calcinosis, Injection site haematoma, Injection site haemorrhage, Injection site... Calcinosis, Injection site haematoma, Injection site haemorrhage, Injection site pain, Injection site reaction; Loss of personal independence in daily activities More
Bleeding post vaccine, followed by immense pain, and formation of small lump inside muscle, causing ... Bleeding post vaccine, followed by immense pain, and formation of small lump inside muscle, causing pain during activity. Pain caused patiwnt to withdraw from normal activity. Doctor assessed on June 23 that hematoma and calcium deposit had formed due to administration of vaccine. More
2847452 F VA 06/27/2025 HPV9
 MERCK & CO. INC.
Fatigue, Nausea, Pelvic pain Fatigue, Nausea, Pelvic pain
nausea; pelvic pain; fatigue; This spontaneous report was received from a patient's sister and ... nausea; pelvic pain; fatigue; This spontaneous report was received from a patient's sister and refers to a currently 51-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) (dose, strength, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date, the patient had pelvic pain after getting the vaccine and also experienced fatigue and nausea and she recently received laboratory without provided result. At the reporting time, the outcome of events was unknown. The causal relationship between the events and suspect vaccine was not provided. Operator Of Device: Lay User/Patient. Lot# is being requested and will be submitted if received. More
2847453 F NY 06/27/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
HCP noted that her appointment was after 12 months.; No additional AE; Information has been received... HCP noted that her appointment was after 12 months.; No additional AE; Information has been received from Business Partner/CRO on 25-Jun-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) female patient of unknown age. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), (lot # and expiration date were not reported). The patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9), for the treatment of Prophylaxis. On an unknown date, the patient experienced HCP noted that her appointment was after 12 months.. On an unknown date, the patient experienced No additional AE. At the reporting time, the outcome of HCP noted that her appointment was after 12 months. and No additional AE was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. More
2847454 F FL 06/27/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pruritus, Urticaria Pruritus, Urticaria
Hives; Itching; This non-serious case was reported by a consumer via call center representative and ... Hives; Itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included cardiac pacemaker insertion (pacemaker insertion (cardiac)) and covid-19 (had COVID infection four times). Concurrent medical conditions included hypertension, fruit allergy (allergy (hives) with stewed tomatoes) and allergy (has reactions (allergy/sensitivity) to unspecified allergens). Concomitant products included losartan, amlodipine, citalopram and acetylsalicylic acid (Aspirin). In APR-2025, the patient received the 1st dose of Shingrix (intramuscular use, unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Hives) and pruritus (Verbatim: Itching). The patient was treated with calamine, menthol, zinc oxide (Calamine) and triamcinolone acetonide (Triamcinolone). The outcome of the hives and pruritus were not resolved. It was unknown if the reporter considered the hives and pruritus to be related to Shingrix. It was unknown if the company considered the hives and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 23-JUN-2025 The reporter was the patient. She had her first Shingrix dose and she did not know the exact date. The pharmacy where she received the vaccination did not provide the lot number and expiry date to her. About two weeks after vaccination, she developed hives and itching from head to toe in 2025. She treated the hives and itching with calamine lotion. Her healthcare provider treated the hives and itching with a Z-pack (azithromycin), triamcinolone cream, and an unknown medication that came in a taper pack. The hives have not resolved. The itching has worsened. She planned to see a dermatologist. Nothing else was reported. More
2847455 0.33 M FL 06/27/2025 DTAPIPVHIB
 SANOFI PASTEUR
 UK196AA
No adverse event, Product preparation error, Product preparation issue No adverse event, Product preparation error, Product preparation issue
pentacel components were administered separately and that the hib was reconstituted with sterile wat... pentacel components were administered separately and that the hib was reconstituted with sterile water with no reported adverse event; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)] components separately and that the hib was reconstituted with sterile water with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Rotavirus vaccine (Rotavirus vaccine) and Pneumococcal vaccine conj 15 V (CRM197) (Vaxneuvance) both for Prophylactic vaccination (Immunisation). On 24-Jun-2025, the patient received a dose of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine components separately and that the hib was reconstituted with sterile water (formulation: Suspension for injection) (lot UK196AA, strength: standard, frequency: once and expiry date: 30-Mar-2026) via intramuscular route (one on the left thigh, the other on the right thigh) for Immunization with no reported adverse event (wrong technique in product usage process) (Latency: same day). Reportedly, Pentacel was administered separately- reporter was unsure which side had the DTaP- IPV and which side had the Hib. Action taken was not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2847468 F OH 06/27/2025 RAB
 SANOFI PASTEUR
Feeling abnormal, Product dose omission issue Feeling abnormal, Product dose omission issue
feeling badly; missed second dose of pre-exposure imovax therapy due to feeling badly; Initial infor... feeling badly; missed second dose of pre-exposure imovax therapy due to feeling badly; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age female patient who had missed second dose of pre-exposure Rabies (Hdc) Vaccine [Imovax Rabies] therapy due to feeling badly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, caller stated that the patient missed second dose of pre exposure suspect Rabies (Hdc) Vaccine, Powder and solvent for suspension for injection, (lot number, expiry date and strength not reported) for Immunization therapy due to feeling badly (routine immunisation schedule incomplete) (unknown latency). Information on the batch number was requested corresponding to the one at time of event occurrence On an unknown date the patient was feeling badly (feeling abnormal) (unknown latency). Reportedly,patient missed second dose on day 7, now day 11. Pharmacist stated patient missed second dose of preexposure IMOVAX therapy due to feeling badly. She stated it is now day 11 and pharmacist requested recommendation for schedule of second dose. HCP (health care professional) stated patient has no fever, is under the weather like her children, has a sore throat, and it is not related to Imovax injection. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event Feeling abnormal. At time of reporting, the outcome was Unknown for the event Feeling abnormal. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. More
2847525 M FL 06/27/2025 UNK
 UNKNOWN MANUFACTURER
No adverse event, Product availability issue No adverse event, Product availability issue
Consumer called to report his father went in for his 3rd dose of TICE BCG today but was told they di... Consumer called to report his father went in for his 3rd dose of TICE BCG today but was told they did not have a dose for him today due to the shortage of the product.; no AE; This spontaneous report was received from a consumer and refers to a male patient of unknown age. The patient's medical history, concurrent conditionsand concomitant therapies were not reported. On an unknown date, the patient started therapy with BCG (TICE BCG LIVE), (once per week), (indication, expiration date, and lot # were not reported). On an unknown date, the patient went in for his 3rd dose of BCG (TICE BCG LIVE), today but was told they did not have a dose for him today due to the shortage of the product (Product availability issue). No adverse event. Additional information is not expected. More
2847526 RI 06/27/2025 MMR
 MERCK & CO. INC.
 X022985
Expired product administered, No adverse event Expired product administered, No adverse event
No symptoms reported.; HCP calling to report inadvertently administering an expired dose of MMRII to... No symptoms reported.; HCP calling to report inadvertently administering an expired dose of MMRII to a patient.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 09-Jun-2025, the patient was vaccinated with an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #X022985, expiration date: 08-Jun-2025), dose number 1, that was reconstituted with sterile diluent (MERCK STERILE DILUENT) for prophylaxis (expired product administered). No adverse event was reported. More
2847527 F CO 06/27/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Incomplete course of vaccination; Incomplete course of vaccination Incomplete course of vaccination; Incomplete course of vaccination
HCP stated female patient started her series at age 45 and has not received their 3rd dose within th... HCP stated female patient started her series at age 45 and has not received their 3rd dose within the guidelines of PI.; No additional AE reported; This spontaneous report was received from a Pharmacist and refers to a 45-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On an unknown date in November 2024, the patient was vaccinated with the first dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date in December 2024, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL๏ฟฝ9) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). The reporter stated that the patient did not receive the third dose. No additional adverse events were reported. Additional information is not expected. More
2847528 F NC 06/27/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.

Incomplete course of vaccination, No adverse event; Incomplete course of vaccina... Incomplete course of vaccination, No adverse event; Incomplete course of vaccination, No adverse event More
female patient last received 2 doses of GARDASIL-9 in 2021 but did not complete the series; No addit... female patient last received 2 doses of GARDASIL-9 in 2021 but did not complete the series; No additional AE; This spontaneous report was received from a nurse referring to a 27-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided. On an unknown date in 2021, she received the first and second dose of Human Papillomavirus 9-valent vaccine, recombinant suspension for injection for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), the reporter did not know why patient did not receive the 3rd dose (Inappropriate schedule of product administration). There was not adverse event reported (No adverse event). More
2847529 F TN 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Lack of injection site rotation Lack of injection site rotation
Patient was vaccinated with RabAvert and Immunoglobulin in the right shoulder; Case reference number... Patient was vaccinated with RabAvert and Immunoglobulin in the right shoulder; Case reference number US-BN-2024-002008 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1305) on 07-Jun-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication was not reported. On an unknown date, the patient was scratched by a bat. On 05-Jun-2024, unknown time after the animal exposure, the patient was vaccinated with a dose of RabAvert (batch number: unknown) at an unknown dose, via intramuscular use in right deltoid for post exposure prophylaxis. On an unknown date, the patient was vaccinated with the co-suspect immunoglobulin (brand name: unknown, batch number: unknown) at an unknown dose, via unknown route for unknown indication. As reported, patient was vaccinated with RabAvert shot on the right deltoid and they gave the Immunoglobulin shots around the hand where the scratch or bite took place and there was little residual, so they gave it in the right shoulder as well (explicitly coded as 'lack of vaccination site rotation'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Rabipur vaccine. Additional information received by a health care professional via Med Communication (reference number: USBAV24-1307) on 07-Jun-2024: included additional reference number (USBAV24-1307), reporter information, confirmation of animal exposure and Rabavert site of administration.; Reporter's Comments: A female patient of unknown age was vaccinated with the co-suspect immunoglobulin, at an unknown dose, via unknown route for unknown indication. Reportedly, the patient was vaccinated with RabAvert shot on the right deltoid and they gave the Immunoglobulin shots around the hand where the scratch or bite took place and there was little residual, so they gave it in the right shoulder as well which is considered as lack of vaccination site rotation. Lack of vaccination site rotation is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Rabipur vaccine. The patient's medical history and concomitant medication was not reported. 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 was vaccinated with the co-suspect immunoglobulin, at an unknown dose, via unknown route for unknown indication. Reportedly, the patient was vaccinated with RabAvert shot on the right deltoid and they gave the Immunoglobulin shots around the hand where the scratch or bite took place and there was little residual, so they gave it in the right shoulder as well which is considered as lack of vaccination site rotation. Lack of vaccination site rotation is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Rabipur vaccine. The patient's medical history and concomitant medication was not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2847530 F TX 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received first dose of Rabavert for pre-exposure and did not receive the second dose on day ... Patient received first dose of Rabavert for pre-exposure and did not receive the second dose on day seven; Case reference number US-BN-2024-002069 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-1402) on 18-Jun-2024 and concerns a female patient. The patient's medical history and concomitant medication were not provided. On 20-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 pre-exposure vaccination. As reported, patient did not get the second dose on day seven (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 Rabavert. No further information was provided.; Reporter's Comments: A female patient was vaccinated with the first dose of Rabavert for pre-exposure vaccination. As reported, patient did not get the second dose on day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient was vaccinated with the first dose of Rabavert for pre-exposure vaccination. As reported, patient did not get the second dose on day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847531 F NC 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received day zero dose of RabAvert and was supposed to receive the day seven dose but cant g... Patient received day zero dose of RabAvert and was supposed to receive the day seven dose but cant get it; Case reference number US-BN-2024-002110 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1497) on 26-Jun-2024 and concerns an adult female patient. The patient's medical history and concomitant medication were not provided. On an unspecified date, reported as day zero, 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. As reported patient received day zero dose and was supposed to receive the day seven dose but could not get it (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 Med Communications on 02-Jul-2024 included missing description from the initial source form.; Reporter's Comments: An adult female patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported the patient received day zero dose and was supposed to receive the day seven dose but could not get it, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult female patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported the patient received day zero dose and was supposed to receive the day seven dose but could not get it, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. More
2847532 CA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product preparation issue Product preparation issue
The patient received only diluent of RabAvert; The patient received only diluent of RabAvert; Case r... The patient received only diluent of RabAvert; The patient received only diluent of RabAvert; Case reference number US-BN-2024-002121 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1545) on 01-Jul-2024 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with only a diluent of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication (explicitly coded as 'product administration error' and 'active ingredient not added to diluent'). As reported, the reporter wanted to know how long the powder goof would for at room temperature. At the time of the initial report, it was unknown if the patient experienced an adverse event due to RabAvert. No further information was provided.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with only a diluent of RabAvert, at an unknown dose, route, and site of administration, for unknown indication which is considered as product administration error and 'active ingredient not added to diluent. Product administration error and product preparation error are both considered listed per company conventions. At this point, it was unknown if the patient experienced an adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Product administration error and product preparation error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender was vaccinated with only a diluent of RabAvert, at an unknown dose, route, and site of administration, for unknown indication which is considered as product administration error and 'active ingredient not added to diluent. Product administration error and product preparation error are both considered listed per company conventions. At this point, it was unknown if the patient experienced an adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Product administration error and product preparation error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1545: More
2847533 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product administered at inappropriate site Product administered at inappropriate site
Patient received last dose of Rabavert, but it was administered in the buttock, instead of the delto... Patient received last dose of Rabavert, but it was administered in the buttock, instead of the deltoid; Case reference number US-BN-2024-002123 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1549) on 02-Jul-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient was vaccinated with, as reported, last dose of Rabavert (batch number: unknown) at an unknown dose, route and site of administration for unknown indication. As reported, a dose of Rabavert was administered in the buttock, instead of 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. No further information was provided.; Reporter's Comments: A patient of unknown age and gender with a dose of Rabavert was administered in the buttock, instead of the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Rabavert. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown age and gender with a dose of Rabavert was administered in the buttock, instead of the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Rabavert. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. More
2847534 F NC 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received the first dose of RabAvert on 05-Jul-2024, for pre-exposure, and missed the sec... The patient received the first dose of RabAvert on 05-Jul-2024, for pre-exposure, and missed the second dose; Case reference number US-BN-2024-002192 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1663) on 15-Jul-2024 and concerns a 25-years-old female patient. The patient's medical history and concomitant medication details were not provided. On 05-Jul-2024, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, or route of administration, for pre-exposure prophylaxis. As reported the patient missed 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 25-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure prophylaxis. As reported the patient missed the second 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. 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 25-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure prophylaxis. As reported the patient missed the second 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. 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
2847535 F TX 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Incomplete course of vaccination Incomplete course of vaccination
The patient received two doses of RabAvert in May-2024, for pre-exposure prophylaxis, and did not re... The patient received two doses of RabAvert in May-2024, for pre-exposure prophylaxis, and did not receive the third dose; Case reference number US-BN-2024-002193 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1664) on 15-Jul-2024 and concerns a 28-years-old female patient. The patient's medical history and concomitant medication details were not provided. On 23-May-2024, 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 prophylaxis against rabies. On 30-May-2024, seven days after the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration. As reported, the vaccination with the first and the second dose of RabAvert was almost eight weeks ago and the patient never got the third dose (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 28-years-old female patient never got the third dose of RabAvert which is considered as incomplete course of vaccination. Incomplete course of vaccination 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 28-years-old female patient never got the third dose of RabAvert which is considered as incomplete course of vaccination. Incomplete course of vaccination 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
2847536 M NE 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration, Product administered at inappr... Inappropriate schedule of product administration, Product administered at inappropriate site More
The patient received the first and second RabAvert vaccine in thighs; The patient received the first... The patient received the first and second RabAvert vaccine in thighs; The patient received the first dose of RabAvert two days after animal exposure and second dose five days after animal exposure; Case reference number US-BN-2024-002252 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1761) on 24-Jul-2024 and concerns a 68-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 16-Jul-2024, the patient was bitten by bat. On 18-Jul-2024, two days after animal exposure, the patient was vaccinated with the three doses of co-suspect immunoglobulins (brand name: unknown, batch number unknown), at an unknown dose, administered in the wound and then in shoulders, for post-exposure prophylaxis and then with the first dose of RabAvert (batch number: unknown), at an unknown dose and route of administration, in right thigh, for post-exposure prophylaxis. As reported, the RabAvert vaccine was administered in thigh because it was not supposed to receive in the same place as immunoglobulin (explicitly coded as 'vaccine administered at inappropriate site' and 'inappropriate schedule of vaccine administered'). On 21-Jul-2024, five days after animal exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose and route of administration, in left thigh (explicitly coded as 'vaccine administered at inappropriate site' and '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. Additional information received from consumer via Med Communications (reference number: USBAV24-1765) on 24-Jul-2024 included co-suspect information, additional reporter, and reference number.; Reporter's Comments: A 68-year-old male patient was vaccinated with the first two doses of RabAvert for post-exposure prophylaxis of a bat bite, on days 2 and 5 after the exposure (which is considered inappropriate schedule of vaccine administered). The patient received the RabAvert doses in the thigh to avoid application on the same site as the immunoglobulin, which is considered vaccine administration at inappropriate site for RabAvert. No associated adverse events were reported. The events are listed as per company convention. No medical history information was available. Inappropriate schedule of vaccine administration and vaccine administration at inappropriate site are not related to RabAvert, but to human factors. The case is non-serious.; Sender's Comments: A 68-year-old male patient was vaccinated with the first two doses of RabAvert for post-exposure prophylaxis of a bat bite, on days 2 and 5 after the exposure (which is considered inappropriate schedule of vaccine administered). The patient received the RabAvert doses in the thigh to avoid application on the same site as the immunoglobulin, which is considered vaccine administration at inappropriate site for RabAvert. No associated adverse events were reported. The events are listed as per company convention. No medical history information was available. Inappropriate schedule of vaccine administration and vaccine administration at inappropriate site are not related to RabAvert, but to human factors. The case is non-serious. More
2847537 F DC 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00447
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
The second dose of RabAvert delayed one day; Case reference number US-BN-2024-002276 is a spontaneou... The second dose of RabAvert delayed one day; Case reference number US-BN-2024-002276 is a spontaneous case initially received from a nurse via Med Communication (reference number USBAV24-1827) on 31-Jul-2024 and concerns a *43-year-old female patient*. The patient's medical history and concomitant medication were not reported. *On 24-Jul-2024, reported as week ago, the patient received the first dose of RabAvert (batch number: FDP00447, expiry date: 30-Apr-2027), at a dose of 1.00, intramuscularly*, at an unknown site of administration, for pre-exposure vaccination. *On 01-Aug-2024, reported as delayed one day, eight days after the first dose, the patient received the second dose of RabAvert (batch number: FDP00555, expiry date: 30-Sep-2027), at a dose of 1.00, intramuscularly, * at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). *As reported, the second dose was delayed one day to match with the patient's son schedule* (explicitly coded as 'inappropriate schedule of vaccine administered'). At the time of this follow up report, the patient did not experience fever, and the patient *did not experience any other adverse event due to RabAvert*. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from a nurse on 14-Aug-2024 included: confirmation that the patient did not experience fever, and that the second dose was delayed for one day. The case is linked to case ID US-BN-2024-002277 due to the same report and family member. Follow up information received from a nurse on 12-Sep-2024: New information included patient's details, Rabavert dosing information, and confirmation that patient did not experience any adverse event due to RabAvert vaccine.; Reporter's Comments: A 43-year-old female patient received the second dose of RabAvert for pre-exposure vaccination, as reported with one day delay, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 reported. 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 43-year-old female patient received the second dose of RabAvert for pre-exposure vaccination, as reported with one day delay, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 reported. 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
2847538 M FL 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP0055
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Patient received second dose of preexposure prophylaxis with Rabavert on day 10, instead of day seve... Patient received second dose of preexposure prophylaxis with Rabavert on day 10, instead of day seven; Case reference number US-BN-2024-002289 is a spontaneous case initially received from a health care professional via Med Communications (reference number: USBAV24-1849) on 01-Aug-2024 and concerns a 40-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 22-Jul-2024, the patient was vaccinated with the first dose of RabAvert (batch number: FDP0055), at an unknown dose, via intramuscular use in unknown site of administration, for pre-exposure prophylaxis. On 01-Aug-2024, ten days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: FDP0055), at an unknown dose, via intramuscular use in unknown site of administration (explicitly coded as 'inappropriate schedule of drug 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 40-year-old male patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis, as reported ten days after the first dose, which is considered as inappropriate schedule of drug 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 40-year-old male patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis, as reported ten days after the first dose, which is considered as inappropriate schedule of drug 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
2847539 M PA 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product preparation issue Product preparation issue
The patient only received the diluent and not the vial that contained the actual vaccine; The patien... The patient only received the diluent and not the vial that contained the actual vaccine; The patient only received the diluent and not the vial that contained the actual vaccine; Case reference number US-BN-2024-002293 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1865) on 02-Aug-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient had contact with an animal. On an unspecified date, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose and site, intramuscularly, for post-exposure rabies prophylaxis. On the same date, the patient received a dose of immunoglobulin human anti-rabies (HRI), at an unknown dose, route, or site of administration. On 02-Aug-2024, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose or site, administered intramuscularly. As reported, the patient only received the diluent and not the vial that contained the actual vaccine (explicitly coded as 'active ingredient not added to diluent' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to the RabAvert vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age was vaccinated with the second dose of RabAvert, at an unknown dose or site, administered intramuscularly. Reportedly, the patient only received the diluent and not the vial that contained the actual vaccine which is considered as active ingredient not added to diluent 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 adverse event due to the 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 male patient of unspecified age was vaccinated with the second dose of RabAvert, at an unknown dose or site, administered intramuscularly. Reportedly, the patient only received the diluent and not the vial that contained the actual vaccine which is considered as active ingredient not added to diluent 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 adverse event due to the 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
2847540 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Expired product administered Expired product administered
The patient received RabAvert vaccine which expired in Apr-2024; Case reference number US-BN-2024-00... The patient received RabAvert vaccine which expired in Apr-2024; Case reference number US-BN-2024-002315 is a spontaneous case initially received from physician via Med Communications (reference number: USBAV24-1894) on 07-Aug-2024 and concerns patient of unspecified gender or age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, as reported the patient had been exposed to a bat but was not bitten. On 06-Aug-2024, unknown amount of time after contact with bat, the patient received the first dose of RabAvert (batch number: unknown; expiration date: Apr-2024), at unknown dose, route or site of administration (explicitly coded as 'expired vaccine used'). 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 patient of unknown demographics was vaccinated with a dose of RabAvert, which had expired approximately 4 months earlier. Indication was exposure to a bat, but without a bite. This is considered expired vaccine used, which is listed per company convention. No associated adverse events were reported. The patient's medical history and concomitant medication details were not provided. The use of expired vaccine is not related to RabAvert, but to a human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of RabAvert, which had expired approximately 4 months earlier. Indication was exposure to a bat, but without a bite. This is considered expired vaccine used, which is listed per company convention. No associated adverse events were reported. The patient's medical history and concomitant medication details were not provided. The use of expired vaccine is not related to RabAvert, but to a human error. The case is non-serious. USBAV24-1894: More
2847541 M AZ 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Inappropriate schedule of product administration Inappropriate schedule of product administration
The patient received the first dose of RabAvert on day 0 and second dose on day 4; Case reference nu... The patient received the first dose of RabAvert on day 0 and second dose on day 4; Case reference number US-BN-2024-002346 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1967) on 14-Aug-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 day zero, the patient received the first dose of RabAvert vaccine (batch number: unknown), at an unknown dose, route or site of administration, for pre-exposure. On an unspecified date, reported as day four, the patient received the second dose of RabAvert vaccine (batch number: unknown), at an unknown dose, route or site of administration (explicitly coded ' 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 vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age received the second dose of RabAvert vaccine for pre-exposure, reported as on the day 4, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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 second dose of RabAvert vaccine for pre-exposure, reported as on the day 4, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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. USBAV24-1967: More
2847542 F TX 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00533
Incorrect route of product administration Incorrect route of product administration
The patient received a dose of RabAvert vaccine subcutaneously instead of intramuscularly by mistake... The patient received a dose of RabAvert vaccine subcutaneously instead of intramuscularly by mistake; Case reference number US-BN-2024-002350 is a spontaneous case initially received from a other health professional via Med Communications (reference number USBAV24-1978) on 15-Aug-2024 and concerns a female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, reported as last week, the patient was vaccinated with the first dose of RabAvert (batch number: FDP00533), at an unknown dose, intramuscularly for pre-exposure prophylaxis. On an unspecified date, unknown amount of time after first dose of RabAvert, reported as today, the patient was vaccinated with the second dose of RabAvert (batch number: FDP00533), at an unknown dose, subcutaneously (explicitly coded as 'Inappropriate route of vaccination'). As reported, the second dose of RabAvert was administered subcutaneously instead intramuscularly by mistake. At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccine. Additional information received from pharmacist via Med Communication (reference number: USBAV24-1983) on 15-Aug-2024: included additional reporter, confirmation of patient's date of birth, confirmation that second dose of RabAvert was given subcutaneously, and reference number. Additional information received from Bavarian Nordic on 16-Aug-2024: Information included additional reference number (BN_2024_02939). Additional information received from pharmacist via Med Communication (reference number: USBAV24-1993) on 16-Aug-2024: included additional reported, confirmation of batch number and additional reference number.; Reporter's Comments: A female patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route 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 was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1978: USBAV24-1983: USBAV24-1993: More
2847543 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Product preparation issue Product preparation issue
The patient was administered a dose of Rabavert, but it appears that the freeze-dried component of t... The patient was administered a dose of Rabavert, but it appears that the freeze-dried component of the vaccine was not properly diluted; The patient was administered a dose of Rabavert, but it appears that the freeze-dried component of the vaccine was not properly diluted; Case reference number US-BN-2024-002377 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-2035) on 19-Aug-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was vaccinated with a dose of RabAavert (batch number: unknown), at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. As reported, the freeze-dried component of the vaccine was not properly diluted (explicitly coded as 'product concentrate not diluted' and 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert. Additional information received from health care professional via Med Communication (reference number: USBAV24-2061) on 21-Aug-2024: included reference number (USBAV24-2061).; Reporter's Comments: A patient of unknown age and gender was vaccinated with a dose of RabAavert, at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. Reportedly, the freeze-dried component of the vaccine was not properly diluted which is considered as product concentrate not diluted 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 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 for both reported events. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with a dose of RabAavert, at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. Reportedly, the freeze-dried component of the vaccine was not properly diluted which is considered as product concentrate not diluted 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 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 for both reported events. The case is non-serious. More
2847544 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 Unknown
Arthralgia, Mobility decreased, Musculoskeletal stiffness, Product administered ... Arthralgia, Mobility decreased, Musculoskeletal stiffness, Product administered at inappropriate site More
The patient received too high RabAvert vaccine, injected either into the shoulder joint or subacromi... The patient received too high RabAvert vaccine, injected either into the shoulder joint or subacromial bursa; The patient had limited mobility and range of motion in shoulder joint and persistent pain; The patient had limited mobility and range of motion in shoulder joint and persistent pain; Case reference number US-BN-2024-002376 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-2062) on 21-Aug-2024 and concerns a *24-years-old* female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient received HRIG (immunoglobulin human anti-rabies; batch number: unknown), at an unknown dose, route or site of administration for post exposure prophylaxis. On unspecified dates, reported as on day zero, three and seven the patient received three doses of RabAvert (batch number: unknown), at an unknown dose, route or site of administration for post exposure prophylaxis. On 06-Aug-2024, on day 14, the patient received the fourth dose of RabAvert *(batch number: FDP00543; expiration date: Sep-2027 ), at dose of 1 ml, intramuscularly*, at unknown site of administration which was also reported as too high, and patient believed that it was injected either into the shoulder joint or subacromial bursa (explicitly coded as 'vaccine administered at inappropriate site'). *On 08-Jun-2024 at 07:48 *, as reported in the past two weeks since receiving the injection, *immediately after vaccination* the patient had *severe* limited mobility and range of motion in shoulder joint and persistent pain. * On unspecified date, the patient had four views for left shoulder, due to clinical history left shoulder pain and stiffness; technique: the left shoulder was examined in the internal rotation, external rotation, axillary, and trans scapular Y projections, comparison: none, findings: there is no fracture, subluxation, or dislocation, the acromioclavicular and glenohumeral joints appear grossly intact, the bony mineralization is within normal limits, there was not radiopaque foreign body seen, impression: no evidence of acutely displaced fracture or dislocation of the left shoulder. * *At the time of follow up report, the patient did not recover from events of 'mobility decreased' and 'joint pain'.* The reporter assessed the events of 'mobility decreased' and 'joint pain' as non-serious and possibly related to RabAvert. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up report received from consumer on 17-Sep-2024 new information include: dosing information for fourth dose of RabAvert, volume, route of administration, batch number and expiration date, patient age, severity, start date and outcome for events of 'mobility decreased' and 'joint pain', and results of performed investigation. Additional information received from consumer via Med Communications on 17-Sep-2024 included additional reference number USBAV24-2395.; Reporter's Comments: A 24-years-old female patient received the fourth dose of RabAvert, at dose of 1 ml, intramuscularly, for post exposure prophylaxis. Reportedly, the patient believed that it was injected either into the shoulder joint or subacromial bursa, which is considered as vaccine administered at inappropriate site. Two days after the fourth dose of RabAvert was administered, also reported as in the past two weeks since receiving the injection, the patient had severe limited mobility and range of motion in shoulder joint and persistent pain. Arthralgia is listed and expected for RabAvert, whilst mobility decreased is unlisted and unexpected. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was not resolved. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of arthralgia and mobility decreased have been considered as related 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: A 24-years-old female patient received the fourth dose of RabAvert, at dose of 1 ml, intramuscularly, for post exposure prophylaxis. Reportedly, the patient believed that it was injected either into the shoulder joint or subacromial bursa, which is considered as vaccine administered at inappropriate site. Two days after the fourth dose of RabAvert was administered, also reported as in the past two weeks since receiving the injection, the patient had severe limited mobility and range of motion in shoulder joint and persistent pain. Arthralgia is listed and expected for RabAvert, whilst mobility decreased is unlisted and unexpected. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was not resolved. Considering plausible temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the events of arthralgia and mobility decreased have been considered as related 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
2847545 F 06/27/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00543
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient received two doses of RabAvert for pre-exposure on 13-Aug-2024 and 23-Aug-2024; Case referen... Patient received two doses of RabAvert for pre-exposure on 13-Aug-2024 and 23-Aug-2024; Case reference number US-BN-2024-002390 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2096) on 23-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 13-Aug-2024, the patient was vaccinated with the first dose of RabAvert (batch number: FDP00543), at an unknown dose, administered intramuscularly in unknown site of administration, for pre-exposure. On 23-Aug-2024, 10 days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: FDP00543), at an unknown dose, administered intramuscularly in 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 female patient of unknown age was vaccinated with the second dose of RabAvert for pre-exposure, 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. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the second dose of RabAvert for pre-exposure, 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. 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
2847546 39 F MO 06/27/2025 COVID19
 PFIZER\BIONTECH
Arrhythmia, Electrocardiogram ambulatory abnormal, Injection site pain, Malaise,... Arrhythmia, Electrocardiogram ambulatory abnormal, Injection site pain, Malaise, Ventricular extrasystoles More
Sore injection site, feeling sick within 24 hrs and lasting 24 hrs Sore injection site, feeling sick within 24 hrs and lasting 24 hrs
2847547 61 F AK 06/27/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2A54M
TY2TY
Herpes zoster, Neck pain, Swelling; Herpes zoster, Neck pain, Swelling Herpes zoster, Neck pain, Swelling; Herpes zoster, Neck pain, Swelling
She has shingles, started with sore and swollen neck She has shingles, started with sore and swollen neck
2847548 12 F NC 06/27/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 CX4HL
Injection site erythema, Injection site pain, Injection site warmth Injection site erythema, Injection site pain, Injection site warmth
On the patient's left arm, deltoid area, shows redness, warm and tenderness. Measuring 3 inch ... On the patient's left arm, deltoid area, shows redness, warm and tenderness. Measuring 3 inch in a circular diameter. Vaccine was given on 06/24/25 and patient was brought in by caregiver, Stepparent. More
๐Ÿ“‹ Privacy Policy & Data Disclaimer