🏥 VAERS Vaccine Data Browser

🔒 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.

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

💡 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 "📥 Export CSV" to download filtered data (max 10,000 records)

💡 Frequently Asked Questions (FAQ)

What is this site?

🏥 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:

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

Limitations:

  • ⚠️ Reports are unverified - not investigated before publication
  • ⚠️ Cannot determine if vaccine caused the event
  • ⚠️ Underreporting - not all adverse events are reported
  • ⚠️ Overreporting - coincidental events may be reported
  • ⚠️ 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?

⚠️ 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
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2867895 39 M NC 10/23/2025 FLU3
 SANOFI PASTEUR
 UT8804AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse event. Just reporting the med error based on patient's age. No adverse event. Just reporting the med error based on patient's age.
2867898 75 F PA 10/23/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Amino acid level increased, Brain fog, Fatigue, Nitrite urine absent, Pyrexia; U... Amino acid level increased, Brain fog, Fatigue, Nitrite urine absent, Pyrexia; Urinary tract infection More
I don?t know if my UTI is a result of the Covid vaccination, but I hadn?t felt well after the shot. ... I don?t know if my UTI is a result of the Covid vaccination, but I hadn?t felt well after the shot. I was mildly ill for 2 days, with fatigue and a slight fever, then just days of brain fog and more fatigue. When my UTI symptoms appeared and I tested myself, I contacted my PCP and he prescribed 5 days of Macrobid. I?m still taking that medication now. More
2867899 55 F IL 10/23/2025 FLU3
 SANOFI PASTEUR
 UT8770MA
Arthralgia, Malaise, Pain Arthralgia, Malaise, Pain
10 days post vaccination feeling ill, body aches & painful joints 10 days post vaccination feeling ill, body aches & painful joints
2867900 30 F NC 10/23/2025 FLU3
 SANOFI PASTEUR
 UT8804AA
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
No adverse event. Reporting med error due to age of patient. No adverse event. Reporting med error due to age of patient.
2867902 35 F NC 10/23/2025 FLU3
 SANOFI PASTEUR
Immediate post-injection reaction, Mobility decreased, Neuralgia Immediate post-injection reaction, Mobility decreased, Neuralgia
Patient is a staff member that received her vaccine at a staff mass vaccination event. Patient repor... Patient is a staff member that received her vaccine at a staff mass vaccination event. Patient reported that she had immediate nerve pain with her vaccine, decreased range of motion shortly after, and increased pain over time. Patient did not observe where the needle went into her arm, however patient stated if was given more dorsally than she felt she has received vaccines in the past. More
2867903 82 F PA 10/23/2025 COVID19
 MODERNA
 3052731
Dizziness Dizziness
Patient stated she felt dizzy the day after her vaccine. She went to the ER, but no abnormalities we... Patient stated she felt dizzy the day after her vaccine. She went to the ER, but no abnormalities were found. More
2867905 40 F OR 10/23/2025 COVID19
 PFIZER\BIONTECH
Balance disorder, Dizziness, Vestibular disorder Balance disorder, Dizziness, Vestibular disorder
Dizziness and imbalance became worse. This has become persistent over time . It has been so far diag... Dizziness and imbalance became worse. This has become persistent over time . It has been so far diagnosed as inner ear vestibular issue. though not 100% certain. More
2867906 52 F VA 10/23/2025 COVID19
 MODERNA
 3052296
Contusion, Headache, Neuralgia, Trigeminal neuralgia Contusion, Headache, Neuralgia, Trigeminal neuralgia
PATIENT STATED SHE EXPERIENCED A BRUISE THAT TOOK OVER ONE WEEK TO HEAL, TRIGEMINAL NEURALGIA/CONSTA... PATIENT STATED SHE EXPERIENCED A BRUISE THAT TOOK OVER ONE WEEK TO HEAL, TRIGEMINAL NEURALGIA/CONSTANT HEADACHE, NERVE PAIN IN ARM More
2867908 43 F 10/23/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052549
3052549
Arthralgia, Dyspnoea, Eye contusion, Fatigue, Joint swelling; Menstruation delay... Arthralgia, Dyspnoea, Eye contusion, Fatigue, Joint swelling; Menstruation delayed, Myalgia More
Two days following vaccine developed painful golf-ball sized swelling on top of wrists that took sev... Two days following vaccine developed painful golf-ball sized swelling on top of wrists that took several weeks to subside. Also developed muscular pain, fatigue, black undereye circles, and easily winded. This is ongoing now almost two months later. My period was also delayed which happened following a previous covid vaccination. More
2867910 52 M NM 10/23/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SEQIRUS, INC.
SEQIRUS, INC.
 NA0589
NA0589
AX4241A
AX4241A
Chest pain, Chills, Dizziness, Fatigue, Lacrimation increased; Pyrexia, Rhinorrh... Chest pain, Chills, Dizziness, Fatigue, Lacrimation increased; Pyrexia, Rhinorrhoea, Syncope; Chest pain, Chills, Dizziness, Fatigue, Lacrimation increased; Pyrexia, Rhinorrhoea, Syncope More
REPORTED BY WIFE: PATIENT HAS HAD A FEVER, CHILLS, RUNNY NOSE, WATERY EYES, FATIGUE, CHEST PAIN, DIZ... REPORTED BY WIFE: PATIENT HAS HAD A FEVER, CHILLS, RUNNY NOSE, WATERY EYES, FATIGUE, CHEST PAIN, DIZZINESS, AND HE FAINTED ONCE SINCE SUNDAY 10/19. PATIENT HAS REFUSED TO SEEK MEDICAL CARE. WIFE WAS ADVISED 10/23 TO HAVE HIM SEE A DOCTOR DUE TO THE CHEST PAIN, DIZZINESS, AND FAINTING. More
2867912 33 F AR 10/23/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 ER8736
ER8736
ER8736
ER8736
Anorectal manometry, Autonomic neuropathy, Barium swallow, Biopsy skin, Chronic ... Anorectal manometry, Autonomic neuropathy, Barium swallow, Biopsy skin, Chronic fatigue syndrome; Coagulopathy, Gastrointestinal motility disorder, Immunoglobulin therapy, Laboratory test, Migraine; Muscle contractions involuntary, Muscular weakness, Neurogenic bladder, Oesophageal manometry, Oesophageal motility disorder; Optic nerve injury, Small fibre neuropathy, Syncope, Urodynamics measurement More
progressive autonomic neuropathy that began with syncope that increased in frequency and lead to eso... progressive autonomic neuropathy that began with syncope that increased in frequency and lead to esophageal dysmotility, GI dysmotility, chronic daily migraine, Neurogenic bladder small fiber neuropathy. of course testing was significantly limited at onset due to pandemic shut down. i also devolved chronic fatigue syndrome, damage to my optic nerves (73 percent left on the left eye), and chronic muscle weakness and fasciculations. All symptoms have been progressive since onset. I have been given IVIG to slow progression but IV access has been problematic and i have not been able to have a successful port placed because i have developed something where my body clots of anything that they try to put in it. More
✓
2867913 50 F 10/23/2025 FLU4
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Injection site bruising, Injection site induration, Injection site mass; Injecti... Injection site bruising, Injection site induration, Injection site mass; Injection site bruising, Injection site induration, Injection site mass More
patien has hard lump and multiple brusies around injection site. patien has hard lump and multiple brusies around injection site.
2867914 50 F PA 10/23/2025 FLU3
 SANOFI PASTEUR
 U8827AA
Erythema, Oedema, Paraesthesia Erythema, Oedema, Paraesthesia
DEVELOPED EDEMA, REDNESS, AND TINGLING FROM BELOW RIGHT EAR EXTENDING DOWN TO BELOW RIGHT ELBOW. TOO... DEVELOPED EDEMA, REDNESS, AND TINGLING FROM BELOW RIGHT EAR EXTENDING DOWN TO BELOW RIGHT ELBOW. TOOK BENADRYL 25 MG ORALLY AND ALL SYMPTOMS RESOLVED IN LESS THAN 24 HOURS More
2867915 33 F TX 10/23/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Injection site pain, Pain, Tenderness Injection site pain, Pain, Tenderness
On 10/1/25 flu shot on left shoulder and vaccine was burning more than normal and associate is expe... On 10/1/25 flu shot on left shoulder and vaccine was burning more than normal and associate is experiencing pain while moving or putting pressure on arm 16 days later More
2867916 88 F KS 10/23/2025 RSV
RSV
 PFIZER\WYETH
PFIZER\WYETH
 mm9168
mm9168
Arthralgia, Dizziness, Dyspnoea, Dysstasia, Fall; Muscular weakness Arthralgia, Dizziness, Dyspnoea, Dysstasia, Fall; Muscular weakness
After vaccine, patient was getting out of chair and rph helped assist. Patients legs could not suppo... After vaccine, patient was getting out of chair and rph helped assist. Patients legs could not support and patient fell to the ground. She did not hit her head but was unable to get back up. RPh called 911. while waiting on help, patient was short of breath, complaining of knee pain, and felt lightheaded/dizzy. Pt daughter said she has fallen before and has vertigo. patient was then transported to hospital via ambulance. More
✓
2867917 13 M NC 10/23/2025 FLU3
HEPA
HPV9
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 3F7A5
3255P
Y019751
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Medical records show patient was already up to date on Hepatits A and HPV vaccines. Patient received... Medical records show patient was already up to date on Hepatits A and HPV vaccines. Patient received a 3rd Hepatitis A and has received 4 HPV vaccines. No adverse reactions noted. More
2867918 100 F KY 10/23/2025 FLU3
 SEQIRUS, INC.
 409166
Cyanosis, Seizure like phenomena, Unresponsive to stimuli Cyanosis, Seizure like phenomena, Unresponsive to stimuli
Patient became unresponsive, with seizure-like symptoms and blue lips for approx 2 minutes. EMS was ... Patient became unresponsive, with seizure-like symptoms and blue lips for approx 2 minutes. EMS was contacted and pharmacist administered epinephrine auto-injector 0.15mg x 1 dose. After epi administration, patient became responsive within 1 minute and remained alert until emergency response arrived. EMS arrived within 10 minutes after onset and took control of patient. Patient was transported to hospital by ambulance. More
2867919 65 F WI 10/23/2025 COVID19
UNK
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER

Chest pain, Musculoskeletal pain, Nausea, Pain in jaw; Chest pain, Musculoskelet... Chest pain, Musculoskeletal pain, Nausea, Pain in jaw; Chest pain, Musculoskeletal pain, Nausea, Pain in jaw More
Chest pain, pain in my jaw pain in my back on the right side under my shoulder blade and nausea Chest pain, pain in my jaw pain in my back on the right side under my shoulder blade and nausea
2867920 76 F CA 10/23/2025 FLU3
 SANOFI PASTEUR
Injected limb mobility decreased, Injection site pain, Pain Injected limb mobility decreased, Injection site pain, Pain
I got an injecton in left arm and I felt it hit the bone and i can not raise my arm, and when i move... I got an injecton in left arm and I felt it hit the bone and i can not raise my arm, and when i move my arm it feels likesomething is hold my bone More
2867921 52 M PA 10/23/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
Rash Rash
papular rash left arm. upper back and b/l antecubital region, treated with 10 mh zyrtec. papular rash left arm. upper back and b/l antecubital region, treated with 10 mh zyrtec.
2867922 76 M OH 10/23/2025 FLU3
 SANOFI PASTEUR
 U8837AA
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient says he came to the pharmacy counter requesting a Covid vaccine. The typing technician must ... Patient says he came to the pharmacy counter requesting a Covid vaccine. The typing technician must have misunderstood and thought he asked for a Flu vaccine, so she processed a flu vaccine. The vaccinating technician claims to have asked the patient in the clinic room which vaccine he was needing today; she claims that the patient told her he was there for a flu vaccine. So that is what she administered. The patient then came back later stating that he looked at his receipt and saw that he was administered a flu vaccine, but he wanted a Covid vaccine. Patient just received the shot so he is not experiencing any symptoms yet at this time. More
2867923 34 F TX 10/23/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 2L353
Arthralgia, Injected limb mobility decreased, Injection site pain Arthralgia, Injected limb mobility decreased, Injection site pain
Flu shot she having pain in right shoulder. Pain started day after injection worse than normal but s... Flu shot she having pain in right shoulder. Pain started day after injection worse than normal but she assumed it was just normal pain. Has progressively gotten worse. Is affecting range of motion. Deltoid/shoulder pain. Appointment scheduled for 10/23/25. Reported on 10/21/25 More
2867924 13 F OH 10/23/2025 FLU3
 SANOFI PASTEUR
 U8889CA
Extra dose administered Extra dose administered
Patient requested vaccine while in urgent care for appt. When asked if she had received patient stat... Patient requested vaccine while in urgent care for appt. When asked if she had received patient stated no . Patient given vaccine and had received one week prior. More
2867925 53 M MI 10/23/2025 FLU3
MMR
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 ES4H5
Z008441
Contraindication to vaccination; Contraindication to vaccination Contraindication to vaccination; Contraindication to vaccination
Gave live vaccine and he has hx of Kidney transplant Gave live vaccine and he has hx of Kidney transplant
2867926 69 M NY 10/23/2025 FLU3
 SANOFI PASTEUR
 U8855CA
Chronic obstructive pulmonary disease, Condition aggravated, Hypoxia Chronic obstructive pulmonary disease, Condition aggravated, Hypoxia
Pulmonologist called and informed PCP office that patient had COPD exacerbation and hypoxemia after... Pulmonologist called and informed PCP office that patient had COPD exacerbation and hypoxemia after receiving the flu shot both last year and this year, resulting in ER visits. Recommended not to give same brand next year. More
2867927 12 M MN 10/23/2025 FLU3
HPV9
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 J5T3B
Y020464
U8660AC
Rash, Rash papular; Rash, Rash papular; Rash, Rash papular Rash, Rash papular; Rash, Rash papular; Rash, Rash papular
papular rash to the trunk papular rash to the trunk
2867928 62 F NE 10/23/2025 FLU3
 SEQIRUS, INC.
Rash, Rash erythematous, Rash pruritic Rash, Rash erythematous, Rash pruritic
itchy rash, fluid filled, red, started on left forearm, spread to left torso, right arm, right shoul... itchy rash, fluid filled, red, started on left forearm, spread to left torso, right arm, right shoulder. Dr said NOT shingles. Thinks it is from an area on right forearm that is thought to be from a plant allergy. But it had been there for 1-2 weeks and blew up within 12 hrs of the vaccine. Rx Clobetasol given for 2-3 weeks of application to rashes. injection was : Influenza, MDCK, trivalent, PF. More
2867930 73 F CO 10/23/2025 FLU3
 SANOFI PASTEUR
 UT8820BA
Erythema, Feeling hot, Swelling Erythema, Feeling hot, Swelling
redness, hot , swelling redness, hot , swelling
2867931 7 F TX 10/23/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052579
UT8873JA
Erythema, Skin warm, Swelling; Erythema, Skin warm, Swelling Erythema, Skin warm, Swelling; Erythema, Skin warm, Swelling
Redness, swelling and warm to the touch started the following day after vaccine. Redness, swelling and warm to the touch started the following day after vaccine.
2867932 7 F MI 10/23/2025 COVID19
DTAP
FLU3
IPV
 PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 LN7302
4ca03c2
3F7A5
Y1A212M
Injection site pain; Injection site pain; Injection site pain; Injection site pa... Injection site pain; Injection site pain; Injection site pain; Injection site pain More
The patient experienced no symptoms or adverse reactions following vaccination. The patient reported... The patient experienced no symptoms or adverse reactions following vaccination. The patient reported no issues other than mild, expected soreness at the injection site, which is a normal response after receiving vaccines. More
2867933 75 F NJ 10/23/2025 FLU3
PNC20
 SEQIRUS, INC.
PFIZER\WYETH
 407261
LC5485
Injection site cellulitis, Injection site erythema, Injection site warmth; Injec... Injection site cellulitis, Injection site erythema, Injection site warmth; Injection site cellulitis, Injection site erythema, Injection site warmth More
Patient had redness at injection site on right arm. Over the next few days, redness spread, and felt... Patient had redness at injection site on right arm. Over the next few days, redness spread, and felt hot to the touch. Patient went to urgent care and was diagnosed with cellulitis that patient believes she got when she was vaccinated. More
2867935 52 F CA 10/23/2025 FLU3
FLU3
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 7FY52
7FY52
Headache, Influenza like illness, Lip swelling, Pain, Paraesthesia; Rhinorrhoea,... Headache, Influenza like illness, Lip swelling, Pain, Paraesthesia; Rhinorrhoea, Throat irritation More
10/21/2025 during our off-site flu clinic, employee developed an allergic reaction to the flu vaccin... 10/21/2025 during our off-site flu clinic, employee developed an allergic reaction to the flu vaccine. We administered the vaccine around 2:30pm. Employee came back around 2:45pm complaining of tingling sensation of her fingers, swelling of lips and itchy throat. Patient took Benadryl PO 25mg around 3pm. Her allergic reaction subsided around 3:40pm but she was still drowsy from the Benadryl. We stayed with her until she was seen by a doctor around 3:50pm. Vitals are normal. Advised her to call and report the incident to workers comp. 10/22/2025 She mentioned that after we left, she was given another dose of Benadryl. They ended up sending her to ED, they administered EpiPen and she stayed for observation for couple of hours. She also had a follow up earlier today. Also, she is experiencing flu like symptoms, headache, body ache, and runny nose. Advised her to call workers comp to report the incident. Employee called worker comp to discuss claim on 10/23 More
2867939 39 F CO 10/23/2025 FLU3
 SANOFI PASTEUR
Arthralgia, Arthritis Arthralgia, Arthritis
R shoulder joint inflammation and pain progressively worse 4 days after administration of Covid and ... R shoulder joint inflammation and pain progressively worse 4 days after administration of Covid and Flu vaccines. Vaccine information unknown. More
2867941 81 F MI 10/23/2025 COVID19
 MODERNA
 3052736
Blood glucose increased, Dizziness, Feeling hot, Vomiting Blood glucose increased, Dizziness, Feeling hot, Vomiting
Patient received vaccine at 12:48pm. Just before returning from lunch at 2pm she let the technician ... Patient received vaccine at 12:48pm. Just before returning from lunch at 2pm she let the technician that vaccinated her know she was not feeling well. She said she had vomited a little, she was warm, and dizzy. When questioned she stated no problems breathing, no mouth/lip swelling, no rash/hives. She stated she had not eaten yet today but that her glucose was 200. She has a CBGM. We did check her blood pressure and it was 140/84 and pulse was 96. She had 2 people with her and was going to go home and eat and report back. She did call back within the hour and state she was still warm and a little dizzy but much better. More
2867942 54 F TX 10/23/2025 FLU3
HEP
HEPA
MMR
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
 2NG23
T5D73
Z27PB
Y018703
U8620AA
Peripheral swelling, Rash, Visual impairment; Peripheral swelling, Rash, Visual ... Peripheral swelling, Rash, Visual impairment; Peripheral swelling, Rash, Visual impairment; Peripheral swelling, Rash, Visual impairment; Peripheral swelling, Rash, Visual impairment; Peripheral swelling, Rash, Visual impairment More
After 10 minutes, Client's R Forearm started to swell with fine non itchy rash. Client started ... After 10 minutes, Client's R Forearm started to swell with fine non itchy rash. Client started to see black spots, so laid down on clinic bed. 911 called. 1600: BP 170/90. O2 100%. No SOB. Orient X3. Lungs clear. Benadryl 50 mg IM given in L thigh at 1611. EMS called. Client refused to go to ER. BPP 150/80 @ 1615. States she will continue to take oral Benadryl. Ambulatory from clinic at 1645. More
2867943 67 F CO 10/23/2025 COVID19
COVID19
FLU3
FLU3
 PFIZER\BIONTECH
PFIZER\BIONTECH
SANOFI PASTEUR
SANOFI PASTEUR



Acute left ventricular failure, Cardioversion, Catheterisation cardiac, Dyspnoea... Acute left ventricular failure, Cardioversion, Catheterisation cardiac, Dyspnoea, Echocardiogram; Ejection fraction decreased, Hypervolaemia, Intensive care, White blood cell count increased; Acute left ventricular failure, Cardioversion, Catheterisation cardiac, Dyspnoea, Echocardiogram; Ejection fraction decreased, Hypervolaemia, Intensive care, White blood cell count increased More
Within 3 days of vaccines (on 9/29/25) I had worsening shortness of breath (10/1/25) but was out of ... Within 3 days of vaccines (on 9/29/25) I had worsening shortness of breath (10/1/25) but was out of town. I had been having shortness of breath but it got worse. On 10/7, I went to the hospital and was transferred to a bigger hospital where I spent 12 days, including 5 days in ICU. I was diagnosed with acute left sided heart failure. I do not know that the vaccines contributed but I had a slightly elevated WBC in the ER. I was told that it might be related to the vaccines. None of the doctors mentioned the vaccines after admission but I thought it was worth reporting More
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2867945 82 F WV 10/23/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 u8855aa
z006076
Contusion, Erythema, Nausea, Peripheral swelling, Vomiting; Contusion, Erythema,... Contusion, Erythema, Nausea, Peripheral swelling, Vomiting; Contusion, Erythema, Nausea, Peripheral swelling, Vomiting More
Redness and bump on arm, bruising, nausea, and vomiting Redness and bump on arm, bruising, nausea, and vomiting
2867946 77 F NY 10/23/2025 COVID19
COVID19
 MODERNA
MODERNA
 3051995
3051995
Computerised tomogram normal, Electric shock sensation, Immediate post-injection... Computerised tomogram normal, Electric shock sensation, Immediate post-injection reaction, Injection site bruising, Injection site cellulitis; Injection site discolouration More
pain immediately after administration, 5 days post administration bruising developed. A couple weeks... pain immediately after administration, 5 days post administration bruising developed. A couple weeks passed and pain got worse, "feels like a shot of electricity". roughly 4 weeks later injection site turned purple. patient went to urgent care day 27 post administration and was diagnosed with cellulitis. A CT scan was done and there was no active bleeding. patient received IV antibiotics with contrast (iopdmiol with tiperacillin) and has been transitioned to oral antibiotics. was on augmentin but was transitioned to bactrim 10/23/25. More
2867947 54 F CA 10/23/2025 FLU3
TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 P327D
K4979
3EG9B
Cough, Dizziness, Hypotension, Pain; Cough, Dizziness, Hypotension, Pain; Cough,... Cough, Dizziness, Hypotension, Pain; Cough, Dizziness, Hypotension, Pain; Cough, Dizziness, Hypotension, Pain More
Patient called into the office to state that she was having low blood pressure with dizziness while ... Patient called into the office to state that she was having low blood pressure with dizziness while at work the night after she got her vaccinations. Patient also had body aches and is starting to have a cough. Patient was at the pharmacy at time of call and still felt dizzy. Advised patient to go to the Urgent Care but patient declined. Patient is going to go home and rest. More
2867949 65 F AZ 10/23/2025 COVID19
 PFIZER\BIONTECH
 na4457
Injection site bruising, Injection site swelling Injection site bruising, Injection site swelling
Pt has Side effect of bruising and swelling on the site of the injection. Pt has Side effect of bruising and swelling on the site of the injection.
2867950 70 F FL 10/23/2025 FLU3
RSV
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 u8837ca
544sd
Injection site bruising, Injection site erythema, Injection site pain, Periphera... Injection site bruising, Injection site erythema, Injection site pain, Peripheral swelling; Injection site bruising, Injection site erythema, Injection site pain, Peripheral swelling More
patient left arm where the RSV vaccine was administered - 7 days after administration starting notic... patient left arm where the RSV vaccine was administered - 7 days after administration starting noticing increase in pain in the arm and pain was traveling and arm was beginning to become swollen and red. pain starting at shoulder and traveling down through elbow. redness was at a injection site and presented as a bruise at first changing into an almost ulcerative looking wound. required urgent care treatment with antibiotic for 10 days and monitoring- urgent care was visited 10 days after vaccine administration. month later still large 1 inch large would at vaccine administration site. More
2867952 31 F 10/23/2025 FLU3
FLU3
 SEQIRUS, INC.
SEQIRUS, INC.
 AX5586A
AX5586A
Discomfort, Feeling abnormal, Flushing, Hypoaesthesia, Hypoaesthesia oral; Joint... Discomfort, Feeling abnormal, Flushing, Hypoaesthesia, Hypoaesthesia oral; Joint swelling, Musculoskeletal stiffness, Neck pain More
On 10/20/25 within 15 minutes of vaccine administration, (L *deltoid) *=it seemed like it was given ... On 10/20/25 within 15 minutes of vaccine administration, (L *deltoid) *=it seemed like it was given too high as it was less than 3 fingers from the top of the shoulder, L side of the neck started to become sore and stiff. Within 20 minutes numbness started at the TMJ area and radiated to the chin. L side of tongue also became numb. I also started to feel a little flushed and spacey. Went back to employee health and reported the event. The next day it was escalated to workman's comp. That day I had intermittent numbness of the joint and tongue, the joint swelled, and it started to having a feeling of heaviness. As of 10/24/25 the joint is still swollen, feels heavy, and there's an area on the left side of the tongue that feels like it has been burned after eating something hot. I went to the workman's comp physician and he said because there was no injury to the injection site he was not able to do anything. He said it seemed like a systemic response and to see a PCP, neurologist, or allergist. Did not prescribe anything or request any sort of labs as it was no longer relevant to his area of practice (resulting limb injury because he is an orthopedic doctor). More
2867953 42 F KS 10/23/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 33CM4
Intercepted product prescribing error Intercepted product prescribing error
Prescriber ordered a high-dose flu vaccine for a 42-year-old female. Regular strength flu vaccine pr... Prescriber ordered a high-dose flu vaccine for a 42-year-old female. Regular strength flu vaccine procured and administered. More
2867957 FL 10/23/2025 HPV9
HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 1957404
Y009051
Y009051
1957404
Extra dose administered; Extra dose administered; Extra dose administered; Extra... Extra dose administered; Extra dose administered; Extra dose administered; Extra dose administered More
No adverse event; HCP reports that the patient received an extra dose of GARDASIL 9 and the third an... No adverse event; HCP reports that the patient received an extra dose of GARDASIL 9 and the third and fourth doses were administered prior to the minimal interval that is outlined. Please see patients dosing schedule below for background. No additional information wa; HCP reports that the patient received an extra dose of GARDASIL 9 and the third and fourth doses were administered prior to the minimal interval that is outlined. Please see patients dosing schedule below for background. No additional information wa; This spontaneous report was received from an Other health professional and refers to a 33-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Sep-2023, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection (lot #1957404, expiration date: 05-Oct-2025), dose number 1, 0.5 mL (0.5ml/ series dose 1) for prophylaxis. On 14-Sep-2024, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection (lot #1957404, expiration date: 05-Oct-2025), dose number 2, 0.5 mL (dose 2) for prophylaxis. On 25-Nov-2024, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection (lot #Y009051, expiration date: 08-Oct-2026), dose number 3, 0.5 mL (dose 3) for prophylaxis (Inappropriate schedule of product administration). On 22-Jan-2025, the patient was vaccinated with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) Injection (lot #Y009051, expiration date: 08-Oct-2026), dose number 4, 0.5 mL (dose 4) for prophylaxis (Extra dose administered). It was reported that the patient received an extra dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and the third and fourth doses were administered prior to the minimal interval that was outlined. No additional information was provided. There was no additional adverse event (No adverse event). More
2867960 M WY 10/23/2025 PPV
PPV
 MERCK & CO. INC.
MERCK & CO. INC.

Arthralgia, Blood pressure increased, Burning sensation, Chest discomfort, Chest... Arthralgia, Blood pressure increased, Burning sensation, Chest discomfort, Chest pain; Headache, Incorrect route of product administration, Myalgia, Tinnitus, Vein disorder More
He said felt like he was having another heart attack; blood pressure went through the roof; muscular... He said felt like he was having another heart attack; blood pressure went through the roof; muscular pains; his ears started ringing; chest tightened up; chest pains; shoulder started hurting; his arm started burning; his veins got hard; severe headache; An HBP administered the vaccine through his IV and his arm; This spontaneous report was received from a 65-year-old male patient, referring on himself. The patient's medical history included a heart attack (reported as "He said felt like he was having another heart attack") on an unspecified date and hospitalization (reported as "he was in the hospital prior to receiving the vaccine"). The patient's concurrent conditions included low blood pressure. Concomitant medications included amlodipine maleate, isosorbide dinitrate, lisinopril dihydrate, omeprazole sodium, potassium chloride, rosuvastatin calcium, Vitamin b12 (Cobamamide), Aspirin (Acetylsalicylic acid;Ascorbic acid), atenolol, ezetimibe od, furosemide sodium and levothyroxine sodium. The reporting patient stated he was in the hospital prior to receiving the vaccine due to low blood pressure and then on the day he was being discharged, on 04-Oct-2025; his healthcare professional (HCP) recommended he get the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) along with another vaccine. On 04-Oct-2025, the patient was vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), (lot # and expiration date were not reported) as Prophylaxis. It was confirmed that a Hospital-Based Physician (HBP) administered the vaccine through his intravenous (IV) arm. After the administration of the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) vaccine through his IV, his arm started burning. He quickly started to experience a severe headache, he said his blood pressure went through the roof, chest pain, muscular pain and his veins got hard. He said his ears started ringing, the chest tightened up and shoulder started hurting. He said felt like he was "having another heart attack" (cardiac disorder). Then, he had to stay in the hospital for about 4 days after receiving vaccine. He said it was probably not from the vaccine but from how it was administered. He said he tried aspirin, acetaminophen (TYLENOL) and ibuprofen, but nothing helps with the headache. He said his blood pressure was just now getting under control and that his HCP has adjusted his blood pressure medication. At the reporting time, the patient was recovering from all the adverse events. The causal relationship between the arm started burning, headache, blood pressure went through the roof, chest pain, muscular pain, veins got hard, ears started ringing, chest tightened up, shoulder started hurting and the feeling like he was "having another heart attack" (cardiac disorder) with the dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) was not provided. Lot # is being requested and will be submitted if received More
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2867961 OR 10/23/2025 HPV9
 MERCK & CO. INC.
 Z002903
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; patient received improperly stored GARDASIL 9; This spontaneous report was receive... No additional AE; patient received improperly stored GARDASIL 9; This spontaneous report was received from a nurse and refers to a(n) 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 15-Oct-2025, the patient received improperly stored Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), lot #Z002903, expiration date: 15-Dec-2026, 0.5 mL, administered for prophylaxis (route and anatomical site were not reported) (Product storage error). The temperature excursion (TE) was reported as: 4 Hours 30 Minutes @ -7 C. Previous TE: 2 Hours 45 Minutes @ 12.2 C. No additional AE (No adverse event). On 15-Oct-2025, the patient experienced patient received improperly stored GARDASIL 9. On an unknown date, the patient experienced No additional AE. At the reporting time, the outcome of No additional AE and patient received improperly stored GARDASIL 9 was unknown. The action taken with Human Papillomavirus 9-valent Vaccine, Recombinant was reported as not applicable. More
2867962 0.33 M PA 10/23/2025 DTPPVHBHPB
PNC
RVX
 MSP VACCINE COMPANY
PFIZER\WYETH
UNKNOWN MANUFACTURER
 U7829AA

2142138
Injection site erythema, Injection site swelling; Injection site erythema, Injec... Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling More
red swelling around the inject site; red swelling around the inject site; This spontaneous report wa... red swelling around the inject site; red swelling around the inject site; This spontaneous report was received from a Consumer or other non health professional and refers to a 4 month-old male patient. The patient's medical history and concurrent conditions were not reported. Historical drugs included Vaxelis (Diphtheria vaccine toxoid;Hepatitis b vaccine rHBsAg (yeast);HIB vaccine conj (menigococcal protein);Pertussis vaccine acellular 5-component;Polio vaccine inact 3v (Vero);Tetanus vaccine toxoid). Concomitant therapies were not reported. On 20-Oct-2025, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), lot #2142138, expiration date: 28-Jun-2026 as prophylaxis (dose and route of administration were not reported), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, ... (VAXELIS), lot #U7829AA, expiration date: 14-Jul-2026, dose number 2, 1 dosage form, as prophylaxis (route of administration was not reported) and Pneumococcal vaccine conj 7v (CRM197)(PREVNAR) (dose, route of administration, indication, expiration date, and lot # were not reported). On the same day at 03:00 pm, the patient experienced red swelling around the inject site, it was also stated that it was a "large reaction". Tylenol was provided as treatment for the event. At the reporting time, the patient had not recovered from red swelling around the inject site and red swelling around the inject site. The causal relationship between the event of red swelling around the inject site and the suspect vaccines was unknown. Lot # is being requested for Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq) and will be submitted if received.; Reporter's Comments: Keywords : BP More
2867964 86 F FL 10/23/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Paraesthesia, Polyneuropathy Paraesthesia, Polyneuropathy
drug induced polyneuropathy/Tingling in toes and fingers; This serious case was reported by a consum... drug induced polyneuropathy/Tingling in toes and fingers; This serious case was reported by a consumer via call center representative and described the occurrence of polyneuropathy in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included non-hodgkin's lymphoma (in 2020). Concomitant products included RSV VACCINE, Flu unspecified (Influenza vaccine), COVID-19 VACCINE and rituximab (Rituxan). On 17-JAN-2025, the patient received the 1st dose of Shingrix. In JAN-2025, less than a month after receiving Shingrix, the patient experienced polyneuropathy (Verbatim: drug induced polyneuropathy/Tingling in toes and fingers) (serious criteria GSK medically significant). The outcome of the polyneuropathy was unknown. It was unknown if the reporter considered the polyneuropathy to be related to Shingrix. The company considered the polyneuropathy to be unrelated to Shingrix. Linked case(s) involving the same patient: US2025AMR132241 Additional Information: GSK Receipt Date: 13-OCT-2025 The patient reported that on 31st October 2024, she got her COVID-10 and flu shot (unknown manufacturer) and on 9th November 2024, she got an RSV shot (unknown manufacturer). She received her first dose of Shingrix and she developed tingling in her fingers and toes in January 2025. At her doctor's appointment in February, she was told that she had drug induced polyneuropathy. The batch number was not provided and a request for this information has been made. This case is linked with US2025AMR132241, reported by same reporter.; Sender's Comments: A case of Polyneuropathy, less than a month after receiving Shingrix in a elderly female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (h/o non-hodgkin's lymphoma and concomitant RSV vaccine, Influenza vaccine, COVID-19 vaccine and rituximab). US-GSK-US2025AMR132241:same patient More
2867965 61 F TX 10/23/2025 COVID19
COVID19
FLU3
FLU3
TDAP
TDAP
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
UNK
UNK
H4K3S
H4K3S
Injection site bruising, Injection site erythema, Injection site mass, Injection... Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site swelling, Irritability, Pain, Pruritus, Skin discolouration; Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site swelling, Irritability, Pain, Pruritus, Skin discolouration; Injection site bruising, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus; Injection site swelling, Irritability, Pain, Pruritus, Skin discolouration More
pain at the injection site; Injection site swelling; Injection site bruising; Itchy/a itching on her... pain at the injection site; Injection site swelling; Injection site bruising; Itchy/a itching on her left arm/ Injection site itching; Injection site redness; has lump the size of a golf ball/injection site mass; irritated; Her arm hurts to lift it; she experienced a itching on her left arm; dark/red; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H4K3S) for prophylaxis. Co-suspect products included Influenza vaccine rHA 3v (baculovirus) (Flublok) for prophylaxis and COVID-19 VACCINE for prophylaxis. The patient's past medical history included covid-19 (COVID did attack her lungs and was aggravated bronchial asthma) and bronchial asthma (last time bronchial asthma affected the consumer was 15 years ago). Previously administered products included iron infusion. Concurrent medical conditions included blood pressure and thyroid disorder. On 16-SEP-2025, the patient received Boostrix (intramuscular, right arm), Flublok (intramuscular, left arm) and COVID-19 VACCINE (left arm). In SEP-2025, an unknown time after receiving Boostrix and not applicable after receiving Flublok and COVID-19 VACCINE, the patient experienced injection site pain (Verbatim: pain at the injection site), injection site swelling (Verbatim: Injection site swelling), injection site bruising (Verbatim: Injection site bruising), injection site itching (Verbatim: Itchy/a itching on her left arm/ Injection site itching), injection site erythema (Verbatim: Injection site redness), injection site lump (Verbatim: has lump the size of a golf ball/injection site mass), irritability (Verbatim: irritated), pain upon movement (Verbatim: Her arm hurts to lift it), pruritus (Verbatim: she experienced a itching on her left arm) and skin discoloration (Verbatim: dark/red). The patient was treated with hydrocortisone. The outcome of the injection site pain, injection site swelling, injection site bruising, injection site itching, injection site erythema, injection site lump, irritability, pain upon movement, pruritus and skin discoloration were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, injection site bruising, injection site itching, injection site erythema, injection site lump, irritability, pain upon movement, pruritus and skin discoloration to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the reporter considered the irritability, pain upon movement, pruritus and skin discoloration to be related to Flublok and COVID-19 VACCINE. It was unknown if the company considered the injection site pain, injection site swelling, injection site bruising, injection site itching, injection site erythema, injection site lump, irritability, pain upon movement, pruritus and skin discoloration to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the irritability, pain upon movement, pruritus and skin discoloration to be related to Flublok and COVID-19 VACCINE. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 23-SEP-2025, 24-SEP-2025 and 25-SEP-2025. The consumer was the reporter. The reporter states she was vaccinated with a tetanus vaccine, flu vaccine and covid vaccine on 16 SEP 2025. She had the flu shot and covid vaccine administered in the left arm. The tetanus vaccine was administered in her right arm. The consumer was unable to provide the name/manufactures of the vaccines that were administered and could not provide the lot numbers. The consumer state that she experienced a itching on her left arm, however, that has resolved. The consumer state that a few days later her right arm started itching. The consumer stated that her right arm at the injection site is painful, itchy, swollen, red, bruised, has lump the size of a golf ball, is irritated and her arm hurts to lift it. The reporter stated that she went back to the vaccinating pharmacy for examination and was told to put a warm compress on the areas and apply hydrocortisone cream for the itching. Consumer stated that she took blood pressure medication, thyroid medication, and an iron infusion (name/frequency/dose not disclosed.) More
2867968 54 F VA 10/23/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 7nx5y
Extra dose administered, Wrong product administered Extra dose administered, Wrong product administered
Wrong drug; the patient received 2 Engerix B doses; This non-serious case was reported by a other h... Wrong drug; the patient received 2 Engerix B doses; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 54-year-old female patient who received HBV (Engerix B pediatric) (batch number 7nx5y, expiry date 12-DEC-2026) for prophylaxis. Co-suspect products included HAB (Twinrix) for prophylaxis. On 06-OCT-2025, the patient received Engerix B pediatric. On an unknown date, the patient did not received Twinrix. On 06-OCT-2025, an unknown time after receiving Engerix B pediatric, the patient experienced wrong vaccine administered (Verbatim: Wrong drug) and accidental overdose (Verbatim: the patient received 2 Engerix B doses). The outcome of the wrong vaccine administered and accidental overdose were not applicable. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK Receipt Date: 07-OCT-2025 The practice manager who states that a patient was given the wrong medication yesterday. Patient was supposed to get an Engerix B, Hepatitis A and Hepatitis B vaccine, instead, the patient received 2 Engerix B doses, one was an adult dose and the other was a pediatric dose. More
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