πŸ₯ VAERS Vaccine Data Browser

πŸ”’ 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.

πŸ“– Help & Search Guide

Column Icons Legend

πŸ’€ Death
πŸ₯ Hospitalized
πŸš‘ Emergency Room
β™Ώ Disability
⚠️ Life Threatening

How to Search

πŸ’‘ 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 "πŸ“₯ Export CSV" to download filtered data (max 10,000 records)

πŸ’‘ Frequently Asked Questions (FAQ)

What is this site?

πŸ₯ 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:

  • βœ… Early warning system for potential safety signals
  • βœ… Open and transparent - publicly accessible
  • βœ… Accepts all reports regardless of likelihood of causation
  • βœ… 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
πŸ”„ Reset πŸ“₯ Export CSV
ID Age Sex State Date β–Ό Onset Days Vaccine Manufacturer Lot # Symptoms Narrative πŸ’€ πŸ₯ πŸš‘ β™Ώ ⚠️
2866726 33 F TX 10/17/2025 COVID19
 PFIZER\BIONTECH
 EW0161
Pain, Sleep disorder Pain, Sleep disorder
I got my COVID vaccines at the pharmacy. My first dose was on 4/17/2021 and the second dose was on 5... I got my COVID vaccines at the pharmacy. My first dose was on 4/17/2021 and the second dose was on 5/27/2021, I was forced to go to a hospital for the first time in my life at age 33 on 6/3/2021. It s important that I disclose that I had severe side effects from getting the COVID vaccine in April/ May of 2021. I usually sleep on my right side and was unable to do so during that timeframe it felt like my breast was getting pinched. Outlier anomalies that I have never felt before, I was in a lot of pain and knew it was linked to the covid vaccines so I went to the hospital. Pain was over a month-two. More
2866727 63 F CA 10/17/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 G2HA7
Injection site erythema, Injection site pain, Injection site swelling, Injection... Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth More
Swelling, redness, warmth and pain and tenderness of the left upper arm. Seen on 10/16/25 with ongoi... Swelling, redness, warmth and pain and tenderness of the left upper arm. Seen on 10/16/25 with ongoing pain, redness and warmth measuring 5x6cm area of the arm. More
2866729 48 F 10/17/2025 FLU3
 SANOFI PASTEUR
 U8864AA
Cold sweat, Dizziness, Injection site haemorrhage, Injection site swelling, Pall... Cold sweat, Dizziness, Injection site haemorrhage, Injection site swelling, Pallor More
Pt started bleeding and the injection site swelled up within a minute. The patient got very dizzy an... Pt started bleeding and the injection site swelled up within a minute. The patient got very dizzy and white and had a cold sweat. We put an ice pack on her neck and the injection site and took her blood pressure. After about 10-15 minutes, she was feeling better and could walk to her car. More
2866730 58 F WV 10/17/2025 FLU3
 SEQIRUS, INC.
Chills, Pain Chills, Pain
I don?t know answers for item 17 but it wouldn?t let me continue. Around 2:30 pm, i began experienci... I don?t know answers for item 17 but it wouldn?t let me continue. Around 2:30 pm, i began experiencing chills. The office wasn?t cold but i used the space heater for the rest of the day. I continue to experience the chills and around 5:30, i experienced body aches. More
2866739 68 F CA 10/17/2025 FLU3
 SANOFI PASTEUR
Arthralgia, Mobility decreased Arthralgia, Mobility decreased
Right shoulder pain and limited range of motion Right shoulder pain and limited range of motion
2866740 76 M FL 10/17/2025 FLU3
 SANOFI PASTEUR
Contusion, Injection site pain, Joint swelling, Muscle swelling, Muscle tightnes... Contusion, Injection site pain, Joint swelling, Muscle swelling, Muscle tightness More
pt had mild pain common post vaccination at injection site, then 4-5 days later the right arm bicep ... pt had mild pain common post vaccination at injection site, then 4-5 days later the right arm bicep began to swell to about 2.5 times normal size and harden... 3 days later bruising started to spread where the swelling was and down the arm, following the swelling going down the arm from bicep to forearm. More
2866741 42 F WI 10/17/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 ZE423
Injected limb mobility decreased, Injection site pain, Injection site swelling, ... Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain, Product administered at inappropriate site More
10/16/25 Teammate called Teammate health to report persistent pain of left deltoid since her 10/1/25... 10/16/25 Teammate called Teammate health to report persistent pain of left deltoid since her 10/1/25 Flu vaccination. Reported injection given higher on her deltoid. Having diminished left shoulder range of motion due to pain. Minimal swelling, no redness, no fever. More
2866743 72 F TN 10/17/2025 COVID19
 MODERNA
Extra dose administered Extra dose administered
2 shots given, on accident. 2 shots given, on accident.
2866744 49 F CT 10/17/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052035
3052035
Diarrhoea, Dysgeusia, Dysstasia, Fatigue, Gastrointestinal pain; Pain Diarrhoea, Dysgeusia, Dysstasia, Fatigue, Gastrointestinal pain; Pain
Patient reported having intense fatigue that pt has trouble standing on both feet, nasty tastes in m... Patient reported having intense fatigue that pt has trouble standing on both feet, nasty tastes in mouth and irritated GI tract, including a lot of diarrhea and sharp pain as if something is burning. More
2866745 54 M NV 10/17/2025 COVID19
 MODERNA
Influenza like illness, Pain in extremity, Wrong product administered Influenza like illness, Pain in extremity, Wrong product administered
This request is intended to report a COVID vaccine administration error by (withheld name) Pharmacy ... This request is intended to report a COVID vaccine administration error by (withheld name) Pharmacy in (city, state withheld). The patient receiving the vaccine had submitted an online appointment request to Pharmacy where he specifically requested the non-mRNA vaccine (ie novavax) prior to the appointment. Upon arrival, no paperwork or confirmation was provided by Pharmacy as to what vaccine was going to be administered. The patient was then injected and thus left the Pharmacy location assuming he had received the non-mRNA version that he had specifically requested online prior to the appointment. Later that night, around 9pm, the patient?s arm started feeling sore (more sore than it had when he previously received the non-mRNA version a year before). The next morning, the patient started feeling very sick/ill (something he had not experienced previously with the non-mRNA version). After checking his online records at Pharmacy, he then learned that The vaccine the Pharmacy administered was not the non-mRNA version. Pharmacy had mistakenly administered the MRNA Spikevax, (Pharmacy incorrectly administered the Moderna SPIKEVAX mRNA instead of the requested non-mRNA version). More
2866746 77 F NM 10/17/2025 FLU3
 SANOFI PASTEUR
 UT8763FA
Arthralgia, External ear pain, Headache, Neck pain, Pain in extremity Arthralgia, External ear pain, Headache, Neck pain, Pain in extremity
Patient states has pain in arm above wrist, shoulder, neck, outer ear and headache Patient states has pain in arm above wrist, shoulder, neck, outer ear and headache
2866747 79 M NM 10/17/2025 FLU3
 SANOFI PASTEUR
 UT8763FA
Injection site pain Injection site pain
Pain in upper arm near injection site Pain in upper arm near injection site
2866748 65 F MO 10/17/2025 COVID19
PNC21
 MODERNA
MERCK & CO. INC.
 3052549
Y013009
Peripheral swelling, Pruritus; Peripheral swelling, Pruritus Peripheral swelling, Pruritus; Peripheral swelling, Pruritus
Patient reports localized swelling and itching in arms beginning after vaccination. Swelling (to ten... Patient reports localized swelling and itching in arms beginning after vaccination. Swelling (to tennis ball size) and itching of one arm has not subsided. Advised patient to go to urgent care or see a provider right away. Patient said they were unable to until Monday. Advised patient to use OTC allergy medication, apply ice, and go to urgent care/provider. Patient stated they will see routine provider on Monday and go to ER, More
2866749 71 F CA 10/17/2025 COVID19
FLU3
 PFIZER\BIONTECH
SANOFI PASTEUR
 NA0739
UT8820BA
Extra dose administered, Pain in extremity; Extra dose administered, Pain in ext... Extra dose administered, Pain in extremity; Extra dose administered, Pain in extremity More
Upon checking in a vaccine appointment for the patient she confirmed she was here for FLU vaccine in... Upon checking in a vaccine appointment for the patient she confirmed she was here for FLU vaccine in addition to the scheduled covid vaccine appointment. Shots covered by insurance. Upon reviewing intake form Pharmacist did not take note of last FLU vaccine date which was 09/2025. Patient was notified and confirmed of vaccines being administered prior to administration and had no questions. Patient verbally notified pharmacist after administration that she has already received the flu shot the month prior at a fire department clinic. Advised to wait 15 minutes at pharmacy. Patient was not alleging any ADR at the in pharmacy. When pharmacist called to check in she was upset at error and reported sore arm so she took ibuprofen and tired took a long nap. Advised to go to ER if having symptoms More
2866750 72 F 10/17/2025 COVID19
 PFIZER\BIONTECH
Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Sleep d... Arthralgia, Injected limb mobility decreased, Injection site pain, Pain, Sleep disorder More
About 3 days after getting the shot in my right arm, that shoulder and upper arm muscle were hurting... About 3 days after getting the shot in my right arm, that shoulder and upper arm muscle were hurting. I took 2 Tylenol PM, but for some strange reason I just couldn't go to sleep. After this that arm and muscle really hurt 4 days. Eventually the pain went away and I now have normal arm use. I couldn't lift, grab, or move it without pain. . The first 4 Pfizer Covid vaccines before this one didn't make any extreme side affects. More
2866751 85 F FL 10/17/2025 COVID19
 PFIZER\BIONTECH
 NA0589
Strabismus, Vision blurred Strabismus, Vision blurred
Patient claims before bedtime the same day as Comirnaty was administered that she struggled to focus... Patient claims before bedtime the same day as Comirnaty was administered that she struggled to focus her eyes and that one eye crossed followed by the opposite eye. She had taken melatonin 10mg prior to event but has been taking melatonin for approximately 6 month without ever having a similar reaction. More
2866752 31 F DE 10/17/2025 UNK
 UNKNOWN MANUFACTURER
Injection site haemorrhage, Pain, Pain in extremity Injection site haemorrhage, Pain, Pain in extremity
On October 3, 2025 I went into the pharmacy to receive 3 vaccines. I received the flu, pneumonia, an... On October 3, 2025 I went into the pharmacy to receive 3 vaccines. I received the flu, pneumonia, and TDAP vaccines. I was given one injection in my right arm and two in my left. After the second injection in my left the pharmacist made a comment about how I was bleeding and that doesn?t normally happen. Later that day I started to experience severe pain in my left arm that has continued since then. The pain has not improved at all in the two weeks since the injection. I have sever pain when lifting my left arm, getting dressed/undressed, lifting anything with my left arm. and laying on that side. More
2866753 9 F CO 10/17/2025 COVID19
FLUN3
 MODERNA
MEDIMMUNE VACCINES, INC.
 3053253
YF3413B
Nervousness, Syncope; Nervousness, Syncope Nervousness, Syncope; Nervousness, Syncope
PATIENT FEINTED A COUPLE MINUTES AFTER VACCINE AFTER STANDING FROM CHAIR TO LEAVE. SHE WAS VERY NERV... PATIENT FEINTED A COUPLE MINUTES AFTER VACCINE AFTER STANDING FROM CHAIR TO LEAVE. SHE WAS VERY NERVOUS BUT NO OTHER ISSUES NOTED AND NO PREVIOUS HISTORY More
2866754 76 M NY 10/17/2025 FLU3
 SANOFI PASTEUR
 U8855DA2026/06
Tinnitus Tinnitus
High frequency noise in ears, persistent High frequency noise in ears, persistent
2866755 34 M CA 10/17/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 es4h5
Erythema, Lip swelling, Swelling face, Urticaria Erythema, Lip swelling, Swelling face, Urticaria
Patient developed swelling face (including hives), red nose and swollen lips and cheeks with redness... Patient developed swelling face (including hives), red nose and swollen lips and cheeks with redness; took claritin and put hydrocortisone 1%. He experienced the swollen adverse reactions around 4:00am following the shot of 12:00pm the day before. Prior to this in April he experienced the allergic similar but not as severe as this one from the COVID 2024-2025 vaccine. More
2866756 62 M PA 10/17/2025 FLU3
 SEQIRUS, INC.
 407245
Incorrect dose administered Incorrect dose administered
Patient was given a 65+ vaccine but was not 65 Patient was given a 65+ vaccine but was not 65
2866757 37 M 10/17/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 3052736
U8823CA
Loss of consciousness, Unresponsive to stimuli; Loss of consciousness, Unrespons... Loss of consciousness, Unresponsive to stimuli; Loss of consciousness, Unresponsive to stimuli More
Patient became unresponsive after receiving vaccinations, EMS was called. Pt regained consciousness,... Patient became unresponsive after receiving vaccinations, EMS was called. Pt regained consciousness, and nurse was with patient until paramedics arrived to check on pt. Pt then refused to be taken to hospital and went home with wife. More
2866758 48 M CA 10/17/2025 FLU3
 SANOFI PASTEUR
 U8847CA
Incorrect dose administered, No adverse event Incorrect dose administered, No adverse event
No known adverse events reported. The patient was administered the wrong dose. He needed to be admin... No known adverse events reported. The patient was administered the wrong dose. He needed to be administered the Fluzone single- dose and instead he received the Fluzone high-dose single dose. More
2866764 1 F TX 10/17/2025 HEPA
HEPA
HIBV
HIBV
MMRV
MMRV
PNC20
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
PFIZER\WYETH
PFIZER\WYETH
 MB399
MB399
UK166AB
UK166AB
Z007851
Z007851
MA2523
MA2523
Erythema, Pyrexia, Rash, Rash macular, Rhinorrhoea; Viral infection; Erythema, P... Erythema, Pyrexia, Rash, Rash macular, Rhinorrhoea; Viral infection; Erythema, Pyrexia, Rash, Rash macular, Rhinorrhoea; Viral infection; Erythema, Pyrexia, Rash, Rash macular, Rhinorrhoea; Viral infection; Erythema, Pyrexia, Rash, Rash macular, Rhinorrhoea; Viral infection More
Patient was seen 9/4/25 in clinic for re-evaluation of ear after middle ear infections and vaccinati... Patient was seen 9/4/25 in clinic for re-evaluation of ear after middle ear infections and vaccinations. She developed fever 9/5/25 and 9/6/25. She was seen in ER for evaluation. She was diagnosed with viral syndrome and given instructions to treat w/ Tylenol & Motrin. Mom was told ears were mildly red and given amoxicillin script. Mom did not fill medication was viral. Last fever spike was 9/6 (Saturday). On 9/7 developed red splotchy rash on face, chest, belly, back, upper arms and legs. No itching. No blistering. No peeling. No change. Clear runny nose. Suspects this is secondary to. As predicted possible side effects timing since fever occurred within the after vaccination and rash. More
2866765 11 F IL 10/17/2025 MNQ
MNQ
TDAP
TDAP
 SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 U8574AA
U8574AA
37F34
37F34
Blood glucose, Computerised tomogram head, Head injury, Laboratory test, Loss of... Blood glucose, Computerised tomogram head, Head injury, Laboratory test, Loss of consciousness; Pain in extremity, Pallor; Blood glucose, Computerised tomogram head, Head injury, Laboratory test, Loss of consciousness; Pain in extremity, Pallor More
A few hours after vaccines were given in clinic, patient was shopping with her mother, when she comp... A few hours after vaccines were given in clinic, patient was shopping with her mother, when she complained of her left arm hurting, followed by pallor and loss of consciousness. She hit the back of her head on the floor due to loss of consciousness. She had brief jerking movements, followed by regained consciousness at which point she was alert and upset. Her mother immediately left the store and took her to the emergency room. She was evaluated with a head CT and other lab work and was discharged. She has fully recovered and denies any headaches or other symptoms of concussion. She reports bilateral upper arm pain but has a normal exam with full strength and range of motion. More
2866766 22 M MI 10/17/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
 U7829AA
No adverse event, Underdose No adverse event, Underdose
Inaccurate dose given to an adult no adverse outcomes no symptoms Inaccurate dose given to an adult no adverse outcomes no symptoms
2866767 52 F IL 10/17/2025 FLU3
FLU3
FLU3
VARZOS
VARZOS
VARZOS
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UT8779LA
UT8779LA
UT8779LA
93N9J
93N9J
93N9J
Dizziness, Ear pain, Eye pruritus, Fatigue, Headache; Impaired work ability, Inj... Dizziness, Ear pain, Eye pruritus, Fatigue, Headache; Impaired work ability, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth; Malaise, Pyrexia, Rhinorrhoea; Dizziness, Ear pain, Eye pruritus, Fatigue, Headache; Impaired work ability, Injection site erythema, Injection site pain, Injection site rash, Injection site warmth; Malaise, Pyrexia, Rhinorrhoea More
Patient received Fluzone & Shingrix on same arm IM on 9-30-25. Patient reports while at work lat... Patient received Fluzone & Shingrix on same arm IM on 9-30-25. Patient reports while at work late on 9-30-25 around 6PM she started having fatigue & malaise. Was sent home from work. Next day on 10-1-25, pt woke up with runny nose, headache, and itchiness, redness to injection sites. Pt also reports she started having bilateral ear pain. Later on at night on 10-1-25 to next day at 3AM Pt reports fever of 102F. Pt reports she took Tylenol at the time with little relief. Pt came in on 10-3-2025 for sick visit appointment. Covid/Flu test negative. On 10-3-25 pt reports symptoms of fatigue, malaise, runny nose with clear discharge, bilateral ear pain / discomfort, headache and dizziness. Severe itching on 10-3-25. Noted redness, tenderness and injection site warm to touch. Pt denies symptoms of nausea, vomiting, diarrhea, abdominal pain. Temperature 98.2F. Pt prescribed Prednisone 10mg 1 tab daily for 4 days and generic Flonase nasal spray given f/u appt for 10-6-2025. Patient cancelled appointment 10-6-25. Called and spoke with patient on 10-17-2025, patient reports she is doing much better now, no symptoms to report. Patient states the rash/redness at injection site was there for 2 weeks before it went away. More
1725990 F NY 10/16/2025 COVID19
COVID19
 PFIZER\BIONTECH
UNKNOWN MANUFACTURER

Thrombosis; Thrombosis Thrombosis; Thrombosis
when I got the Vaccine, the COVID Vaccine, I got a life-threatening blood clot; This is a spontaneou... when I got the Vaccine, the COVID Vaccine, I got a life-threatening blood clot; This is a spontaneous report received from an Other HCP, Program ID. A 70-year-old female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Paxlovid. The following information was reported: THROMBOSIS (medically significant, life threatening), outcome "unknown", described as "when I got the Vaccine, the COVID Vaccine, I got a life-threatening blood clot". Therapeutic measures were taken as a result of thrombosis. Clinical information: During an inbound call for financial assistance, the patient stated her Husband went to pick up the Paxlovid. After confirming the reason for the call they stated, they had Paxlovid before when COVID was an epidemic, and she didn't pay anything. She was a Nurse Practitioner and have to work next week, not that you know that's more important than my health. After explaining the programs, stated, they have a handicapped daughter. Also stated she have a fever, she was sorry, she was not thinking clearly, Maybe she don't need the Paxlovid. she could probably do without it. Also reported while offering to provide the website for enrollment that she got the Vaccine, the COVID Vaccine, she got a life-threatening blood clot. So she was on Eliquis for the rest of her life. So, she got a little nervous when while walking through the financial requirement website, and stated that the Eliquis costs, because of the COVID Vaccine. When going over financials of the household, she stated her husband was disabled, her daughter was disabled. When advising there are two ways to enroll into the program she stated they can do it then yea because she really don't think she can work on the computer right then. At the end of the call, she stated she was on Eliquis. The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown will be requested and submitted if and when received.; Sender's Comments: Based on the information available and plausible temporal association, the causal relationship between the reported event THROMBOSIS and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. More
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2866202 F WA 10/16/2025 HPV9
 MERCK & CO. INC.
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
No additional AE; it has been over 5 months since the patient received her first dose of the GARDASI... No additional AE; it has been over 5 months since the patient received her first dose of the GARDASIL 9 vaccine and has not yet received her second dose of the vaccine.; This spontaneous report was received from a Registered Nurse and refers to a 31-year-old female patient. The patient's concurrent conditions, medical history, previous drug reactions, drug allergies and concomitant therapies were not reported. In March 2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9) (route of administration, site of administration, lot #, and expiration date were not provided) as prophylaxis. In approximately October 2025 (Reported as over 5 months), the patient had not yet received her second dose of the vaccine (Inappropriate schedule of product administration). No additional adverse event reported. More
2866207 F 10/16/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 7HZ93
Injection site erythema, Injection site pain, Injection site swelling Injection site erythema, Injection site pain, Injection site swelling
Injection site pain; Red; swollen; very painful lasting over two days/ achy; This non-serious case w... Injection site pain; Red; swollen; very painful lasting over two days/ achy; This non-serious case was reported by a consumer and described the occurrence of injection site pain in a 58-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7HZ93) for prophylaxis. On 01-OCT-2025, the patient received Arexvy .5 ml. On 01-OCT-2025, less than a day after receiving Arexvy, the patient experienced injection site pain (Verbatim: Injection site pain). In OCT-2025, the patient experienced erythema (Verbatim: Red), swelling (Verbatim: swollen) and pain (Verbatim: very painful lasting over two days/ achy). The outcome of the injection site pain was not resolved and the outcome of the erythema, swelling and pain were resolved (duration 2 days). It was unknown if the reporter considered the injection site pain, erythema, swelling and pain to be related to Arexvy. It was unknown if the company considered the injection site pain, erythema, swelling and pain to be related to Arexvy. Additional Information: GSK Receipt Date: 03-OCT-2025 The patient self-reported this case for herself. The patient received the Arexvy vaccine and experienced injection site pain, red swollen and very painful lasting over two days which was also achy. The injection site pain symptom was not treated. More
2866209 56 F NE 10/16/2025 PPV
VARZOS
 UNKNOWN MANUFACTURER
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Nausea; Nausea Nausea; Nausea
Nausea; This non-serious case was reported by a consumer via call center representative and describe... Nausea; This non-serious case was reported by a consumer via call center representative and described the occurrence of nausea in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Pneumococcal vaccine for prophylaxis. Concurrent medical conditions included asthma. On 09-OCT-2025, the patient received Shingrix (left arm) and Pneumococcal vaccine (left arm). On 09-OCT-2025, 30 min after receiving Shingrix and Pneumococcal vaccine, the patient experienced nausea (Verbatim: Nausea). The outcome of the nausea was not resolved. It was unknown if the reporter considered the nausea to be related to Shingrix and Pneumococcal vaccine. It was unknown if the company considered the nausea to be related to Shingrix and Pneumococcal vaccine. Additional Information: GSK Receipt date: 09-OCT-2025 The patient received Shingrix and pneumonia vaccine on the same day in left arm. The patient did not have name of the Pneumonia vaccines. About 30 minutes after given the vaccine, the patient experienced nausea. More
2866210 M 10/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interacti... Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 1 year after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix. The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK receipt date: 08-OCT-2025 The case was received from the patient via interactive digital media. The patient asked that what they mean get the shingles shot. The patient was glad that he got the shot because he developed the shingles about a year later and it was not really bad one long line in about three spots patient was lucky. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Vaccination failure, 1 year after receiving unknown dose of Shingrix in a male subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. More
2866211 M SC 10/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
never got another dose; This non-serious case was reported by a pharmacist via call center represent... never got another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who did not receive HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose on 06-JUL-2017). The patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: never got another dose). The outcome of the incomplete course of vaccination was 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: 02-OCT-2025 The pharmacist reported a patient got first dose of Twinrix vaccine and never got another dose. Now the patient wanted to get Engerix-B, and this pharmacy does not have Twinrix. The pharmacist said follow up would be fine to get more details and see if patient got a different vaccine The batch number was not provided upon follow- up with the reporter. More
2866212 M 10/16/2025 COVID19
 PFIZER\BIONTECH
Cerebral palsy Cerebral palsy
My Son developed a Cerebs palsy after the shot; This is a spontaneous report received from a Consume... My Son developed a Cerebs palsy after the shot; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBRAL PALSY (medically significant), outcome "unknown", described as "My Son developed a Cerebs palsy after the shot". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2866213 F 10/16/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective COVID-19, Drug ineffective
taking the medication (Paxlovid) in the past as well as having the Pfizer vaccine; taking the medic... taking the medication (Paxlovid) in the past as well as having the Pfizer vaccine; taking the medication (Paxlovid) in the past as well as having the Pfizer vaccine; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "taking the medication (Paxlovid) in the past as well as having the Pfizer vaccine". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Transferring agent stated, she mentioned taking the medication (Paxlovid) in the past as well as having the Pfizer vaccine (Clarified as Pfizer Covid vaccine ) in the past. When Probed for any adverse event with the Paxlovid, consumer stated, "Was that a question? I heard you said Paxlovid and the vaccine. I couldn't make out what you said before that. No, I have not. I took it (Paxlovid) I was given it (Paxlovid) a year ago by my Primary Care provider and I had no problem." When clarified if there is no concern with the Paxlovid and vaccine, consumer stated, "No, no problem. No, I don't have any questions." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2866247 M 10/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Inappropriate schedule of product administration, Nerve injury, Pain Inappropriate schedule of product administration, Nerve injury, Pain
nerve damage to the right side of head and neck; chronic pain/pain; received another shot at the age... nerve damage to the right side of head and neck; chronic pain/pain; received another shot at the age of 77 years; This serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a 77-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine with an associated reaction of herpes zoster (received a shot at the age of 66 years). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve damage (Verbatim: nerve damage to the right side of head and neck) (serious criteria other: serious as per reporter), pain (Verbatim: chronic pain/pain) (serious criteria other: Serious as per reporter) and drug dose administration interval too long (Verbatim: received another shot at the age of 77 years). The outcome of the nerve damage and pain were not resolved and the outcome of the drug dose administration interval too long was not applicable. The reporter considered the nerve damage and pain to be related to Shingles vaccine. The company considered the nerve damage and pain to be unrelated to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR126565 Additional Information: GSK Receipt Date: 05-OCT-2025 This case was reported by a patient via interactive digital media. Patient was suffering from nerve damage to the right side of head and neck for 38 months and in pain 24 by 7. Patient's doctor said that it might be another year or two before it was well, patient did not take pain medications for 8 months and the pain was the same as it was when he was taking the pain medications. The batch number was not provided, and unable to contact the reporter.; Sender's Comments: A case of Nerve injury and Pain, unknown time after receiving 2nd dose of Shingles vaccine in a 77-year-old male subject. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow up has not been received. US-GSK-US2025AMR126565:Case for 1st dose More
2866309 F PA 10/16/2025 PNC21
 MERCK & CO. INC.
 Y019158
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
REDNESS; ITCHINESS AT INJECTION SITE; LOCAL SWELLING; Information has been received from the Food Dr... REDNESS; ITCHINESS AT INJECTION SITE; LOCAL SWELLING; Information has been received from the Food Drug Administration (FDA) (agency number 2849342-1) on 16-SEP-2025. This spontaneous report refers to a 81-year-old female patient. The patient's medical history was not reported. The patient's medical history included diabetic and high blood pressure. Concurrent conditions and concomitant therapies were not reported. On 05-Jul-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (valid lot #Y019158, expiration date: 20-May-2026) administered by intramuscular route in right arm for prophylaxis. On 05-Jul-2025, the patient experienced local swelling (injection site swelling), redness (injection site erythema) and itchiness at injection site injection site (injection site pruritus). The patient had improved and helped with icing. The patient recovered from all the events on an unspecified date. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXINE) regarding the events was not applicable. The causal relationship between all the events and the suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-09-16 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2849342 , Central date : 2025-09-16 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : More
2866310 OR 10/16/2025 UNK
 UNKNOWN MANUFACTURER
 Z006889
No adverse event, Syringe issue, Underdose No adverse event, Syringe issue, Underdose
No additional AE; Caller reported that the syringe needle leaked (about 1-2 drops) and during admini... No additional AE; Caller reported that the syringe needle leaked (about 1-2 drops) and during administration to patient, resulting in the patient receiving the less than recommended dose.; Caller reported that the syringe needle leaked (about 1-2 drops) and during administration to patient, resulting in the patient receiving the less than recommended dose.; Caller reported that the syringe needle leaked (about 1-2 drops) and during administration to patient, resulting in the patient receiving the less than recommended dose.; This spontaneous report was received from a pharmacist and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-Oct-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (reported as CAPVAXIVE INJ 168 mcg/ml 1DS X 10 SYRINGES 00006434702) 0.5 ml/dose, quantity: 1 (lot #Z006889 with expiration date reported as and upon internal validation confirmed to be 09-Sep-2026) administered for prophylaxis (route of administration and vaccination site were not reported). The syringe needle leaked (about 1-2 drops) during the administration to the patient, resulting in the patient receiving less than the recommended dose (accidental underdose; poor quality device used; syringe issue). No symptoms were reported (no adverse event). Photos were not available to be sent. The product quality complaint (PQC) product was not available for retrieval as it was discarded after administration. No additional adverse event (AE) or PQC was noted. More
2866311 NY 10/16/2025 HPV9
HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.


No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No additional AE reported; their three dose series of GARDASIL 9 earlier than the recommended interv... No additional AE reported; their three dose series of GARDASIL 9 earlier than the recommended intervals as follows: FRIST DOSE: 6/8/2025; SECOND DOSE: 7/11/2025; THIRD DOSE: 10/10/2025; This spontaneous report was received from a pharmacist 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 08-Jun-2025, the patient was vaccinated with first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (route, lot # and expiration date were not reported) for prophylaxis. On 11-Jul-2025, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (route, lot # and expiration date were not reported) for prophylaxis. On 10-Oct-2025, the patient was vaccinated with third dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) 0.5 mL (route, lot # and expiration date were not reported) for prophylaxis. This dose was administered earlier than the recommended intervals (inappropriate schedule of product administration). No additional adverse event was reported (no adverse event). Lot # is being requested and will be submitted if received. More
2866312 MA 10/16/2025 HPV9
 MERCK & CO. INC.
 N021571
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
HCP reports that the patient received their first dose of GARDASIL 9 on 01/23/2018 and has not rece... HCP reports that the patient received their first dose of GARDASIL 9 on 01/23/2018 and has not received their second dose yet; no additional AE; This spontaneous report was received from a Pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-Jan-2018, the patient started therapy with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASILοΏ½9), (lot #N021571, expiration date: 29-Apr-2020), dose number 1, 0.5 mL as prophylaxis. It was stated by the pharmacist that the patient had not received the second dose yet (Inappropriate schedule of vaccine administered). No additional adverse event was reported. More
2866313 10/16/2025 FLUN3
 MEDIMMUNE VACCINES, INC.
No adverse event, Product storage error No adverse event, Product storage error
temp tag (scanning app) showed it had exceeded safe temp. Tried to report through the app, was malfu... temp tag (scanning app) showed it had exceeded safe temp. Tried to report through the app, was malfunctioning and was unable to either request a new unit or to report temp failure; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided). No medical history was reported. No concomitant products were reported. The patient received Flumist (expiration date(s) 08-DEC-2025), via unspecified route, on an unknown date. The patient received 1 dose(s). A Patient administered Flumist. The report contains a Potential SAE associated with the Accuspray Single Dose device. A malfunction has been reported for the Accuspray Single Dose device as a result of Adverse Event Without Identified Device or Use Problem. On an unknown date, the patient experienced temp tag (scanning app) showed it had exceeded safe temp. tried to report through the app, was malfunctioning and was unable to either request a new unit or to report temp failure (preferred term: Product storage error). It is unknown if any action was taken with Flumist (flumist, influenza virus vaccine polyvalent, q/laiv). The outcome of the event(s) of temp tag (scanning app) showed it had exceeded safe temp. tried to report through the app, was malfunctioning and was unable to either request a new unit or to report temp failure was unknown. The event was considered non-serious. This case was marked as suppressed due to Medication Error with no AE. Device Information: Combination Product Report: Yes Product As Reported: Flumist Brand Name: FLUMIST Product Role:Suspect Device Problem code:Adverse Event Without Identified Device or Use Problem Manufacturer Name:ASTRAZENECA Labeled for single use:No Sample was available. Investigation by AstraZeneca/MedImmune Quality Assurance provided no indication that the complaint resulted from the manufacturing or packaging of the concerned batches Non-Significant correction on 16-Oct-2025: Null flavor for the reporter and patient details were added. Narrative amended. More
2866314 M 10/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Fatigue, Headache, Myalgia Fatigue, Headache, Myalgia
Fatigue; Muscle ache; Headache; This non-serious case was reported by a consumer via call center rep... Fatigue; Muscle ache; Headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis. On 07-OCT-2025, the patient received Shingrix. In OCT-2025, less than a week after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue), muscle pain (Verbatim: Muscle ache) and headache (Verbatim: Headache). The outcome of the fatigue, muscle pain and headache were unknown. It was unknown if the reporter considered the fatigue, muscle pain and headache to be related to Shingrix and Shingrix Pre-Filled Syringe Device. It was unknown if the company considered the fatigue, muscle pain and headache to be related to Shingrix and Shingrix Pre-Filled Syringe Device. 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: 08-OCT-2025 The reporter stated that he had Shingrix administered 07th October 2025. The healthcare professional stated that he had muscle aches, fatigue and headache. Consumer declined to provide any information or demographic information. More
2866315 10/16/2025 COVID19
COVID19
FLUX
FLUX
PPV
PPV
RVX
RVX
VARZOS
VARZOS
 UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
UNK
Asthenia, Erythema, Fall, Feeling hot, Nasopharyngitis; Pain in extremity; Asthe... Asthenia, Erythema, Fall, Feeling hot, Nasopharyngitis; Pain in extremity; Asthenia, Erythema, Fall, Feeling hot, Nasopharyngitis; Pain in extremity; Asthenia, Erythema, Fall, Feeling hot, Nasopharyngitis; Pain in extremity; Asthenia, Erythema, Fall, Feeling hot, Nasopharyngitis; Pain in extremity; Asthenia, Erythema, Fall, Feeling hot, Nasopharyngitis; Pain in extremity More
Soreness in my arms; Cold; Hot; had no forces until I fell out of bed; Fell out of bed; Red stain; T... Soreness in my arms; Cold; Hot; had no forces until I fell out of bed; Fell out of bed; Red stain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis, Herpes zoster (Shingles vaccine) for prophylaxis, COVID-19 vaccine for prophylaxis and Pneumococcal vaccine for prophylaxis. On 12-SEP-2025, the patient received RSV vaccine (unknown arm), Flu vaccine (unknown arm), Shingles vaccine (unknown arm), COVID-19 vaccine (unknown arm) and Pneumococcal vaccine (unknown arm). In SEP-2025, less than a week after receiving RSV vaccine, Flu vaccine, Shingles vaccine, COVID-19 vaccine and Pneumococcal vaccine, the patient experienced pain in arm (Verbatim: Soreness in my arms), cold (Verbatim: Cold), feeling hot (Verbatim: Hot), strength loss of (Verbatim: had no forces until I fell out of bed), fall (Verbatim: Fell out of bed) and erythema (Verbatim: Red stain). The patient was treated with paracetamol (Tylenol) and ibuprofen. The outcome of the pain in arm, cold, feeling hot, strength loss of, fall and erythema were resolving. It was unknown if the reporter considered the pain in arm, cold, feeling hot, strength loss of, fall and erythema to be related to RSV vaccine, Flu vaccine, Shingles vaccine, COVID-19 vaccine and Pneumococcal vaccine. It was unknown if the company considered the pain in arm, cold, feeling hot, strength loss of, fall and erythema to be related to RSV vaccine, Flu vaccine, Shingles vaccine, COVID-19 vaccine and Pneumococcal vaccine. Additional Information: GSK receipt date: 16-Sep-2025 This case was reported by a consumer via interactive digital media. On Friday at noon, patient had five vaccines, this one, flu, pneumonia, shingles and covid, three on the left arm and two on the right each. Patient felt sore in arms, cold, hot, and had no forces until patient fell out of bed. On Sunday patient felt better but noticed red stain and felt hot but Tuesday was less and took Tylenol and Ibuprofen. Patient used to take care for two nieces.; Sender's Comments: US-GSK-US2025AMR120040:Original Case Number : US2025AMR120040 More
2866317 10/16/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Ophthalmic herpes zoster, Vaccination failure Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Suspected vaccination failure; have them now in my eyes; have them now in my face and scalp; This se... Suspected vaccination failure; have them now in my eyes; have them now in my face and scalp; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: have them now in my eyes) (serious criteria GSK medically significant) and herpes zoster (Verbatim: have them now in my face and scalp). The outcome of the vaccination failure was not reported and the outcome of the ophthalmic herpes zoster and herpes zoster were not resolved. It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and herpes zoster to be related to Shingles vaccine. The company considered the vaccination failure and ophthalmic herpes zoster to be unrelated to Shingles vaccine. It was unknown if the company considered the herpes zoster to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 11-OCT-2025 This case was reported by a patient via interactive digital media. The patient had shingles now (at the time of reporting) in his/her eyes and face and scalp and he/she got the shot. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding ophthalmic herpes zoster and herpes zoster were unknown at the time of reporting. The batch number was not provided, and we are unable to contact the reporter.; Sender's Comments: A case of Vaccination failure and Ophthalmic herpes zoster, on an unknown date, an unknown time after receiving Shingles vaccine, in a patient. Based on the available information a?possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received. More
2866318 F 10/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Pain in extremity Pain in extremity
UPPER ARM STARTED HURTING A LOT ABOUT,vaccine injury; This non-serious case was reported by a consum... UPPER ARM STARTED HURTING A LOT ABOUT,vaccine injury; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, 2 hrs after receiving Shingrix, the patient experienced injection site pain (Verbatim: UPPER ARM STARTED HURTING A LOT ABOUT,vaccine injury). The outcome of the injection site pain was resolved. It was unknown if the reporter considered the injection site pain to be related to Shingrix. It was unknown if the company considered the injection site pain to be related to Shingrix. Additional Information: GSK receipt date: 12-OCT-2025 The patient stated that within about 2 hours after receiving the Shingrix immunization, her upper arm started hurting a lot about and reported as vaccine injuries. The batch number was not provided, and we are unable to contact the reporter. More
2866320 66 F AZ 10/16/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 2YY25
Local reaction Local reaction
large local reaction/took about a month for her arm to go back to normal; This non-serious case was ... large local reaction/took about a month for her arm to go back to normal; This non-serious case was reported by a nurse via call center representative and described the occurrence of arm discomfort in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2YY25) for prophylaxis. Previously administered products included Prevenar (received Prevenar 20 on an unknown date and had large local reaction). On 02-JUL-2018, the patient received the 1st dose of Boostrix. In JUL-2025, several hours after receiving Boostrix and several hours after starting Boostrix, the patient experienced arm discomfort (Verbatim: large local reaction/took about a month for her arm to go back to normal). The outcome of the arm discomfort was resolved (duration 1 month). It was unknown if the reporter considered the arm discomfort to be related to Boostrix and Boostrix Pre-Filled Syringe Device. It was unknown if the company considered the arm discomfort to be related to Boostrix and Boostrix Pre-Filled Syringe Device. 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: 16-SEP-2025 Nurse reported that a patient had some reactions to couple of vaccines and they wanted to see is that if there is a common ingredient between the 2 vaccines, one of them was Tdap the Boostrix. Patient had a large local reaction with Prevenar 20 and then in 2018 she received what they believe to be Tdap and got a very large reaction to that and it seemed that both of those they started within hours, over subsequent days and it took about a month for her arm to go back to normal. The Prevenar 20 was administered in JUN-2025 and second dose of Tdap was received by the patient on 01-NOV-2018, however for the 2nd dose, they are not sure if this was a Boostrix vaccine. More
2866321 56 M TX 10/16/2025 HEP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 LG749
LG749
Underdose; Underdose Underdose; Underdose
Underdose; Underdose; This non-serious case was reported by a pharmacist via call center representat... Underdose; Underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 56-year-old male patient who received HBV (Engerix B) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. Co-suspect products included HBV (Engerix B) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis. On 27-JUN-2025, the patient received the 1st dose of Engerix B. On 31-JUL-2025, the patient received the 2nd dose of Engerix B. On 27-JUN-2025, an unknown time after receiving Engerix B and Engerix B, the patient experienced accidental underdose (Verbatim: Underdose). On 31-JUL-2025, the patient experienced accidental underdose (Verbatim: Underdose). The outcome of the accidental underdose and accidental underdose 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: 16-SEP-2025 The reporter reported that an adult patient had two doses of the series for Engerix-B, but they just realized that both doses were only 0.5 ml. More
2866322 F 10/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Product administered at inappropriate site Product administered at inappropriate site
vaccine was administered little above the elbow instead of the deltoid muscle; This non-serious case... vaccine was administered little above the elbow instead of the deltoid muscle; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of vaccine administered at inappropriate site in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccine administered at inappropriate site (Verbatim: vaccine was administered little above the elbow instead of the deltoid muscle). The outcome of the vaccine administered at inappropriate site was not applicable. Additional Information: GSK Receipt Date: 19-SEP-2025 A pharmacist reported that a patient had received the first dose of Shingrix a couple of days ago and the vaccine was administered little above the elbow instead of the deltoid muscle. The patient was concerned about the validity of the dose. They were not sure if the vaccine was given IM or SC. The reporter did not provide the precise date of administration and mentioned that patient is in her low 60οΏ½s (not precise age was mentioned). More
2866323 M FL 10/16/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
second dose missing/not taken; This non-serious case was reported by a pharmacist via call center re... second dose missing/not taken; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who did not receive HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose on 01 Oct 2024 with batch D4774 expiry date 12 Sep 2026). The patient did not receive the 2nd dose of Twinrix. The patient experienced incomplete course of vaccination (Verbatim: second dose missing/not taken). The outcome of the incomplete course of vaccination was 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: 02-OCT-2025 Pharmacist mentioned that a patient received first dose of Twinrix on 01 Oct 2024, and they had not received yet second or third dose. They were not aware of any prior Hepatitis A or Hepatitis B vaccines. More
2866324 F CA 10/16/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Rash Rash
developed a rash after getting Shingrix; This non-serious case was reported by a physician via call ... developed a rash after getting Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: developed a rash after getting Shingrix). The outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to Shingrix. It was unknown if the company considered the rash to be related to Shingrix. Additional Information: GSK Receipt Date: 06-OCT-2025 A Doctor of Medicine called to ask for information about the post-reactivity between Shingrix and the Varicella vaccine. The reporter stated that a patient had developed a rash after receiving Shingrix. The patient enquired whether she could receive the Varicella vaccine. The batch number was not provided upon follow- up with the reporter. More
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