🏥 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 💀 🏥 🚑 ♿ ⚠️
2861433 55 F FL 09/25/2025 FLU3
FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 u8832ca
u8832ca
u8832ca
u8832ca
Extra dose administered, Fatigue, Headache; Extra dose administered; Extra dose ... Extra dose administered, Fatigue, Headache; Extra dose administered; Extra dose administered, Fatigue, Headache; Extra dose administered More
I am reporting vaccine administration error that occurred today. I left a message for my primary car... I am reporting vaccine administration error that occurred today. I left a message for my primary care doctor about this. I feel tired and have a headache. I went to the Pharmacy to receive a Nuvaxovid vaccine. Before my appointment, pharmacy called me 4 times to verify information. They kept getting confused as to my vaccination and my husband's. (We had appointments for different days, but pharmacy system put us together because our address is the same.) Pharmacy's website did not ask for any COVID-19 information to determine my eligibility. It is a very confusing website. Meanwhile, I went to get my vaccine, and the technician, was again confused about who was getting the shot and which shots were being given. I had to reiterate that I was getting the Nuvaxovid shot, and my husband was getting his flu shot and Nuvaxovid shot on Saturday. When I received my shot, the tech did not verify my name nor double-check her paperwork. I received a call 10 minutes after I left, informing me that she had given me my husband's flu shot! I had already received my flu/pneumonia vaccinations at pharmacy on 9/18/2025. The tech told me I needed to return and give her the paperwork that she had given me at my appointment. I returned and spoke with the pharmacist on duty, who assured me that getting 2 flu shots was not a problem. She profusely apologized and took back the paperwork. I told her that the entire process was confusing and there were clearly NO protocols in place via Pharmacy system or onsite, and that this needed to be rectified. I am still dealing with the fall out as a result because it is showing in the Department of Health's system that I received a COVID shot today. More
2861434 12 M NJ 09/25/2025 FLU3
FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
 UT8817KA
UT8817KA
UT8817KA
Arthralgia, Asthenia, Blood creatine phosphokinase, Blood thyroid stimulating ho... Arthralgia, Asthenia, Blood creatine phosphokinase, Blood thyroid stimulating hormone, Borrelia test; C-reactive protein increased, Full blood count, Metabolic function test, Pain in extremity, Paraesthesia; Red blood cell sedimentation rate, Thyroxine normal, X-ray of pelvis and hip normal More
Leg pain, weakness, paresthesias started to right leg, now left as well. Positive hip and arm pain. ... Leg pain, weakness, paresthesias started to right leg, now left as well. Positive hip and arm pain. Still investigating and monitoring. More
2861436 55 M CA 09/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 5Y9CA
Herpes zoster, Varicella virus test positive Herpes zoster, Varicella virus test positive
Patient developed herpes zoster on his forehead/crown. This was confirmed with NAAT swab. Patient developed herpes zoster on his forehead/crown. This was confirmed with NAAT swab.
2861437 26 F NE 09/25/2025 FLU3
 GLAXOSMITHKLINE BIOLOGICALS
 9JC49
Pruritus, Urticaria Pruritus, Urticaria
Spoke with employee over the phone and they stated at 0730 after receiving the influenza vaccine at ... Spoke with employee over the phone and they stated at 0730 after receiving the influenza vaccine at around 0715 that started itch all over their body and small red welts appeared. They went home and took 1 Benadryl. Stated having symptom relief but around 1400 they state itching started to worsen. Denies swelling to face and throat, no difficulty breathing, no fast heartrate, no dizziness or weakness. Recommended employee go to urgent care for further evaluation. More
2861438 81 F KY 09/25/2025 COVID19
 MODERNA
 3052133
Pain Pain
Patient reported pain in right arm from MNEXSPIKE vaccine at 4-5 hours after injection. Patient coul... Patient reported pain in right arm from MNEXSPIKE vaccine at 4-5 hours after injection. Patient could not move arm due to severe pain until next day. The patient did not report until 3 days after injection when her arm was feeling better. She wanted adverse reaction reported for MODERNA More
2861439 64 F CA 09/25/2025 COVID19
COVID19
 MODERNA
MODERNA

Arthralgia, Chills, Fatigue, Headache, Injection site pain; Insomnia, Myalgia, N... Arthralgia, Chills, Fatigue, Headache, Injection site pain; Insomnia, Myalgia, Nausea, Oedema peripheral, Tenderness More
pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, axillary swelling or ten... pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, axillary swelling or tenderness, nausea, insomnia More
2861440 54 F TX 09/25/2025 PNC21
 MERCK & CO. INC.
 Z006076
Injection site rash, Injection site swelling Injection site rash, Injection site swelling
The patient stated the same day later in the evening she experienced a rash and swelling in the area... The patient stated the same day later in the evening she experienced a rash and swelling in the area, she went to see her primary care provider, and came into the pharmacy 9/25/25 to let us know of the reaction to report. More
2861441 1.25 F ID 09/25/2025 DTAPIPV
 SANOFI PASTEUR
 U8383AB
No adverse event, Wrong product administered No adverse event, Wrong product administered
Pt behind in vaccination status.. Plan was to administer Vaxelis and Quadracel was taken from vacci... Pt behind in vaccination status.. Plan was to administer Vaxelis and Quadracel was taken from vaccine refrigerator and administered inadvertently to patient. While doing a QC this am the error was caught. Dr. and parent notified. No symptoms or adverse reactions have been noted thus far. More
2861442 70 F 09/25/2025 FLU3
 SANOFI PASTEUR
 ut8820ca
Injection site bruising, Injection site swelling Injection site bruising, Injection site swelling
pt had bruising and swelling at injection site but no other symptoms (no pain) pt had bruising and swelling at injection site but no other symptoms (no pain)
2861444 82 M DE 09/25/2025 PNC21
 MERCK & CO. INC.
 3052155
Pain in extremity, Pain in jaw, Trismus Pain in extremity, Pain in jaw, Trismus
patient experienced severe pain the day after the vaccine from left chin to left arm. pt also experi... patient experienced severe pain the day after the vaccine from left chin to left arm. pt also experienced difficulty opening mouth More
2861445 58 M PA 09/25/2025 COVID19
FLU3
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 B0002
J245K
Headache, Impaired work ability; Headache, Impaired work ability Headache, Impaired work ability; Headache, Impaired work ability
In September of 2025, patient advised (withheld name) County State Health Center that he has been ex... In September of 2025, patient advised (withheld name) County State Health Center that he has been experiencing headaches since he received flu and COVID vaccination on 11/13/2024. He believes the headaches are due to these vaccinations. He states the headaches are debilitating and he is unable to work. He was referred to seek medical evaluation by a primary care provider. VAERS report completed by staff. Patient advised to submit patient VAERS report as well. More
2861446 68 M WA 09/25/2025 RSV
 PFIZER\WYETH
 LL8391
Extra dose administered, No adverse event Extra dose administered, No adverse event
The patient received first RSV vaccine on 09/2023. Patient was in clinic receiving vaccines and requ... The patient received first RSV vaccine on 09/2023. Patient was in clinic receiving vaccines and requested the RSV. The laptop using could not see full detail of immunizations history. Patient tolerated vaccine with no issues. The patient was monitored for 15 mins after the vaccine given. More
2861447 80 M MN 09/25/2025 COVID19
 PFIZER\BIONTECH
 EN6203
COVID-19, SARS-CoV-2 test positive COVID-19, SARS-CoV-2 test positive
Hospitalization related to COVID 19 following completion of primary vaccine series Hospitalization related to COVID 19 following completion of primary vaccine series
✓
2861448 60 F GA 09/25/2025 FLU3
 SEQIRUS, INC.
 406985
Arthralgia, Neck pain, Pain, Pain in extremity Arthralgia, Neck pain, Pain, Pain in extremity
Patient returned to the pharmacy on 9/25/25 complaining of shooting pain in her left arm radiating t... Patient returned to the pharmacy on 9/25/25 complaining of shooting pain in her left arm radiating to her shoulder and neck. She said the pain started after her shot. More
2861449 90 F AL 09/25/2025 COVID19
FLU3
 PFIZER\BIONTECH
SEQIRUS, INC.
 NA0587
407261
Feeling abnormal, Unresponsive to stimuli; Feeling abnormal, Unresponsive to sti... Feeling abnormal, Unresponsive to stimuli; Feeling abnormal, Unresponsive to stimuli More
The patient said she felt strange and became unresponsive to tapping and yelling her name about 1-2 ... The patient said she felt strange and became unresponsive to tapping and yelling her name about 1-2 minutes after the immunizations were given. We called 911. We placed the patient on the floor. She was breathing. No signs of adverse reactions like swelling, redness, etc. She opened her eyes and was able to speak to us within 1-2 minutes. We gave her some water and continued to monitor her. We checked her BP, which was 166/133. The paramedics soon arrived and took over with her vitals. Her vitals were good. They said she was most likely dehydrated and did not need to get emergency care. The patient said she was fine, just slightly nauseous. I recommended that she call her doctor. She sipped on coconut water slowly and her sister called her primary care doctor to fit her in while still at the pharmacy. We escorted the patient and sister to their vehicle to be safe. They headed straight to the doctor. He said her blood pressure was lower than he wanted and adjusted some of her meds and sent her home. Upon a follow up call with her sister later on that day, she said that patient is doing well and is keeping extra watch over her blood pressure and keeping her hydrated. More
2861450 4 M TX 09/25/2025 DTAPIPV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 5C79N
XX9N4
Z008197
Eye swelling, Swelling face; Eye swelling, Swelling face; Eye swelling, Swelling... Eye swelling, Swelling face; Eye swelling, Swelling face; Eye swelling, Swelling face More
swelling on eyes and face on the right side swelling on eyes and face on the right side
2861451 8 M NY 09/25/2025 FLU3
 SANOFI PASTEUR
 u8832aa
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient is only 8 and was given the Flublok vaccine. Patient has had no adverse effects Patient is only 8 and was given the Flublok vaccine. Patient has had no adverse effects
2861452 9 M WI 09/25/2025 FLU3
 SANOFI PASTEUR
 U8767AA
Injection site erythema, Injection site swelling, Injection site warmth, Pruritu... Injection site erythema, Injection site swelling, Injection site warmth, Pruritus More
Redness noted night of vaccination, next morning swelling with more redness. After school patient c... Redness noted night of vaccination, next morning swelling with more redness. After school patient came home with more redness, swelling, warmth to injection site. Itchiness to left arm as well. Advised ice to area and benadryl for patient. No systemic allergy reactions noted. More
2861453 75 F GA 09/25/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 U8837BA
Z003579
Injection site erythema, Injection site swelling, Injection site warmth; Injecti... Injection site erythema, Injection site swelling, Injection site warmth; Injection site erythema, Injection site swelling, Injection site warmth More
PATIENT HAD REDNESS,, SWELLING, AND INJECTION AREA WAS WARM TO TOUCH PATIENT HAD REDNESS,, SWELLING, AND INJECTION AREA WAS WARM TO TOUCH
2861454 83 F KS 09/25/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 MH72Y
Injection site inflammation, Injection site pain, Injection site swelling, Injec... Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth More
Patient had a reaction that appeared sometime between 5-7 days later. Pain and inflammation that ext... Patient had a reaction that appeared sometime between 5-7 days later. Pain and inflammation that extended down toward the elbow and up into the shoulder area. The area was raised and warm to the touch per caregiver and the patient stated she "could not touch the area without crying." At home nurse care recommended benadryl and the inflammation/ pain started to resolve. As of today, 9/25/25, the reaction has resolved and the patient is no longer experiencing discomfort. More
2861455 55 F MN 09/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 342XP
Head discomfort, Injection site pruritus, Injection site warmth Head discomfort, Injection site pruritus, Injection site warmth
Patient started feeling itchy and hot to the touch around the site the injection was given. Has an i... Patient started feeling itchy and hot to the touch around the site the injection was given. Has an itching sensation feeling in the head More
2861456 46 F 09/25/2025 MNQ
 SANOFI PASTEUR
Inappropriate schedule of product administration Inappropriate schedule of product administration
Patient was administered the 2nd MenQuadfi dose 4 weeks too early Patient was administered the 2nd MenQuadfi dose 4 weeks too early
2861457 13 F VA 09/25/2025 FLU3
 SANOFI PASTEUR
 u8837aa
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Child age 13 years was given High Dose Adult Flu Vaccine for ages 65 and older. Patient left with ... Child age 13 years was given High Dose Adult Flu Vaccine for ages 65 and older. Patient left with parent after receiving vaccine, no symptoms or signs of adverse reaction noted as they left the health department. The error was discovered by the Nurse Supervisor. More
2861458 37 F CO 09/25/2025 VARCEL
 MERCK & CO. INC.
 Y017915
Product preparation error Product preparation error
RN diluted vaccine with Normal Saline instead of Sterile water. Patient was informed and patient cam... RN diluted vaccine with Normal Saline instead of Sterile water. Patient was informed and patient came back and received vaccine with the proper diluted on the same day. More
2861459 34 F FL 09/25/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 Unknown
Unknown
Unknown
Unknown
Antinuclear antibody, Asthma late onset, Chest pain, Computerised tomogram, Fati... Antinuclear antibody, Asthma late onset, Chest pain, Computerised tomogram, Fatigue; Full blood count normal, General physical health deterioration, Headache, Hypotension, Loss of personal independence in daily activities; Magnetic resonance imaging, Metabolic function test, Musculoskeletal stiffness, Nausea, Pain; Pulmonary mass, Vertigo, Weight fluctuation More
My personal story of what I believe are long-term side effects from the COVID-19 vaccine I received ... My personal story of what I believe are long-term side effects from the COVID-19 vaccine I received in 2021. As a 38-year-old woman who was previously in excellent health with no prior medical conditions or chronic issues, the sudden and persistent decline in my well-being has been devastating. I have a loving husband of 15 years and three wonderful children who depend on me, yet I now struggle daily to fulfill my roles as a wife and mother. I desperately seek your assistance in advancing research into these potential adverse effects, as well as help in becoming part of a clinical study or obtaining the answers I need to reclaim my life?and I am certain many others are suffering alone in similar silence. Before the vaccine, I enjoyed an active lifestyle free from any autoimmune, cardiovascular, or musculoskeletal problems. However, several months after receiving the vaccine, I began experiencing mild chest pain and neck stiffness. These symptoms were initially intermittent but have since escalated dramatically, resulting in constant, unspecific pain that makes every day a challenge to endure. I can no longer physically do the things I once could, such as playing with my children, exercising, or even handling household tasks without significant discomfort. This has profoundly affected my family and my quality of life. In seeking answers, I have undergone extensive medical evaluations, but no clear cause has been identified. My recent ANA Profile test, conducted on August 27, 2025, showed negative results for all 11 biomarkers, including anti-dsDNA at 3 IU/mL (negative <5) and others below 0.9 AI (e.g., RNP Antibodies at 0.3 AI, Smith Antibodies at <0.2 AI). Additionally, my Complete Blood Count (CBC) and Comprehensive Metabolic Panel (CMP) have revealed no signs of inflammation or other abnormalities. Doctors have suggested that my unspecific symptoms point to fibromyalgia, but this diagnosis feels inadequate given the timing and my prior health. I have tried medications commonly prescribed for fibromyalgia, but they either exacerbate my symptoms or provide only 2-3 tolerable days before the pain returns in full force. Furthermore, there seems to be insufficient data or knowledge among healthcare providers to explore other tests or treatment options for this constant, unspecific pain, leaving me without viable paths forward. The close temporal link between my vaccination and the onset of these symptoms leads me to fear that the mRNA COVID-19 vaccine may have triggered a long-term adverse reaction, possibly involving undetected immune dysregulation or inflammatory processes. Emerging studies and case reports indicate that others have faced similar post-vaccination challenges, underscoring the urgent need for more comprehensive research. As someone directly impacted, I implore you to champion increased funding and initiatives for studies into delayed vaccine effects, including mechanisms that might explain cases like mine where standard diagnostics fall short. Your intervention could bring relief and understanding not just to me, but to countless families affected by these unresolved health issues. I would be immensely grateful for any guidance, including referrals to ongoing clinical trials or studies where I could participate, or direct support in investigating my case further. Please advise on how I can share my full medical history to aid this important work. Thank you for your commitment to the well-being of all and for considering my plea. I eagerly await your response. More
2861460 17 F NC 09/25/2025 FLU3
MENB
MNQ
 SANOFI PASTEUR
PFIZER\WYETH
SANOFI PASTEUR
 UT8792MA
MA2480
U8574AA
Injection site erythema, Injection site pruritus, Injection site swelling; Injec... Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling; Injection site erythema, Injection site pruritus, Injection site swelling More
Patient developed a red, swollen area on her left thigh that was about 1 1/2 inches in diameter. The... Patient developed a red, swollen area on her left thigh that was about 1 1/2 inches in diameter. The patient states that it was itchy at first but that resolved. Patient still has slight redness to the area and swelling 3 days after injection. More
2861461 38 F IL 09/25/2025 RAB
 NOVARTIS VACCINES AND DIAGNOSTICS
 FDP00600
Dysphagia, Rash, Throat tightness Dysphagia, Rash, Throat tightness
reports having throat tightness and rash. pt having difficulty drinking water. reports having throat tightness and rash. pt having difficulty drinking water.
2861462 84 F AZ 09/25/2025 COVID19
FLU3
 MODERNA
SANOFI PASTEUR
 8146670
UT8794DA
Throat tightness; Throat tightness Throat tightness; Throat tightness
Patient made aware that she has not had any adverse reactions to last FLU and COVID vaccines in the ... Patient made aware that she has not had any adverse reactions to last FLU and COVID vaccines in the past. I did have the epinephrine pen available in the vaccine room just in case the patient was to experience anaphylaxis. I told the patient to sit in the waiting room with husband post vaccine and after 10 minutes patient came to consult window and I ran to the vaccine room with the patient and she said she felt her throat closing up and I administered 1 epinephrine pen into her left thigh. Patient sat in room with pharmacist for 10 minutes and the pharmacist gave her cold water to drink and had husband sit with her. After about 40 minutes and offering to call ambulance the patient decided to go home and then (pharmacist) called the patient 2 hours after to see how she was doing . Patient replied she was feeling much better. More
2861463 58 F NC 09/25/2025 FLU3
PNC21
 SANOFI PASTEUR
MERCK & CO. INC.
 TFAA2535
Z006076
Injection site erythema; Injection site erythema Injection site erythema; Injection site erythema
Patient had redness around injection site by Tuesday 9/23/25, came into pharmacy to show pharmacist ... Patient had redness around injection site by Tuesday 9/23/25, came into pharmacy to show pharmacist and redness had migrated down from possible injection site on Left Deltoid to close to the inside of arm. Went to PCP today 9/25/25 and received an antibiotic and a steroid for injection site reaction. More
2861464 55 M MI 09/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NY2AT
Fatigue, Rash, Rash macular, Tenderness Fatigue, Rash, Rash macular, Tenderness
PT called and wanted to report side effects of his first shingrix shot. Pt stated the first days he ... PT called and wanted to report side effects of his first shingrix shot. Pt stated the first days he was tired and was sensitive to the touch but it went away then the next day having blotchy red spots on the right side of body (pt received shot on left side of body). Spots are not itchy just blotchy and is on his neck and chest. Pt not having any other symptoms. I told patient to monitor his symptoms and if it gets worst then to call his doctor. More
2861465 40 F PA 09/25/2025 COVID19
COVID19
 MODERNA
MODERNA
 3052586
3052586
Arthralgia, Fatigue, Headache, Pain, Pain in extremity; Polymenorrhoea Arthralgia, Fatigue, Headache, Pain, Pain in extremity; Polymenorrhoea
pt schedule appointment for Mnexspike 2025-2026. At check in window on 9/18/25, confirmed wanting Mo... pt schedule appointment for Mnexspike 2025-2026. At check in window on 9/18/25, confirmed wanting Moderna vacine. Pharmacy technician processed for Moderna Spikevax. RPH asked pt what vaccine they wanted before injecting. Pt answered Moderna. After injecting Spikevax, pt wanted to make sure it was the newest Moderna, in which the RPH said yes the newest Moderna Spikevax 2025-26. Pt then said no I meant is it the newest one. She pulled up a google site showing mNEXSPIKE. RPH called pt on 9/25/25. pt stated after being vaccinated she had side effects (headache, exhaustion, achiness, joint pain, arm pain, and she got her period 1 week early). Rheumatologist was called but unable to reach them at time of VAERS submission. Will try again later. PT doesn't feel that she needs to get checked out by any other medical provider in regards to being given the wrong Moderna vaccine. More
2861469 0.25 PA 09/25/2025 RVX
 UNKNOWN MANUFACTURER
 Y003753
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
no adverse effects; a patient who is 15 weeks and 5 days old received their first dose of ROTATEQ.; ... no adverse effects; a patient who is 15 weeks and 5 days old received their first dose of ROTATEQ.; This spontaneous report was received from a physician assistant on 24-Sep-2025, referring to a 15-week-old and 5-day-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 24-Sep-2025, the patient (15-week-old and 5-day-old) was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq), (lot #Y003753, expiration date: 18-Oct-2025), administered by Oral route as prophylaxis (Product administered to patient of inappropriate age). No additional information was provided to further clarify the details. The caller said they administered the dose approximately 40 minutes prior to calling the company and no adverse effects were noted (no adverse event). More
2861470 09/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Polymyalgia rheumatica Polymyalgia rheumatica
Polymyalgia Rheumatica; This serious case was reported by a consumer via interactive digital media a... Polymyalgia Rheumatica; This serious case was reported by a consumer via interactive digital media and described the occurrence of polymyalgia rheumatica in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. In OCT-2024, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced polymyalgia rheumatica (Verbatim: Polymyalgia Rheumatica) (serious criteria GSK medically significant). The outcome of the polymyalgia rheumatica was not reported. It was unknown if the reporter considered the polymyalgia rheumatica to be related to RSV vaccine. The company considered the polymyalgia rheumatica to be unrelated to RSV vaccine. Additional Information: GSK Receipt Date: 22-SEP-2025 This case was reported by a patient via interactive digital media. The patient got his/her RSV shot last October and the reaction was polymyalgia rheumatica. The patient would take chances this year; Sender's Comments: A case of Polymyalgia rheumatica, on an unknown time after receiving RSV vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK vaccine product cannot be ascertained. Consent for further follow up has not been received More
2861471 F 09/25/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 UNK
UNK
Burning sensation, Headache, Herpes zoster, Magnetic resonance cholangiopancreat... Burning sensation, Headache, Herpes zoster, Magnetic resonance cholangiopancreatography, Magnetic resonance imaging abdominal; Rash, Scan with contrast More
Developed Shingles; This non-serious case was reported by a consumer and described the occurrence of... Developed Shingles; This non-serious case was reported by a consumer and described the occurrence of shingles in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included sclerosing cholangitis (n autoimmune disorder of the bile ducts.), cholesterol and hypertension. Concomitant products included amlodipine and rosuvastatin. On 19-AUG-2025, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25-AUG-2025, 6 days after receiving Shingrix, the patient experienced shingles (Verbatim: Developed Shingles). The patient was treated with valaciclovir (Valacyclovir). The outcome of the shingles was not resolved. It was unknown if the reporter considered the shingles to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix. Additional Information: GSK Receipt Date: 29-AUG-2025 Patient noticed a rash on my face, in front of right ear. It felt like poison ivy but did not itch. Earlier on the same day, patient underwent an abdominal MRI/MRCP with Gadavist (gadobutrol) contrast to monitor Primary Sclerolsing Cholangitis (PSC) an autoimmune disorder of the bile ducts. The rash was first noted a few hours after the procedure was completed. By the next day the rash had spread to right cheek, right jawline, back and front of neck on right, upper and lower right shoulder and back of right upper arm near axilla. There is some intermittent burning, and also occasional pain on the right side of my head, more involving the scalp rather than a headache. On 27Aug2025, patient was prescribed valacyclovir 1 gram 3 times/day for 7 days after in-person evaluation by the physician. Started med the same day. My physician told me that the shingles started in cervical nerve 3 and spread to C2 and C4. He explained why the Shingrix vaccine does not cause a rash (not a live virus). More
2861472 F DC 09/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Inappropriate schedule of product administration Inappropriate schedule of product administration
she received the first and second shot of Shingrix 5 years apart/ Time above range; This non-serious... she received the first and second shot of Shingrix 5 years apart/ Time above range; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: she received the first and second shot of Shingrix 5 years apart/ Time above range). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 02-SEP-2025 The patient self-reported this case for herself. More
2861473 M 09/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
he forgot to have his second dose administered/ consumer states he will have his second dose adminis... he forgot to have his second dose administered/ consumer states he will have his second dose administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose almost one year ago in 2024). The patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: he forgot to have his second dose administered/ consumer states he will have his second dose administered). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 10-SEP-2025 The patient self-reported this case for himself. No further information obtained. Patient did not want to provide additional information. More
2861474 09/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Pain in extremity, Rash Pain in extremity, Rash
arm hurt from my shoulder to my elbow; arm hurt from my shoulder to my elbow; rash across my arm; Th... arm hurt from my shoulder to my elbow; arm hurt from my shoulder to my elbow; rash across my arm; 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. On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: arm hurt from my shoulder to my elbow), arthralgia (Verbatim: arm hurt from my shoulder to my elbow) and rash (Verbatim: rash across my arm). The outcome of the pain in arm, arthralgia and rash were not reported. It was unknown if the reporter considered the pain in arm, arthralgia and rash to be related to RSV vaccine. It was unknown if the company considered the pain in arm, arthralgia and rash to be related to RSV vaccine. Additional Information: GSK Receipt Date: 31-AUG-2025 This case was reported by a patient via interactive digital media. Patient said that he/she never reacted like this to any vaccine. More
2861475 09/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
COVID-19 COVID-19
Chinese Wuhan Virus; This non-serious case was reported by a consumer via interactive digital media ... Chinese Wuhan Virus; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of covid-19 in an unspecified number of patients who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. On an unknown date, the patients received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patients experienced covid-19 (Verbatim: Chinese Wuhan Virus). The outcome of the covid-19 was not reported. It was unknown if the reporter considered the covid-19 to be related to RSV vaccine. It was unknown if the company considered the covid-19 to be related to RSV vaccine. Additional Information: GSK receipt date: 09-SEP-2025 Every person the reporter knew who had taken the jabs had contracted the Chinese Wuhan Virus. More
2861476 F 09/25/2025 RVX
 UNKNOWN MANUFACTURER
 UNK
Cough, Malaise, Respiratory tract congestion Cough, Malaise, Respiratory tract congestion
Sick; little coughing; chest congestion; This non-serious case was reported by a consumer via intera... Sick; little coughing; chest congestion; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 78-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis. The patient's past medical history included bronchitis (had to be hospitalized twice). In SEP-2025, the patient received RSV vaccine. In SEP-2025, an unknown time after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick), cough (Verbatim: little coughing) and chest tightness (Verbatim: chest congestion). The outcome of the sickness, cough and chest tightness were not resolved. It was unknown if the reporter considered the sickness, cough and chest tightness to be related to RSV vaccine. It was unknown if the company considered the sickness, cough and chest tightness to be related to RSV vaccine. Additional Information: GSK Receipt Date: 17-SEP-2025 The patient got the respiratory syncytial virus vaccine shot two weeks ago from reporting. The patient was sick, only had a little coughing and very little chest congestion. There was no sinus congestion or headaches. The reporter convinced respiratory syncytial virus shot prevented from getting sicker. This case was linked with case US2025AMR120795 reported by the same reporter, for different patient.; Sender's Comments: US-GSK-US2025AMR120795:Case for husband/same reporter More
2861477 09/25/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Pain Herpes zoster, Pain
broke out with shingles very painful; This non-serious case was reported by a consumer via interacti... broke out with shingles very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: broke out with shingles very painful). The outcome of the shingles was not reported. It was unknown if the reporter considered the shingles to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine. Additional Information: GSK receipt date: 23-SEP-2025 This case was reported by a patient via interactive digital media. The patient got the vaccine and the next day he/she broke out with shingles that was very painful. More
2861478 M CA 09/25/2025 DTAPIPV
 GLAXOSMITHKLINE BIOLOGICALS
 4L454
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
administration below the recommended age range; This non-serious case was reported by a other health... administration below the recommended age range; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis. On 02-SEP-2025, the patient received Kinrix. On 03-SEP-2025, 1 days after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration below the recommended age range). The outcome of the inappropriate age at vaccine administration 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: 10-SEP-2025 Reporter stated that 4 month old patient received Kinrix instead of individual DTaP and IPV vaccine. More
2861479 VA 09/25/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
patient received doses of Shingrix vaccine after a temperature excursion; This non-serious case was ... patient received doses of Shingrix vaccine after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 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 incorrect storage of drug (Verbatim: patient received doses of Shingrix vaccine after a temperature excursion). The outcome of the incorrect storage of drug was not applicable. Additional Information: GSK Receipt Date: 11-SEP-2025 Chief of pharmacy called to report that they had a temperature excursion and asked about the stability of Boostrix and Shingrix after a temperature excursion of 32.8 degree C for 93 hours. No prior excursion. HCP (health care professional) mentioned they administered 6 doses of Boostrix and 4 doses of Shingrix after this temperature excursion to 10 different patients and wanted to know do they need to revaccinate them. HCP only mentioned the initials of the patients who received the doses but did not provide further information about gender, age, lot number or expiration date. This was 1 of 10 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025117354:same reporter US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117352:same reporter, different patient US-GSK-US2025117361:same reporter US-GSK-US2025117358:same reporter US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117362:same reporter, different patient US-GSK-US2025117369:same reporter, different patient US-GSK-US2025117365:same reporter, different patient More
2861480 VA 09/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
patient received doses of Boostrix vaccine after a temperature excursion; This non-serious case was ... patient received doses of Boostrix vaccine after a temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: patient received doses of Boostrix vaccine after a temperature excursion). The outcome of the incorrect storage of drug 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: 11-SEP-2025 Chief of pharmacy called to report that they had a temperature excursion and asked about the stability of Boostrix and Shingrix after a temperature excursion of 32.8 degree C for 93 hours. No prior excursion. HCP (health care professional) mentioned they administered 6 doses of Boostrix and 4 doses of Shingrix after this temperature excursion to 10 different patients and wanted to know do they need to revaccinate them. HCP only mentioned the initials of the patients who received the doses but did not provide further information about gender, age, lot number or expiration date. This was 1 of 10 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025117352:same reporter, different patient US-GSK-US2025117353:same reporter, different patient US-GSK-US2025117365:same reporter, different patient US-GSK-US2025117354:same reporter, different patient US-GSK-US2025117361:same reporter, different patient US-GSK-US2025117358:same reporter, different patient US-GSK-US2025117362:same reporter, different patient US-GSK-US2025117369:same reporter, different patient US-GSK-US2025117367:same reporter, different patient More
2861481 VA 09/25/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Product storage error Product storage error
10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This no... 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: 10 patients received doses of Shingrix and Boostrix vaccines after a temperature excursion.). The outcome of the incorrect storage of drug 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: 11-SEP-2025 The reporter called to report that they had a temperature excursion and asked about the stability of Boostrix and Shingrix after a temperature excursion of 32.8 degree C for 93 hours. No prior excursion. HCP (health care professional) mentioned they administered 6 doses of Boostrix and 4 doses of Shingrix after this temperature excursion to 10 different patients and wanted to know do they need to revaccinate them. HCP only mentioned the initials of the patients who received the doses but did not provide further information about gender, age, lot number or expiration date. This was 1 of 10 linked cases reported by the same reporter.; Sender's Comments: US-GSK-US2025117354:same reporter US-GSK-US2025117349:same reporter, different patient US-GSK-US2025117353:same reporter, Different patient US-GSK-US2025117362:same reporter US-GSK-US2025117361:same reporter US-GSK-US2025117369:same reporter US-GSK-US2025117365:same reporter US-GSK-US2025117352:same reporter US-GSK-US2025117367:same reporter More
2861482 70 F 09/25/2025 COVID19
COVID19
FLUX
FLUX
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness; Fatigue, Head... Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness; Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness More
soreness and tenderness in the arm; soreness and tenderness in the arm; headache; muscle ache; nause... soreness and tenderness in the arm; soreness and tenderness in the arm; headache; muscle ache; nausea; tiredness/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache) and NAUSEA (nausea) in an 8-decade-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue). At the time of the report, TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue) outcome was unknown. No concomitant medication was reported. She had fatigue, headache, muscle ache, soreness and tenderness in the arm, nausea, and tiredness after her previous Covid vaccines and Flu vaccine. However, she noted that those side effects were not severe enough to require medical assistance or hospitalization. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to MOD-2025-789525 (Patient Link). Reporter did not allow further contact More
2861483 70 F 09/25/2025 COVID19
COVID19
FLUX
FLUX
 MODERNA
MODERNA
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER
 AU3238B
AU3238B
Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness; Fatigue, Head... Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness; Fatigue, Headache, Myalgia, Nausea, Pain in extremity; Tenderness More
soreness and tenderness in the arm; soreness and tenderness in the arm; headache; muscle ache; nause... soreness and tenderness in the arm; soreness and tenderness in the arm; headache; muscle ache; nausea; tiredness/Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache) and NAUSEA (nausea) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. AU3238B and 062120) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Influenza vaccine for an unknown indication. No Medical History information was reported. On 30-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Jun-2024, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue). At the time of the report, TENDERNESS (soreness and tenderness in the arm), PAIN IN EXTREMITY (soreness and tenderness in the arm), HEADACHE (headache), MYALGIA (muscle ache), NAUSEA (nausea) and FATIGUE (tiredness/Fatigue) outcome was unknown. No concomitant medication was reported. She had fatigue, headache, muscle ache, soreness and tenderness in the arm, nausea, and tiredness after her previous Covid vaccines and Flu vaccine. However, she noted that those side effects were not severe enough to require medical assistance or hospitalization. It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported. This case was linked to MOD-2025-789525 (Patient Link). Reporter did not allow further contact More
2861484 70 M 09/25/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Headache; Headache Headache; Headache
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE ... headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 70-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown. No concomitant medication was reported. It was reported that patient also received the same vaccine Mnexspike and he doesn't feel 100 percent, but he does not have a headache. It was unknown if the patient experienced any additional symptoms and events. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2025-789595 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2025-789595:Husband's case More
2861485 81 F 09/25/2025 COVID19
 MODERNA
Cerebrovascular accident Cerebrovascular accident
stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASC... stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in an 81-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Pacemaker insertion (cardiac). Previously administered products included for Product used for unknown indication: Herpes zoster (Shingles). Past adverse reactions to the above products included No adverse effect with Herpes zoster. Concomitant products included Atorvastatin calcium (Atorvastatin) for an unknown indication. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In February 2025, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in February 2025 due to CEREBROVASCULAR ACCIDENT. The patient was treated with Clopidogrel bisulfate (Clopidogrel) for Anticoagulant therapy, at a dose of 75 milligram. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) had resolved with sequelae. The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown. It was reported that, the patient had every vaccine from Moderna. She had a stroke 8 months ago, she had confirmed it occurred in beginning of February 2025, for which she went to hospital. She had been living in an assisted living or a nursing home since then. She had gotten vaccines her whole life aside from the Moderna COVID-19 vaccines as she believed in vaccines. She had received her shingles and had gotten them all. But she clarified that, she had not received anything this year including flu shot and shingles shot. It was reported that, she wanted to know if she should get Moderna COVID-19 vaccine and if there was a relationship between COVID-19 shots and stroke. The patient did not experience any additional symptoms/events.; Reporter's Comments: Patient's advanced age and unreported cardiovascular medical history (suggested by Pacemaker insertion and concomitant medication) was assessed as strong confounding factor. The benefit-risk relationship of product is not affected by this report. More
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2861486 F CA 09/25/2025 COVID19
COVID19
 MODERNA
PFIZER\BIONTECH

Hyperhidrosis; Hyperhidrosis Hyperhidrosis; Hyperhidrosis
Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDR... Sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Co-suspect product included non-company product Tozinameran (Pfizer BioNTech COVID-19 vaccine) for an unknown indication. No Medical History information was reported. In July 2025, the patient received dose of Tozinameran (Pfizer BioNTech COVID-19 vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Sweating). At the time of the report, HYPERHIDROSIS (Sweating) outcome was unknown. No concomitant medication was reported. The patient had side effects like sweating. She still had it with the other vaccine too, by Pfizer. The patient always had excessive problems, like getting the vaccine. The last dose of the Moderna COVID vaccine was received probably in 2023. Sweating occurred after the vaccine. No additional details were provided. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not reported. This case was linked to US-MODERNATX, INC.-MOD-2021-016530 (Patient Link). More
2861487 30 M 09/25/2025 COVID19
COVID19
 MODERNA
MODERNA
 NDC 80777-112-9
NDC 80777-112-9
Asthma, Chills, Headache, Myalgia, Pyrexia; Respiratory tract congestion, Vaccin... Asthma, Chills, Headache, Myalgia, Pyrexia; Respiratory tract congestion, Vaccination site movement impairment More
chest congestion; light asthma; couldn't lift arm on injection; fever; chills; headache; muscle... chest congestion; light asthma; couldn't lift arm on injection; fever; chills; headache; muscle ache; This spontaneous case was reported by a physician and describes the occurrence of RESPIRATORY TRACT CONGESTION (chest congestion), ASTHMA (light asthma), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm on injection), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) in a 30-year-old male patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. NDC 80777-112-96) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. On 15-Sep-2025, the patient experienced RESPIRATORY TRACT CONGESTION (chest congestion) (seriousness criterion medically significant), ASTHMA (light asthma) (seriousness criterion medically significant), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm on injection) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant), CHILLS (chills) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and MYALGIA (muscle ache) (seriousness criterion medically significant). At the time of the report, RESPIRATORY TRACT CONGESTION (chest congestion), ASTHMA (light asthma), VACCINATION SITE MOVEMENT IMPAIRMENT (couldn't lift arm on injection), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report. More
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