🏥 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 💀 🏥 🚑 ♿ ⚠️
2835402 65 F CO 04/09/2025 FLU3
RSV
 SANOFI PASTEUR
PFIZER\WYETH
 UT8437AA
KC7884
Injection site pain, Magnetic resonance imaging abnormal, Muscle oedema; Injecti... Injection site pain, Magnetic resonance imaging abnormal, Muscle oedema; Injection site pain, Magnetic resonance imaging abnormal, Muscle oedema More
Patient developed left arm pain near injection site after she recieved the vaccines above. MRI of th... Patient developed left arm pain near injection site after she recieved the vaccines above. MRI of the left shoulder did show some edema in her posterior deltoid area. More
2835403 1.58 M IN 04/09/2025 COVID19
 PFIZER\BIONTECH
 LN6739
Product preparation issue Product preparation issue
PATIENT WAS GIVEN THE 0.3 ML DOSE FROM AN UNDILUTED VIAL. NO ADVERSE SIGN/SYMPTOMS HAVE BEEN NOTICED... PATIENT WAS GIVEN THE 0.3 ML DOSE FROM AN UNDILUTED VIAL. NO ADVERSE SIGN/SYMPTOMS HAVE BEEN NOTICED AT THIS TIME. THE ERROR WAS FOUND WITHIN AN HOUR OF ADMINISTERING THE DOSE TO THE PATIENT AND MOTHER WAS IMMEDIATLEY NOTIFIED. WE EXPLAINED TO MOM THAT Dose does not need repeated and mom knows to watch for local side effects at the injection site (redness, swelling, and tenderness) and systemic effects (decreased appetite, drowsiness, fever, irritability). Mom was very understanding and did not have any further questions. More
2835404 16 F KS 04/09/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
PFIZER\WYETH
SANOFI PASTEUR
 1967338

u7673aa
Urticaria; Urticaria; Urticaria Urticaria; Urticaria; Urticaria
The day following the injections- father reported that there was 2 small "hives" where the... The day following the injections- father reported that there was 2 small "hives" where the injections were given (right deltoid only). He gave her benedryl. Did not have any troubles breathing. Today, the "hives" were gone, but there was slight bruising where the injections were given. He reported information via phone, staff did not see site. More
2835405 67 F FL 04/09/2025 COVID19
 PFIZER\BIONTECH
 EL 1283
Idiopathic environmental intolerance, Parosmia Idiopathic environmental intolerance, Parosmia
I developed Multiple Chemical Sensitivities in January of 2022 after receiving injection number 1 on... I developed Multiple Chemical Sensitivities in January of 2022 after receiving injection number 1 on 1/8/21; injection #2 on 1/29/21 - Pfizer Lot#EL9262 and final booster on 12/13/21. Location DOH - Orange - Pfizer Lot#FJ1620 . I have suffered from smells affecting my normal day to day life. I have gone to every kind of doctor with no relief. More
✓
2835406 41 F TX 04/09/2025 TDAP
 SANOFI PASTEUR
 U7961AA
Back pain, Chest pain, Dyspnoea, Pain, Pyrexia Back pain, Chest pain, Dyspnoea, Pain, Pyrexia
Patient started having the following symptoms day after receiving vaccine: chest pain, shortness of ... Patient started having the following symptoms day after receiving vaccine: chest pain, shortness of breath, body ache, backache, and fever for 2 days More
2835407 17 M TX 04/09/2025 MNQ
 SANOFI PASTEUR
 U8124AB
Loss of consciousness Loss of consciousness
Child started to pass out. Child started to pass out.
2835408 37 F FL 04/09/2025 COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN


Aphasia, Asthenia, Cerebrovascular accident, Dizziness, Dysarthria; Hypoaesthesi... Aphasia, Asthenia, Cerebrovascular accident, Dizziness, Dysarthria; Hypoaesthesia, Magnetic resonance imaging abnormal, Migraine, Nausea, Tooth fracture; Tremor More
My first stroke i didn't know that i had it, it was on my right side. And when i found out that... My first stroke i didn't know that i had it, it was on my right side. And when i found out that had multiple strokes on 05/15/2023, that you learned about the first stroke. The first doctor he told me that it looked like i got hit in the head but there was a language barrier, and this was in (redacted). My face was numb and i could not speak and slurring my words. Another doctor gave me medication after i was getting migraines but he didn't see anything about the stoke. Later on in 2023 on 05/18 they did a MRI, that's when they told me that it was a stroke. They did an x ray on my mouth and they broke my tooth and i was not supposed to have go under after a stroke but they still did. When i moved to (redacted) i started seeing the doctor. I went to Regional Hospital 01/2025 - because i thought i was having another stoke they did another MRI. But my arm was numb on the left side from hand to shoulder. I am having weakness in my whole body and i am shaking and feeling nauseous and dizzy. More
2835409 51 F WA 04/09/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LX4454
LX4454
Chills, Decreased appetite, Diarrhoea, Injection site erythema, Injection site p... Chills, Decreased appetite, Diarrhoea, Injection site erythema, Injection site pain; Injection site pallor, Injection site swelling, Injection site warmth, Neuralgia, Pain More
site reaction with pain, swelling, hyperthermia, firmness, erythema and white blanching, nerve pain.... site reaction with pain, swelling, hyperthermia, firmness, erythema and white blanching, nerve pain. Systemic: body aches, diarrhea, felt chills. sweating. decreased appetite. More
2835410 69 M TN 04/09/2025 FLU3
FLU3
 SANOFI PASTEUR
SANOFI PASTEUR
 U8515DA
U8515DA
Atrial fibrillation, Blood pressure decreased, Blood test, Cardioversion, Dizzin... Atrial fibrillation, Blood pressure decreased, Blood test, Cardioversion, Dizziness; Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory abnormal, Heart rate irregular, Sleep disorder More
Awoke to dizziness at ~3:30am. Returned to sleep and arose to same feeling at ~7:30am. Took ECG wi... Awoke to dizziness at ~3:30am. Returned to sleep and arose to same feeling at ~7:30am. Took ECG with smart Watch at 7:59am and discovered I was in A-fib for the first time in my life. My pulse rate was erratic between 142 and 92 BPM. My BP was also generally low and unstable. My historic BP is !118-128/72-78 with a resting pulse rate of 68-78. I have and have never had any caridac, repsiratory or other infirmity and live a healthy lifestyle. I went to Hospital and was admitted for 3 days in cardiac observation. During that time a variety of drug therapies were used to force conversion. I was taken on day 3 to do a cardio-converion but converted on my own seconds after the removal of the Ultrasound tool inserted in my esophagus to check for clots in the atrial appendage and before the doctor pressed the button to shock me into can attempt at conversion. I was released with a regimen of blood thinner (Eloquis) 5mg 2xday, anti-arrhythmic (Propafenone HCL) 150mg, and blood pressure regulator (Metoprolol Tartrate) 25mg. I stopped the drug therapy after 2 weeks of non-recurrence and my personal health history. My heart rate, bp and pulse-ox were tracking normally and historically. I did experience a recurrence wand was subsequently hospitalized again on 02/10/2025 at the same hospital under the care of the same physician. I corrected once again using Amiodarone intravenously and was discharged on 02/12/2025 with only Amiodarone HCL 200mg (2xday) which was reduced by the physician 4weeks later to 200mg (1xday) and a referral to Dr, an electro-physiologist at facility for a planned Atrial Ablation. (*The referred physician has yet to respond with a schedule for the procedure.) More
✓
2835411 65 F FL 04/09/2025 PNC20
 PFIZER\WYETH
 lx4482
Injection site erythema, Injection site infection, Injection site pain, Injectio... Injection site erythema, Injection site infection, Injection site pain, Injection site swelling More
pain at injection site, swelling, redness, inflammation at injection site, pain at injection site, swelling, redness, inflammation at injection site,
2835412 67 F MO 04/09/2025 TDAP
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 L5229
354M3
Dizziness, Injection site mass, Vomiting; Dizziness, Injection site mass, Vomiti... Dizziness, Injection site mass, Vomiting; Dizziness, Injection site mass, Vomiting More
VOMITING NIGHT OF SHOTS, DIZZINESS FROM DAY OF SHOT 3/26/25 UNTIL TODAY 4/9/25, KNOTS ON EACH ARM W... VOMITING NIGHT OF SHOTS, DIZZINESS FROM DAY OF SHOT 3/26/25 UNTIL TODAY 4/9/25, KNOTS ON EACH ARM WHERE SHOT ADMINISTERED. More
2835413 46 M AL 04/09/2025 TD
 SANOFI PASTEUR
 U8303AA
Chills, Injection site erythema, Injection site pain, Injection site swelling, P... Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia More
pt reports tenderness, redness, and swelling to site of infection, fevers/chills pt reports tenderness, redness, and swelling to site of infection, fevers/chills
2835414 6 F MI 04/09/2025 MMRV
 MERCK & CO. INC.
 y016874
Rash Rash
Pt was given second dose of MMRV, around 10 mins after admin. she started to develop a rash.. pr... Pt was given second dose of MMRV, around 10 mins after admin. she started to develop a rash.. provider went in to see patient. she was given children's Benadryl and solu medrol More
2835415 51 F NC 04/09/2025 COVID19
 PFIZER\BIONTECH
Computerised tomogram, Magnetic resonance imaging, Migraine, Scan with contrast Computerised tomogram, Magnetic resonance imaging, Migraine, Scan with contrast
Started getting migraines 2 months after the vaccine. Have been and still being treated for migrain... Started getting migraines 2 months after the vaccine. Have been and still being treated for migraines More
✓
2835416 04/09/2025 VARZOS
 UNKNOWN MANUFACTURER
 UNK
Herpes zoster, Vaccination failure Herpes zoster, Vaccination failure
Suspected vaccination failure; got shot but still got it; This serious case was reported by a consum... Suspected vaccination failure; got shot but still got it; 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) and shingles (Verbatim: got shot but still got it). The outcome of the vaccination failure and shingles were not reported. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine. Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got it (shingles). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: "Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine." More
2835417 1 M ME 04/09/2025 MMRV
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
 Y009347
Y003892
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event More
Patient had no visual signs or symptoms while in the office for more than 30 minutes. Adverse event ... Patient had no visual signs or symptoms while in the office for more than 30 minutes. Adverse event was that patient was given Varicella and Proquad on the same day. More
2835418 63 F OH 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 xk5hc
Rash, Rash pruritic Rash, Rash pruritic
New onset rash on face reported at PCP visit 5/6/24- small round raised area on right cheek area som... New onset rash on face reported at PCP visit 5/6/24- small round raised area on right cheek area some itching, pcp notes state patient was weeding leading up to rash and pcp did not document rash may be related to vaccine that was given the week prior- however, patient believes they may be related. Rash treated with 6 day oral course of medrol dose pack and then a week later given clobetasol propionate cream 0.05% applied twice daily. Office visit 6/4/24 reports rash present on left side upper back that has been present for a week and patient indicated she had been working in her yard. Once again, no mention in pcp documentation that this may have been caused by vaccine; ketoconazole cream 2% once daily started. More
2835419 47 M CO 04/09/2025 COVID19
 MODERNA
Injection site pain Injection site pain
Following vaccine patient report persistent left lower deltoid pain. He suspects the vaccine was adm... Following vaccine patient report persistent left lower deltoid pain. He suspects the vaccine was administered low in his deltoid and that is leading to the persistent discomfort. More
2835420 4 M CA 04/09/2025 VARCEL
 MERCK & CO. INC.
 Y017062
Pyrexia, Urticaria Pyrexia, Urticaria
Hives, and high temperature Hives, and high temperature
2835421 76 M MI 04/09/2025 COVID19
COVID19
 NOVAVAX
NOVAVAX
 6024MF014A
6024MF014A
Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Cond... Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea; Respiratory failure More
Name: Age: 76 y.o. DOB: 9/XX/1948 Admit date: 4/5/2025 Discharge date: 04/07/2025 Attending ... Name: Age: 76 y.o. DOB: 9/XX/1948 Admit date: 4/5/2025 Discharge date: 04/07/2025 Attending Physician at the Time of Discharge: MD Primary Care Physician: MD Reason for Admission: Acute on chronic hypoxic respiratory failure due to COVID-19 Brief Summary of Hospital Stay: Patient is a 76 y.o. M with NSCLC, COPD, ongoing tobacco abuse, Chronic respiratory failure on 2L NC. He presented for evaluation of shortness of breath. He was diagnosed with acute on chronic hypoxic respiratory failure and acute COPD exacerbation due to COVID-19. He was treated with steroids, remdesivir, and scheduled duoneb. He had rapid improvement in symptoms and was weaned to his baseline 2L NC. Continued to improve and was discharged home at his baseline. Will continue prednisone on discharge to complete a 5 day course. Follow-up with PCP. The patient was discharged in stable condition with improvement of symptoms and appropriate follow up planned. Issues Requiring Follow Up: Follow-up with PCP. Follow-up with oncology and pulmonology as previously scheduled. Discharged to Home. More
✓
2835422 60 F MS 04/09/2025 PNC21
 MERCK & CO. INC.
 Y013009
Rash Rash
Pt. stated she broke out in a rash on her torso, shoulders, and back - pt. was instructed by her phy... Pt. stated she broke out in a rash on her torso, shoulders, and back - pt. was instructed by her physician to take famotidine and cetirizine by mouth until resolved More
2835423 67 F CA 04/09/2025 TDAP
 SANOFI PASTEUR
 U8264AA
Contusion, Immediate post-injection reaction, Peripheral swelling Contusion, Immediate post-injection reaction, Peripheral swelling
She had immediate swelling and bruising in right arm. No other symptoms. I notified provider immedia... She had immediate swelling and bruising in right arm. No other symptoms. I notified provider immediately and she examined the patient. We applied a cooling pack and had the patient wait in office for 20 minutes. Patient was instructed to call us immediately if she has any other reactions. More
2835424 11 M AL 04/09/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 Y011500
X7R4Z
CX4HL
Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripher... Erythema, Peripheral swelling; Erythema, Peripheral swelling; Erythema, Peripheral swelling More
Left Arm: Redness and swelling, 3x2 inches. Will observe the swollen area and note any increase Left Arm: Redness and swelling, 3x2 inches. Will observe the swollen area and note any increase
2835425 44 F MA 04/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
Arthralgia, Pain in extremity Arthralgia, Pain in extremity
pt has had sore arm/shoulder since vaccination pt has had sore arm/shoulder since vaccination
2835426 69 F 04/09/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
"my arm is red, swollen and very itchy at the injection site (like a bad allergic reaction) and... "my arm is red, swollen and very itchy at the injection site (like a bad allergic reaction) and spreading down toward my elbow" More
2835427 63 F MD 04/09/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Fatigue, Injection site erythema, Injection site warmth, Pain, Pyrexia; Urticari... Fatigue, Injection site erythema, Injection site warmth, Pain, Pyrexia; Urticaria More
Pt developed fever, fatigue, body aches starting the next day and lasting 24-36hr. Developed rubor/... Pt developed fever, fatigue, body aches starting the next day and lasting 24-36hr. Developed rubor/calor near injection site three days later, as well as hives on the left side of her trunk and left lower extremity that same day. More
2835428 64 F VA 04/09/2025 PNC21
 MERCK & CO. INC.
 y019158
Injection site bruising, Injection site erythema Injection site bruising, Injection site erythema
redness ,and bruising at the site of injection redness ,and bruising at the site of injection
2835429 11 M NC 04/09/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 9M2R7
Erythema, Pain in extremity, Peripheral swelling Erythema, Pain in extremity, Peripheral swelling
RT ARM SWELLING, REDNESS AND PAIN; PT GIVEN ZYRTEC 10 MG IN OUR OFFICE ON 4/2/2025. FATHER ADVISED T... RT ARM SWELLING, REDNESS AND PAIN; PT GIVEN ZYRTEC 10 MG IN OUR OFFICE ON 4/2/2025. FATHER ADVISED TO CONTINUE ZYRTEC 10 MG BID UNTIL SWELLING DECREASED; MOTRIN PRN FOR PAIN. PATIENT DUE SECOND DOSE OF MENVEO AT AGE 16 YR; DAD ADVISED TO GIVE PATIENT ZYRTEC 10 MG PRIOR TO APPOINTMENT DATE. More
2835430 57 F VA 04/09/2025 COVID19
VARZOS
 PFIZER\BIONTECH
GLAXOSMITHKLINE BIOLOGICALS
 lm2223
47n3y
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
Patient came in to receive both her updated Covid vaccine and her 2nd dose Shingles. Upon inputting ... Patient came in to receive both her updated Covid vaccine and her 2nd dose Shingles. Upon inputting the information into the system after the patient received both vaccines we noticed the expiration date of the Covid vaccine was expired(03/11/2025). The patient has been talked to and she is coming back to get a in date Covid vaccine and has not experience any adverse reactions thus far. Pfizer was contacted, as was the CDC. More
2835431 54 F IL 04/09/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
 012L20A
012L20A
012L20A
029K20A
029K20A
029K20A
Arthralgia, Asthenia, Brain fog, Depression, Fatigue; Headache, Insomnia, Labora... Arthralgia, Asthenia, Brain fog, Depression, Fatigue; Headache, Insomnia, Laboratory test normal, Myalgia, Sleep apnoea syndrome; Tinnitus; Arthralgia, Asthenia, Brain fog, Depression, Fatigue; Headache, Insomnia, Laboratory test normal, Myalgia, Sleep apnoea syndrome; Tinnitus More
After the first dose, that night, I developed terrible brain fog and headaches that still have not ... After the first dose, that night, I developed terrible brain fog and headaches that still have not went away. I was never a headache person at all prior to this. My doctor at the time said my brain fog was age related. Within a week after the second dose I developed the worst muscle pain along with severe tinnitus. Followed by SEVERE fatigue, weakness, depression, joint pain. I was having trouble sleeping. I went to a doctor and found out I have sleep apnea and continually have several symptoms that appear after ANY type of exertion. None of the doctors in my healthcare system will say this is related to the vaccine but it all started within a week of having the second dose. More
✓
2835432 80 F WA 04/09/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 4BN95
Injection site erythema, Injection site pain, Injection site reaction, Musculosk... Injection site erythema, Injection site pain, Injection site reaction, Musculoskeletal stiffness More
Patient reports redness at the injection site "size of tennis ball" without improvement af... Patient reports redness at the injection site "size of tennis ball" without improvement after 6 days. Also reports pain/stiffness at the injection site. More
2835433 86 F NE 04/09/2025 PNC21
 MERCK & CO. INC.
 y019158
Pruritus, Rash Pruritus, Rash
about 24 hours after the shot a rash developed on the shoulder down to the elbow on anterior and lat... about 24 hours after the shot a rash developed on the shoulder down to the elbow on anterior and lateral arm. Patient reported itching deep under the skin but not topically. rash still present 7 days post immunization but is receding and itching has subsided. More
2835434 0.17 M TX 04/09/2025 DTAPHEPBIP
HEP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 B532G
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient was given Hep B vaccine in two different forms at the same time-Pediarix (DTaP, IPV, Hep B) ... Patient was given Hep B vaccine in two different forms at the same time-Pediarix (DTaP, IPV, Hep B) and Engerix-B (Hep B) More
2835435 41 F OR 04/09/2025 MENB
PNC20
 NOVARTIS VACCINES AND DIAGNOSTICS
PFIZER\WYETH
 DD72H
LX4483
Arthralgia, Injection site pain, Injection site swelling, X-ray limb; Arthralgia... Arthralgia, Injection site pain, Injection site swelling, X-ray limb; Arthralgia, Injection site pain, Injection site swelling, X-ray limb More
Acute pain of right shoulder - Right upper arm and shoulder pain post-vaccination x 1 week - Pain de... Acute pain of right shoulder - Right upper arm and shoulder pain post-vaccination x 1 week - Pain deep in shoulder joint, extending into deltoid muscle insertion with swelling and tenderness - Icing and ibuprofen provide some relief - Prescribed meloxicam 15 mg once daily for pain management - Prescribed methocarbamol, starting with half dose at night for muscle relaxation and sleep - full DUR performed including discussion regarding use, possible side effects, and all questions answered. - Advised against operating machinery or driving taking muscle relaxer - initial x-ray of right shoulder given reduce ROM and TTP over anterior AC joint - US of upper arm given ongoing swelling and tenderness near insertion of deltoid muscle - r/o hematoma, abscess, - Will continue to monitor symptoms; red flag precautions given for when to seek immediate medical attention. Orders: meloxicam (MOBIC) 7.5 mg tablet; Take 1 tablet by mouth Daily as needed for Pain. methocarbamol (ROBAXIN) 750 mg tablet; Take 1-2 tablets by mouth every 6 hours as needed for Muscle spasms for up to 3 days. More
2835436 16 F MI 04/09/2025 HEP
 MERCK & CO. INC.
 42B22
No adverse event, Wrong product administered No adverse event, Wrong product administered
Patient was given the wrong vaccine. No current adverse effect at this time Patient was given the wrong vaccine. No current adverse effect at this time
2835437 1 F MT 04/09/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 2Y534
Expired product administered Expired product administered
administered expired dose of Havrix; This non-serious case was reported by a nurse via call center r... administered expired dose of Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 23-month-old female patient who received HAV (Havrix) (batch number 2Y534, expiry date 02-MAR-2025) for prophylaxis. On 27-MAR-2025, the patient received Havrix. On 27-MAR-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: administered expired dose of Havrix). The outcome of the expired vaccine used was not applicable. Additional Information: GSK receipt date: 02-APR-2025 The nurse reported that the expired dose of Havrix was administered to a patient which led to, expired vaccine used. The vaccine administration facility was the same as primary reporter. More
2835438 F 04/09/2025 VARZOS
VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNKNOWN MANUFACTURER


Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes z... Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure; Herpes zoster, Vaccination failure More
Suspected vaccination failure; I start developing shingles; This serious case was reported by a cons... Suspected vaccination failure; I start developing shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and Shingles vaccine. On an unknown date, an unknown time after receiving Shingrix, Shingrix and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I start developing shingles). The outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingles vaccine. The company considered the vaccination failure to be unrelated to Shingrix, Shingrix and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingrix, Shingrix and Shingles vaccine. Additional Information: GSK receipt date: 02-APR-2025 Patient reported that she received vaccine for shingles, she got the original vaccine in 2015, and then she got both Shingrix vaccine in 2020 and 2021. Reporter stated that she started developing shingles, she thought the 1st time she had a case was in 2017, and it was never been severe. Since 2017 that she had it at least 2 or maybe 3 more times. She was trying to see if she should get another dose of Shingrix. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingrix Dose 1, Shingrix Dose 2 and Shingles vaccine. More
2835439 M 04/09/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 3T5L9
Expired product administered Expired product administered
Administration of expired vaccine.; This non-serious case was reported by a nurse via call center re... Administration of expired vaccine.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HBV (Engerix B) (batch number 3T5L9, expiry date 09-MAR-2025) for prophylaxis. On 03-APR-2025, the patient received Engerix B. On 03-APR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Administration of expired vaccine.). The outcome of the expired vaccine used 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: 04-APR-2025 The nurse practitioner mentioned that a patient received an expired dose of Engerix-B on 3rd April 2025 which led to expired vaccine used. The nurse asked if the patients should be re vaccinated.; Sender's Comments: US-GSK-US2025040983:same reporter/ Different patient US-GSK-US2025040987:same reporter/ Different patient US-GSK-US2025040989:same reporter/ Different patient US-GSK-US2025040991:same reporter/ Different patient More
2835440 F FL 04/09/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 52N4S
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Bexsero - Administration to patient older than 25 years of age; This non-serious case was reported b... Bexsero - Administration to patient older than 25 years of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 31-year-old female patient who received Men B NVS (Bexsero) (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis. On 22-JAN-2025, the patient received Bexsero. On 22-JAN-2025, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero - Administration to patient older than 25 years of age). 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: 07-APR-2025 The nurse reported that the administration of Bexsero to a female patient 31 year old and the vaccine was administered by mistake. The nurse asked for safety information. The patient received a dose of Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration. More
2835441 60 M FL 04/09/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
MODERNA
























Abdominal distension, Abdominal pain, Addison's disease, Alanine aminotrans... Abdominal distension, Abdominal pain, Addison's disease, Alanine aminotransferase, Amnesia; Amylase, Angiogram, Antibody test, Arthralgia, Aspartate aminotransferase; Biopsy, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium; Blood chloride, Blood cholesterol, Blood corticotrophin, Blood cortisol, Blood creatine phosphokinase; Blood creatine phosphokinase MB, Blood creatinine, Blood culture, Blood follicle stimulating hormone, Blood glucose; Blood lactate dehydrogenase, Blood luteinising hormone, Blood oestrogen, Blood potassium, Blood prolactin; Blood sodium, Blood testosterone, Blood testosterone free, Blood thyroid stimulating hormone, Blood triglycerides; Blood urea, Body temperature, Bone densitometry, Bronchitis, C-reactive protein; COVID-19 pneumonia, Carbon dioxide, Cardiac stress test, Chest X-ray, Chills; Coagulation test, Colonoscopy, Computerised tomogram, Computerised tomogram head, Computerised tomogram heart; Computerised tomogram thorax, Constipation, Culture, Culture urine, Dermatologic examination; Echocardiogram, Electrocardiogram, Endoscopy, Erythema, Fistula; Full blood count, Gastric emptying study, Gastrointestinal examination, Globulin, Glomerular filtration rate; Glycosylated haemoglobin, Haemorrhoids, Herpes zoster, High density lipoprotein, Hydronephrosis; Intestinal obstruction, Laboratory test, Liver function test, Loss of consciousness, Low density lipoprotein; Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging thoracic, Metabolic function test, Microscopy; Myalgia, Nasopharyngeal swab, Nephrolithiasis, Non-high-density lipoprotein cholesterol, Oncological evaluation; Ophthalmological examination, Osteoarthritis, Oxygen saturation, Pain in extremity, Peripheral swelling; Physical examination, Platelet count, Pneumonia, Positron emission tomogram, Prostatic specific antigen; Protein total, Pseudo Cushing's syndrome, Pulmonary function test, Pyrexia, Radioisotope scan; Rash, Rectal prolapse, Red blood cell sedimentation rate, Rheumatoid arthritis, Rheumatological examination; SARS-CoV-2 test, Serum ferritin, Sex hormone binding globulin, Skin exfoliation, Sleep study; Streptococcus test, Tendon rupture, Thyroid function test, Total cholesterol/HDL ratio, Troponin; Ultrasound Doppler, Urine analysis, Urological examination, Urticaria, Vaccination site cellulitis; Weight, White blood cell count, X-ray, X-ray limb More
worsening Autoimmune Rheumatoid Arthritis; abdominal distension; Recurrent Covid 19 Pneumonia; const... worsening Autoimmune Rheumatoid Arthritis; abdominal distension; Recurrent Covid 19 Pneumonia; constipation; symptoms of obstruction/ Recurrent severe GI symptoms of obstruction; Iatrogenic Cushing's Syndrome; If I have a meal I often "pass-out" immediately after; severe abdominal pain; the development of hemorrhoids; he developed cellulitis in his upper left thigh at an injection site; osteoarthritis; He developed rectal prolapse while trying to move his bowels; He had a single drink, then developed amnesia and bizarre behavior for the next 18 hours; developed more red spots and rash all over my body; a rash developed on both arms within a few hours/ a total body rash and welts occurred; Skin sloughing of the arms occurred; Left kidney stone; hydronephrosis; Tears in left achilles tendon and peroneus brevis; A left knee superficial bursa fistula; Addison's disease, with pituitary, adrenal and gonadal dysfunction; Upper Respiratory infections including Bronchitis; Pneumonia; severe right scapular pain radiating to the chest wall/ a rash appeared with vesicles/ Shingles; developed fever; chills; injection arm became painful; injection arm became painful, erythematous, and twice the size of the left arm; erythematous; arthralgia; myalgia; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS, PSEUDO CUSHING'S SYNDROME, ABDOMINAL DISTENSION, CONSTIPATION, INTESTINAL OBSTRUCTION, COVID-19 PNEUMONIA, PNEUMONIA, ADDISON'S DISEASE, HYDRONEPHROSIS, TENDON RUPTURE, FISTULA, LOSS OF CONSCIOUSNESS and NEPHROLITHIASIS in a 7-decade-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product Semaglutide (Ozempic) for HbA1C. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2022, the patient started Semaglutide (Ozempic) (unknown route) .25 milligram once a week. In January 2021, the patient experienced PAIN IN EXTREMITY (injection arm became painful), PERIPHERAL SWELLING (injection arm became painful, erythematous, and twice the size of the left arm), ERYTHEMA (erythematous), PYREXIA (developed fever) and CHILLS (chills). In 2021, the patient experienced RHEUMATOID ARTHRITIS (worsening Autoimmune Rheumatoid Arthritis) (seriousness criteria hospitalization and medically significant), ARTHRALGIA (arthralgia) and MYALGIA (myalgia). On 24-Aug-2021, the patient experienced HERPES ZOSTER (severe right scapular pain radiating to the chest wall/ a rash appeared with vesicles/ Shingles). In 2022, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and BRONCHITIS (Upper Respiratory infections including Bronchitis). In 2023, the patient experienced PSEUDO CUSHING'S SYNDROME (Iatrogenic Cushing's Syndrome) (seriousness criteria hospitalization and medically significant), CONSTIPATION (constipation) (seriousness criterion hospitalization), INTESTINAL OBSTRUCTION (symptoms of obstruction/ Recurrent severe GI symptoms of obstruction) (seriousness criteria hospitalization and medically significant), ADDISON'S DISEASE (Addison's disease, with pituitary, adrenal and gonadal dysfunction) (seriousness criterion medically significant), TENDON RUPTURE (Tears in left achilles tendon and peroneus brevis) (seriousness criterion medically significant) and FISTULA (A left knee superficial bursa fistula) (seriousness criterion medically significant). In July 2023, the patient experienced HYDRONEPHROSIS (hydronephrosis) (seriousness criterion medically significant). On 11-May-2024, the patient experienced RASH (developed more red spots and rash all over my body). In May 2024, the patient experienced SKIN EXFOLIATION (Skin sloughing of the arms occurred) and URTICARIA (a rash developed on both arms within a few hours/ a total body rash and welts occurred). In 2024, the patient experienced NEPHROLITHIASIS (Left kidney stone) (seriousness criterion medically significant). On 17-Sep-2024, the patient experienced COVID-19 PNEUMONIA (Recurrent Covid 19 Pneumonia) (seriousness criteria hospitalization and medically significant). On 11-Nov-2024, the patient experienced RECTAL PROLAPSE (He developed rectal prolapse while trying to move his bowels). In November 2024, the patient experienced AMNESIA (He had a single drink, then developed amnesia and bizarre behavior for the next 18 hours). On an unknown date, the patient experienced ABDOMINAL DISTENSION (abdominal distension) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (If I have a meal I often "pass-out" immediately after) (seriousness criterion medically significant), ABDOMINAL PAIN (severe abdominal pain), HAEMORRHOIDS (the development of hemorrhoids), VACCINATION SITE CELLULITIS (he developed cellulitis in his upper left thigh at an injection site) and OSTEOARTHRITIS (osteoarthritis). The patient was hospitalized from 17-Sep-2024 to 20-Sep-2024 due to ABDOMINAL DISTENSION, CONSTIPATION, COVID-19 PNEUMONIA, INTESTINAL OBSTRUCTION and PSEUDO CUSHING'S SYNDROME. The patient was treated with Crestor, Coq10, Acthar, Lidocaine, Semaglutide, Olumiant, Prednisone, Hydrocortisone, Z-pak , Benadryl, Zovirax, Dulcolax, Vitamin d, Magnesium, Lorazepam, Mounjaro) Testosterone, Phentermine, Bupropion, Furosemide, Dhea, Calcium, Milk of magnesia, Lasix, Mvi, Vitamin K, Stonehenge health dynamic mushrooms, Melatonin Tirzepatide, LInzess, Meloxicam, Flurinex, Valacyclovir, Reclast, Colace, Xifaxan, Glucophage. PAIN IN EXTREMITY had resolved. In 2021, PERIPHERAL SWELLING and ERYTHEMA had resolved. In September 2021, HERPES ZOSTER outcome was unknown. In October 2024, FISTULA had resolved. At the time of the report, RHEUMATOID ARTHRITIS, PSEUDO CUSHING'S SYNDROME, ABDOMINAL DISTENSION, CONSTIPATION, INTESTINAL OBSTRUCTION and ABDOMINAL PAIN had not resolved, ARTHRALGIA, COVID-19 PNEUMONIA, PNEUMONIA, ADDISON'S DISEASE, HYDRONEPHROSIS, NEPHROLITHIASIS, BRONCHITIS, SKIN EXFOLIATION, HAEMORRHOIDS, VACCINATION SITE CELLULITIS, OSTEOARTHRITIS, URTICARIA, PYREXIA, CHILLS, MYALGIA and RASH outcome was unknown, TENDON RUPTURE, RECTAL PROLAPSE and AMNESIA was resolving and LOSS OF CONSCIOUSNESS had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. He was in his usual state of good health, taking no medications on a regular basis until Jan-2016. Patient denied any history of hypertension, diabetes, myocardial infarction, CVA, peptic ulcer disease, etc. In Dec-2017, patient started a slow taper of the Prednisone to eliminate this medication. Quick tapers in the past led to significant painful symptoms and were not successful. Beginning at that time the dose was reduced 1mg every 3-4 days. As of 01-Jan-2018 he was taking 6mg daily in the morning. Furthermore, he had a 5.5-hour infusion of Remicade to potentially decrease the Rheumatologic side effects and to assist with the steroid taper. Patient's medical history also included symptoms of neurogenic bowel, and multiple orthopedic injuries. In 2018, his joints hurt; all his muscles were weak. He was unable to raise his right arm laterally due to pain in the deltoid region, and a spontaneous hematoma of the right biceps appeared without trauma, turning the entire arm ecchymotic. Weakness developed in both hands, and incredible disabling fatigue. Doctor recommended resuming higher dose. On 01-Mar-2018, the entire set of symptoms increased and ultimately by 05-Mar, he was quadriparetic. Patient was admitted from 05-Mar to 07-Mar-2018. Discharged on high dose steroids (prednisone 60mg daily). Remicade was halted, and Actemera was prescribed. He was admitted for cardio-pulmonary issues on 07-Apr-2018. Between 07-Mar to 07-Apr-2018, the medications were followed diligently, but new symptoms appeared- severe muscle spasms in both hands with the slightest of intentional activities. The extremity muscle pain/weakness persisted, and developed increasing difficulty dressing, going up and down stairs, and performing fine motor activities. He also developed constant dizziness/nausea, a sense of imbalance, more severe respiratory distress. He was brought to the urgent care center to rule-out a cardiopulmonary event. From a cardiac perspective he had an EKG and echocardiogram to rule-out myocardial infarction, congestive heart failure, etc. On 10-Apr-2018, he was discharged on high dose Prednisone (again), antibiotic prophylaxis (Bactrim DS, 1 tab three time weekly), an increased dose of Actemera (162mg weekly instead of biweekly), two inhalers including a long-acting steroid inhaler and an Albuterol rescue inhaler. The Actemera did not lead to any improvement in the Autoimmune RA. From a diagnostic perspective the cell count was very high, consistent with an inflammatory arthritis. From therapeutic perspective steroids were injected into both knees. Over the subsequent three months the rheumatologic medications were altered. Patient took Humira and Methotrexate (MTX) every seven days. Patient was able to reduce the steroids from a dose of 60 mg daily in Jan-2018 to 3 mg daily in Jul-2018. Starting in mid-Jun-2018, patient began experiencing mid-spinal pain without any accompanying neurological symptoms. This pain was in the thoracic region and when severe it caused posterior rib pain in the region with deep breathing. There was no numbness or weakness in the upper or lower extremities. Doctor felt that these symptoms were not necessarily related to inflammatory arthritis. Since patient took steroids continuously for more than two years, she was concerned about steroid induced osteoporosis and fracture. The pain on the evening of 13-Jul-2018 was much worse. Patient required several doses of oral narcotics. Patient's concern was this sudden onset of pain and spinal compression was due to the use of catabolic steroids continuously leading to bony changes in the spine. Osteopenia/Osteoporosis was diagnosed. On Labor Day weekend he developed worsening muscle and joint symptoms. The muscular symptoms were consistent with the flu. All his joints became painful. On Saturday evening of that weekend his bilateral knee pain increased significantly. After attending a dinner, he was unable to walk. The pain persisted and NSAID's were not effective. During the subsequent 72 hours the pain continued, requiring narcotics. Both knees developed effusions and the right knee was triple the size of the left. Doctor recommended increase Prednisone to 20 mg daily, increase the MTX to 20 mg weekly and bilateral knee aspirations. Whereas the aspirate from both knees was highly inflammatory consistent with an Autoimmune process. Patient developed severe URI/Cough/Bronchitis and was treated with Cefuroxime. The situation improved, but not completely. From Jun-2018 to Jul-2018, he developed worsening Spinal and Thoracic pain with no numbness or weakness of upper or lower extremities. From Oct-2018 to Nov-2018: Migratory joint symptoms continued including shoulders, wrists, knees elbows and ankles. A reduction in steroids from 5mg to 3mg daily was not tolerated. The Prednisone was increased to 5mg again and the MTX was increased to 25mg weekly on 03-Nov-2018. This led to severe abdominal pain and fatigue. On 05-Nov-2018, he developed dyspnea, wheezing and a cough. He was placed on Cefuroxime and the steroids were increased. Three doses of Humira and MTX were held during this episode. On 03-Nov-2018, this increased dose of MTX led to severe fatigue and abdominal discomfort. Humira was taken on 04-Nov-2018 and the symptom complex worsened. On 05-Nov-2018, patient developed dyspnea, wheezing and a cough. This situation worsened. He was evaluated and treated by his Pulmonologist. He was placed on Cefuroxime (500 mg BID x 10 days). Due to his immunocompromised status, it was recommended that he increase his steroids temporarily. The weekly Humira and MTX were held during this episode as these medications can lead to worsening of the Pneumonia. A total of three doses of Humira and MTX were held. Patient felt well during this hiatus and was able to exercise without difficulty. On 06-Dec-2018 he restarted the Humira as the joint symptoms reappeared. Within 12 hours he developed a rash, myalgias, joint pains (knees, elbows, hands, and back), and welts. The welts disappeared with a dose of Prednisone (20mg). However, the subsequent 24 hours were horrible with an increase in flu-like symptoms. The flight was extremely cold, and the flu-like symptoms were much worse on the flight. He was unable to ambulate at the airport and required a wheelchair to retrieve his luggage. He was unable to sleep Friday night due to pain and on Saturday morning the facial rash and welts reappeared. He spoke with the covering Rheumatologist and restarted MTX (10 mg). This led to NO improvement in symptoms. On Monday doctor recommended an increase in steroids. Patient took 20 mg Monday (10-Dec-2018) at night and was able to sleep and felt better in terms of muscle and joint symptoms. The persistent discomfort was in the region of the right humerus and deltoid regions. Patient remained off Humira and MTX from early Dec-2018, but as a result the Prednisone was increased from 5 to 10-20 mg daily, dependent upon severity of symptoms. Despite the joint symptoms he exercised nearly every day between 26-Dec-2018 and 14-Jan-2019. During that three-week period a bigger problem was related to voiding, abdominal pain and abdominal distension, an increase in size of the abdominal wall hernia and alteration in bowel habits. He denied any BPR but did have constipation. This had been a problem since commencing Keytruda. He took several types of cathartics with variable success, and at times had symptoms of an ileus, with abdominal distension, tenderness at the hernia site, and increased voiding symptoms. 06-Dec-2018: Humira was restarted due to an increase in joint symptoms. Within 12 hours of this SQ dose he developed multiple joint pains, swelling in the knees, a rash followed by large welts all over body. The welts disappeared with a 20mg dose of Prednisone. He was flying home. By the time the flight landed he was unable to walk due to joint pain, myalgia, and flu-like symptoms and was transported via wheelchair through the airport. The covering Rheumatologist suggested trying a lower dose of MTX (10mg), which led to no improvement in the condition. Developed pulmonary symptoms, which led to hospitalization in Mar-2019. Patient also had what appeared to be an infected cyst on the left cheek, which had not resolved in over 8 weeks. On 14-Feb-2019, two days after taking his weekly MTX, his joint symptoms suddenly increased and bilateral knee effusions redeveloped (right greater than left). His upper respiratory infection returned and was treated simply with OTC medication. On 19-Feb-2019 doctor re-evaluated him, aspirated 35-40 mls. of fluid from each knee and injected steroids. The knees subsequently improved. Steroids were injected into the site. In mid-February, the respiratory symptoms worsened. He was given a Z-Pak as well as a cough suppressant with codeine. A temporary increase in Prednisone was also recommended (20 mg BID). This produced no significant improvement and therefore his Rheumatologist was consulted and Levaquin (500 mg daily), a decrease in the steroid dose, and halting the MTX was recommended. As of 11-Mar-2019 the following symptoms persisted- constant shortness of breath and sensation of wheezing, severe fatigue, infected rhinorrhea, constant cough and chest discomfort with infected appearing mucous, constant dizziness and intermittent headaches, constant flushed face without being in the sun and diffuse abdominal pain. On 22-Mar-2019, he had supposedly had a follow-up appointment post hospitalization with a Pulmonologist. That morning his O2 saturation was 96% upon awakening, room air. With nebulizer therapy it increased only 1%. Patient also noted a significant increase in the left flank ecchymosis, the appearance of a petechial rash on his back and chest wall, and another significant ecchymotic region in the perineum extending posterior to the gluteal muscles and anterior to the mid-thigh and bilateral inguinal regions (suggestive of a pelvic bleed). He was advised to slowly continue the steroid taper (1.0 mg per week), with the goal of eliminating this medication. If successful, the MTX and TNF Inhibitors would also be eliminated thereafter. Upon returning he developed identical upper respiratory symptoms again, including constant shortness of breath, intermittent wheezing, rhinorrhea, constant cough, etc. He consulted doctor and a five-day course of Zithromax was ordered. Doctor was also consulted, and she recommended holding both Methotrexate and Simponi. The rhinorrhea improved but the asthma-like symptoms persisted: cough, respiratory distress, and wheezing. Patient had been slowly decreasing the Prednisone to 3 mg daily with no worsening of the joint symptoms. However, due to the respiratory distress he had to increase the Prednisone to 5-10mg qd or bid. At night he was often unable to lie down without severe respiratory distress. The last dose of Simponi was administered on 01-Apr-2019. The last few times he took MTX he developed several days of severe abdominal pain. He was unable to eat without nausea, vomiting, or diarrhea. This occurred twice within 12 hours of taking the medication. Between 09-May and 16-May-2019, his physical stamina deteriorated. He slept at least 3-5 hours in the late afternoon, every day. He had a constant feeling of flu-like symptoms that was all his muscles ached constantly. He experienced chills every afternoon. Doctor evaluated him thereafter, and recommended continuing the Simponi, not the MTX. The joint symptoms in both knees improved on 10-Aug-2019, whereas, the hand and wrist symptoms persisted, but were tolerated. Patient had nuclear gastric emptying study to evaluate possible gastroparesis, and neurogenic small and large bowel. On 10-Nov-2019, he developed daily episodes of flu-like and migratory arthritis symptoms. Motrin, Advil, or Excedrin were utilized around the clock for knee, quadriceps, hand and wrist pain with bending, etc. He awakened every night feeling septic. Bilateral knee effusions redeveloped, and bilateral LE lymphedema. Every day he was extremely fatigued and required multiple-hour naps. Development of recurrent severe joint and skin manifestations of Autoimmune RA in April and May-2020. Some improvement in joint pain with the use of Plaquenil between Mar-2020 and Sep-2020. Intermittent severe exhaustion during July and Aug-2020 requiring multiple hour naps during every day. Several discussions were partaken regarding the potential use of Sirolimus or Chemotherapy as the next step. Patient felt better with the oldest oral medication, compared to all other medications, namely Plaquenil. He has basically experienced no side effects; whereas the other two courses of treatment have deadly side effects and were far more complicated. During October and Nov-2020 the knee pain somewhat improved and was tolerable most of the time. Unfortunately, the pain and weakness in the fingers, hands, wrists and forearms increased significantly. Severe fatigue was always omnipresent. Possible gastroparesis and neurogenic bowel dysfunction in 2020-never confirmed on any radiological studies. He also used steroids which produced the typical side effects of weight gain (over 45 lbs.), muscle loss. When the steroids were reduced, the rheumatologic and fatigue related symptoms were unbearable. He utilized NSAID's again initially without increasing the steroids. None of them were helpful. He woke up at night in severe pain and this necessitated an additional dose of 5-10 mg of Prednisone daily. A significant amount of fluid was removed bilaterally (60 mls/side), and Medrol was injected into each knee simultaneously. Doctor also suggested a "lubricant", such as Synvisc in the future. After this procedure the pain and knee swelling improved. Ambulation became less bothersome. In terms of symptoms, he continued to experience back pain, but this like many other pains was tolerated out of necessity. He continued to experience migratory joint symptoms especially the shoulders, greater than the wrists, then the knees, then the elbows and ankles, in that order. He tried to decrease the steroids (down to 3 mg per day), whereas the Humira and MTX remained on the same weekly doses. Unfortunately, the reduction in steroids was not clinically feasible and the dose of Prednisone was kept at 5 mg daily, the MTX was increased to 25 mg weekly. In Jun-2019 Patient experienced multiple dental issues. He fractured a tooth, requiring a Root Canal and reconstruction. He also required two Wisdom Teeth extractions. Due to persistent tooth and jaw pain a CT of the Jaw was performed. This showed no evidence of fracture or abscess. It was performed due to the complications associated with Osteoporosis secondary to prolonged steroid use and the use of Fosamax. As of Sept-2019, the repaired teeth remain painful to touch, but the situation is being tolerated. Patient was able to return on 09-Jul-2019 for one month. He was determined to improve his physical status, and all the deterioration produced by the Prednisone and other drugs. He exercised many hours daily (swimming, weightlifting, biking and golf). He lost 18 lbs. in 18 days with this regimen and simultaneously decreasing meal intake (high protein low carb diet). The problem from an RA perspective has been severe knee pain and swelling, episodes of myalgias, arthralgias, and flu-like symptoms. His knees were aspirated in early June (60 mls. on the right and 40 mls. on the left) and Medrol was injected bilaterally. The effusions reappeared in two weeks. On 7/7/19 repeat aspirations were necessary (40 mls. on the left and 60 mls. on the right). At that time Synvisc was injected bilaterally and a lower dose of Medrol. Exercise was recommended to "move" the lubricant throughout the joint spaces. With the weight loss the Sleep Apnea disappeared. Patient had a Simponi Infusion on 06-Aug-2019. He tolerated this for 24 hours but then developed transient respiratory symptoms, increased myalgias and arthralgias. Doctor evaluated him on 07-Aug-2019 and felt that the left-sided Adenopathy was not clinically significant and required no biopsy or node dissection, etc. Due to the exacerbation of symptoms with the first IV infusion of Simponi at 200 mg, patient requested a decrease in dose for the second infusion. It had been necessary to take Motrin and Excedrin every evening to diminish the chills; otherwise, he would never be able to sleep. Knees and quadriceps were especially painful, and in the AM, it was very difficult to bend my knees. His hands and wrists were more affected than previously. Every afternoon between 10 and 18-Nov-19, Patient would pass out from fatigue. He awakened late every night with the feeling of "being septic": myalgia, arthralgia, chills, etc., which only partially resolved with 400-800 mg of Advil. Significant effusions redeveloped in both knees, right greater than left, as well as bilateral LE Lymphedema. Bilateral knee aspirations and injected Medrol simultaneously was performed. 70 mls was removed from the right and 40 mls from the left. That evening he had no septic symptoms and the following morning he felt much better. His conclusion was that this episode was a flair of the Autoimmune RA and a reaction to the IV infusion. On the morning of 09-Feb-2020, he attended a brunch with six people. Within an hour of the meal, he developed significant abdominal distension. No one else became ill. He was admitted from the ER. The nausea, vomiting and diarrhea halted. He was at bowel rest for 24 hours; a surgical consult was obtained to rule-out a surgical abdomen, given history of a recurrent abdominal wall hernia and RLQ pain. Blood cultures were presumably negative. He was discharged on 12-Feb-2020 in improved condition. However, between 12 and 18-Feb-2020 he was unable to advance diet. He ate soup and once or twice tried solid food. The latter caused distension, pain, and passed a minimal amount of gas. The pain remained diffuse, and he always had a sensation of impending N+V or desire to move bowels but could not. Between 20 and 22-Feb multiple cathartics were utilized sequentially until it led to a massive amount of bowel movement. This included three Dulcolax tablets, then 24 hours of MiraLAX continuously, followed by one bottle of Magnesium Citrate and ultimately one ounce of Lactulose. The distension disappeared after the bowel movements. However, the distension, tympany, and pain returned on 23-Feb and remained on 24-Feb. In the morning of 24-Feb, a GI consultation was obtained. He had hypoactive bowel sounds, significant distension and pain especially at the site of the recurrent hernia. On 28-Feb-2020, patient was evaluated. Doctor believed that the TNF inhibitors may be contributory to recent symptoms and stopped them. Prednisone was not eliminated. On examination, he had significant bilateral knee effusions. Doctor aspirated both, performed a cell count, and injected steroids. He experienced daily waves of severe joint and muscle pain, a sensation of fever and chills, all of which he experienced throughout Keytruda therapy. Physician believed that the recurrent hernia could not lead to severe symptoms, but it should be repaired electively via a laparoscopic approach with mesh. Simultaneously the abdomen should be examined for adhesions, etc. He scheduled an upper endoscopy and colonoscopy for 09-Mar-2020, to rule out common etiologies. Future treatment would be predicated upon the findings of these two operative procedures. Ingestion of normal food was attempted the day after the procedure, and this led to severe abdominal pain and distension again. On 11-Mar-2020, he was awakened with continued abdominal pain and distension along with welts and hives on trunk and extremities. He took usual medications added Claritin. The rash disappeared in several days. Patient was able to eat small meals without gastric distension or a feeling of bowel obstruction. Bowel habits were not normal. If he did not move his bowels within several days, he became distended in the lower abdomen and required a combination of MiraLAX powder and Dulcolax tablets. Patient did not perceive the sense of bowel fullness or the desire to move his bowels on most occasions. The cathartics took 24-36 hours to be effective and then they produced diarrhea. Comparatively speaking, this set of symptoms was far superior to continuous bowel distension and pain, which he perceived in the past as possibly SBO. Nonetheless, patient usually ate only one meal per day and did not tolerate more, or "heavier" foods. He was unable to bend his right elbow to brush his teeth, pick up a cup and drink, or take a pill. The right biceps were painful and became more atrophic. He was unable to sleep on his right side because pressure on the right arm was very painful. There was no numbness to suggest a neurological cause. In terms of medications, his last infusion of Remicade proceeded on 30-Jan-2020, after which the four hospital admissions occurred. In terms of Prednisone, it clearly remained essential. On Tuesday 07-Apr-2020, he inadvertently forgot his morning dose for the first time in three years. That evening every joint and every muscle group became extremely painful. He was also significantly fatigued. He had not felt this bad from a joint or muscle perspective in several years. The following morning, he realized this situation and took 10mg of Prednisone upon arising and 5mg in the evening with improvement in all his symptoms. The muscle and joint symptoms exacerbate when the bilateral knee infusions increase. In April he was taking 10mg of Prednisone daily, but increased this when the effusions reappeared. Doctor performed bilateral aspirations on 20-Apr-2020. Furthermore, he was placed on Plaquenil 200mg BID. Despite the complexity of the situation and the degree of symptoms, he was much happier and in less pain than when he had severe bowel symptoms, distension, and the possibility of a surgical bowel obstruction. Between 05-May and 28-May-2020 the abdominal distension steadily decreased, tolerance of normal foods improved and bowel function slowly improved. Constipation remained, however. On the other hand, he developed massive welts, erythema, skin exfoliation, and increased bruising throughout his entire body in mid-May. It was extremely painful. He initially thought this was related to Plaquenil, and thus halted it. He had no reduction in the welts or worsening of joint symptoms for 48 hours. Then he began to experience worsening muscle and joint pain. He took several doses of Motrin and the rash increased within fifteen minutes of each dose. Thus, he believed the Motrin was the culprit not the Plaquenil. Patient was unable to walk without assistance on 15-May-2020. Doctor aspirated both knees in June and July. Doctor examined him and obtained lab data. Patient considered Rituxan, but ultimately decided to continue Plaquenil since the side effect profile was miniscule, and the continuation of Prednisone far less dangerous than the chemotherapeutic agent Rituxan. On 03-Sep-2020 he had an interval skin check, and several small lesions were frozen, but no melanoma was suspected. Patient tried to halt the Prednisone and the Plaquenil for the two weeks between 31-Aug-2020 and 15-Sep-2020. For the first week he had absolutely no significant symptoms. By the end of the second week however, he was extremely fatigued, and his hands began to hurt again. On 15-Sep-2020 he took 5mg of Prednisone and 400mg of Plaquenil. This reversed his symptoms within several hours. Patient continued the Plaquenil (400mg qd) and Prednisone (10mg qd) since that time. During Oct-2020 and Nov-2020, he had- nearly constant fatigue, increased pain and weakness in fingers, hands, wrists and forearms, persistent constipation and intermittent orthostasis which correlated with tamsulosin. Patient had 9 years of intense follow-up scans, including MRIs (Brain, T and LS Spines), CTs (chest, abdomen, pelvis), inguinal ultrasounds, laboratories, etc. Prednisone, Solumedrol IV, oral Medrol dose packs, etc., had been utilized continuously since Jul-2017. Joint injections of Medrol had been utilized for seven years also. He had received recurrent bilateral knee effusions requiring numerous aspirations and steroid injections (approximately 45 sets of bilateral aspirations) between 2017 and 2024. Patient had hives, welts with Enbrel. Welts and skin exfoliation, and increased skin bleeding with Advil liquigels on multiple occasions in May-2020; this resolved. Positive for DOE, chest muscle discomfort in 2017-2018 resulting in hospitalization; Positive for chronic right and left pedal edema, right greater than left due to radical LN dissection. Within several hours of Moderna vaccination, the injection arm became painful, erythematous, and twice the size of the left arm. This was treated with Benadryl (50mg), Prednisone (10mg) and Advil (400mg). All muscles and joints ached. The left arm was very painful for 3-4 days and was unable to lie upon the left side. He developed fever, chills and it felt like a recurrence of COVID-19. He took high dose steroids with a five-day taper. The pain in the arm lasted for two weeks. The arm swelling and eryt More
✓
2835442 M 04/09/2025 COVID19
 MODERNA
Death Death
Dead; This spontaneous case was reported by a patient family member or friend and describes the occu... Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No concomitant medications were reported. Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporters' family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws. No treatment medications were reported. This case was created for reporter's brother. This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 08-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: Very little information provided at this time. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784180:Master Case; Reported Cause(s) of Death: Dead More
✓
2835443 F 04/09/2025 COVID19
 MODERNA
Death Death
Dead; This spontaneous case was reported by a patient family member or friend and describes the occu... Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporters' family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws. No treatment medications were reported. This case was created for reporter's sister-in-law. This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 08-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: Very little information provided at this time. The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784180:Master Case; Reported Cause(s) of Death: Dead More
✓
2835444 M 04/09/2025 COVID19
 MODERNA
Death Death
Dead; This spontaneous case was reported by a patient family member or friend and describes the occu... Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided No Concomitant medications provided by the reporter. Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporter family) because of that covid vaccine. Reporter stated that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws. No treatment medications provided by the reporter. This case was created for reporter's brother-in-law. This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 09-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784180:Master case; Reported Cause(s) of Death: Dead More
✓
2835445 F 04/09/2025 COVID19
 MODERNA
Death Death
Dead; This spontaneous case was reported by a patient family member or friend and describes the occu... Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No Concomitant medications provided by the reporter. Reporter stated that in 3 years, she lost 7 family members (7 people were dead from reporter family) because of that covid vaccine. Reporter stated that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws. No treatment medications provided by the reporter. This case was created for reporter's sister-in-law. This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 09-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784180:Master case; Reported Cause(s) of Death: Dead More
✓
2835446 M 04/09/2025 COVID19
 MODERNA
Death Death
Dead; This spontaneous case was reported by a patient family member or friend and describes the occu... Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medications were reported. Reporter stated that in 3 years, she lost 7 family members (7 people were dead in caller's family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws. Treatment medication was not reported. This case was created for reporter's brother-in-law. This case was linked to US-MODERNATX, INC.-MOD-2025-784180 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 09-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784180:Master case; Reported Cause(s) of Death: Dead More
✓
2835447 73 F 04/09/2025 COVID19
PNC21
 MODERNA
MERCK & CO. INC.
 8080799
Y011819
Vaccination site erythema, Vaccination site pruritus; Vaccination site erythema,... Vaccination site erythema, Vaccination site pruritus; Vaccination site erythema, Vaccination site pruritus More
INJECTION SITE PRURITUS; INJECTION SITE ERYTHEMA; This spontaneous case was reported by a patient an... INJECTION SITE PRURITUS; INJECTION SITE ERYTHEMA; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (INJECTION SITE PRURITUS) and VACCINATION SITE ERYTHEMA (INJECTION SITE ERYTHEMA) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 8080799) for COVID-19 prophylaxis. Co-suspect product included non-company product Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) for an unknown indication. Previously administered products included for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included Drug allergy with Codeine. Concurrent medical conditions included Drug allergy (Codeine). On 15-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Pneumococcal vaccine conj 21v (CRM197) (Capvaxive) (Intramuscular use) 1 dosage form. On 15-Jan-2025, the patient experienced VACCINATION SITE PRURITUS (INJECTION SITE PRURITUS) and VACCINATION SITE ERYTHEMA (INJECTION SITE ERYTHEMA). At the time of the report, VACCINATION SITE PRURITUS (INJECTION SITE PRURITUS) and VACCINATION SITE ERYTHEMA (INJECTION SITE ERYTHEMA) had not resolved. Concomitant medication was not reported. Patient had received 2 vaccines on 15-Jan-2025 (Spikevax and Capvaxive vaccines), and since then, patient had reported of redness and itching on the injection site. Patient called and reported that, the symptoms started on evening of 15-Jan-2025 and lasted until now. Hospitalization, emergency room or office visit was not required. Treatment medication was not reported. More
2835448 M 04/09/2025 COVID19
 MODERNA
Death Death
Dead; This spontaneous case was reported by a patient family member or friend and describes the occu... Dead; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Dead) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medication was not reported. Reporter stated that in 3 years, she lost 7 family members (7 people were dead in caller's family) because of that covid vaccine. Reporter specified that the 7 people who were dead were her husband, her brother, her sister, several sister-in-laws, and several brother-in-laws. This case was created for reporter's husband. Treatment medication was not reported. This case was linked to US-MODERNATX, INC.-MOD-2025-784193, US-MODERNATX, INC.-MOD-2025-784202, US-MODERNATX, INC.-MOD-2025-784184, US-MODERNATX, INC.-MOD-2025-784208, US-MODERNATX, INC.-MOD-2025-784209, US-MODERNATX, INC.-MOD-2025-784211, US-MODERNATX, INC.-MOD-2025-784212 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2025: Upon internal review on 08-Apr-2025, significant correction was performed to remove case classification of Invalid and to update suspect product coding to Spikevax NOS.; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-784184:Her brother US-MODERNATX, INC.-MOD-2025-784202:several sister-in-laws US-MODERNATX, INC.-MOD-2025-784193:Reporter's sister US-MODERNATX, INC.-MOD-2025-784208:several brother-in-laws US-MODERNATX, INC.-MOD-2025-784209:People's case US-MODERNATX, INC.-MOD-2025-784211:Several sister in Law case US-MODERNATX, INC.-MOD-2025-784212:several brother-in-laws; Reported Cause(s) of Death: Dead More
✓
2835449 67 F 04/09/2025 COVID19
COVID19
 MODERNA
MODERNA
 027A21A
027A21A
Cardiac discomfort, Colonoscopy, Feeding disorder, Feeling abnormal, Illness; Mu... Cardiac discomfort, Colonoscopy, Feeding disorder, Feeling abnormal, Illness; Muscle twitching, Pancreatic carcinoma, Skin injury, Weight, Weight decreased More
she is extremely ill; pancreatic cancer; She is not able to eat; lost weight; neurological issues; s... she is extremely ill; pancreatic cancer; She is not able to eat; lost weight; neurological issues; skin wrecked; Poisoned; She also complains of twitches; many heart problems; vaccine destroyed her life/She feels she is not the same person she was; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (she is extremely ill), PANCREATIC CARCINOMA (pancreatic cancer), FEEDING DISORDER (She is not able to eat), WEIGHT DECREASED (lost weight), NERVOUS SYSTEM DISORDER (neurological issues), SKIN INJURY (skin wrecked), POISONING (Poisoned), MUSCLE TWITCHING (She also complains of twitches), CARDIAC DISCOMFORT (many heart problems) and FEELING ABNORMAL (vaccine destroyed her life/She feels she is not the same person she was) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A, 0329A21A and 003721-2A) for COVID-19 prophylaxis. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (she is extremely ill) (seriousness criterion disability), PANCREATIC CARCINOMA (pancreatic cancer) (seriousness criteria disability and medically significant), FEEDING DISORDER (She is not able to eat) (seriousness criterion disability), WEIGHT DECREASED (lost weight) (seriousness criterion disability), NERVOUS SYSTEM DISORDER (neurological issues) (seriousness criterion disability), SKIN INJURY (skin wrecked) (seriousness criterion disability), POISONING (Poisoned) (seriousness criteria disability and medically significant), MUSCLE TWITCHING (She also complains of twitches) (seriousness criterion disability), CARDIAC DISCOMFORT (many heart problems) (seriousness criterion disability) and FEELING ABNORMAL (vaccine destroyed her life/She feels she is not the same person she was) (seriousness criterion disability). At the time of the report, ILLNESS (she is extremely ill), PANCREATIC CARCINOMA (pancreatic cancer), FEEDING DISORDER (She is not able to eat), WEIGHT DECREASED (lost weight), NERVOUS SYSTEM DISORDER (neurological issues), SKIN INJURY (skin wrecked), POISONING (Poisoned), MUSCLE TWITCHING (She also complains of twitches), CARDIAC DISCOMFORT (many heart problems) and FEELING ABNORMAL (vaccine destroyed her life/She feels she is not the same person she was) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: She also had colonoscopies and she believes she had pancreatic cancer from Moderna vaccines. On an unknown date, Weight: Lost weight. Relevant Medical History (vaccines within the past 4 weeks, medical conditions) was reported as none. Patient was completely healthy. Concomitant product use was not provided by the reporter. Patient had major problems since taking the Moderna vaccines. Her cardiologist told that had been "poisoned". She believed she was "passing away from this garbage." She also adds that she was extremely ill, her cardiologist would be doing an ECG next week. She had colonoscopies and she believes she had pancreatic cancer from Moderna vaccines. She was not able to eat, she lost weight. She also complains of twitches and neurological issues, and that her skin was wrecked. She felt she was not the same person she was, she was ill and believed to be poisoned. She added she felt she lost 3 years of her and that the vaccine destroyed her life. She was having a heart monitor and many heart problems. Compensation was not an issue, according to her but she wishes she had an antidote to reverse the effects from the vaccine. It was unknown if the patient experienced any additional symptoms/events. Treatment information was not provided. Reporter causality was not reported.; Reporter's Comments: Due to lack of biological plausibility, the causality of the events Pancreatic carcinoma and poisoning was assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report. More
✓
2835450 81 F NY 04/09/2025 COVID19
 MODERNA
 3043160
Pain, Vaccination site discolouration, Vaccination site erythema, Vaccination si... Pain, Vaccination site discolouration, Vaccination site erythema, Vaccination site swelling More
More swollen than from previous Pfizer vac injections; About 2 weeks later, dark red at injection si... More swollen than from previous Pfizer vac injections; About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed; About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed; Much sorer than previous 4 Pfizer COVID vac for 4 days; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Much sorer than previous 4 Pfizer COVID vac for 4 days), VACCINATION SITE SWELLING (More swollen than from previous Pfizer vac injections), VACCINATION SITE ERYTHEMA (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) and VACCINATION SITE DISCOLOURATION (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) in an 81-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043160) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 4), Pfizer vaccine (Dose 3), Pfizer vaccine (Dose 3), Pfizer vaccine (Dose 4) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included Pain with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine; and Swelling with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. On 22-Aug-2024, the patient received fifth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. In 2024, the patient experienced VACCINATION SITE DISCOLOURATION (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed). On 05-Sep-2024, after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced VACCINATION SITE SWELLING (More swollen than from previous Pfizer vac injections). In September 2024, the patient experienced VACCINATION SITE ERYTHEMA (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed). On an unknown date, the patient experienced PAIN (Much sorer than previous 4 Pfizer COVID vac for 4 days). At the time of the report, PAIN (Much sorer than previous 4 Pfizer COVID vac for 4 days), VACCINATION SITE SWELLING (More swollen than from previous Pfizer vac injections) and VACCINATION SITE ERYTHEMA (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) had resolved and VACCINATION SITE DISCOLOURATION (About 2 weeks later, dark red at injection site which then spread, coned, crusted, left white mark when healed) outcome was unknown. The concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. The treatment drug information was not reported. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2025: Live follow up received: Significant information received in which dose updated from 1 mL to 0.5mL, event of vaccine overdose was deleted, event verbatim updated for Vaccination site swelling and Pain and reference number was added. More
2835451 M 04/09/2025 COVID19
 PFIZER\BIONTECH
Polymyositis Polymyositis
Polymyosytis; This is a spontaneous report received from a Consumer or other non HCP from medical in... Polymyosytis; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 62-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (manufacturer Unknown , Dose1), for Covid-19 Immunization. The following information was reported: POLYMYOSITIS (medically significant), outcome "unknown", described as "Polymyosytis". The patient was diagnosed with POLYMYOSYTIS that could have been induced by the Pfizer COVID vaccine that was administered to him 2-3 years ago. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
📋 Privacy Policy & Data Disclaimer