๐Ÿฅ VAERS Vaccine Data Browser

๐Ÿ”’ Privacy & Data Disclaimer

About This Site

This is a public data browser for the Vaccine Adverse Event Reporting System (VAERS). By using this site, you acknowledge and agree to the following:

Data Source & Accuracy

  • Public Data: All data displayed comes from the publicly available VAERS database maintained by the CDC and FDA.
  • No Verification: VAERS accepts all reports without verifying medical accuracy. Reports do not prove causation between vaccines and adverse events.
  • Anyone Can Report: Healthcare providers, patients, family members, and anyone else can submit reports to VAERS.
  • Research Purpose: This data is for transparency, research, and monitoring vaccine safety signals only.

Your Privacy

  • No Personal Data Collection: This site does not collect, store, or track any personal information about visitors.
  • No Cookies: We do not use cookies except for remembering that you've seen this disclaimer (stored locally in your browser).
  • No Analytics: We do not use Google Analytics or any other tracking services.
  • Search Privacy: Your searches and filters are not logged or stored on our servers.
  • Public Data Only: The VAERS data shown here is already public and contains no personally identifiable information.

Medical Disclaimer

  • Not Medical Advice: This tool is for informational purposes only and does not provide medical advice.
  • Consult Healthcare Providers: Always consult qualified healthcare professionals for medical decisions.
  • No Liability: We are not responsible for decisions made based on this data.

Data Interpretation

  • The presence of a report does not mean the vaccine caused the adverse event.
  • Coincidental events are often reported (e.g., a heart attack that happened to occur after vaccination).
  • Serious adverse events must be reported by law, even if unrelated to the vaccine.
  • The database is useful for detecting safety signals that require further investigation.

๐Ÿ“– Help & Search Guide

Column Icons Legend

๐Ÿ’€ Death
๐Ÿฅ Hospitalized
๐Ÿš‘ Emergency Room
โ™ฟ Disability
โš ๏ธ Life Threatening

How to Search

๐Ÿ’ก Search Tips:
  • Select Year: Choose a specific year OR "All Years" to search across all data
  • All Years requires filters: When searching all years, you must select at least one filter (lot number, vaccine type, outcome, etc.) for performance
  • Lot number tracking: Use "All Years" + Lot Number to track lots across multiple years
  • Combine filters: Use multiple filters together to narrow results (e.g., Age + Vaccine Type + Death)
  • VAERS ID: Search for specific report by ID number
  • Age: Enter exact age (e.g., 25) or decimal (e.g., 0.5 for 6 months)
  • State: Enter 2-letter state code (e.g., CA, NY, TX)
  • Vaccine Type: Search partial names (e.g., "COVID19", "FLU", "HPV")
  • Manufacturer: Search by company (e.g., "PFIZER", "MODERNA")
  • Lot Number: Search specific vaccine lot (works great with "All Years")
  • Symptoms: Search for any symptom keyword (e.g., "fever", "rash")
  • Death/Hospitalized: Filter to only show cases with these outcomes

Understanding the Data

  • Reports are unverified: VAERS accepts all reports without medical verification
  • Not proof of causation: A report does not mean the vaccine caused the event
  • Anyone can report: Healthcare providers, patients, and family members can submit reports
  • Multiple vaccines: One report may list multiple vaccines given at the same time
  • Blank fields: Not all fields are required, so some data may be missing

Using the Table

  • Sort columns: Click column headers (ID, Age, Sex, Date, Died) to sort
  • Expand text: Click "More" to see full narrative or symptom text
  • Navigate pages: Use pagination controls at top and bottom of table
  • Export results: Click "๐Ÿ“ฅ Export CSV" to download filtered data (max 10,000 records)

๐Ÿ’ก Frequently Asked Questions (FAQ)

What is this site?

๐Ÿฅ VAERS Vaccine Data Browser is an independent, third-party data browser for publicly available VAERS (Vaccine Adverse Event Reporting System) data.

Important: This site is NOT affiliated with, endorsed by, or operated by the CDC, FDA, or any government agency. We are an independent service that makes public VAERS data easier to search and analyze.

What is VAERS?

VAERS (Vaccine Adverse Event Reporting System) is a national early warning system established in 1990 to detect possible safety problems with vaccines. It's co-managed by the CDC (Centers for Disease Control and Prevention) and FDA (Food and Drug Administration).

VAERS accepts and analyzes reports of adverse events (possible side effects) after a person has received a vaccination.

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

  • Publicly available - Published by the CDC/FDA on their official website
  • De-identified - Contains no personally identifiable information (names, addresses, contact info removed)
  • Legally accessible - Available to researchers, media, and the general public under FOIA (Freedom of Information Act)
  • Not protected health information - Once de-identified and published by the government, it's no longer covered by HIPAA restrictions

This site displays the same public data available at vaers.hhs.gov/data.

Why does this site exist?

We believe in transparency and public access to health data. While the CDC/FDA provide VAERS data, their official site:

  • Is difficult to search and filter
  • Requires downloading large CSV files and technical knowledge
  • Is not user-friendly for the average person

This independent site makes the same publicly available data easier to search, filter, and understand for researchers, journalists, healthcare workers, and concerned citizens.

Where does the data come from?

All data is downloaded directly from the official CDC/FDA VAERS website at vaers.hhs.gov/data.

The data is:

  • Publicly released by the CDC/FDA every week
  • Available as downloadable CSV files
  • Imported into this site's database for easier searching
  • Displayed exactly as provided (no modifications or filtering)

This site does not collect, modify, or add to the official VAERS data.

My vaccine lot number matches one with deaths/serious events - should I be worried?

Important context:

  • VAERS reports do NOT prove causation - A report means an event occurred after vaccination, but doesn't mean the vaccine caused it
  • Anyone can report - Reports are not verified for medical accuracy before being published
  • Coincidences happen - When millions of people get vaccinated, some will experience unrelated medical events afterward
  • Large lot numbers - Popular vaccines may have hundreds of thousands of doses from one lot number
  • More vaccinations = more reports - Lots used widely will naturally have more reports

What to do:

  • Don't panic - VAERS data requires expert analysis to interpret
  • Talk to your doctor if you have concerns
  • Check official CDC/FDA safety communications for genuine safety signals
  • Remember: billions of vaccine doses have been safely administered

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

  • โš ๏ธ Reports are unverified - not investigated before publication
  • โš ๏ธ Cannot determine if vaccine caused the event
  • โš ๏ธ Underreporting - not all adverse events are reported
  • โš ๏ธ Overreporting - coincidental events may be reported
  • โš ๏ธ Incomplete data - not all fields are required

Bottom line: VAERS is an important tool for safety monitoring, but individual reports should not be used as proof that a vaccine caused harm.

What are "adverse events"?

An adverse event is any undesirable health occurrence that happens after vaccination, including:

  • Common reactions: Sore arm, mild fever, fatigue (usually expected)
  • Serious events: Hospitalization, disability, life-threatening illness, death
  • Coincidental events: Medical conditions that would have occurred anyway

Important: An adverse event doesn't mean the vaccine caused it - only that it occurred after vaccination. Many reported events are coincidental or unrelated.

Why are some lot numbers listed multiple times?

This is normal and expected! A person may receive multiple doses of the same vaccine from the same lot number:

  • COVID vaccines require 2-3 doses
  • HPV, Hepatitis B, and other vaccines have multi-dose schedules
  • Each dose is recorded as a separate entry

Example: Person receives Pfizer COVID dose 1 (lot ABC123) and dose 2 (lot ABC123) - lot ABC123 appears twice in their report.

How often is this data updated?

The CDC/FDA releases new VAERS data every Friday. This site is typically updated:

  • Weekly or bi-weekly for recent data
  • Check the available years to see what data is currently loaded
  • During updates, the site may be in maintenance mode temporarily

Where can I learn more?

โš ๏ธ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
๐Ÿ”„ Reset ๐Ÿ“ฅ Export CSV
ID Age Sex State Date โ–ผ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative ๐Ÿ’€ ๐Ÿฅ ๐Ÿš‘ โ™ฟ โš ๏ธ
2839914 74 M 05/07/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
MG5S9
Fatigue, Injection site erythema, Injection site mass, Injection site pain, Inje... Fatigue, Injection site erythema, Injection site mass, Injection site pain, Injection site swelling; Injection site warmth, Pain in extremity, Sleep disorder More
Patient woke up in the middle of the night with soreness in the arm. In the morning, he noticed arm ... Patient woke up in the middle of the night with soreness in the arm. In the morning, he noticed arm is red, warm, tender, and slightly swollen with a "little ball" at the injection site. He's been extremely fatigued throughout the day. More
2839915 51 F OH 05/07/2025 PNC20
 PFIZER\WYETH
 LX2497
Gait disturbance, Nervous system disorder Gait disturbance, Nervous system disorder
I am having neurological issues, my legs have became weak and it is hard to walk. I am having neurological issues, my legs have became weak and it is hard to walk.
โœ“
2839916 40 F CA 05/07/2025 MMR
MMR
MMR
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 2JX7Y
2JX7Y
2JX7Y
Arthralgia, Fatigue, Hypoaesthesia, Joint stiffness, Lymph node pain; Lymphadeno... Arthralgia, Fatigue, Hypoaesthesia, Joint stiffness, Lymph node pain; Lymphadenopathy, Malaise, Musculoskeletal stiffness, Pain in extremity, Pyrexia; Sleep disorder More
Taken from patient's message sent to MD: Starting Monday 4/21 I woke up feeling sick with... Taken from patient's message sent to MD: Starting Monday 4/21 I woke up feeling sick with painful and enlarged lymphs around my ears, throat, neck and back of the head. Symptoms continued all week with slight fever and fatigue. Started feeling better on Sat 4/26, then Tues 4/29 started having extremely stiff and painful joints in my wrist and hands. Very bad numbness at night, been waking up all night with extreme pain and numbness in my hands (especially Left). This morning 5/2 started to feel stiffness and pain in my ankles and feet. While still having the hand issues. More
2839917 1 M OH 05/07/2025 HIBV
MMR
PNC15
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 97F4B
X027447
Y010032
Y010374
Pyrexia; Pyrexia; Pyrexia; Pyrexia Pyrexia; Pyrexia; Pyrexia; Pyrexia
DEVELOPED HIGH FEVERS OF 105 DEVELOPED HIGH FEVERS OF 105
2839918 74 F TX 05/07/2025 COVID19
 PFIZER\BIONTECH
 LP1776
Expired product administered, No adverse event Expired product administered, No adverse event
pt was given comirnaty on 4/30/25 expiration date was 4/26/25. Pt has had no adverse reactions or p... pt was given comirnaty on 4/30/25 expiration date was 4/26/25. Pt has had no adverse reactions or problems. She has been contacted to return to clinic to have another vaccination. More
2839919 17 M WI 05/07/2025 MENB
MENB
 PFIZER\WYETH
PFIZER\WYETH
 HP9987
HP9987
Dizziness, Dyskinesia, Eye movement disorder, Hypoacusis, Hypotonia; Nausea, Pal... Dizziness, Dyskinesia, Eye movement disorder, Hypoacusis, Hypotonia; Nausea, Pallor, Paraesthesia, Vision blurred More
Patient received meningococcal group B vaccine and within a couple minutes, patient turned pale and ... Patient received meningococcal group B vaccine and within a couple minutes, patient turned pale and slumped to the left side sitting in the chair. Patient began making abnormal movements with arms and trunk of body along with head. Mouth was open and eyes were rolling back. Mother stated patient's name and patient was able to respond. This lasted 15 to 30 seconds. Provider notified immediately and came into the room to examine patient. Patient became nauseous but did not vomit. Patient reported tingling in their hands, blurry vision and muffled hearing. Patient also complained of being tired and dizzy. Patient declined any chest pain or headache. Patient's symptoms improved within 5 to 10 minutes. Blood pressures were taken in 5 minute increments while patient was being monitored from incident. Patient was then able to tolerate drinking sips of apple juice and was able to eat a graham cracker. Patient was able to stand up without feeling dizzy or having any pain. Provider re-examined patient and discharged patient from the clinic. All questions and concerns from Mother were answered by provider. Mother instructed to contact provider if any other questions or concerns come up. More
2839920 15 F NV 05/07/2025 DTAPHEPBIP
 GLAXOSMITHKLINE BIOLOGICALS
Lethargy, Loss of consciousness Lethargy, Loss of consciousness
5 MINUTES AFTER RECEEIVING VACCINE THAT I DENIED, MY DAUGHTER PASS OUT FOR A MINUTE AND WAS BEING A... 5 MINUTES AFTER RECEEIVING VACCINE THAT I DENIED, MY DAUGHTER PASS OUT FOR A MINUTE AND WAS BEING A BIT LOTHARGIC, IM ACTUALLY VERY DISSAPOINTED WITH FACILITY, MY DAUGHTER NEVER RECEIVED FIRST DOSAGE More
2839921 1.75 M MI 05/07/2025 FLU3
HEPA
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 370648
H3N97
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No adverse event. Incorrect dosage given (12 year & older) No adverse event. Incorrect dosage given (12 year & older)
2839922 1.5 F PA 05/07/2025 HEPA
HEPA
HEPA
HEPA
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y015910
Y015910
Y015910
Y015910
Circumstance or information capable of leading to medication error, Scratch, Und... Circumstance or information capable of leading to medication error, Scratch, Underdose; Circumstance or information capable of leading to medication error, Skin abrasion, Syringe issue, Underdose; Circumstance or information capable of leading to medication error, Scratch, Underdose; Circumstance or information capable of leading to medication error, Skin abrasion, Syringe issue, Underdose More
Child was receiving 2nd dose of Hep A. When medical assistant went to administer, parent did not hav... Child was receiving 2nd dose of Hep A. When medical assistant went to administer, parent did not have efficient hold on childs leg-needle pulled out and scratched patients' right thigh. Most of the Hep A vaccine spilled onto father leg. Less than half of the Hep A was injected to the patient. Patient was wiped clean. No reactions to actual vaccine. More
2839923 81 F GA 05/07/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 7L3ST
Circumstance or information capable of leading to medication error, Extra dose a... Circumstance or information capable of leading to medication error, Extra dose administered More
Patient spoke another language and we resorted to using a translator to help her fill out her questi... Patient spoke another language and we resorted to using a translator to help her fill out her questionnaire. During this process we accidently pulled the immunization history for her husband who has a very similar name. Her husband did need and rsv vaccine but she had already gotten one in February of this year so she did not need the dose we gave her today on 5/7/25. This mistake occurred due to a language barrier and a breakdown in our system. Patient was fine after receiving the vaccine. More
2839925 82 M WA 05/07/2025 TD
 UNKNOWN MANUFACTURER
 U0827AA
No adverse event No adverse event
N/A no adverse symptoms, no change in treatment. N/A no adverse symptoms, no change in treatment.
2839926 0.5 M MI 05/07/2025 DTPPVHBHPB
 MSP VACCINE COMPANY
Expired product administered Expired product administered
Administered Expired vaccine .contacted parents and vaccine will be readministered. Administered Expired vaccine .contacted parents and vaccine will be readministered.
2839927 11 M NC 05/07/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 DL4YY
Injection site erythema, Injection site swelling Injection site erythema, Injection site swelling
Swelling and redness of RT arm near injection site all throughout the day (05/07/25). Swelling and redness of RT arm near injection site all throughout the day (05/07/25).
2839928 55 F NC 05/07/2025 PNC21
 MERCK & CO. INC.
 1045A
Aphasia, Dizziness, Paraesthesia Aphasia, Dizziness, Paraesthesia
Patient was ordered PCV 21 vaccine after physical visit by provider. PCV 21 vaccine administered by ... Patient was ordered PCV 21 vaccine after physical visit by provider. PCV 21 vaccine administered by nurse per order in patient's left upper arm. Patient was fasting at the time for blood work. Patient tolerated immunization well, walked to check out within clinic. At check out patient reports 10 minutes after vaccination that she felt suddlenly light headed and that it was hard to talk, noting she might faint. Sat down in the lobby and asked for help. RN came out to assess and assist patient, she brought patient back to exam room. Patient BP 132/82, HR 74 at 11:34. Patient laid on exam table with multiple blankes and hot packs complaining of shaking and chills with continued light headed ness. 12:08 patient BP 132/82, HR 75, O2 saturation 100% on room air. Patient complains of feeling tingly all over the exterior of her body. Denies chills or shaking at this time. Light headedness comes and goes. Denies itching, no swelling or rash, or changes in breathing. 12:45 Patient's blood pressure 115/74 HR 72. Provider advised patient to take home dose of PRN xanax once spouse at chair side. Patient ate crackers and states she is feeling much better. Moved to sitting position and responding with spouse. At 1:20 patient got up without assistance to bathroom, stable when walking, no complaint of light headed or dizziness. Patient departed clinic unassisted. All symptoms resolved. More
2839929 51 F CA 05/07/2025 HEP
HEP
PNC20
PNC20
 DYNAVAX TECHNOLOGIES CORPORATION
DYNAVAX TECHNOLOGIES CORPORATION
PFIZER\WYETH
PFIZER\WYETH
 945665
945665
LX4484
LX4484
Fatigue, Injection site erythema, Injection site swelling, Nausea, Pruritus; Ras... Fatigue, Injection site erythema, Injection site swelling, Nausea, Pruritus; Rash; Fatigue, Injection site erythema, Injection site swelling, Nausea, Pruritus; Rash More
Patient received her PCV-20 and Heplisav-B vaccines on 4/30/25; both immunizations administered to r... Patient received her PCV-20 and Heplisav-B vaccines on 4/30/25; both immunizations administered to right deltoid per patient request. No reactions during post-vaccine 15-minute monitoring. Patient has no allergies, and confirmed that she had no prior known reactions to vaccines. Patient returned on 5/7/25 for another previously scheduled appointment, and reported that she had some redness/swelling at the injection site starting on 4/30/25 until Saturday, 5/3/25. Patient also reported having rash, itchiness, tiredness, and nausea (without vomiting) during this time period. Patient stated that she took Claritin, which helped her symptoms. Injection site still appeared a little red on 5/7/25. Reaction reported to the patient's PCP. Per MD, patient can continue to take Claritin as needed, with no other interventions needed at this time. Patient will be following up with PCP on 5/21/25; provider will discuss vaccine reactions with patient prior to ordering any additional doses of Heplisav-B, as it is unknown whether patient reaction to Heplisav-B vaccine, PCV-20 vaccine, or both. More
2839930 11 F PA 05/07/2025 MNQ
TDAP
 SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 U8558BA
EB4999
Blood pressure decreased, Hyperhidrosis, Pallor, Syncope, Visual impairment; Blo... Blood pressure decreased, Hyperhidrosis, Pallor, Syncope, Visual impairment; Blood pressure decreased, Hyperhidrosis, Pallor, Syncope, Visual impairment More
Patient left immediately after vaccine administration and felt faint while checking out. Patient sat... Patient left immediately after vaccine administration and felt faint while checking out. Patient sat down in chart prior to fainting d/t black spots in vision. She became diaphoretic, pale, and had a drop in her blood pressure. More
2839931 59 F WA 05/07/2025 COVID19
PNC20
TDAP
 PFIZER\BIONTECH
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS


Syncope; Syncope; Syncope Syncope; Syncope; Syncope
Vasovagal syncope Vasovagal syncope
2839933 16 F WI 05/07/2025 HPV9
MENB
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
 y012776
49m9n
Erythema, Feeling hot, Peripheral swelling; Erythema, Feeling hot, Peripheral sw... Erythema, Feeling hot, Peripheral swelling; Erythema, Feeling hot, Peripheral swelling More
Left arm redness, warmth, swelling that started the evening of the injection, and persisted for 6 da... Left arm redness, warmth, swelling that started the evening of the injection, and persisted for 6 days, at which time she came in to the office. She took Tylenol without improvement. More
2839934 62 F TX 05/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 MG5S9
Injection site erythema, Injection site haemorrhage, Injection site pruritus, In... Injection site erythema, Injection site haemorrhage, Injection site pruritus, Injection site swelling More
Patient called on 5/7/25 at 1023am to report adverse effects from her second shingles vaccine (recei... Patient called on 5/7/25 at 1023am to report adverse effects from her second shingles vaccine (received on 5/5/25) at the localized injection site (left deltoid) of redness, swelling, and itchiness. She did report that scratching caused it to bleed. Apology was given and was told that we are required to report this incident and to reach out to Pharmacy manager if she has unresolved issues. More
2839935 1 M AL 05/07/2025 HEPA
MMR
PNC15
VARCEL
 MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y008483
Y014096
Z003633
Y013347
Pallor, Rash, Rash maculo-papular; Pallor, Rash, Rash maculo-papular; Pallor, Ra... Pallor, Rash, Rash maculo-papular; Pallor, Rash, Rash maculo-papular; Pallor, Rash, Rash maculo-papular; Pallor, Rash, Rash maculo-papular More
rash that started on the face and spread to the extremities and trunk, blanching erythematous maculo... rash that started on the face and spread to the extremities and trunk, blanching erythematous maculopapular rash to face, trunk, extremities. More
2839936 69 F TX 05/07/2025 MMR
 MERCK & CO. INC.
 Y015020
Erythema, Food allergy, Pruritus, Rash Erythema, Food allergy, Pruritus, Rash
Rash, redness and severe itching reported by patient after administration and continued until now. ... Rash, redness and severe itching reported by patient after administration and continued until now. Rash has subsided but not completely. Patient also reported development of allergy to shrimp and salmon, which she had never had before. I recommended Benadryl to patient in the meantime and advised her to contact her PCP if reaction continues. More
2839937 0.5 F MA 05/07/2025 COVID19
DTPPVHBHPB
PNC15
RV5
 MODERNA
MSP VACCINE COMPANY
MERCK & CO. INC.
MERCK & CO. INC.



Abdominal pain upper, Diarrhoea; Abdominal pain upper, Diarrhoea; Abdominal pain... Abdominal pain upper, Diarrhoea; Abdominal pain upper, Diarrhoea; Abdominal pain upper, Diarrhoea; Abdominal pain upper, Diarrhoea More
Stomach pain and diarrhea for 1.5 weeks; Stomach pain and diarrhea for 1.5 weeks; This spontaneous c... Stomach pain and diarrhea for 1.5 weeks; Stomach pain and diarrhea for 1.5 weeks; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain and diarrhea for 1.5 weeks) and DIARRHOEA (Stomach pain and diarrhea for 1.5 weeks) in a 6-month-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect products included non-company products Vaxelis for an unknown indication, Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) for an unknown indication and Rotavirus vaccine live reassort oral 5v (Rotateq) for an unknown indication. Concurrent medical conditions included Cold. On 12-Feb-2025, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (unknown route) 1 dosage form, dose of Vaxelis (unknown route) 1 dosage form, dose of Pneumococcal vaccine conj 15v (CRM197) (Vaxneuvance) (unknown route) 1 dosage form and dose of Rotavirus vaccine live reassort oral 5v (Rotateq) (Oral use) 2 dosage form. On 14-Feb-2025, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain and diarrhea for 1.5 weeks) and DIARRHOEA (Stomach pain and diarrhea for 1.5 weeks). In February 2025, ABDOMINAL PAIN UPPER (Stomach pain and diarrhea for 1.5 weeks) and DIARRHOEA (Stomach pain and diarrhea for 1.5 weeks) had resolved. The action taken with mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Unknown) was unknown. Medications at the time of vaccination, history/ allergies were none. No concomitant medication was reported. Moderna, Vaxelis, Vaxneuvance was given via syringe at site LG and Rotateq via oral route at site MO. On 12-Feb-2025, patient also received 1 dose of unknown vaccine via syringe at site LG. No treatment medication was reported. More
2839938 F AZ 05/07/2025 COVID19
 MODERNA
Dementia Alzheimer's type Dementia Alzheimer's type
at the end had Alzheimer's; This spontaneous case was reported by a patient family member or fr... at the end had Alzheimer's; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (at the end had Alzheimer's) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. Concurrent medical conditions included Food allergy (was allergic to corn). On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (at the end had Alzheimer's) (seriousness criterion medically significant). At the time of the report, DEMENTIA ALZHEIMER'S TYPE (at the end had Alzheimer's) had not resolved. No concomitant medications were reported. The patient did not experience any additional symptoms or events No treatment medications were reported. Company comment: Very limited information provided in this case report precludes meaningful medical assessment. Temporal relationship was not provided, as well as the patient's age and medical history. Although there was lack of information at this point, until the date, there is no evidence to suggest that the suspect product can cause Alzheimer's disease and due to lack of biological plausibility, the causality is assessed as not related to the suspect product. The benefit-risk relationship of the product is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2025-785740 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2025: Live follow-up received contains non-significant information and added Reference ID. On 28-Apr-2025: Live follow-up received contains non-significant information and added Reference ID. On 29-Apr-2025: Live follow-up received contains non-significant information and added Reference ID.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785740:Master Case (Patient, Spikevax 2024-25 PFS) More
2839939 81 F AZ 05/07/2025 COVID19
 MODERNA
Pain in extremity, Underdose Pain in extremity, Underdose
sore arm; he gave me a half a dose of the regular dose for an adult; This spontaneous case was repor... sore arm; he gave me a half a dose of the regular dose for an adult; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and UNDERDOSE (he gave me a half a dose of the regular dose for an adult) in an 81-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The patient's past medical history included Pacemaker insertion (cardiac), Physical therapy (had physical therapy for 4.5 months following the Pfizer shot) and Hospitalization (I was in the hospital for a week). Previously administered products included for Drug use for unknown indication: z-pack erythromycin tablets (z-pack erythromycin tablets), Maxide, z-pack erythromycin tablets (z-pack erythromycin tablets), Maxide, Penicillin and Maxide; for Product used for unknown indication: Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 2), Flu Shot, Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included Adverse drug reaction NOS with Pfizer vaccine, Pfizer vaccine and z-pack erythromycin tablets; Allergic reaction NOS with Penicillin; Concussion with Maxide; Fall with Maxide; Frozen shoulder with Pfizer vaccine and Pfizer vaccine; Neck stiffness with Pfizer vaccine and Pfizer vaccine; Pain in arm with Pfizer vaccine, Pfizer vaccine and z-pack erythromycin tablets; Passed out with Maxide; and Vaccination adverse reaction with Flu Shot. Family history included Penicillin allergy (diagnosis from childhood) since an unknown date. Concurrent medical conditions included Allergy (allergy issues/ I'm allergic to whatever it is) and Allergy to antibiotic. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and UNDERDOSE (he gave me a half a dose of the regular dose for an adult). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and UNDERDOSE (he gave me a half a dose of the regular dose for an adult) outcome was unknown. No concomitant medications were reported. It was reported that patient had a weight of around 103๏ฟฝ104 lbs, and she had been 5 feet tall. She also reported that, due to having many allergy issues, it had been very difficult for her to distinguish them from a normal reaction. She had received a couple of Moderna shots, with the last one administered in late September or early October of 2024. She reported that she had known it had been "banned" because she had visited her sister in another state. She had received the shot and, upon seeing the actual vaccine and the needle going into her arm, had experienced a burning sensation and pain. This discomfort had lasted intermittently for around 33 weeks before subsiding. Then, moving forward to late March or early April, she had not had the data on her regarding a visit to the doctor but had been prescribed medication, of which she had taken one pill and had subsequently experienced heartburn and acid reflux. She had also taken Doxycycline, after which she had contacted the doctor's office and discarded the pills. She had reported that she had not been sick until the time of reporting; however, she had mentioned that, in the past, she had taken Z-Pack Erythromycin tablets, for which she had obtained a prescription that had been filled on April 4th or 5th. She had been uncertain but had reiterated that it was likely the 5th when she had taken only one of the tablets, which had caused her to have a very severe reaction. It had been the same reaction she had previously experienced when she had received her first COVID-19 shots at the beginning of the pandemic, during which she had "taken" two namely, the two original Pfizer vaccines and the second Pfizer vaccine. She had experienced tensed or froze the muscles in her neck and shoulders, which was exactly what had occurred after taking erythromycin. In addition, she had felt pain at the site where she had received the Moderna shot, and as the previous night, it had been burning and painful, persisting in that manner. She had then questioned whether anyone else had experienced a similar reaction and had wondered whether the person who had administered the shot had injected it into the muscle or the nerve. She had been uncertain about what had caused that reaction and why she had now developed the same reaction to an antibiotic. She had reported that she had been trying to work with a pharmacist who might be able to help her understand her condition. She had believed that there was something in the fillers common to both the vaccine and the antibiotic, to which she was allergic. However, she had reported that she had been unable to determine exactly what the cause had been and had struggled to figure it out. She had asked whether anyone else had experienced similar pain and burning sensations, and if that had been the case, she had wondered why she had not experienced such reactions before. She had mentioned that she had visited the Moderna website to check for information about potential side effects while gathering details. She had stated that her weight had fluctuated between 100 and 103 pounds and that she had been 5 feet tall. She had recounted that after receiving the Pfizer shot, her allergy doctor, who had been licensed to administer the Moderna vaccine, had given her a half dose initially because she had required a booster shot. He had provided her with half the standard adult dose. Later she had questioned whether the dosage had been too high for her body weight. She had also mentioned that she had undergone a titer test, which had shown a result of around 100%. Her healthcare provider had then recommended that she receive the full dose and had stated that, for her last couple of Moderna booster shots, she had received the full adult dosage. She wanted to know whether the provider had administered the shot into a muscle or a nerve, as she had wondered whether that had caused the reaction. She had mentioned that she had not experienced such a reaction previously and had suspected that the shot had likely been injected into a muscle. She had believed this to be the case because, based on her reaction to the antibiotic and the Pfizer vaccine, the effects had appeared to have involved the muscles. She had described the reaction as causing her muscles to feel frozen, extremely tight, or strained. She had explained that, prior to contacting MIS, she had consulted her allergy doctor, who had advised her to be cautious and had provided specific instructions, particularly regarding antibiotics. He had warned her against taking antibiotics unless she had confirmed a bacterial infection. She had also mentioned that she had been allergic to penicillin since childhood, which had concerned her doctor. Additionally, she had visited her orthopedic surgeon, who had prescribed physical therapy for her muscle issues in the neck and shoulders. She had noted that, while the reaction had not been as severe as the one she had experienced with the Pfizer vaccine, it had still been a concern. Although the surgeon had not been particularly worried about the Moderna shot, she had felt that it had contributed to the overall reaction affecting her shoulder. She had mentioned that she had undergone physical therapy for 4.5 months following the Pfizer shot, as prescribed. She had claimed that she had continued therapy for as long as necessary and had felt fine until she had taken the antibiotic. She had initially received two Pfizer shots at the start of the pandemic. Every booster shot she had received since then had been Moderna. She had stated that the last shot she had received, in September or October of 2024, had been the first to cause significant pain and burning sensations. She had recalled that, prior to that, she had typically experienced a sore arm for a few days or a week before the discomfort had resolved. She had compared her reaction to the flu shot, noting that something different had occurred with the last dose, leading to prolonged burning and pain that had fluctuated over time. She had suspected that the shot had been injected into her muscles, as the symptoms had varied based on her movements, particularly since the injection had been administered in her right arm, and she was right-handed. She had expressed dissatisfaction with her primary doctor and had reiterated that her allergy doctor had advised her to exercise extreme caution when taking medications, as she had experienced severe reactions in the past. She had recalled an incident from years ago in which she had taken a single pill of Maxide, passed out, hit her head on the concrete kitchen floor, and sustained a brain concussion, which had required hospitalization for a week. She had emphasized that her situation at the time of reporting had not been life-threatening but had sought clarification regarding whether the reaction had been caused by the shot being injected into a muscle. She had also questioned whether the dosage had been too high for her body weight and had requested recommendations related to that concern. She had asked whether, given that the normal adult dosage might have been too high for her body weight, she could have received a pediatric dosage. She had explained that, upon discussing this with her allergy doctor, she had attempted to find a provider willing to administer a pediatric dose. However, she had been informed that it was against medical protocols, and her request had been denied. She had inquired whether she had been due for another booster shot.She had asked about the CDC's recommendations for people aged 65 and older regarding COVID-19 boosters. She had admitted that she had not recently checked the CDC's website for updated guidance. She had questioned how long the effects of her previous dose had been expected to last and when she should seek another booster shot. She had also wondered when the appropriate time would be to request a titer test to measure her antibody levels. She had sought information on whether massaging the area where she had received the injection could improve circulation or alleviate the symptoms. She had speculated that the vaccine might have remained in the muscle instead of circulating properly. She had wondered whether a massage therapist could help and whether such a treatment would be beneficial. She had asked whether a pharmacist could examine available reference materials to check the ingredients in the Pfizer and Moderna vaccines. She had specifically wanted to determine whether the fillers used in both vaccines had been the same, as she had suspected that she had been allergic to one of those components. She had explained that she had only begun experiencing muscle-related reactions after taking an antibiotic, and she had believed that her allergic response to the antibiotic had triggered a resurgence of symptoms related to the COVID-19 vaccines. She had then asked whether she should receive another COVID-19 shot. She had asked for an estimation of whether the likelihood had been high that the dosage had been injected into the muscle and whether that could have explained her reaction. She had also mentioned that her allergy doctor had recommended that she receive another shot, though she had expressed uncertainty about proceeding with it. She had hesitated about paying for another shot and had considered consulting her primary doctor. However, she had been contemplating changing primary doctors due to dissatisfaction with her previous provider's attitude. She had restated that her allergy doctor had encouraged her to get another vaccine, as her last dose had been administered in late September or early October of 2024, and she had questioned whether she had been due for another booster. The reporter had then remarked that if she had already developed sufficient antibodies, she might not have needed another shot. She had also acknowledged her ongoing pain and had planned to undergo physical therapy to address it. She had reflected on the challenges she had faced in distinguishing allergic reactions from normal vaccine side effects due to her extensive history of allergies. The patient did not experience any additional symptoms or events. No treatment medications were reported This case was linked to MOD-2025-785740 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2025: Live follow-up received contains non-significant information and reference ID added On 28-Apr-2025: Live follow-up received contains non-significant information and reference ID added On 29-Apr-2025: Live follow-up received contains non-significant information and reference ID added More
2839940 81 F AZ 05/07/2025 COVID19
 MODERNA
Burning sensation, Dyspepsia, Gastrooesophageal reflux disease, Pain, Vaccinatio... Burning sensation, Dyspepsia, Gastrooesophageal reflux disease, Pain, Vaccination site pain More
heartburn; acid reflux; pain in what the shot where I got the Moderna shot; I got a burning sensatio... heartburn; acid reflux; pain in what the shot where I got the Moderna shot; I got a burning sensation and pain; I got a burning sensation and pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN (I got a burning sensation and pain), BURNING SENSATION (I got a burning sensation and pain), DYSPEPSIA (heartburn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and VACCINATION SITE PAIN (pain in what the shot where I got the Moderna shot) in an 81-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. Co-suspect product included non-company product Erythromycin for an unknown indication. The patient's past medical history included Pacemaker insertion (cardiac) (with a pacemaker), Physical therapy (had physical therapy for 4.5 months following Pfizer shot) and Hospitalization (I was in the hospital for a week). Previously administered products included for Drug use for unknown indication: z-pack erythromycin tablets (Z-Pack Erythromycin tablets), z-pack erythromycin tablets (Z-Pack Erythromycin tablets), Penicillin, Maxide, Maxide and Maxide; for Product used for unknown indication: Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 2) and Flu shot. Past adverse reactions to the above products included Adverse drug reaction NOS with Pfizer vaccine, Pfizer vaccine and z-pack erythromycin tablets; Allergic reaction NOS with Penicillin; Concussion with Maxide; Fall with Maxide; Frozen shoulder with Pfizer vaccine and Pfizer vaccine; Neck stiffness with Pfizer vaccine and Pfizer vaccine; Pain in arm with Pfizer vaccine, Pfizer vaccine and z-pack erythromycin tablets; Passed out with Maxide; and Vaccination adverse reaction with Flu shot. Family history included Penicillin allergy (diagnosis from childhood) since an unknown date. Concurrent medical conditions included Allergy (have so many allergy issues) and Allergy to antibiotic (reaction from antibiotic). In 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. In April 2025, the patient started Erythromycin (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN (I got a burning sensation and pain), BURNING SENSATION (I got a burning sensation and pain), DYSPEPSIA (heartburn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and VACCINATION SITE PAIN (pain in what the shot where I got the Moderna shot). The patient was treated with Doxycycline at an unspecified dose and frequency. At the time of the report, PAIN (I got a burning sensation and pain) and BURNING SENSATION (I got a burning sensation and pain) had resolved and DYSPEPSIA (heartburn), GASTROOESOPHAGEAL REFLUX DISEASE (acid reflux) and VACCINATION SITE PAIN (pain in what the shot where I got the Moderna shot) outcome was unknown. No concomitant medications were reported. It was reported that patient had a weight of around 103๏ฟฝ104 lbs, and she had been 5 feet tall. She also reported that, due to having many allergy issues, it had been very difficult for her to distinguish them from a normal reaction. She had received a couple of Moderna shots, with the last one administered in late September or early October of 2024. She reported that she had known it had been "banned" because she had visited her sister in another state.She had received the shot and, upon seeing the actual vaccine and the needle going into her arm, had experienced a burning sensation and pain. This discomfort had lasted intermittently for around 33 weeks before subsiding. Then, moving forward to late March or early April, she had not had the data on her regarding a visit to the doctor but had been prescribed medication, of which she had taken one pill and had subsequently experienced heartburn and acid reflux. She had also taken Doxycycline, after which she had contacted the doctor's office and discarded the pills.She had reported that she had not been sick until the time of reporting; however, she had mentioned that, in the past, she had taken Z-Pack Erythromycin tablets, for which she had obtained a prescription that had been filled on April 4th or 5th. She had been uncertain but had reiterated that it was likely the 5th when she had taken only one of the tablets, which had caused her to have a very severe reaction. It had been the same reaction she had previously experienced when she had received her first COVID-19 shots at the beginning of the pandemic, during which she had "taken" two namely, the two original Pfizer vaccines and the second Pfizer vaccine. This case was linked to US-MODERNATX, INC.-MOD-2025-785837 (E2B Linked Report). This case was linked to MOD-2025-785844 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2025: Live follow-up received contains non-significant information and reference ID added On 28-Apr-2025: Live follow-up received contains non-significant information and reference ID added On 29-Apr-2025: Live follow-up received contains non-significant information and reference ID added; Sender's Comments: US-MODERNATX, INC.-MOD-2025-785837:Reporter sister-in-law's mother case More
2839941 F NH 05/07/2025 COVID19
 NOVAVAX
 3024MF012
COVID-19, Gait disturbance, Pain, Type II hypersensitivity, Vaccination failure COVID-19, Gait disturbance, Pain, Type II hypersensitivity, Vaccination failure
Walking got worse; It was itchy, hard, type 2 reaction; It was itchy, hard, type 2 reaction; And thi... Walking got worse; It was itchy, hard, type 2 reaction; It was itchy, hard, type 2 reaction; And this time I was so sore because she rubbed it; It was itchy, hard, type 2 reaction; It was itchy, hard, type 2 reaction; She had COVID again recently and it almost killed her; COVID; Vaccination failure; This serious initial spontaneous safety report was received by Novavax on 29-Apr-2025 from an other health professional via Novavax Medical Information (AE Number: NOV25-00250). A 43 year-old female was vaccinated with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula)(Intramuscular) (LOT: 3024MF012) on 04-Oct-2024. The following medical history was reported: LONG COVID, HYPOGAMMAGLOBULINEMIA, AUTO-INFLAMMATORY CONDITION, YAOS SYNDROME, MCAS, POTS, SMALL FIBER NEUROPATHY FROM LONG COVID, SEVERE ASTHMA, VOCAL CORD DYSFUNCTION, METABOLIC SYNDROME, AUTONOMIC DYSFUNCTION, SEVERE GASTROPARESIS, GI DYSMOTILITY, LATEX ALLERGY, PENICILLIN ALLERGY, BEES ALLERGY, BEES WAX AND HONEY ALLERGY, METRONIDAZOLE ALLERGY, IODINE CONTRAST ALLERGY and IMMUNOCOMPROMISED. The following concomitant medications were reported: GAMMAGARD(immunoglobulin human normal), SULFADIAZINE(sulfadiazine), METFORMIN(metformin), MESTINON(pyridostigmine bromide), FAMOTIDINE(famotidine), LORATADINE(loratadine), ASPIRIN [ACETYLSALICYLIC ACID](acetylsalicylic acid), CROMOLYN [CROMOGLICATE SODIUM](cromoglicate sodium), MAGNESIUM(magnesium), NIACIN(nicotinic acid), MIRTAZAPINE(mirtazapine), NALTREXONE(naltrexone), SYMBICORT(formoterol fumarate), ALBUTEROL [SALBUTAMOL](salbutamol), ATROVENT(ipratropium bromide), FLONASE [FLUTICASONE PROPIONATE](fluticasone propionate), BENADRYL [DIPHENHYDRAMINE](diphenhydramine), VYVANSE(lisdexamfetamine mesilate), METOPROLOL(metoprolol), CORLANOR(ivabradine hydrochloride), NATAZIA(estradiol valerate), SLYND(drospirenone), ZYRTEC [CETIRIZINE HYDROCHLORIDE](cetirizine hydrochloride), MITOCHONDRIAL NRG(creatine) and DIGESTIVE ENZYMES [BETAINE HYDROCHLORIDE;BROMELAINS;CELLULASE;PANCREATIN;PAPAIN](betaine hydrochloride). On an unspecified dates, after vaccination the patient experienced "It was itchy, hard, type 2 reaction" (Type II hypersensitivity) (Serious: Other Medically Important Condition), "Walking got worse" (Gait disturbance), "It was itchy, hard, type 2 reaction" (Injection site pruritus), "It was itchy, hard, type 2 reaction" (Injection site mass), and "And this time I was so sore because she rubbed it" (Pain). On 04-Oct-2024, day 1 after vaccination the patient experienced Vaccination failure (Vaccination failure) (Serious: Other Medically Important Condition). On 30-Dec-2024, 88 days after vaccination the patient experienced "She had COVID again recently and it almost killed her" (COVID-19) (Serious: Other Medically Important Condition). Relevant lab tests included: COVID-19 TEST(Result: Positive, Test Date: 30-Dec-2024). At the time of reporting, the event outcomes of Type II hypersensitivity, Gait disturbance, Injection site pruritus, Injection site mass, Pain, and COVID-19 were Unknown and Vaccination failure was Recovered/Resolved. Additional case number for this patient included: 2025-NVX-US-00312. A discrepancy was identified in the source document where the administration date of Novavax vaccine was reported as 01-Oct-2024 and 04-Oct-2024. 04-Oct-2024 was captured in the case.; Sender's Comments: This 43 year-old female experienced Type II hypersensitivity, Vaccination failure, Gait disturbance, Injection site pruritus, Injection site mass, Pain and COVID-19 after vaccination with Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula). The events Type II hypersensitivity, Vaccination failure and COVID-19 were reported as serious. The events Gait disturbance, Injection site pruritus, Injection site mass and Pain were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and COVID-19, Type II hypersensitivity, Gait disturbance, Injection site pruritus, Injection site mass and Pain is considered Possible, and between Novavax COVID-19 Vaccine, Adjuvanted (2024 - 2025 Formula) and Vaccination failure is considered Related. More
2839942 F NH 05/07/2025 COVID19
 UNKNOWN MANUFACTURER
Injection site mass, Type II hypersensitivity Injection site mass, Type II hypersensitivity
I didn't really get much of a type 2 reaction, you know the big bump on your arm; I didn't... I didn't really get much of a type 2 reaction, you know the big bump on your arm; I didn't really get much of a type 2 reaction, you know the big bump on your arm; This serious initial spontaneous safety report was received by Novavax on 29-Apr-2025 from an Other health professional via contact center (MI No. NOV25-00250). A 42-year-old female was vaccinated with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (Intramuscular) (Lot number was not provided in the report) on Nov-2023. The following medical history was reported: HYPOGAMMAGLOBULINEMIA, AUTO-INFLAMMATORY CONDITION, YAO SYNDROME, LONG COVID, MCAS, POTS, SMALL FIBER NEUROPATHY FROM LONG COVID, SEVERE ASTHMA, VOCAL CORD DYSFUNCTION, METABOLIC SYNDROME, AUTONOMIC DYSFUNCTION, SEVERE GASTROPARESIS, GI DYSMOTILITY, LATEX ALLERGY, PENICILLIN ALLERGY, BEE ALLERGY, BEE'S WAX AND HONEY ALLERGY, METRONIDAZOLE ALLERGY, IODINE CONTRAST ALLERGY and IMMUNOCOMPROMISED. The following concomitant medications were reported: MITOCHONDRIAL NRG(d-ribose), GAMMAGARD(immunoglobulin human normal), SULFADIAZINE(sulfadiazine), METFORMIN(metformin), MESTINON(pyridostigmine bromide), FAMOTIDINE(famotidine), LORATADINE(loratadine), ACETYSALICYLIC ACID(acetylsalicylic acid), CROMOLYN [CROMOGLICIC ACID](cromoglicic acid), DIGESTIVE ENZYMES [BETAINE HYDROCHLORIDE;BROMELAINS;CELLULASE;PANCREATIN;PAPAIN](betaine hydrochloride), MAGNESIUM(magnesium), NIACIN(nicotinic acid), MIRTAZAPINE(mirtazapine), NALTREXONE(naltrexone), SYMBICORT(formoterol fumarate), ALBUTEROL [SALBUTAMOL SULFATE](salbutamol sulfate), ATROVENT(ipratropium bromide), FLONASE [MOMETASONE FUROATE](mometasone furoate), BENADRYL [ACRIVASTINE](acrivastine), VYVANSE(lisdexamfetamine mesilate), METOPROLOL(metoprolol), CORLANOR(ivabradine hydrochloride), NATAZIA(estradiol valerate), SLYND(drospirenone) and ZYRTEC [LEVOCABASTINE HYDROCHLORIDE](levocabastine hydrochloride). On unspecified dates after vaccination the patient experienced "I didn't really get much of a type 2 reaction, you know the big bump on your arm (Type II hypersensitivity) (Serious: Other Medically Important Condition)" and "I didn't really get much of a type 2 reaction, you know the big bump on your arm" (Injection site mass). At the time of reporting, the outcomes of events Type II hypersensitivity and Injection site mass were Unknown. Additional case number for this patient included: 2025-NVX-US-00307.; Sender's Comments: This 42-year-old female experienced Type II hypersensitivity and Injection site mass after vaccination with COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). The event Type II hypersensitivity was reported as serious. The event Injection site mass was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Type II hypersensitivity and Injection site mass is considered Possible. More
2839947 1.08 F CA 05/07/2025 HEPA
HIBV
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 A3X2K
Y013470
Y000225
Y013350
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
No Adverse reaction noted. Called pt.'s mother .Spoke with mother Per mother pt. is stable no... No Adverse reaction noted. Called pt.'s mother .Spoke with mother Per mother pt. is stable no side effects noted. Reviewed side effects of HPV Vaccine Soreness,redness or swelling Health Provider ordered Prevnar 20 . Pt Received HPV. 4/21/25 5 pm Called pt's mother Spoke with mother and was informed Pt. Received HPV instead of Prevnar.20. Reviewed side effects of HPV Soreness,redness or swelling where vaccines was administered. Pt was given Er precautions if severe allergic reaction (hives swelling of the face and throat difficulty breathing call 911 and take pt to nearest hospital. Mother verbalized understanding. 4/22/25 9 20 amCalled pt.'s mother .Spoke with mother Per mother pt. is stable no side effects noted. Reviewed side effects of HPV Vaccine Soreness,redness or swelling where vaccines was administered. Pt was given ER precautions if severe allergic reaction (hives swelling of the face and throat difficulty breathing call 911 and take pt to nearest hospital. Mother verbalized understanding. Pt. Mother requested Immunization card to be mail. Printed and mailed to address on file. 04/23/25 1:15 pmCalled pt.'s mother .Spoke with mother Per mother pt. is stable no side effects noted. Reviewed side effects of HPV Vaccine Soreness,redness or swelling where vaccines was administered. Pt was given ER precautions if severe allergic reaction (hives swelling of the face and throat difficulty breathing call 911 and take pt to nearest hospital. Mother verbalized understanding More
2839949 55 F CA 05/07/2025 COVID19
PNC21
VARZOS
 PFIZER\BIONTECH
MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS
 MD3414
Z002626
A5T73
Injection site erythema, Injection site pain, Injection site warmth; Injection s... Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth; Injection site erythema, Injection site pain, Injection site warmth More
Pt claims day after vaccination she experienced redness around injection site on both arms. Then the... Pt claims day after vaccination she experienced redness around injection site on both arms. Then the right arm redness extended down to elbow, the next day the opposite arm did the same thing and while the right arm went back to normal. Overall redness, warmth, pain alternated between the arms. More
2839950 0.08 M CO 05/07/2025 DTAPIPVHIB
HEP
PNC15
RV5
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 UK168AB
Y015924
Y017360
2096663
Brief resolved unexplained event; Brief resolved unexplained event; Brief resolv... Brief resolved unexplained event; Brief resolved unexplained event; Brief resolved unexplained event; Brief resolved unexplained event More
BRUE BRUE
2839951 17 F IL 05/07/2025 HPV9
 MERCK & CO. INC.
 Y007991
Crying, Fear, Headache, Nausea, Syncope Crying, Fear, Headache, Nausea, Syncope
Pt fainted approximately 2 minutes after HPV vaccine given. She was seated on the exam table and lai... Pt fainted approximately 2 minutes after HPV vaccine given. She was seated on the exam table and laid herself back as she fainted. Mom assisted as she was almost horizontal on the exam table. No injury occurred. Pt woke up on her own after approximately 15 seconds. She cried immediately and was very scared about episode that just occurred. She asked "what happened?" I explained to her that she fainted after her vaccine and that this can happen with the HPV or any vaccine/blood draw, etc. Dr. came to room to evaluate patient. Patient reported that has a headache and is nauseous but otherwise feeling better about 10 minutes after episode. Both parents, Dr., and this RN in the room when patient was advised after 15 minutes she could slowly stand up if she was ready. She was able to stand up with standby assist and reported she feels ok to leave the office. Emesis bag provided to pt in case of vomiting after leaving office. Father did assist her out of the office with his arm around her arm in the event dizziness/fainting reoccurred. Pt discharged with both parents and all belongings. All questions/concerns addressed before discharge. BP at start of visit 115/74 HR - 100. 5 minutes after syncopal episode BP 132/84 HR - 100, 15 minutes after episode BP 121/78 HR - 100 More
2839965 86 F MD 05/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Dizziness Dizziness
Dizziness the next morning Dizziness the next morning
2839966 75 F VA 05/07/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LG5579
EK225
Atrial fibrillation, Feeling abnormal, Paraesthesia; Atrial fibrillation, Feelin... Atrial fibrillation, Feeling abnormal, Paraesthesia; Atrial fibrillation, Feeling abnormal, Paraesthesia More
The patient reported feeling bad that evening and worse the next day. She said she felt like needle... The patient reported feeling bad that evening and worse the next day. She said she felt like needles were poking her all over. The following day she went to the ER where they found her to be in A fib. She followed up with her primary care and they also referred her to also follow up with her cardiac specialist. She has been in A fib before but they feel like the shingles shot made her have another episode. More
2839967 58 F IL 05/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93N4J
Injection site erythema, Injection site inflammation, Injection site mass, Injec... Injection site erythema, Injection site inflammation, Injection site mass, Injection site pain, Injection site warmth More
Patient described a raised bump at the site of injection , patient reported no issues day of injecti... Patient described a raised bump at the site of injection , patient reported no issues day of injection but stated the morning after she woke she felt sore in her arm and the areas was red and inflamed the size of a "ping pong ball", patient did not know if caused specifically by vaccine , but was in process to see a acute care clinic. More
2839968 81 F NJ 05/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 ek225
Pain, Pain in extremity, Paraesthesia Pain, Pain in extremity, Paraesthesia
starting 5/6 patient had sore arm but then woke up 5/7 with total body tingling and was sore from he... starting 5/6 patient had sore arm but then woke up 5/7 with total body tingling and was sore from head to toe(this is 5 days after shot) More
2839969 82 M 05/07/2025 PNC20
 PFIZER\WYETH
 lx4482
No adverse event No adverse event
None stated. None stated.
2839970 71 F NM 05/07/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 A5T73
Blister, Pain, Pemphigoid Blister, Pain, Pemphigoid
Patient claims after 3 weeks the vaccine cause "Bullous pemphigoid" on her hands and feet.... Patient claims after 3 weeks the vaccine cause "Bullous pemphigoid" on her hands and feet. There are multiple blisters on hands/feet that are "opening" and excepetionally painful. More
2839971 62 M CA 05/07/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH

Brain fog, Chest discomfort, Disorientation, Dizziness, Eye pain; Head discomfor... Brain fog, Chest discomfort, Disorientation, Dizziness, Eye pain; Head discomfort, Headache, Neck pain, Rhinorrhoea, Sneezing More
Disorientation, fogginess of the brain, severe headache back of head, severe pain in back of eyes, ... Disorientation, fogginess of the brain, severe headache back of head, severe pain in back of eyes, dizziness, heavy chest, heavy head, severe neck pain, sneezing and runny nose for the first nine days. Thought if he went to sleep, he wouldn't wake up. Still having dizziness and disorientation. More
2839972 58 F GA 05/07/2025 PNC21
VARZOS
 MERCK & CO. INC.
GLAXOSMITHKLINE BIOLOGICALS

Injection site erythema, Injection site swelling; Injection site erythema, Injec... Injection site erythema, Injection site swelling; Injection site erythema, Injection site swelling More
Patient presents to the pharmacy counter 3 days after receiving first dose of Shingrix vaccine in he... Patient presents to the pharmacy counter 3 days after receiving first dose of Shingrix vaccine in her right arm and Capvaxive in her left arm. No adverse reactions to the Capvaxive vaccine but patient has injection site reaction to the Shingrix vaccine which includes large area of redness and swelling on her upper arm. She states that it began as a small area but grew to a cover a much larger area. Patient was given recommendations for how to treat reaction at home including taking OTC pain relievers such as Ibuprofen and placing an ice pack on the area to reduce swelling. She stated that she would follow those recommendations and follow up if not improved after a few days. More
2839973 24 F AZ 05/07/2025 MENB
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
 5AR2D*PRVT-YAHC
U8352AA*PRVT-YA
Arthralgia, Inflammation, Peripheral swelling, Urticaria; Arthralgia, Inflammati... Arthralgia, Inflammation, Peripheral swelling, Urticaria; Arthralgia, Inflammation, Peripheral swelling, Urticaria More
24-48hrs after started to hives on bilateral shoulder expanding to rest of body (side abdomen, thig... 24-48hrs after started to hives on bilateral shoulder expanding to rest of body (side abdomen, thighs/legs, back). Put hydrocortisone and Calamine lotion. Side effect really itchy thus the medication and ice cold baths. Then started to get water retention (swollen feet, ankles). After a day of swollen feet it started to hurt when standing. The swelling progressed behind knees and at elbows. Didn't resolved until two weeks ago. Started using the ibuprofen 2-3days after realizing the swelling was not going away. It relieved a little bit but didn't remove the inflammation completely still felt stiff. Maybe the lymph nodes are clogged told by another person. Tried oiling body and doing "Gah-sha" (chinese remedy?). Was extreme sore 3 days after this. Slowly was getting better. The "Gah-sha" treatment started after most recent telephone call from provider on 4/24 when she explained the symptoms multiple joint pain and hives. Prescribed naproxen for suspected reactive arthritis on 4/25. Swelling joint pain 4 days after the "Gah-sha" started to improve. Not completely resolved about 75% relieved today (5/7). Have to take breaks from arts and crafts. Noticed red eyes about 2-3wks ago. Denies chest pain, palpitations, coughing, wheezing, abdominal pain, N/V, diarrhea, constipation. +dyspnea (only when walk) after initial hives getting little better Didn't seek ED care, because naturally gets hives during the summer. Was somewhere on 4/12-13 which was very sunny and hot. Didn't notice any bug bites in the area. Hives happened about 2-3 other times in the past years. In the past the hives would last 1-2 days and goes away with calamine and hydrocortisone. If didn't then would take allegra. didn't take the allergra this time around. Swelling on bottom of feet started the day after initial visit followed by joint pain two days after. Joint pain started with ankles bilaterally but the moved up to knees, then few days in wrists and elbows. Now every night how she sleeps will feel the joint pain. More
2839974 57 M OK 05/07/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 Ewo162 & Ewo172
Ewo172
Arterial thrombosis, Atrial fibrillation, Cerebral haemorrhage, Coronary arteria... Arterial thrombosis, Atrial fibrillation, Cerebral haemorrhage, Coronary arterial stent insertion; Arterial thrombosis, Atrial fibrillation, Cerebral haemorrhage, Coronary arterial stent insertion More
18 months later went into AFIB, blood clots in right descending arterial. Went into surgery, receive... 18 months later went into AFIB, blood clots in right descending arterial. Went into surgery, received 2 stints. 4 days after found bleeding in lower cerebellum More
2839599 F HI 05/06/2025 HEPA
MMRV
 UNKNOWN MANUFACTURER
MERCK & CO. INC.
 Y007585
Y017511
No adverse event, Product storage error; No adverse event, Product storage error No adverse event, Product storage error; No adverse event, Product storage error
Caller reported vaccines administered after temperature excursions; No additional AEs; This invalid ... Caller reported vaccines administered after temperature excursions; No additional AEs; This invalid spontaneous report was received from a medical assistant and refers to patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot #Y017511, expiration date: 15-Apr-2026) (dose, vaccination site and route of administration were not reported); and with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) (lot #Y011019, expiration date: 18-Jun-2026) (dose, vaccination site and route of administration were not reported) administered for prophylaxis. The vaccines were administered after temperature excursions (temperature: -9.8C; time frame: 2 hours 3 minutes) (product storage error). There was no previous temperature excursion. No other information was provided. No additional adverse events (AEs) or product quality complaint (PQC) was reported. This case was considered invalid due to lack of patients' identifiers. Follow up information was received on 25-APR-2025 via complete questionnaire and refers to a 4-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 11-MAR-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y017511, expiration date: 15-Apr-2026), dose number 1, administered by Subcutaneous route in Left Thigh, and with Hepatitis A Vaccine (previously reported as Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX)), Inactivated (lot #Y007585, expiration date: 31-Oct-2025), dose number 1, administered by Intramuscular route in Right Thigh. This is one of several reports from the same reporter. More
2839600 17 NY 05/06/2025 VARCEL
 MERCK & CO. INC.
 Y015557
No adverse event, Product storage error No adverse event, Product storage error
No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VA... No additional AE /PQC reported.; HCP calling to report T/E (see T/E case# 02786079. ). HCP stated VARIVAX was administered; This spontaneous report was received from a Nurse and refers to a 17-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 31-Mar-2025, the patient was vaccinated with an improperly storage dose of with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), (lot #Y015557, expiration date: 16-Sep-2026) diluted with sterile diluent (MERCK STERILE DILUENT), (indication, expiration date, and lot # were not reported) for prophylaxis. Temperature excursion occurred at -7.8C for 36 minutes. Previous temperature excursion was at (-14.4 C up to -10.4C) -14.0C for 13 minutes. No additional adverse event was reported. More
2839601 PA 05/06/2025 VARCEL
 MERCK & CO. INC.
 X012281
Expired product administered, No adverse event Expired product administered, No adverse event
No additional AE; Customer calling to report that a dose of VARIVAX was administered after its expir... No additional AE; Customer calling to report that a dose of VARIVAX was administered after its expiration date.; Information has been received from Business Partner/CRO on 02-May-2025. This spontaneous report was received from a/an Other health professional and refers to a(n) patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), (lot #X012281, expiration date: 30-Apr-2025). On an unknown date, the patient started therapy with sterile diluent (BAXTER STERILE DILUENT), (lot # and expiration date were not reported). The patient started therapy with sterile diluent (BAXTER STERILE DILUENT), for the treatment of Prophylaxis. The patient started therapy with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE), for the treatment of Prophylaxis. On 01-May-2025, the patient experienced Customer calling to report that a dose of VARIVAX was administered after its expiration date.. On an unknown date, the patient experienced No additional AE. At the reporting time, the outcome of No additional AE and Customer calling to report that a dose of VARIVAX was administered after its expiration date. was unknown. The action taken with sterile diluent and Varicella Virus Vaccine Live (Oka-Merck) was reported as not applicable. More
2839614 69 F FL 05/06/2025 TYP
 BERNA BIOTECH, LTD.
Urticaria Urticaria
Hives start on day 2 and I have complete the 4 oral pills every other day and am still experiencing ... Hives start on day 2 and I have complete the 4 oral pills every other day and am still experiencing hives. My husband also took the same oral vaccine and had a more significant hive reaction. More
2839615 77 M 05/06/2025 MMR
 MERCK & CO. INC.
 Y015995
Pruritus, Urticaria Pruritus, Urticaria
severe itching and hives s/p vaccination requiring intervention severe itching and hives s/p vaccination requiring intervention
2839616 05/06/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 39LB7
Device leakage, Underdose Device leakage, Underdose
While giving Boostrix injection, several drop of vaccine dripped from manufacturer's seal, veri... While giving Boostrix injection, several drop of vaccine dripped from manufacturer's seal, verified that was not leaking from needle attachment. Most of medication was administered into patient's arm. No harm caused to patient. More
2839617 F PA 05/06/2025 COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH


Anxiety, Arthralgia, Fall, Gait disturbance, Gastrooesophageal reflux disease; H... Anxiety, Arthralgia, Fall, Gait disturbance, Gastrooesophageal reflux disease; Hereditary motor and sensory neuropathy, Hypoaesthesia, Laboratory test, Lumbar puncture normal, Migraine; Motor dysfunction, Neuropathy peripheral, Paraesthesia, Reduced facial expression, Tremor More
I received the pfizer COVID-19 vaccine in November of 2022. I started to have symptoms in my feet an... I received the pfizer COVID-19 vaccine in November of 2022. I started to have symptoms in my feet and hands. Tingling and pins and needles feeling in both hands and feet. It progressively got worse. Then on 4/15/2023, I fell flat on my face and could not feel my legs at all. I had to be carried out of the building I was in and taken to an urgent care/Hospital where they told me to see a neurologist. I saw a neurologist on 5/9/2023. She looked at me, examined me, and sent me straight to the ER at the closest hospital. She knew something was not right. I had always taken Moderna COVID but this one time, I was given the Pfizer and that caused this disease to activate and come out so prominently. After every test possible, a spinal tap, multiple attempts at IVIG, I was diagnosed with CMT type 1A. The doctors at the hospital stated that the Pfizer COVID-19 vaccination brought the genetic disease out so prominently. Since I've had this disease for as long as I've lived, and it had stayed dormant, they had come to the conclusion that this vaccination, brought my disease to surface and now I am highly disabled. I can't feel my feet, have tingling in my hands and can barely walk or pick up every day objects. I'm currently in a clinical trial but there is no cure for my disease since it is genetic. I wish I would have never taken the pfizer vaccine. I probably would have still been living a normal life. More
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2839618 64 F TN 05/06/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Paraesthesia Paraesthesia
About a week after receiving my 2nd shingles shot on April 7th, 2025 a began to have a tingling sens... About a week after receiving my 2nd shingles shot on April 7th, 2025 a began to have a tingling sensation on the left side of my neck, beginning at the shoulder and creeping up to the base of my scalp. This happens several times per hour (at least 15 and lasts approximately 15 seconds. It feels like "hair standing on end" and is not painful. It continues to this day. I have had no other changes to my diet, medications or lifestyle that would explain this sensation. I am 65, 5 ft 5 in, 125 lbs. No allergies. Medications, which I have been on for over 5 years, include Wellbutrin, amlodipine, losartan. More
2839619 38 F IL 05/06/2025 HPV9
 MERCK & CO. INC.
Hypersensitivity, Oligomenorrhoea Hypersensitivity, Oligomenorrhoea
I received my first dose of Gardasil 9 on March 5th. After that, I experienced a 14-day delay in my ... I received my first dose of Gardasil 9 on March 5th. After that, I experienced a 14-day delay in my menstrual cycle, which is very unusual for me. I also developed an allergic reaction in my underarm area after the vaccination, which is also strange and has never happened to me before. I believe that the vaccination caused a disruption in my menstrual cycle and may have triggered the allergic reaction. More
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