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
2815908 71 F GA 12/13/2024 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 Lm2221
lm2221
Injected limb mobility decreased, Myalgia, Sleep disorder, X-ray; Arthralgia, In... Injected limb mobility decreased, Myalgia, Sleep disorder, X-ray; Arthralgia, Injection site pain More
shoulder muscle pain that started early during the next day after the shot, difficulty in lifting an... shoulder muscle pain that started early during the next day after the shot, difficulty in lifting and moving left arm, difficulty in lifting light weight with left arm, inability to sleep on left side without pain, right arm must do all the work, left arm almost useless but not entirely useless, use of NSAIDs is limited due to raise in blood pressure that occurs if use is increased. It is still a serious problem at the current time although I hope that it can someday be improved. Physical therapy since 10/30. More
2838491 0.17 M FL 04/29/2025 DTAPHEPBIP
HIBV
PNC20
RV1
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 2G273
Y013270
LK6653
7E9Y2
Autopsy, Death, Sudden infant death syndrome, Toxicologic test; Autopsy, Death, ... Autopsy, Death, Sudden infant death syndrome, Toxicologic test; Autopsy, Death, Sudden infant death syndrome, Toxicologic test; Autopsy, Death, Sudden infant death syndrome, Toxicologic test; Autopsy, Death, Sudden infant death syndrome, Toxicologic test More
04172025. Autopsy and toxicology pending. Presumed SIDS 04172025. Autopsy and toxicology pending. Presumed SIDS
โœ“
2838492 38 F ID 04/29/2025 HPV9
 MERCK & CO. INC.
 1957407
Limb mass, Pain in extremity, Peripheral swelling, Tenderness Limb mass, Pain in extremity, Peripheral swelling, Tenderness
Has been 4 weeks and the patient is still having significant arm pain. Swollen and painful to touch,... Has been 4 weeks and the patient is still having significant arm pain. Swollen and painful to touch, feels like a lump under the skin. More
2838493 4 F AR 04/29/2025 COVID19
 PFIZER\BIONTECH
 LN6739
Expired product administered, No adverse event Expired product administered, No adverse event
Vaccine expired as of 12.4.25. Not as effective after expiration date. Vaccine expired as of 12.4.25. Not as effective after expiration date.
2838494 0.58 M NC 04/29/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
Inappropriate schedule of product administration Inappropriate schedule of product administration
There was a mistake in documentation and the vaccine dose #3 in the series was given early. Was due ... There was a mistake in documentation and the vaccine dose #3 in the series was given early. Was due 7/26, and was given 4/26. More
2838495 41 F 04/29/2025 DTAP
 SANOFI PASTEUR
Dizziness, Exposure during pregnancy, Fatigue, Hot flush, Tachycardia Dizziness, Exposure during pregnancy, Fatigue, Hot flush, Tachycardia
Tachycardia, hot flashes, fatigue, dizziness - 30 weeks pregnant Tachycardia, hot flashes, fatigue, dizziness - 30 weeks pregnant
2838496 54 F IN 04/29/2025 COVID19
 PFIZER\BIONTECH
 LN0591
Expired product administered, No adverse event Expired product administered, No adverse event
Expiration date was 24 April 2025, administered today in error. No adverse reaction to patient. Expiration date was 24 April 2025, administered today in error. No adverse reaction to patient.
2838497 0.5 F AR 04/29/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 LN6739
LN6739
Expired product administered; Expired product administered Expired product administered; Expired product administered
Vaccine Expired. One given 1.15.25 and other on 4.9.25 Vaccine Expired. One given 1.15.25 and other on 4.9.25
2838498 69 F NC 04/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 E754F
Injection site erythema, Pain, Pruritus Injection site erythema, Pain, Pruritus
PATIENT CAME TO THE PHARMACY 3 DAYS AFTER RECEIVING THE SHOT. I DID OBSERVE MULTIPLE RED PATCHES O... PATIENT CAME TO THE PHARMACY 3 DAYS AFTER RECEIVING THE SHOT. I DID OBSERVE MULTIPLE RED PATCHES OUTSIDE THE INJECTION SITE. SHE REPORTED FEELING SORENESS AND PAIN THE EVENING OF THE SHOT. THE REDNESS EXTENDED BEYOND THE INJECTION SITE WITH PAIN AND ITCHNESS TWO DAYS AFTER. SHE ALREADY STARTED ON BENADRYL TABLET AT TIME OF REPORTING THIS INCIDENCE ON 4/28/25. I RECOMMENDED USING BENADRYL CREAM AS WELL. I FOLLOEWD UP WITH HER TODAY 4/29/25 AND SHE IS STILL EXPERINCING THE REACTION. I CALLED HER DR AND THEY CONTACTED HER AND SCHEDULLED A VISIT WITH HER THIS AFTERNOON More
2838499 3 F TN 04/29/2025 IPV
 SANOFI PASTEUR
 Y1a201m
No adverse event, Wrong product administered No adverse event, Wrong product administered
Pt's vaccine record was assessed by PHN and determined that patient was due for MMR, Varicella,... Pt's vaccine record was assessed by PHN and determined that patient was due for MMR, Varicella, Hepatitis A, Hepatitis B, and PCV vaccines. At the time of vaccine preparation, IPV vaccine prepared instead of Hepatitis B vaccine. Error was not caught by PHN until documenting at which time patient had already received the incorrect vaccine. Pt did not have any signs or symptoms after vaccine administration. Parents were called around 15-20 minutes following vaccine administration and pt was given correct Hepatitis B vaccine. More
2838500 51 F TX 04/29/2025 PNC21
 MERCK & CO. INC.
 Y019157
Lymphadenitis, Nausea, Vertigo, Vomiting Lymphadenitis, Nausea, Vertigo, Vomiting
Severe inflammation of lymph nodes for 1 week. When this calmed down after 1 week, then developed se... Severe inflammation of lymph nodes for 1 week. When this calmed down after 1 week, then developed severe vertigo that causes nausea/ vomiting. Currently the vertigo is being evaluated by ENT. More
2838501 49 F OH 04/29/2025 HEPAB
MMR
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 324BY
Y019108
LX4482
Dizziness, Loss of consciousness, Urinary incontinence; Dizziness, Loss of consc... Dizziness, Loss of consciousness, Urinary incontinence; Dizziness, Loss of consciousness, Urinary incontinence; Dizziness, Loss of consciousness, Urinary incontinence More
The patient received three vaccines. Shortly after administration (around 5 minutes), patient felt d... The patient received three vaccines. Shortly after administration (around 5 minutes), patient felt dizzy and sat down on benches near customer service. She then passed out and slipped onto the floor. The patient lost control of bladder but quickly regained consciousness. The life squad was called for evaluation, and the patient went with them to the hospital to be further checked out. More
2838502 64 F 04/29/2025 PNC20
 PFIZER\WYETH
 LX4484
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Erythema, swelling, pruritis at injection site beginning the day after vaccination. Lasted for sever... Erythema, swelling, pruritis at injection site beginning the day after vaccination. Lasted for several days. More
2838503 61 F ND 04/29/2025 PNC20
TDAP
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LK6651
L5229
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa... Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm More
Left arm red, swollen and warm to touch. Improving since last week. Left arm red, swollen and warm to touch. Improving since last week.
2838504 9 M CO 04/29/2025 HPV9
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 y012865
u8438AA
No adverse event; No adverse event No adverse event; No adverse event
no symptoms no symptoms
2838505 71 M NY 04/29/2025 COVID19
 MODERNA
 066K21A
Rash morbilliform Rash morbilliform
Measles_like spots that began on instep of @ foot.. Dr was seen 1/4/23 , could not DX. Blothced <... Measles_like spots that began on instep of @ foot.. Dr was seen 1/4/23 , could not DX. Blothced <typical on both legs rose to knee caps and to a much lesser degree to thighs ,hips , inside forearms..was mistakenly DX'd as livedo reicularis,,6/29/23 @facility DX'd as LGL.. Sought assistance @another facility 8/1/23. ,referred to Hospital for Special Surgery hematologist More
2838507 12 F GA 04/29/2025 HPV9
 MERCK & CO. INC.
 Y012508
Injection site abscess, Injection site discharge, Injection site swelling Injection site abscess, Injection site discharge, Injection site swelling
MOM DESCRIBED PT HAVING AN ABSCESS AT THE SITE OF THE INJECTION. MOM ALSO REPORTED THAT PT HAD SWEL... MOM DESCRIBED PT HAVING AN ABSCESS AT THE SITE OF THE INJECTION. MOM ALSO REPORTED THAT PT HAD SWELLING. MOM WAS ABLE TO EXPRESS YELLOW EXUDATE FROM SITE More
2838508 17 F TX 04/29/2025 MENB
 PFIZER\WYETH
 GX1463
Asthenia, Dizziness, Gait disturbance, Headache Asthenia, Dizziness, Gait disturbance, Headache
Progressive weakness, dizziness, mild headaches, unsteady walk Progressive weakness, dizziness, mild headaches, unsteady walk
2838509 60 F TX 04/29/2025 COVID19
COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA
MODERNA



Brain fog, Chills, Computerised tomogram, Dyspnoea, Fatigue; Headache, Impaired ... Brain fog, Chills, Computerised tomogram, Dyspnoea, Fatigue; Headache, Impaired driving ability, Impaired work ability, Malaise, Pain in extremity; Brain fog, Chills, Computerised tomogram, Dyspnoea, Fatigue; Headache, Impaired driving ability, Impaired work ability, Malaise, Pain in extremity More
Severe Pain in my hands. Chills were so bad, I couldn't put on enough layers plus I went to be... Severe Pain in my hands. Chills were so bad, I couldn't put on enough layers plus I went to bed under blankets. Breathing difficulty. Headaches. Severe Fatigue. Brain Fog I had breathing spells for about a year after. Went to Pulmonlogist could not replicate. I continue to have days that I feel sick but not. I have had covid so many times since that I can't count. To this day I suffer from Severe fatigue and hand pain to the point I can't use my hands without pain. It is making it hard for me to work. I almost have had wrecks because of my brain. I have been in Sales all my career and required to drive from client to client. In the last 5 days I have been severely fatigue 3 out of the 5. More
2838510 22 F TX 04/29/2025 HPV9
 MERCK & CO. INC.
 1965046
Extra dose administered Extra dose administered
n/a n/a
2838511 53 F GA 04/29/2025 PNC20
VARZOS
 PFIZER\WYETH
GLAXOSMITHKLINE BIOLOGICALS
 LA6406
LY93M
Diarrhoea, Erythema, Tenderness; Diarrhoea, Erythema, Tenderness Diarrhoea, Erythema, Tenderness; Diarrhoea, Erythema, Tenderness
diarrhea, tenderness and redness of arm down to elbow for last 2 days diarrhea, tenderness and redness of arm down to elbow for last 2 days
2838512 27 F 04/29/2025 TDAP
 SANOFI PASTEUR
 U8232AA
Exposure during pregnancy, Inappropriate schedule of product administration, No ... Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event More
Patient is a 27-year-old female who was 35.3 weeks pregnant This patient received 2 TDAP doses in a ... Patient is a 27-year-old female who was 35.3 weeks pregnant This patient received 2 TDAP doses in a 6-week time frame. The first dose administered on 3/7/25 and the second was given on 4/24/25. Patient did not have a reaction to the 2nd TDAP. Patient was called on 4/29/25 and all was well. More
2838513 4 M TN 04/29/2025 MMRV
 MERCK & CO. INC.
 z003308
Extra dose administered Extra dose administered
Give mmrv Already receive 2 doses of MMR Give mmrv Already receive 2 doses of MMR
2838745 0.17 M OR 04/29/2025 DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
DTAPIPVHIB
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
PNC20
 SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
SANOFI PASTEUR
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 UK196AA
UK196AA
UK196AA
UK196AA
UK196AA
UK196AA
UK196AA
UK196AA
MF0415
MF0415
MF0415
MF0415
MF0415
MF0415
MF0415
MF0415
Blister, Blood culture negative, Blood glucose decreased, Constipation, Crying; ... Blister, Blood culture negative, Blood glucose decreased, Constipation, Crying; Crystalluria, Culture urine negative, Dehydration, Diet refusal, Differential white blood cell count; Drug screen negative, Dyskinesia, Electroencephalogram normal, Exaggerated startle response, Flushing; Full blood count, Glucose urine present, Haematuria, Hypophagia, Infant irritability; Lethargy, Metabolic function test, Metamyelocyte count increased, Microscopy, Muscle spasms; Muscular weakness, Platelet count increased, Poor feeding infant, Red blood cells urine negative, Respiratory tract congestion; Skin disorder, Sleep disorder, Thrombocytosis, Tissue infiltration, Unresponsive to stimuli; Urine ketone body present, Urticaria, White blood cells urine negative; Blister, Blood culture negative, Blood glucose decreased, Constipation, Crying; Crystalluria, Culture urine negative, Dehydration, Diet refusal, Differential white blood cell count; Drug screen negative, Dyskinesia, Electroencephalogram normal, Exaggerated startle response, Flushing; Full blood count, Glucose urine present, Haematuria, Hypophagia, Infant irritability; Lethargy, Metabolic function test, Metamyelocyte count increased, Microscopy, Muscle spasms; Muscular weakness, Platelet count increased, Poor feeding infant, Red blood cells urine negative, Respiratory tract congestion; Skin disorder, Sleep disorder, Thrombocytosis, Tissue infiltration, Unresponsive to stimuli; Urine ketone body present, Urticaria, White blood cells urine negative More
The patient is a 2-month-old child who was recently admitted on 4/24/25 for dehydration. He was admi... The patient is a 2-month-old child who was recently admitted on 4/24/25 for dehydration. He was admitted from the ER due to poor oral intake and fussiness following his 2-month vaccinations. He had a temperature of 99-100๏ฟฝF in the evening after vaccination but no fever since then. During hospitalization, he was placed on IV fluids and improved. Blood sugars were stable prior to discharge. Blood cultures showed no growth after 3 days. CBC had a mild thrombocytosis of 542 with 1 metamyelocyte. Urine drug screen was negative. Urine culture showed no growth. He had 1+ ketones, 3 white cells, 1 red cell, and 150 glucose in his urine with initial presentation of a glucose of 222. Initial presentation of glucose in the ER was a blood glucose of 45, and he was given glucose gel and D10, which was probably responsible for his elevated blood glucose and his glucose in his urine. He is here for follow-up. He is accompanied by his mother. The patient's mother reports that he experienced an adverse reaction to his vaccines, manifesting as a refusal to eat, hives, abnormal spasms, and the presence of blood in his urine. These symptoms appeared within an hour of the vaccination. He also exhibited lethargy, holding the nipple in his mouth without sucking or eating. Once the IV treatment began, he resumed eating but with weakened mouth muscles, resulting in milk spillage. The mother had to downgrade the nipples to accommodate this change. He also developed a pinkish discoloration in his diaper, which was attributed to dehydration or urate crystals. His cry has changed, sounding more congested and different. He had some vesicles that were opening up on his left foot, but there is no evidence of cellulitis, redness, or swelling. He was unresponsive during his hospital stay but has since regained his smile. He became lethargic within an hour of the vaccines, crying constantly and inconsolable for hours. He stopped eating completely, developed hives, and exhibited red flushes under his feet and legs. He also displayed unusual movements, falling forward and backward rapidly, which continued even in his sleep, disrupting his sleep pattern. These symptoms were most severe in the first 24 hours post-vaccination. He became easily startled by loud noises. His condition has improved, with the exception of a change in his cry and persistent muscle spasms. His coloration has returned to normal. He did not have a bowel movement for a few days after the vaccination but did not have any blood in his stool. The mother is considering giving him probiotic drops and is seeking advice on this. Diet, Intake & Output: The patient is bottle-fed. He had poor oral intake following his vaccinations but resumed eating after IV treatment. He did not have a bowel movement for a few days after the vaccination. Sleep: The patient's sleep pattern was disrupted by unusual movements following his vaccinations. He would wake up due to muscle spasms and cry before falling back asleep. During admission, did have IV infiltration: noted to have left foot IV infitration on the evening of 4/24. Hyaluronidase given with good resolution. Still with some skin breakdown. More
โœ“
2838746 0.5 F 04/29/2025 HIBV
 MERCK & CO. INC.
 Y003145
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was mistakely given an extra dose of PedvaxHib at her 6 month well check. No adverse event... Patient was mistakely given an extra dose of PedvaxHib at her 6 month well check. No adverse event has been reported. This VAERS entry is FYI due to extra vaccine administered. More
2838748 12 M IA 04/29/2025 HPV9
 MERCK & CO. INC.
 Y010656
Loss of consciousness Loss of consciousness
passed out. cool wet cloth, sips of water, doctor evaluation, recovery time 20-30 minutes. left clin... passed out. cool wet cloth, sips of water, doctor evaluation, recovery time 20-30 minutes. left clinic in stable condition with parent More
2838749 54 F FL 04/29/2025 PNC21
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
 Y011819
U8232AA
Headache, Malaise, Vomiting; Headache, Malaise, Vomiting Headache, Malaise, Vomiting; Headache, Malaise, Vomiting
Patients husband came by and ask if it was normal for a patient to get sick after receiving vaccines... Patients husband came by and ask if it was normal for a patient to get sick after receiving vaccines- he said the patient had a headache and was throwing up. More
2838751 80 F PA 04/29/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 AE435
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given an additional dose of RSV vaccine. No adverse reactions reported by patient. Patient was given an additional dose of RSV vaccine. No adverse reactions reported by patient.
2838752 77 M TX 04/29/2025 COVID19
 PFIZER\BIONTECH
 MD3414
Skin warm Skin warm
Patient complained of ear being hot to the touch Patient complained of ear being hot to the touch
2838918 18 F ID 04/29/2025 HPV9
 MERCK & CO. INC.
 Y012864
Extra dose administered, No adverse event Extra dose administered, No adverse event
NONE- third dose was given to patient. Patient was only supposed receive two dose of vaccine. I ref... NONE- third dose was given to patient. Patient was only supposed receive two dose of vaccine. I referred to database to find patients current vaccination needs. Database had duplicate accounts for patient due to recent name change. Database used indicated patient was due for HPV vaccine. Vaccine was administered. Pt has not had adverse reaction up to this point. More
2838919 82 M CA 04/29/2025 COVID19
 PFIZER\BIONTECH
 LM7786
Expired product administered Expired product administered
Administered Expired Covid 19 (Comirnaty) expired 04/07/2025 by mistake Administered Expired Covid 19 (Comirnaty) expired 04/07/2025 by mistake
2838920 79 M IL 04/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 93n4j
Inappropriate schedule of product administration, No adverse event Inappropriate schedule of product administration, No adverse event
pt received 2nd dose shingix 19 days early, no reaction at this time; pt to communicate with pharmac... pt received 2nd dose shingix 19 days early, no reaction at this time; pt to communicate with pharmacy should anything come up More
2838921 CA 04/29/2025 COVID19
 PFIZER\BIONTECH
 LM7786
Expired product administered Expired product administered
Administered expired Covid 19 (Comirnaty) expired 04/07/2025 by mistake Administered expired Covid 19 (Comirnaty) expired 04/07/2025 by mistake
2838922 23 F AZ 04/29/2025 HEP
HPV9
 DYNAVAX TECHNOLOGIES CORPORATION
MERCK & CO. INC.

Back pain, Pain; Back pain, Pain Back pain, Pain; Back pain, Pain
shooting lower back pain when turning. Patient reports getting better the next day. advised tyelonol... shooting lower back pain when turning. Patient reports getting better the next day. advised tyelonol and ibuprofen, if getting worse or continuing then reach out PCP More
2838923 63 F NM 04/29/2025 MMR
 MERCK & CO. INC.
 x024178
Psoriasis, Rash, Urticaria Psoriasis, Rash, Urticaria
urticarial rash to upper arms, then psoriatic patches on hands, then urticarial rash to neck, chest... urticarial rash to upper arms, then psoriatic patches on hands, then urticarial rash to neck, chest and legs. More
2838924 F FL 04/29/2025 COVID19
 PFIZER\BIONTECH
Blood test, Computerised tomogram, Dementia Alzheimer's type, Magnetic reso... Blood test, Computerised tomogram, Dementia Alzheimer's type, Magnetic resonance imaging, X-ray More
Diagnosed with Alzheimer's, currently in drug trials Diagnosed with Alzheimer's, currently in drug trials
2838925 1.25 F 04/29/2025 DTAP
 SANOFI PASTEUR
Injection site erythema, Muscle spasms Injection site erythema, Muscle spasms
Injection site redness. Swelling. Right arm spasms. Injection site redness. Swelling. Right arm spasms.
2838926 0.83 F FL 04/29/2025 IPV
 SANOFI PASTEUR
Rash, Rash erythematous Rash, Rash erythematous
Less than 48 hours after the vaccine was administered our child developed a rash, it was generalized... Less than 48 hours after the vaccine was administered our child developed a rash, it was generalized across her entire body. Small red, raised bumps. We saw the pediatrician who said to wait a week and it should go away. When it didn?t we saw a pediatric dermatologist who said it could be vaccine related and otherwise could not explain it. They suggested applying a steroid cream. The rash has persisted and it has been approximately 6 weeks now. More
2838927 55 F CA 04/29/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 597C4
Brain operation, Neuralgia Brain operation, Neuralgia
Patient developed trigeminal nerve pain 1 week after received vaccine and had to go through brain s... Patient developed trigeminal nerve pain 1 week after received vaccine and had to go through brain surgery 11 month after. More
2838928 0.5 M FL 04/29/2025 DTAPIPVHIB
PNC20
 SANOFI PASTEUR
PFIZER\WYETH
 UK045AA
LG5577
Injection site pain, Injection site swelling, Injection site warmth; Injection s... Injection site pain, Injection site swelling, Injection site warmth; Injection site pain, Injection site swelling, Injection site warmth More
Extremely swollen upper thigh, injection sights visible for 5 days, hot to touch, painful for baby f... Extremely swollen upper thigh, injection sights visible for 5 days, hot to touch, painful for baby for 5 days More
2247882 53 F LA 04/28/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 331308A
331308A
331308A
331308A
331308A
331308A
Alopecia, Blood test, Collagen disorder, Condition aggravated, Connective tissue... Alopecia, Blood test, Collagen disorder, Condition aggravated, Connective tissue disorder; Erythema, Hypersensitivity, Illness, Inflammation, Livedo reticularis; Loss of personal independence in daily activities, Movement disorder, Pruritus, Restless legs syndrome, Sepsis; Swelling, White blood cell count, White blood cell count abnormal; Burning sensation, Eyelid function disorder, Peripheral swelling, Pruritus, Rheumatoid arthritis; Swelling face, Urticaria More
Sepsis; while in hospital, had severe reaction after booster; Had been 100 percent swollen, glows in... Sepsis; while in hospital, had severe reaction after booster; Had been 100 percent swollen, glows in the dark, bright red, hot itching non stop; Over 2 years now, turns bright red/Had been 100 percent swollen, glows in the dark, bright red, hot itching non stop; Had been 100 percent swollen, glows in the dark, bright red, hot itching non stop; Skin still mottled from sepsis; twitching leg syndrome; White blood cell count about 123, still cleary sick; White blood cell count about 123, still cleary sick; Swollen, could barely move fingers/can't move fingers; collagen over produced entire body; lost a lot of hair; Spiked proteins, causing inflammation and redness; Has not been able to work because of that shot; Connective tissues tightened up; had allergic reaction; This is a spontaneous report received from a Consumer or other non HCP. A 53-year-old female patient received BNT162b2 (COMIRNATY), on 21Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 53 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: comirnaty (DOSE 1, LOT: EP6955), administration date: 20Mar2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "Cough"; comirnaty (DOSE 2, LOT: Looks like EW0151; Had partial hysterectomy for fibroids on 19Nov2021), administration date: 10Apr2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "fibroids", "sick", "rash", "Sepsis", "Coma", "allergic reaction", "constipation", "vomiting", "shaky leg syndrome", "lost lot of her memory", "Could not walk". Medical History: No, was 100 percent healthy before. The patient was no allergic to any previous vaccination, medications, food or other products. The patient did not receive any other vaccines on the same date as the Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. Concomitant Products: They had her on so many medications, in hospital, wants to say, like 30 pills, like 60 pills a day. Did not need anything but antibiotics and IV hydration. They did not have her on any of that. They had her on sedation medication, anxiety medication, sleeping, sedation. There were things she should not have been on. They are all documented, does not have access to that right now. The following information was reported: SEPSIS (prolonged hospitalization) with onset 2021, outcome "unknown"; CONDITION AGGRAVATED (prolonged hospitalization) with onset 2021, outcome "not recovered", described as "while in hospital, had severe reaction after booster"; SWELLING (non-serious), PRURITUS (non-serious), outcome "not recovered" and all described as "Had been 100 percent swollen, glows in the dark, bright red, hot itching non stop"; ERYTHEMA (non-serious), outcome "not recovered", described as "Over 2 years now, turns bright red/Had been 100 percent swollen, glows in the dark, bright red, hot itching non stop"; LIVEDO RETICULARIS (non-serious), outcome "not recovered", described as "Skin still mottled from sepsis"; RESTLESS LEGS SYNDROME (non-serious), outcome "unknown", described as "twitching leg syndrome"; WHITE BLOOD CELL COUNT ABNORMAL (non-serious), outcome "unknown", ILLNESS (non-serious), outcome "not recovered" and all described as "White blood cell count about 123, still cleary sick"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "Swollen, could barely move fingers/can't move fingers"; COLLAGEN DISORDER (non-serious), outcome "unknown", described as "collagen over produced entire body"; ALOPECIA (non-serious), outcome "unknown", described as "lost a lot of hair"; INFLAMMATION (non-serious), outcome "unknown", described as "Spiked proteins, causing inflammation and redness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "not recovered", described as "Has not been able to work because of that shot"; CONNECTIVE TISSUE DISORDER (non-serious), outcome "unknown", described as "Connective tissues tightened up"; HYPERSENSITIVITY (non-serious), outcome "not recovered", described as "had allergic reaction". The patient prolonged hospitalization for sepsis, condition aggravated (start date: 30Nov2021, discharge date: 29Dec2021, hospitalization duration: 30 day(s)). The patient underwent the following laboratory tests and procedures: White blood cell count: 123; Blood test: positive, notes: 4.27; positive, notes: 1.9. Therapeutic measures were taken as a result of sepsis, condition aggravated. Clinical course: She was admitted to hospital, with sepsis and got Covid-19 booster, while in hospital, had severe reaction after booster. Clarified, caller hospitalized 30Nov2021, with sepsis, received Covid-19 booster, 21Dec2021. Call regarding Pfizer Covid-19 booster. Actually had horrible adverse reaction, still having, from that shot, spiked proteins. Swollen, could barely move fingers. A lot has happened since 21Dec2021. Does not even know what to do right now. Had been doing plasma injections by Pfizer. Was put on plasma infusions by doctor, about 2 years before and, 4 months. Has not been able to work because of that shot. Looking for help, calling to see if she can continue copay assistance. Because of that shot, has not been able to work, it has destroyed her life. Connective tissues tightened up, had allergic reaction. Over 2 years now, turns bright red, can't move fingers, collagen over produced entire body, has been horrible. Clarified, caller referring to copay assistance for plasma injections by Pfizer, Hemoglobin IVG. Specific name provided and clarified with caller, as she thinks as, Pangyza. Instantly, had adverse reaction in hospital. Hospital kept denying, saying it was fine, she was not fine. Lost a lot of hair. Had been 100 percent swollen, glows in the dark, bright red, hot itching non stop. White blood cell count about 123, still clearly sick, was never treated for sepsis. Skin still mottled from sepsis. Severe reaction: Next morning, woke up, does not know what they gave her. They sedated her, was out, 100 percent swollen, does have photos. Was bright red, like half her body, left side body was real dark shade, almost like black, definitely a circulation problem. Had twitching leg syndrome, could not stop shaking. Clarified, was all eft side, hands, feet, up forearm. Has picture of that, from kneecap, down to foot. Like almost black color, not blue, very dark, like black. The other side was little bit lighter. Outcome of event: Still swollen really, still turns bright red, it really never left. Treatment: Because of Pfizer plasma infusion, has gotten a lot better. Got rid of a lot collagen coupling, and over producing it caused. The infusion has gotten rid of most of that. Seems like fingers super tight, skin turns bright red. Still really stiff, can't make fist, can't straighten out finger, still tight around eye socket, skin connective tissue, fascia. Tries to do yoga and all that. Has been dealing with it, a long time. Spiked proteins, causing inflammation and redness. It causes spike proteins, causing havoc within her body, still causing inflammation, can't get it out. Inflammation, the red on skin, just turns red, was like she could not stand in sun longer than like, 2 minutes. For about year and half, drenched in sweat, wet, so is so bright, still, even with all the plasma infusions, still red.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500086574 same patient, different vaccine dose/ events;US-PFIZER INC-202500087098 same patient, different vaccine dose/ events;US-PFIZER INC-202500086583 same patient, different vaccine dose/ events; More
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2838195 F MI 04/28/2025 VARCEL
 MERCK & CO. INC.
 Y014182
No adverse event, Product storage error No adverse event, Product storage error
No additional AE; HCP called and reported inadvertent administration of VARIVAX after a temperature ... No additional AE; HCP called and reported inadvertent administration of VARIVAX after a temperature excursion that occurred on 31JAN2025.; This case has been migrated from the previous safety database to the current safety database and assigned new Case ID: 2231763. The previous case ID: 2502USA001424. As a consequence of migration, the follow-up report may indicate in the appropriate field that it is an initial report. This spontaneous report has been received from a nurse concerning to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter. On 31-JAN-2025 and 03-FEB-2025, multiple patients were vaccinated with a improperly storage doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, lot # involved Y014182 (valid lot number, expiration date reported and validated as 20-AUG-2026) and Y003891 (valid lot number, expiration date reported and validated as 06-FEB-2026) reconstituted with sterile diluent (lot # and expiration date were not reported) administered as prophylaxis (strengths, doses, routes and anatomical locations of administration were not provided). The doses were administered after undergoing a temperature excursion of 21 Fahrenheit (F) for 2 hours, 12 minutes, o seconds and 14.3 F for 1 hour 5 minutes 0 seconds. It was reported a previous temperature excursion of 31 F for 4 hours 0 minutes 0 seconds (product storage error). No additional adverse event was reported. Follow up information has been received from the nurse on 06-FEB-2025. The reported stated that previously provided temperature excursion was incorrect. The vaccine was reevaluated, however no details where reported. The nurse stated that the varicella virus vaccine live (Oka/Merck) (VARIVAX) was administered to patients after providing the previously incorrect temperature excursion. Follow-up was received on 10-APR-2025 from a registered nurse. The patient details were updated. On 03-FEB-2025, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX). On the same date, the patient was vaccinated with measles, mumps and rubella (Wistar RA 27-3) virus vaccine (MMR II) subcutaneously on right thigh with lot # Y010046 with second dose and was vaccinated with Diphtheria vaccine toxoid;Pertussis vaccine acellular;Tetanus vaccine toxoid (DTAP/DVP) intramuscularly on left thigh with lot # 47838AA.; Sender's Comments: Priority : 5 , Is case serious : No , Index user :, Index date : 2025-04-14 , MNSC number : 02747559 , CLIC number : , ESTAR number : , IRMS number :, Central date : 2025-04-10 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number : US-009507513-2231763 More
2838196 ID 04/28/2025 HIBV
 MERCK & CO. INC.
 X022981
Product storage error Product storage error
PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from... PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-Mar-2025, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) Injection (0.5ML, lot #X022981, expiration date: 21-May-2026, strength unknown), administered by Intramuscular route for the treatment of Prophylaxis after a temperature excursion (Product storage error). Operator Of Device: Health Professional Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) experienced the temperature excursion below 54.19 Fahrenheit degrees (F) for 2 hours 45 minutes. No previous temperature excursions. No other information provided. No product quality complaints reported. More
2838197 ID 04/28/2025 HIBV
 MERCK & CO. INC.
 X022981
Product storage error Product storage error
Caller reported PEDVAX HIB was administered after a temperature excursion; This spontaneous report w... Caller reported PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-Mar-2025, the patient started therapy with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) Injection (0.5ML, lot #X022981, expiration date: 21-May-2026, strength unknown), administered by Intramuscular route for the treatment of Prophylaxis after a temperature excursion (Product storage error). Operator Of Device: Health Professional Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB) experienced the temperature excursion below 54.19 Fahrenheit degrees (F) for 2 hours 45 minutes. No previous temperature excursions. No other information provided. No product quality complaints reported. This is one of five reports from the same reporter. More
2838199 F AZ 04/28/2025 HPV4
HPV4
 MERCK & CO. INC.
MERCK & CO. INC.

Human papilloma virus test positive; Human papilloma virus test positive Human papilloma virus test positive; Human papilloma virus test positive
female patient was administered 2 doses of GARDASIL in her teens/ indicates that the patient *may* ... female patient was administered 2 doses of GARDASIL in her teens/ indicates that the patient *may* be vaccinated soon with a 3rd dose; Inbound transfer of an HCP calling. HCP reported that his 42 year old female patient was administered 2 doses of GARDASIL in her teens and has now tested positive for HPV. HCP refused to offer further information or to be contacted as he st; This spontaneous report was received from a physician and refers to a(n) 42-year-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 an unknown dates (when the patient was a teenager), the patient was vaccinated with the first and the second dose of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL), formulation: injection (lot #, expiration date, exact dose, route of administration and anatomical location were not provided) for HPV prevention. On an unknown exact day in April 2025 (estimated date, reported as: now), the patient experienced human papilloma virus test positive. It was indicated that the patient may be vaccinated soon with the third dose of vaccine (inappropriate schedule of vaccine administered). At the reporting time, the patient not recovered from the event human papilloma virus test positive. The causal relationship between the event of human papilloma virus test positive and Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL) was unknown/not reported/not provided. More
2838200 55 M NC 04/28/2025 PNC21
 MERCK & CO. INC.
 Unknown
Injected limb mobility decreased, Injection site erythema, Injection site pain, ... Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling More
developed very swollen, reddened area that is painful touch and limits his mobility in his left arm ... developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; developed very swollen, reddened area that is painful touch and limits his mobility in his left arm at the injection site; This spontaneous report was received from a nurse and referred to a 55-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-Apr-2025, the patient was vaccinated with a single dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot# 2002626 was invalid, expiration date reported as 04-Sep-2026; dose considered as 1 dosage form; strength was not reported) via intramuscular route as vaccination by a health professional. About 36-48 hours after receiving Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE), on an unknown date in April 2025, the patient developed very swollen, reddened area that was painful touch and limits his mobility in his left arm at the injection site. No other symptoms reported. The patient had sought medical attention. No treatment was provided at this time. No lab diagnostics/ studies were reported. Outcome of all events was not recovered. The causal relationship between Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) and all the events was not reported. More
2838201 F NY 04/28/2025 HPV9
 MERCK & CO. INC.
Chills, Malaise, Pyrexia Chills, Malaise, Pyrexia
not feeling well; fever; chills; This spontaneous report was received from an office manager and ref... not feeling well; fever; chills; This spontaneous report was received from an office manager and referred to a currently 21-year-old female patient. The patient's medical history included paracetamol (TYLENOL) allergy. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date, the patient was vaccinated with second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9) injection, administered by intramuscular route for vaccination (dose, strength, anatomical site, lot # and expiration date were not reported). On an unknown date (reported as following the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL9)), the patient experienced fever and chills. The patient was not given any treatment for the fever and chills and had resolved on an unknown date (reported as by the time that the patient had called the office to report the side effects). On an unknown date, the patient experienced not feeling well. The patient had been the 3rd dose in the series and was declined due to the patient not feeling well. The 3rd dose had been scheduled on 21-MAR-2025. The outcome of not feeling well was not reported. The action taken with the suspect vaccine was withdrawn. The causal relationship between all events and suspect vaccine was not reported. The reporter considered all events to be life-threatening. Lot # is being requested and will be submitted if received. More
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2838202 04/28/2025 PNC21
 MERCK & CO. INC.
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
They administered the product PCV-21/capvaxive to a baby.; Capvaxive, was being labeled as Prevnar ... They administered the product PCV-21/capvaxive to a baby.; Capvaxive, was being labeled as Prevnar 21.; This spontaneous report was received from a consumer or other non-health professional, via Pfizer and refers to an infant patient (reported as baby) of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (dose, dose number, frequency, vaccination scheme, anatomical location, route of administration, lot number, expiration date was not provided) as prophylaxis (product administered to patient of inappropriate age). Caller reported that Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was being labeled as Prevnar 21 (product label issue). More
2838203 1 AL 04/28/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 W029541
Expired product administered, No adverse event; Expired product administered, No... Expired product administered, No adverse event; Expired product administered, No adverse event More
no additional AE; HCP calling to report expired MMR-II administered on 03/17/25.; This spontaneous r... no additional AE; HCP calling to report expired MMR-II administered on 03/17/25.; This spontaneous report was received from a medical assistant on 24-Apr-2025 and refers to a 1-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 17-Mar-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #W029541, expiration date: 15-Sep-2024), administered for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date not provided) (Expired product administered). The patient was not symptomatic. Unsupported outcome was delivered. Confirmed no temperature excursion (TE). No other information. No additional adverse event (no adverse event). More
2838204 04/28/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
received Bexsero below the age of 10 years; This non-serious case was reported by a other health pro... received Bexsero below the age of 10 years; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis. On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: received Bexsero below the age of 10 years). 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: 17-APR-2025 The reporter stated that pediatric patients in large national health system received Bexsero that are below the age of 10 years which led to inappropriate age at vaccine administration. The reporter stated that this was off label use. The Health Care Professional estimated that over 30 patients in the previous year and some had received one dose and others have received more than one dose. As Per Health Care Professional, recommendations appear to be coming from Pediatric Infectious Disease providers or Pediatric Oncology providers. More
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