🏥 VAERS Vaccine Data Browser

🔒 Privacy & Data Disclaimer

About This Site

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

Data Source & Accuracy

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

Your Privacy

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

Medical Disclaimer

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

Data Interpretation

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

📖 Help & Search Guide

Column Icons Legend

💀 Death
🏥 Hospitalized
🚑 Emergency Room
♿ Disability
⚠️ Life Threatening

How to Search

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

Understanding the Data

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

Using the Table

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

💡 Frequently Asked Questions (FAQ)

What is this site?

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

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

What is VAERS?

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

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

Official VAERS website: vaers.hhs.gov

Is this data HIPAA compliant?

Yes, absolutely. All VAERS data displayed here is:

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

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

Why does this site exist?

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

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

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

Where does the data come from?

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

The data is:

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

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

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

Important context:

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

What to do:

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

Can I trust VAERS data?

VAERS is valuable but has limitations:

Strengths:

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

Limitations:

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

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

What are "adverse events"?

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

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

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

Why are some lot numbers listed multiple times?

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

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

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

How often is this data updated?

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

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

Where can I learn more?

⚠️ DISCLAIMER: This data is from the Vaccine Adverse Event Reporting System (VAERS). Reports do not establish causation between vaccines and adverse events. Anyone can submit a report, and reports are not verified. This is raw data for transparency and research purposes only.
34,052
Total Reports (2025)
500
Deaths Reported
1,634
Hospitalizations
30
ER Visits
1,191
Disabilities
570
Life Threatening
🔄 Reset 📥 Export CSV
ID Age Sex State Date ▼ Onset Days Vaccine Manufacturer Lot # Symptoms Narrative 💀 🏥 🚑 ♿ ⚠️
2839133 50 F IL 05/01/2025 PNC20
 PFIZER\WYETH
 LK6650
Erythema, Fatigue, Peripheral swelling, Skin warm Erythema, Fatigue, Peripheral swelling, Skin warm
redness, warmth, swelling over left arm; worsening over last 2d; fatigue redness, warmth, swelling over left arm; worsening over last 2d; fatigue
2839134 15 F OK 05/01/2025 HPV9
MNQ
 MERCK & CO. INC.
SANOFI PASTEUR
 Y013712
U8375AA
Fall, Headache, Seizure like phenomena, Staring, Tremor; Fall, Headache, Seizure... Fall, Headache, Seizure like phenomena, Staring, Tremor; Fall, Headache, Seizure like phenomena, Staring, Tremor More
Around 30 seconds after she got her HPV and Menquadfi vaccines (in that order) , she fell back on th... Around 30 seconds after she got her HPV and Menquadfi vaccines (in that order) , she fell back on the exam table and had a brief episode of general shakiness, seizure -like, had a blank look in her eyes. This spell was witnessed by her mother and the medical assistant who is the one that gave the vaccines. It lasted around 2-3 seconds as per both observants, after which she made eye contact and stated that her head hurt. At that time, I was called to the room, checked vitals at 4:17 pm (4/30/25), were stable. Observed her for around 20 min, in that process her vitals were checked again, they were still normal. She stated she felt fine, walked in the room. More
2839135 1.5 F NH 05/01/2025 HEPA
 GLAXOSMITHKLINE BIOLOGICALS
 T9TL9
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
Pt was given adult Hep A instead of Pedi Hep A Pt was given adult Hep A instead of Pedi Hep A
2839136 58 F IN 05/01/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 PG3RP
Ear pain, Pain in extremity, Pain in jaw Ear pain, Pain in extremity, Pain in jaw
I had my Tdap given by our associate health on 4/23/25. Next morning noted mild left side jaw pain a... I had my Tdap given by our associate health on 4/23/25. Next morning noted mild left side jaw pain and arm pain yet I thought this was all normal. I took Aleve which helped. The arm pain lessened yet left jaw pain has worsen and now hurting into my left ear. No teeth pain just the jaw. taking Aleve helps a bit yet opening mouth causes more pain to jaw. More
2839137 4 F MA 05/01/2025 DTAPIPV
 SANOFI PASTEUR
 U8209CB
Injection site erythema, Injection site induration, Injection site oedema, Injec... Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth More
Large area of edema to L shoulder at injection site extending to mid-arm , skin tense and hot w/over... Large area of edema to L shoulder at injection site extending to mid-arm , skin tense and hot w/overlying erythema extending from shoulder to elbow, but w/o fluctuance or induration. Pt treated with cephalexin to cover for cellulitis. More
2839138 62 M KS 05/01/2025 PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
 LY8609
LY8609
Arthralgia, Erythema, Fatigue, Myalgia, Pyrexia; Swelling Arthralgia, Erythema, Fatigue, Myalgia, Pyrexia; Swelling
FEVER, JOINT AND MUSCLE PAIN, FATIGUE, PAINFUL SWOLLEN RED AREA ON LEFT SIDE OF NECK THAT MIGRATES D... FEVER, JOINT AND MUSCLE PAIN, FATIGUE, PAINFUL SWOLLEN RED AREA ON LEFT SIDE OF NECK THAT MIGRATES DOWN TO LEFT CHEST MEASURING 6X8 INCHES. BEGAN TREATING SYMPTOMS WITH TYLENOL 1000MG BID - TID. BEGAN AUGMENTIN 875MG BID X 10DAYS, BEGAN ZYRTEC 10MG DAILY ON 04/30/2025. More
2839139 33 M NY 05/01/2025 HEPA
HEPA
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 Z27PB
Z27PB
Dizziness, Electrocardiogram normal, Hyperhidrosis, Nausea, Pallor; Photopsia, S... Dizziness, Electrocardiogram normal, Hyperhidrosis, Nausea, Pallor; Photopsia, Skin discolouration, Tinnitus, Visual impairment, Vomiting More
Pt reported dizziness about 7 min s/p injection. Had tolerated previous vaccination without difficul... Pt reported dizziness about 7 min s/p injection. Had tolerated previous vaccination without difficulty. Hadn't eaten breakfast, no other variables that were suspicious. Pt reported ringing in ears, nausea, vomited x1, darkened/starry vision, appeared pale with dusky lips and appeared diaphoretic. Responded to laying down, time. EKG WNL. Initially BP 60/37 HR 101, improved to WNL s/p laying down and eating snack. More
2839140 66 M TX 05/01/2025 PNC21
 MERCK & CO. INC.
 Y019158
Abdominal discomfort, Blood pressure increased, Feeling abnormal Abdominal discomfort, Blood pressure increased, Feeling abnormal
Patient says he felt sick to his stomach , and had elevated blood pressure for over an hour. He say... Patient says he felt sick to his stomach , and had elevated blood pressure for over an hour. He says he felt he was going to die. More
2839141 20 F OR 05/01/2025 COVID19
COVID19
 MODERNA
MODERNA
 3044069
3044069
Disorientation, Dizziness, Loss of consciousness, Pain in extremity, Pyrexia; Ur... Disorientation, Dizziness, Loss of consciousness, Pain in extremity, Pyrexia; Urticaria More
4/28/2025 at 0830 Moderna COVID-19 Spikevax administered to L deltoid. Later that same day L arm sor... 4/28/2025 at 0830 Moderna COVID-19 Spikevax administered to L deltoid. Later that same day L arm soreness developed with progression to fever in the evening. 4/29/2025 at 0500 woke feeling lightheaded, disoriented, blacking out with hives present on L wrist. At 0700 woke for work- hives present systemically. Presented to urgent care and was directed to the ED. Caregiver reports passing out at check-in. Admitted through ED for 1 night observation. More
✓ ✓
2839142 1.75 F TN 05/01/2025 DTPPVHBHPB
HEPA
HIBV
PNC20
 MSP VACCINE COMPANY
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 U7801AA
TF27T
X017446
HMM0312
Wrong product administered; Wrong product administered; Wrong product administer... Wrong product administered; Wrong product administered; Wrong product administered; Wrong product administered More
Administered Dtap Vaxelis(combination) instead of Dtap only. Also administered HIB, HepA, pneumococc... Administered Dtap Vaxelis(combination) instead of Dtap only. Also administered HIB, HepA, pneumococcal (prevnar 20) during visit. Failed to scan vaccine out before administering. More
2839143 1 M TX 05/01/2025 DTAP
HIBV
PNC20
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
PFIZER\WYETH
 223Y9
Y005248
LX4482
Erythema, Skin warm, Swelling; Erythema, Skin warm, Swelling; Erythema, Skin war... Erythema, Skin warm, Swelling; Erythema, Skin warm, Swelling; Erythema, Skin warm, Swelling More
Swelling, redness, warmth Swelling, redness, warmth
2839144 50 F CA 05/01/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS

Contusion, Heavy menstrual bleeding, Impaired work ability, Polymenorrhoea, Prur... Contusion, Heavy menstrual bleeding, Impaired work ability, Polymenorrhoea, Pruritus; Swelling, Urticaria More
I've had two reactions: within a day of getting the vaccine I got my period over a week early, ... I've had two reactions: within a day of getting the vaccine I got my period over a week early, and it as extremely heavy (filling tampons more than twice as fast as usual), and period lasted twice as long as normal. Second reaction a week and a half later (April 28) was full body hives that bruised, swelled, and itched terribly. I got hives anywhere something rubbed against my skin, requiring a trip to urgent care, a prescription medication, and I haven't been able to work for three days and counting. More
2839145 43 F VA 05/01/2025 HEPA
 MERCK & CO. INC.
 XO25482
Underdose Underdose
Patient given pediatric dose of Vaqta Hep A vaccine. Patient to return to practice 5/2/25 to receive... Patient given pediatric dose of Vaqta Hep A vaccine. Patient to return to practice 5/2/25 to receive remainder of adult dose. No reactions noted. More
2839146 72 F TX 05/01/2025 PNC20
 PFIZER\WYETH
 LX4482
Injection site warmth Injection site warmth
Patient called reporting quarter sized red warm spot where injection site occurred. Pharmacist couns... Patient called reporting quarter sized red warm spot where injection site occurred. Pharmacist counseled patient to monitor area and have doctor evaluate arm to determine reaction to vaccine or infection. Patient will call doctor today 5/1/2025 More
2839147 52 F WI 05/01/2025 PNC20
 PFIZER\WYETH
 LX4484
Injection site erythema, Injection site pruritus, Injection site swelling Injection site erythema, Injection site pruritus, Injection site swelling
Left upper arm injection from 4/21/25 when received the pneumococcal vaccine. Pt reports area swell... Left upper arm injection from 4/21/25 when received the pneumococcal vaccine. Pt reports area swelling, redness and occasional itching. Onset 4/28/25 Patient evaluated by provider on 5/30/25. There is a 5 x 7 area of mild erythema left deltoid region with mild centralized tenderness and no palpable abnormality, induration or fluctuance. No significant edema or increased warmth. Patient advised to observe for any other changes. More
2839148 50 F CT 05/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Mobility decreased, Pain in extremity Mobility decreased, Pain in extremity
painful arm and unable to lift arm after vaccine painful arm and unable to lift arm after vaccine
2839149 5 M MN 05/01/2025 DTAPIPV
DTAPIPV
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 7D2Y4*VFC
7D2Y4*VFC
Y013580*VFC
Y013580*VFC
Erythema, Full blood count normal, Injection site rash, Injection site scab, Pyr... Erythema, Full blood count normal, Injection site rash, Injection site scab, Pyrexia; Rash, Rash papular, Rhinorrhoea, Swelling face; Erythema, Full blood count normal, Injection site rash, Injection site scab, Pyrexia; Rash, Rash papular, Rhinorrhoea, Swelling face More
Parent reports onset of facial redness, rash and swelling around 1300 the day of vaccine. Progressiv... Parent reports onset of facial redness, rash and swelling around 1300 the day of vaccine. Progressive into the evening. Parent recorded fever of 101F at 8:00pm day of vaccines. Woke morning after, 5/1/25, with fever 103.8F and up to 105F, progressive facial rash, swelling, rash to right arm and abdomen. Parent provided with oral dose ibuprofen at home. Parent called clinic to make same day visit. Child presented to clinic 5/1/2025 at 8:20 am with red diffuse, fine papular facial rash with swelling. Fever 101.f, ibuprofen 1 hour prior at home. Tachycardic. Normotensive. Rash to right arm distal to injection site surrounding previously healing small scab/wound present prior to vaccines. Scattered streaky fine red papular rash to abdomen. No airway or acute circulatory compromise. Mild clear rhinorrhea on exam. Sent home with monitoring instructions, supportive cares with antipyrectics and cetirizine. More
2839150 42 F WA 05/01/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945659
Autoantibody negative Autoantibody negative
The patient had a negative titer drawn on 02/11/22. She was then given the Heplisav- 2 shot series w... The patient had a negative titer drawn on 02/11/22. She was then given the Heplisav- 2 shot series which was completed 05/09/22. She should have had another titer drawn a month after her last dose, however, she did not. Today the nurse interpreted the information that the patient had her series completed and the titer came back as negative. The nurse was going to repeat the Hep B (Heplisav) series and have a titer redrawn. After administering the first dose of the second inoculation series the nurse noticed that the first series was given after the negative titer. Therefore, the patient received a booster when all she needed was another titer drawn to determine immunity. More
2839151 72 F NY 05/01/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 58160-0842-52
Asthenia, Decreased appetite, Diarrhoea, Headache Asthenia, Decreased appetite, Diarrhoea, Headache
Severe diarrhea, started 15 hours after I got the vaccine. Very weak, no appetite. Was up about ... Severe diarrhea, started 15 hours after I got the vaccine. Very weak, no appetite. Was up about 25 times during the night to the bathroom. I?m forcing myself to eat. Dull headache. More
2839152 5 M NE 05/01/2025 DTAPIPV
DTAPIPV
DTAPIPV
MMRV
MMRV
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
MERCK & CO. INC.
 Y49BZ
Y49BZ
Y49BZ
Y015992
Y015992
Y015992
Blood thyroid stimulating hormone, Differential white blood cell count, Electroc... Blood thyroid stimulating hormone, Differential white blood cell count, Electrocardiogram normal, Electroencephalogram normal, Full blood count; Malaise, Metabolic function test, Musculoskeletal stiffness, Screaming, Somnolence; Thyroxine free, Unresponsive to stimuli; Blood thyroid stimulating hormone, Differential white blood cell count, Electrocardiogram normal, Electroencephalogram normal, Full blood count; Malaise, Metabolic function test, Musculoskeletal stiffness, Screaming, Somnolence; Thyroxine free, Unresponsive to stimuli More
On 3/4/25, he was not feeling well. Caretaker heard a scream, and found sitting on the toilet, stif... On 3/4/25, he was not feeling well. Caretaker heard a scream, and found sitting on the toilet, stiff. He seemed unresponsive for a few minutes, and then was groggy. He was seen in the ER, where an EKG showed sinus rhythm. CBC with diff, CMP, TSH on 3/5/25 did not reveal a cause. Video EEG on 3/6/25 did not show seizure activity. No further episodes happened after the one described. More
2839153 17 F SC 05/01/2025 MENB
MENB
MNQ
MNQ
 PFIZER\WYETH
PFIZER\WYETH
SANOFI PASTEUR
SANOFI PASTEUR
 LF5302
LF5302
U8375AA
U8375AA
Asthenia, Dehydration, Full blood count, Metabolic function test, Pain; Pregnanc... Asthenia, Dehydration, Full blood count, Metabolic function test, Pain; Pregnancy test, Urine analysis; Asthenia, Dehydration, Full blood count, Metabolic function test, Pain; Pregnancy test, Urine analysis More
Patient had severe body aches and weakness at the end of the day following vaccines. Patient was tak... Patient had severe body aches and weakness at the end of the day following vaccines. Patient was taken to the emergency room by her mother. In the emergency room patient was diagnosed with dehydration and body aches. Patient received toradol and 1 L NS. Patient's symptoms improved while in the ER and was discharged. More
2839154 62 M DE 05/01/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Headache, Myalgia Headache, Myalgia
Muscle Pains and Headache Muscle Pains and Headache
2839155 10 M WA 05/01/2025 HPV9
HPV9
 MERCK & CO. INC.
MERCK & CO. INC.
 Y012921
Y012921
Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness, N... Dizziness, Headache, Immediate post-injection reaction, Loss of consciousness, Nausea; Seizure More
Immediately after receiving the vaccination, patient felt lightheaded and needed to lie down. Shortl... Immediately after receiving the vaccination, patient felt lightheaded and needed to lie down. Shortly after lying down, the patient had a brief loss of consciousness with seizure activity. After about 30 seconds, patient regained consciousness and complained of headache and nausea. Clinic Triage nurses and patient Primary care provider were called in to assist patient. Patient mother agreed to take the patient to the local hospital ER for stabilization and further evaluation. More
2839156 36 F IN 05/01/2025 HPV9
 MERCK & CO. INC.
 Y017907
No adverse event, Product administered at inappropriate site No adverse event, Product administered at inappropriate site
Patient does not report any adverse reactions. Vaccine was given by one of my staff members in ventr... Patient does not report any adverse reactions. Vaccine was given by one of my staff members in ventrogluteal site, which is not a valid site. More
2839157 1.83 M IL 05/01/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 AK334
Product administered to patient of inappropriate age Product administered to patient of inappropriate age
gave boostrix instead of infanrix to 1 yr 10 month baby gave boostrix instead of infanrix to 1 yr 10 month baby
2839158 19 M CO 05/01/2025 COVID19
 MODERNA
Dysphagia, Dyspnoea, Flushing, Rash Dysphagia, Dyspnoea, Flushing, Rash
Pt reports he was getting COVID vaccine and started feeling "flushed, SOB, and difficulty swall... Pt reports he was getting COVID vaccine and started feeling "flushed, SOB, and difficulty swallowing". Upon arrival pt has mild rash to chest that he states is new. More
2839159 9 F OH 05/01/2025 DTAPHEPBIP
MMRV
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
 XP77N
Y014303
Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin wa... Erythema, Peripheral swelling, Skin warm; Erythema, Peripheral swelling, Skin warm More
GOT SHOTS LAST WEEK AND NOW SWOLLEN AND RED AND HOT TO TOUCH RIGHT ARM GOT SHOTS LAST WEEK AND NOW SWOLLEN AND RED AND HOT TO TOUCH RIGHT ARM
2839160 72 F FL 05/01/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 58160-0823-11
58160-0823-11
Arthralgia, Fatigue, Headache, Injection site pain, Injection site swelling; Mya... Arthralgia, Fatigue, Headache, Injection site pain, Injection site swelling; Myalgia More
Moderate Pain and swelling at injection site. Headache. Fatigue, Muscle and joint pain all over... Moderate Pain and swelling at injection site. Headache. Fatigue, Muscle and joint pain all over body. More
2839161 79 M FL 05/01/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 GX3T4
Pain in extremity Pain in extremity
PAIN IN THE ARM THAT HAS PERSISTED FOR 2 WEEKS. ADVISED BY PHYSICIAN TO TAKE OTC NSAIDS AND GIVE IT ... PAIN IN THE ARM THAT HAS PERSISTED FOR 2 WEEKS. ADVISED BY PHYSICIAN TO TAKE OTC NSAIDS AND GIVE IT MORE TIME More
2839162 17 F TX 05/01/2025 MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
 DD72H
Rash, Rash erythematous Rash, Rash erythematous
Quarter sized knot with itchy red rash that is not resolving within a weeks time after vaccination. ... Quarter sized knot with itchy red rash that is not resolving within a weeks time after vaccination. The area has increased in size since getting the vaccine and the rtash covers the upper part of her arm. More
2839163 1 M WA 05/01/2025 MMRV
 MERCK & CO. INC.
 Y018157
Wrong product administered Wrong product administered
Patient was supposed to receive a Varivax, but received Proquad instead. Patient was supposed to receive a Varivax, but received Proquad instead.
2839164 17 M OR 05/01/2025 COVID19
 MODERNA
 3043000
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Patient was given Moderna 6M-11yrs instead of Spikevax 12yrs and older. No adverse event symptoms. Patient was given Moderna 6M-11yrs instead of Spikevax 12yrs and older. No adverse event symptoms.
2839165 29 F NC 05/01/2025 HEP
 DYNAVAX TECHNOLOGIES CORPORATION
 945664
Arthralgia, Injection site pain, Injection site swelling, Pain Arthralgia, Injection site pain, Injection site swelling, Pain
Patient presented today for Heplisav-B #2 reporting that her right deltoid area/upper arm was swolle... Patient presented today for Heplisav-B #2 reporting that her right deltoid area/upper arm was swollen the next day and she had pain in her arm with movement radiating into her right shoulder for at least 4 days. She verbalized concern due to her autoimmune history, and she has a similar prior adverse reaction to the Moderna mRNA Covid-19 vaccine. More
2839166 23 F MI 05/01/2025 COVID19
 NOVAVAX
Injection site rash Injection site rash
Pt experinced a rash on injection site shortly after recieving vaccination Pt experinced a rash on injection site shortly after recieving vaccination
2839167 70 F NV 05/01/2025 COVID19
 UNKNOWN MANUFACTURER
Dizziness, Fatigue, Headache, Nausea Dizziness, Fatigue, Headache, Nausea
Like around 8 at night i just got really tired and i went to bed and started feeling a little dizzy ... Like around 8 at night i just got really tired and i went to bed and started feeling a little dizzy and nauseous. I got up and took some medication and it helped and i woke up and still had a little head ache. More
2839168 14 F AL 05/01/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 3L339
u8493aa
Injection site pain; Injection site pain Injection site pain; Injection site pain
right upper arm pain after immunizations. no warmth, swelling or redness. right upper arm pain after immunizations. no warmth, swelling or redness.
2839169 16 M AR 05/01/2025 HPV9
MENB
MNQ
 MERCK & CO. INC.
NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 Z002903
4M9N
U8256BA
Disturbance in attention, Lethargy, Vision blurred; Disturbance in attention, Le... Disturbance in attention, Lethargy, Vision blurred; Disturbance in attention, Lethargy, Vision blurred; Disturbance in attention, Lethargy, Vision blurred More
Blurry vision, lethargy and couldn't focus well for a few hours. Seen at physician office and m... Blurry vision, lethargy and couldn't focus well for a few hours. Seen at physician office and monitored with no further issues noted. More
2839170 SD 05/01/2025 PNC20
 PFIZER\WYETH
 LX4483
Device breakage Device breakage
it was broken, the neck of the vial snapped off; The initial case was missing the following minimum ... it was broken, the neck of the vial snapped off; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 23Apr2025, this case now contains all required information to be considered valid. This is a spontaneous report received from a Nurse from product quality group. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: LX4483, Expiration Date: 28Feb2026) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), outcome "unknown", described as "it was broken, the neck of the vial snapped off". Causality for "it was broken, the neck of the vial snapped off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction). Additional information: The nurse stated that she put the needle into vial and it snapped off it was not administered to the patient she used another one. Reporter stated it's 0.5 milliliters vial. NDC number is 0005200001. More
2839171 F RI 05/01/2025 COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
UNKNOWN MANUFACTURER
UNKNOWN MANUFACTURER



Ageusia, Anosmia, Blood glucose, Body height, COVID-19; Drug ineffective, Illnes... Ageusia, Anosmia, Blood glucose, Body height, COVID-19; Drug ineffective, Illness, Influenza, SARS-CoV-2 test; Ageusia, Anosmia, Blood glucose, Body height, COVID-19; Drug ineffective, Illness, Influenza, SARS-CoV-2 test More
got Covid; got Covid; lost taste and smell; lost taste and smell; I was so sick; I got a flu; This i... got Covid; got Covid; lost taste and smell; lost taste and smell; I was so sick; I got a flu; This is a spontaneous report received from a Consumer or other non HCP, Program ID:. An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single), as dose 2, single) and as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "brain injury" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: does not take medication, controls with food., Takes a lot of medication, 3 times a day, since blood pressure up., Takes blood pressure medicine 3 times a day,; "High cholesterol" (unspecified if ongoing), notes: does not take medication, controls with food., cholesterol, every night; "Pre diabetic" (unspecified if ongoing), notes: does not take medication, controls with food.; "stomach" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for abdominal discomfort; TYLENOL. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "got Covid"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "not recovered" and all described as "lost taste and smell"; ILLNESS (non-serious), outcome "unknown", described as "I was so sick"; INFLUENZA (non-serious), outcome "unknown", described as "I got a flu". The events "got covid" and "i was so sick" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood glucose: 6.1, notes: was 6.6, corrected with food, not taking any medication for that; 6.6; Body height: shrinking now, notes: Height: Is short, 5, 2, is shrinking now; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19, illness. Clinical course: uring an inbound call for financial assistance, the caller explained that she went to the emergency room yesterday and tested positive for COVID. She was prescribed Paxlovid, but when she went to the pharmacy to get the medication, she was told it costly which almost made her pass out. She was really sick and didn't know what to do. She mentioned that she had COVID twice after receiving all her vaccines years ago. When asked for her birthdate, she said it was tomorrow, if she made it. She confirmed that she had COVID twice in the past after receiving all her vaccines, including boosters. She got COVID twice, one year and then another year, and then she got the flu after that. Now she has COVID again, many years since COVID started, and she lost her taste and smell, which she never regained. Her doctor doesn't know what to do because some people regained their smell, but she never did, and now she has COVID again. She doesn't know why she goes to church every day and visits the market once in a while, that's her life. She has a very simple life, but she's old, and her husband passed away, so she doesn't even know if she got COVID during Easter in the church. She was so sick that she went to the emergency room yesterday. She explained that she has other insurance because she had a lot of problems from the past due to a brain injury, and she got some insurance, otherwise she wouldn't be able to live. After the income verification recording was played, she said she went to the ER yesterday and has the paperwork from them. She went to the emergency clinic. She clarified that she went to the emergency room as an outpatient if the name was needed. When asked if that was where the pharmacy was that had the medication, she responded that she went to and that's when the guy wanted to take a look at her lungs to see if she had pneumonia. She explained that she goes to Pharmacy and has used so many medications from Pfizer because her husband died with two cancers and had very expensive medications for chemo, and she has a brain injury. At the end of the call, she said she had to get this medication because she knew she took it before, and it takes care of the problem. When asked if she had taken Paxlovid before, she said yes, twice. During the warm transfer to DSU agent reference number HBK3WT6V, it was mentioned that the patient had COVID twice before and took Paxlovid both times. She stated that it's not the best, but it works. The full event, including the current COVID after Paxlovid, is being reported. No manufacturer for the vaccine or booster was obtained during this call. After vaccines was very sick, after first one, was really sick, all the side effects, was bad. Second and third then, booster, after booster, lost taste and smell. Unfortunately, never got it back. Clarified, caller got Covid, 2022, 2021, after vaccine booster, got Covid because someone in house had Covid, nobody knew. 2022, had again, took Paxlovid. Had Covid twice before, after all the vaccines and boosters: husband passed away 21, had Covid 2021 and 2022, and now, in 2025. No taste, no smell: Started after she took last 3, last booster from Pfizer .Covid started in 2019, those months of taking the shots. Unknown when she first took the Covid shots. When she started it, had to wait month, take it again. outcome of event: Never got it back, mouth has not taste at all. If she was given poison, would not know it, would have to eat it, that is scary. If given poison, would not know the difference. Clarified, caller had taken Paxlovid twice. When clarifying number of Covid vaccines caller had, including booster, she states, 3 or 4, does not know if she took fifth one. Mouth was so bad tasting with that medicine, the Paxlovid. The taste in her mouth, stomach so mad at her had, to take probiotics. Has acid reflux, had to take antibiotic for that. Had to take with a lot of water. Does not make saliva, has Sjogren's disease. Clarified, she took Paxlovid 2 times. Concomitant Products/Medical Conditions: Takes same medications for almost over 20 years. Has high blood pressure, high cholesterol, pre diabetic, does not take medication, controls with food. Takes a lot of medication, 3 times a day, since blood pressure up. Not name brand but, takes Omeprazole, for stomach. Takes blood pressure medicine 3 times a day, cholesterol, every night. Takes Tylenol every day, twice a day. That has never changed. More
2839172 M MO 05/01/2025 COVID19
 PFIZER\BIONTECH
 LH5978
COVID-19, Drug ineffective COVID-19, Drug ineffective
had COVID four times and he took the vaccine (Pfizer Covid-19 Vaccine); had COVID four times and he ... had COVID four times and he took the vaccine (Pfizer Covid-19 Vaccine); had COVID four times and he took the vaccine (Pfizer Covid-19 Vaccine); This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 65-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknon, single (Lot number: LH5978) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had COVID four times and he took the vaccine (Pfizer Covid-19 Vaccine)". Clinical courses: The reporter's oldest brother had it three or four times. He took Pfizer (Pfizer COVID-19 Vaccine). He has had COVID four times and he took the vaccine. He took it and he has had it multiple times and got very sick with COVID. More
2839173 41 M VA 05/01/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
 FA6780
FA6780
Asthenia, Brain fog, Confusional state, Dyspnoea, Fatigue; Feeling cold, Respira... Asthenia, Brain fog, Confusional state, Dyspnoea, Fatigue; Feeling cold, Respiratory disorder More
Prolonged Fatigue/easily exhausted; Feeling cold all the time; Low Energy level; breathing issues; f... Prolonged Fatigue/easily exhausted; Feeling cold all the time; Low Energy level; breathing issues; feeling out of breath; confusion; brain fog; This is a spontaneous report received from a Consumer or other non HCP. A 41-year-old male patient received BNT162b2 (BNT162B2), on 16Jul2021 at 01:00 as dose 2, single (Lot number: FA6780) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (lot number: EW0217, dose 1, vaccine location: Left arm), administration date: 07Jun2021, when the patient was 41-year-old, for Covid-19 Immunization. The following information was reported: FEELING COLD (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Feeling cold all the time"; ASTHENIA (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Low Energy level"; FATIGUE (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "Prolonged Fatigue/easily exhausted"; BRAIN FOG (disability, life threatening) with onset 30Jul2021, outcome "not recovered"; RESPIRATORY DISORDER (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "breathing issues"; CONFUSIONAL STATE (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "confusion"; DYSPNOEA (disability, life threatening) with onset 30Jul2021, outcome "not recovered", described as "feeling out of breath". Therapeutic measures were taken as a result of fatigue, feeling cold, asthenia, respiratory disorder, dyspnoea, confusional state, brain fog. More
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2839174 F 05/01/2025 COVID19
 PFIZER\BIONTECH
Thrombosis Thrombosis
I had blood clots right away years ago; This is a spontaneous report received from a Consumer or oth... I had blood clots right away years ago; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A female patient received BNT162b2 (COMIRNATY), in 2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2024, outcome "unknown", described as "I had blood clots right away years ago". The patient took covid 19 one shot in 2 different prisons. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2839175 M 05/01/2025 COVID19
 PFIZER\BIONTECH
Myocardial infarction Myocardial infarction
had a heart attack in prison; This is a spontaneous report received from a Consumer or other non HCP... had a heart attack in prison; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "had a heart attack in prison". The patient took covid 19 one shot in 2 different prisons. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received. More
2839176 F 05/01/2025 COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH




Blood culture, Blood test, Body temperature, C-reactive protein, COVID-19; Coagu... Blood culture, Blood test, Body temperature, C-reactive protein, COVID-19; Coagulation test, Computerised tomogram, Culture stool, Echocardiogram, Investigation; Laboratory test, Lymphocyte count, Magnetic resonance imaging, Mesenteric lymphadenitis, Monocyte count; Neurological examination, Neutrophil count, Ophthalmic scan, Physical examination, SARS-CoV-2 antibody test; Ultrasound abdomen, White blood cell count More
Aden mesenteritis; This is a literature report for the following literature source(s). Coronavirus ... Aden mesenteritis; This is a literature report for the following literature source(s). Coronavirus disease 2019 (Covid-19) caused by the severe acute respiratory syndrome coronavirus-2 (SARS-Cov-2) is considered a global public health crisis in 2020, generating significant morbidity and mortality worldwide. To date, the vaccination of the global population, seems to be the only effective strategy to achieve the 'herd immunity' and consequently prevent the virus circulation. This requires the entire population to be vaccinated, including children and adolescent, in addition, since the antibody response to SARS-Cov-2 has been shown to wane in both adults and children, more booster doses are needed. Vaccinating children and adolescents is a very debated topic, both because there are contrasting opinions about their role in spread of SARS Cov-2 and also because, since covid-19 in children has a mild or asymptomatic course in most cases, it is important to carefully assess the risk and benefit of vaccination in this age group. The pediatric vaccination could have many advantages, not only in terms of reducing viral transmission and preventing the disease, especially in the elderly or high risk individuals, but also by contributing, associated with the implementation of preventive measures in children to migrating the downstream effects of pandemic, such as social isolation and interruption of education and also to protect from two long term consequences of SARS-COV-2 infection in children (multisystem inflammatory syndrome associated with coronavirus disease 2019-MIS-C and long covid syndrome). Therefore, to justify childhood vaccination, it is necessary for the scientific community to report all possible adverse events related to the vaccine. This could improve community knowledge about vaccination in children, debunk numerous fake news reports and increase the complications and consent of caregivers to vaccination. In the context we report a possible rare complications post SARS-Cov-2 vaccine aden mesenteritis occurred in a 13-year-old girl after the first dose of BNT162B2. Authors describe a case of a 13-year-old girl who presented to the emergency department with a five day fever (maximum temperature 39.5 degree C). Th mother reported that the girl had received the first dose of SARS-Cov-2 vaccine (BNT162B2) less than twelve hours before the onset date of fever. The fever was associated with a headache that was slightly responsive to anti-inflammatory drugs, abdominal pain, one episodes of vomiting per day and two episodes of diarrhea per day. On the advice of the family pediatrician, the child has started antibiotic therapy with amoxicillin + clavulanic acid with little benefit. The mother denied possible contact with positive cases of SARS-Cov-2 or recent travel. After collecting the patient's medical history, the history was remarkable of recurrent headache symptoms. The remaining family and pathogenically history included no other noteworthy items except the dept of the paternal grandfather from Covid-19 in the previous year. Physical examination on admission was unremarkable, except for a temperature of 38 degree C, hyperemia of the pharynx and slight tenderness on palpation of the abdomen, the child's antigenic and molecular swabs for SARS-CoV-2 were negative. Given the persistent symptoms not associated with a significant clinical finding and the possible link with vaccine administration, the patient was admitted and focused assessment of febrile symptoms, headache and gastrointestinal symptoms was performed. Differential Diagnosis: Investigations and treatment: On admission, the patient performed blood examinations that showed an increase in systemic inflammation index (C-reactive protein-CRP 5.21 mg/dl, cutoff of normality greater than 0.5mg/dl) and a slight increase in white blood cells (10.45x10 3/ul) with an increases in the neutrophil quota (neutrophils 84.5%-8.83x 10 3/ul, lymphocytes 10 %-0.54x 10 3/uL, monocytes 10.1%-1.06x10 3/uL). The examination of blood biochemistry and the study of coagulation indices was within the normal range. Additionally, the patient performed the following instrumental examinations: a CT encephalic scan for persistent headaches that was non-responsive to medication, which was negative, a color doppler echocardiography with normal results, and an abdominal ultrasound, which revealed the presence of enlarge lymph nodes and mesenteric inflammation, consistent with a diagnosis of aden mesenteritis. Thus, the patient started fluid the therapy with saline (0.9%) solution at 50 mL/h and an antibiotic therapy with ceftriaxone ev 2g single daily administration. During hospitalization, the patient also performed the following tests: serology for covid-19, which confirmed positively for Covid-19 IgG (32.77 AU/mL, cutoff of normality less than 10) and covid-19 IgM negative (0.92 AU/mL), a stool culture test that was negative for bacteria, parasites, adenovirus and rotavirus (the search for SARS-Cov-2 in stool was not possible in our laboratory), blood cultures that were negative for anaerobic microorganism. Furthermore, to investigate the girl's persistent headache, we performed an ophthalmic counselling with and examination of the fundus oculi that showed a normal result, and a neurological counselling, who recommended a nuclear magnetic resonance (MRI) of the brain district in the election. The patient performed MRI examination with a diagnosis of non-specific gliosis. Outcome and Follow-up: During the hospital stay, the patient's clinical condition improved, with the last fever peck on the second day of admission an normalized of abnormal symptoms in 3 days. Laboratory test shown normalization of the leucocyte count and the return of inflammatory indices to the normal cutoff at discharge. Abdominal ultrasound showed a reduction mesenteric inflammation and lymph node involvement compared to the first examination. Finally, the patient was discharged in good general condition with an indication of ultrasound and neurological follow-up and the administration of probiotics at home for 10 days. Discussion: Only one year after the outbreak of the pandemic, the collective scientific effort has allowed for the release of effective vaccine against SAR-CoV-2. Different vaccines were authorized for use in adult people, while at pediatric age, RNA-based vaccines are among the most advance candidates. Two vaccines, BNT162B2 (Pfizer-Biontech) and mRNA-1273 (Moderna), have completed experimental, demonstrating safe and effective profiles in children. On 07Dec2021, the authorization of BNT162B2 vaccine was expanded to include children from 5 to 11 years of age. These mRNA vaccines contain nucleoside-modified messenger RNA encoding Spike-protein S, containing the receptor-binding domain that allows for host entry. Few date are available on possible adverse effects of the vaccine in children and adolescents, the current evidence shows that, in children 12-15 years old, local and systemic adverse effects after BNT162B2 vaccines are relatively common, particular after the second dose, most are mild severity and are limited to the first two days after vaccination. The most commonly reported effects are injection site reactions, mainly pain (86% after the first dose, 79% after second dose), swelling and induration of the site (7% after the first dose and 5% after the second dose), redness (6% after first dose and 5% after second dose). Systemic adverse effects are rarer and involve: fatigue (1 degree dose 60%, 2 degree dose 66%), headache (1 degree dose 55%, 2 degree 65%), shiver (1 degree 28%, 2 degree 42%), myalgia (1 degree 24%, 2 degree dose 32%), fever (1 degree 10%, 2 degree 20%), joint pain (1 degree 10%, 2 degree 16%), diarrhea (1 degree 8%, 2 degree dose 6%), and vomiting (1 degree dose 3%, 2 degree 3%). In addition, the mRNA-1273 vaccine showed a good safety and efficacy profile among adolescents. As with the BNT162B2 vaccine, the most common adverse reactions reported after first second injections were injections were injection-site pain (in- 93.1% and 92.4% respectively), headache (in 44.6% and 70.2% respectively) and fatigue (in 47.9% and 67.8% respectively). Regarding the age group of 5-11 years, a Covid-19 vaccination regimen consisting of two 10 ug doses of BNT162B2 administered 21 days apart has proven to be safe, immunogenic and efficacious. In a recent expert consensus on Covid-19 vaccination in the pediatric age group of (withheld), the authors conclude that the common adverse reactions after vaccinations with codi-19 vaccines in children are similar to those after other vaccinations and includes ad include collateral effects, from mild to moderate, which resolved within 24 hour after vaccination. In an interesting meta analysis on the safety and efficacy of Covid-19 vaccine in children and adolescent, including 7 RCTS and 2 observations studies for a total 264674 patients (withheld) have shown that overall effectiveness of the covid-19 vaccine in children is 96.09% and is better than that in adult populations. The development or myocarditis or pericarditis after mRNA vaccines has been documented after vaccine, especially in young adsorbents. Some studies reported an incidence of 6.3-6.7 cases per 100000s vaccine doses in males aged 12-17 years, which increases to 15.1 cases per 100000s vaccine doses in males aged 16-19 years. However, of these patients, most recovered without sequelae and around 6% required intensive care admission. No thrombose and anaphylaxis events were seen in pediatric age, no deaths were reported post vaccine.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of Adenomesenteritis cannot be fully excluded, considering the temporal relationship. More epidemiologic data and cumulative safety reports collected post marketing use are needed to indicate if there exists a potential causal link between the vaccination and such occurrence The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. More
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2839177 F FL 05/01/2025 COVID19
 PFIZER\BIONTECH
COVID-19, Drug ineffective, SARS-CoV-2 test COVID-19, Drug ineffective, SARS-CoV-2 test
COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A... COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID. A 72-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Primary immunization series complete), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Apr2025, outcome "unknown" and all described as "COVID". Clinical course: The patient stated she received the "Pfizer shot and a lot of, like, boosters." The patient was getting ready to get the next boosters. On the morning of 28Apr2025, the patient had a sore throat, and it turned out that she had COVID. The patient also said that in the morning she went to urgent care, and she was tested. The patient said she tested positive for COVID and was prescribed nirmatrelvir; ritonavir (PAXLOVID). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2025) Positive. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received. More
2839185 0.5 M 05/01/2025 HIBV
 MERCK & CO. INC.
 Y003145
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given an extra dose of PedvaxHib at his 6 month well child check in error. He had receiv... Patient was given an extra dose of PedvaxHib at his 6 month well child check in error. He had received a dose at 2 months and again at 4 months and should not have received another dose at 6 months. There was no adverse reaction. Submitting this report because extra vaccine given. More
2839186 0.5 F 05/01/2025 HIBV
 MERCK & CO. INC.
 Y003144
Extra dose administered, No adverse event Extra dose administered, No adverse event
Patient was given an extra dose of PedvaxHib at his 6 month well child check in error. He had receiv... Patient was given an extra dose of PedvaxHib at his 6 month well child check in error. He had received a dose at 2 months and again at 4 months and should not have received another dose at 6 months. There was no adverse reaction. Submitting this report because extra vaccine given. More
2839191 17 F CA 05/01/2025 MENB
MENB
MENB
MENB
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
 ZH7SN
ZH7SN
ZH7SN
ZH7SN
Blood magnesium normal, Blood phosphorus, Blood thyroid stimulating hormone norm... Blood magnesium normal, Blood phosphorus, Blood thyroid stimulating hormone normal, Differential white blood cell count normal, Dizziness; Feeling of body temperature change, Full blood count normal, Headache, Injection site pain, Loss of consciousness; Metabolic function test normal, Migraine, Pregnancy test urine negative, Rash, Rash pruritic; Urine analysis normal, Vision blurred More
Patient states that 2-3 hours after receiving her second dose of MenB vaccine, she felt dizzy with b... Patient states that 2-3 hours after receiving her second dose of MenB vaccine, she felt dizzy with blurred vision, hot and cold changes and itchy rash over her shoulder blade and upper chest; she sought care at ED on same day and was given diphenhydramine and ondansetron and discharged to home after overnight stay in ED. Later in the afternoon on 4/25, patient lost consciousness and was taken to ED--given 1 liter of IV fluids and migraine cocktail and discharged to home. Seen in PCP office on 5/01/2025 and reports persistent migraine headache pains and tenderness to palpation at site of injection More
2839192 78 M WY 05/01/2025 COVID19
VARZOS
 MODERNA
GLAXOSMITHKLINE BIOLOGICALS
 3043836
74NC9
Atrial fibrillation; Atrial fibrillation Atrial fibrillation; Atrial fibrillation
Pt described a episode of Atrial fibrillation, first since S/P Cardiac ablation. Pt sought medical ... Pt described a episode of Atrial fibrillation, first since S/P Cardiac ablation. Pt sought medical treatment and rhythm controlled by Flecainide. More
2839193 75 F 05/01/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 93kk4
93kk4
Back pain, Headache, Mobility decreased, Nausea, Neck pain; Pain, Pain in extrem... Back pain, Headache, Mobility decreased, Nausea, Neck pain; Pain, Pain in extremity, Pelvic pain More
The patient had headache, nausea, body pain, hip pain and neck pain. The following day she had pelvi... The patient had headache, nausea, body pain, hip pain and neck pain. The following day she had pelvic pain, back pain and was bedridden. The back pain is still ongoing and all other symptoms have resolved. The doctor she is now seeing thinks the back pain with sciatica is unrelated to the vaccine. More
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