🏥 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 💀 🏥 🚑 ♿ ⚠️
2853607 11 M GA 08/11/2025 HPV9
MNQ
TDAP
 MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 Y012508
U8558BA /
LX494
Lethargy, Loss of personal independence in daily activities, Pallor; Lethargy, L... Lethargy, Loss of personal independence in daily activities, Pallor; Lethargy, Loss of personal independence in daily activities, Pallor; Lethargy, Loss of personal independence in daily activities, Pallor More
Patient became pale and lethargic after last vaccine was given. Patient feet was then propped up in ... Patient became pale and lethargic after last vaccine was given. Patient feet was then propped up in chair. Cold paper towel placed around patients neck and face. 10:15am BP-83/49 P-68; Patient was given crackers and a coke. 10:20am BP-100/65 P-83. Patient feel better. No longer pale or lethargic. Advised mom via interpreter to wait in the lobby for an additional 15 mins for patient to be monitored. Mom voiced understanding. Advised mom if patient was feeling okay after the additional 15 mins that they could leave. Mom states that she was not going to let child go to school that she was going to keep him home to watch him closely. School excuse given. More
2853608 57 F GA 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 NR4T5
Dizziness, Headache Dizziness, Headache
Received her Shingrix vaccine on Thursday August 7th around 12:30pm, and started feeling dizzy when ... Received her Shingrix vaccine on Thursday August 7th around 12:30pm, and started feeling dizzy when she got home around 15:45pm. She also experienced a slight head that lasted an 1hr 30 minutes. Headache resolved after taking two tablets of Tylenol 500mg and going to bed. She is still feeling dizzy today 08/11/2025, does not have a headache. More
2853609 53 F MI 08/11/2025 HEP
 GLAXOSMITHKLINE BIOLOGICALS
 N733B
Expired product administered Expired product administered
Patient was given a Hep B vaccine that should've been given or discarded by the end of the work... Patient was given a Hep B vaccine that should've been given or discarded by the end of the work day 8/7/2025. More
2853610 61 F AZ 08/11/2025 PNC21
 MERCK & CO. INC.
 z003579
Chills, Fatigue, Full blood count normal, Pain, Pyrexia Chills, Fatigue, Full blood count normal, Pain, Pyrexia
"I began having chills that I couldn't control, severe body aches and very tired and fatig... "I began having chills that I couldn't control, severe body aches and very tired and fatigue including fever. Theses symptoms last 5 days." More
2853611 42 F OH 08/11/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Coagulation factor VIII level increased, Fatigue, Hypersomnia, Immune thrombocyt... Coagulation factor VIII level increased, Fatigue, Hypersomnia, Immune thrombocytopenia, Mobility decreased; Coagulation factor VIII level increased, Fatigue, Hypersomnia, Immune thrombocytopenia, Mobility decreased; Coagulation factor VIII level increased, Fatigue, Hypersomnia, Immune thrombocytopenia, Mobility decreased More
in 2018 I resulted positive for ANA, dsDNA and being treatment for the possibility of Lupus (SLE). I... in 2018 I resulted positive for ANA, dsDNA and being treatment for the possibility of Lupus (SLE). I received the COVID vaccine as a result of my medical conditions including that of asthma. However, after the second/third dose of the vaccination my autoimmune issues seemed to begin to worsen, and it has only been until now that I have been able to place to two together. After, I received the second/third dose of the vaccine I was unable to sit upright, I was extremely tired and slept for approximately two days and was unable to move from the bed. Ever since, it seems that my autoimmune issues have become more profound and recently I discovered I have a high Factor VIII/autoimmune thrombocytopenia. More
✓
2853612 14 M MO 08/11/2025 MNQ
MNQ
TDAP
TDAP
 NOVARTIS VACCINES AND DIAGNOSTICS
NOVARTIS VACCINES AND DIAGNOSTICS
GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
 DL4YY
DL4YY
95P4M
95P4M
Blood glucose, Electrocardiogram, Eye movement disorder, Hyperhidrosis, Loss of ... Blood glucose, Electrocardiogram, Eye movement disorder, Hyperhidrosis, Loss of consciousness; Muscle contracture, Pallor, Posture abnormal, Tremor; Blood glucose, Electrocardiogram, Eye movement disorder, Hyperhidrosis, Loss of consciousness; Muscle contracture, Pallor, Posture abnormal, Tremor More
Approximately 10 minutes after both vaccines were administers, observed patient have a possible sei... Approximately 10 minutes after both vaccines were administers, observed patient have a possible seizure, head was back, eyes rolled to top, bilateral upper extremities contracted up, with visible tremors; this event lasted 15 to 30 seconds; had office staff call 911; patient regained consciousness: was A&O x4, person, place, time and situation. VS: 110/70 manual; LA sitting, AP 64, RR 16;PEERLA intact. Patient was pale, diaphoretic; did regain color. EMS arrived, took VS, EKG, BS; patient father declined medical transport, father stated he would transport to ED. More
2853613 59 M PA 08/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
JANSSEN
 205A21A
205A21A
205A21A
205A21A
205A21A
205A21A
Arthritis infective, Bacterial infection, Bone atrophy, Carpal tunnel syndrome, ... Arthritis infective, Bacterial infection, Bone atrophy, Carpal tunnel syndrome, Computerised tomogram; Coordination abnormal, Dyspnoea, Electrocardiogram, Laboratory test, Magnetic resonance imaging; Mobility decreased, Muscle atrophy, Muscle injury, Muscular weakness, Musculoskeletal stiffness; Nerve injury, Pain, Protein total increased, Respiratory disorder, Retinal detachment; Rotator cuff repair, Scan brain, Trigger finger, Viral infection, Weight decreased; X-ray More
pt states a couple of months after being vaccinated, he developed respiratory problems from a viral ... pt states a couple of months after being vaccinated, he developed respiratory problems from a viral infection. He continued working but he had problems breathing. He became stiff, sore and lost weight rapidly. It was very difficult to get out of a bath tub. He was told he had permanent nerve damage. He had weakness in his hands but much worse in the left hand. He developed trigger finger in both hands. He was barely ambulatory. He had shoulder surgery with Dr. on his left rotator cuff and then developed infection in the shoulder and carpal tunnel in both hands. Bacteria ate away at his muscle and bones. He was referred to Neurologist. His rheumatologist at hospital thought he had ALS. His protein was high and wanted to start him on prednisone. He ended up taking meloxicam for a month but didn't like the side effects. He also had a detached retina. The viral infection has since improved. ALS and rheumatoid arthritis was ruled out. His hands no longer have the coordination that he used to have. His legs are still weak but are better and has permanent muscle damage in his arms and hands. He continues treatment under his PCP. More
✓ ✓ ✓
2853614 17 F VA 08/11/2025 MMR
MMR
 MERCK & CO. INC.
MERCK & CO. INC.
 Z008500
Y013130
Extra dose administered; Extra dose administered Extra dose administered; Extra dose administered
Patient was given two MMR vaccines instead of one dose. Patient was given two MMR vaccines instead of one dose.
2853615 61 M FL 08/11/2025 COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
PFIZER\BIONTECH
 EW0185
EW0185
EW0185
EW0185
EW0187
EW0187
EW0187
EW0187
Antiphospholipid syndrome, Beta-2 glycoprotein antibody positive, Blood test abn... Antiphospholipid syndrome, Beta-2 glycoprotein antibody positive, Blood test abnormal, Cardiac monitoring normal, Cardiolipin antibody positive; Cerebellar stroke, Diplopia, Dizziness, Echocardiogram, Magnetic resonance imaging head abnormal; Nausea, Scan with contrast normal, Ultrasound Doppler, Ultrasound head, Ultrasound scan normal; Vertigo; Antiphospholipid syndrome, Beta-2 glycoprotein antibody positive, Blood test abnormal, Cardiac monitoring normal, Cardiolipin antibody positive; Cerebellar stroke, Diplopia, Dizziness, Echocardiogram, Magnetic resonance imaging head abnormal; Nausea, Scan with contrast normal, Ultrasound Doppler, Ultrasound head, Ultrasound scan normal; Vertigo More
I am an active 65 year old man. I bike 300 miles per month. On Saturday, February 1, 2025, while a... I am an active 65 year old man. I bike 300 miles per month. On Saturday, February 1, 2025, while at dinner I started suffering from extreme vertigo. I felt sick to my stomach. The room was spinning. I was nauseous. I was at a restaurant with my wife at the time. After about 15 minutes, it dissipated. I went home and fell asleep for about 2 hours from about 5PM to 7PM that evening. 2 days later on Sunday morning, February 3, I went for my bike ride. After about 15 miles I had to stop at a traffic light and once again vertigo symptoms came upon me. Once again, they dissipated about 15 minutes later. My wife picked me up and I went home and slept for an approximate 2 hour time frame from 10-12 AM or so. I visited my internist on Monday, Februrary, 3 and he checked me out. We discussed possible treatment for vertigo. But, he also asked me to get a brain MRI (just in case), which I was able to schedule for Wednesday, February 5. The result of that MRI showed that I had multiple cerebellum strokes in the last 48 hours or so and I was immediately taken to the ER. In the ER and hospital my heart was checked with both a heart ultrasound and an esophogeal ultrasound. Those tests both were negative. My arteries in my neck and the back of my head were also checked through an ultrasound with dye. Those tests showed my arteries were clear. I was released from the hospital about 48 hours after admittance. I was a little dizzy (from the cerebellar strokes) and had signs of mild double vision. The acting cardiologist fitted me with a heart monitor for 30 days to check for AFIB but the test showed that I did not have AFIB. I visited my opthamologist re the double vision. She indicated that double vision was common for stroke victims and if it is minor then surgery would not need to be performed. She remarked that the quality of my eyes were outstanding and not consistent with someone who had just had multiple strokes. She thought over time the double vision would disappear. As of today I still have permanent double vision. I also have APS which requires me to be on blood thinners for the rest of my life (5 mg daily). I am also required to take aspirin every day (81 mg). And, I worry about a possible future stroke and so does my wife of 45 years. More
✓ ✓ ✓
2853616 56 M GA 08/11/2025 PNC21
PNC21
 MERCK & CO. INC.
MERCK & CO. INC.

Injection site pain, Lethargy, Oropharyngeal pain, Pain, Pyrexia; Syncope Injection site pain, Lethargy, Oropharyngeal pain, Pain, Pyrexia; Syncope
Fever, body aches, fainting, lethargy, painful injection site. Injection site hurts 4 days later. ... Fever, body aches, fainting, lethargy, painful injection site. Injection site hurts 4 days later. Sore throat started on 4th day after. More
2853617 0.5 F NV 08/11/2025 RV1
 GLAXOSMITHKLINE BIOLOGICALS
 5N2AN
No adverse event, Product administered to patient of inappropriate age No adverse event, Product administered to patient of inappropriate age
Rotarix vaccine (dose #1) was given to a 6-month-old infant. Maximum age to start the series was 3 m... Rotarix vaccine (dose #1) was given to a 6-month-old infant. Maximum age to start the series was 3 months and 2 weeks on 7/3/25. Pt was seen back in IZ Clinic on 8/5/25. Pt is fine as per mother via interpreter. Pt was in no apparent distress. Medication timing error was explained to the mother. She verbalized her understanding via interpreter. She opted for the pt to receive the 2nd dose of Rotarix. Timing of the 1st dose should not affect the efficacy of the remaining Rotarix dose per IZ.Org. More
2853619 18 M IN 08/11/2025 MENB
MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
SANOFI PASTEUR
 TH9NR
u8361aa
Extra dose administered, Wrong product administered; Extra dose administered, Wr... Extra dose administered, Wrong product administered; Extra dose administered, Wrong product administered More
Patient received MenACWY instead of MenB. Patient had 2 previous doses of MenACWY on 5/25/2018 and 7... Patient received MenACWY instead of MenB. Patient had 2 previous doses of MenACWY on 5/25/2018 and 7/28/2023. Previous Bexsero vaccine 1/26/2025. More
2853620 4 F NY 08/11/2025 DTAPIPV
DTAPIPV
 SANOFI PASTEUR
SANOFI PASTEUR
 C5248AA
C5248AA
Blood pressure decreased, Cold sweat, Hyperventilation, Injection site swelling,... Blood pressure decreased, Cold sweat, Hyperventilation, Injection site swelling, Injection site urticaria; Oxygen saturation decreased More
Prior to vaccination Pt BP + PWNL. About 5-7 min after injection, hives and swelling observed near... Prior to vaccination Pt BP + PWNL. About 5-7 min after injection, hives and swelling observed near injection site. Skin appeared/felt clammy. Pt began to hyperventilate. BP increased, O decreased. Ambulated and provided oxygen More
2853621 67 F NY 08/11/2025 COVID19
COVID19
 PFIZER\BIONTECH
PFIZER\BIONTECH

Bedridden, Blindness, Headache, Herpes zoster, Neuralgia; Rash, Scar, Weight dec... Bedridden, Blindness, Headache, Herpes zoster, Neuralgia; Rash, Scar, Weight decreased More
shingles including loss of eye sight, intense headache , weight loss, rash, scarring, bedridden for ... shingles including loss of eye sight, intense headache , weight loss, rash, scarring, bedridden for 4 months-2 months in the dark, headaches and nerve pain still ongoing today. More
2853622 1 M TX 08/11/2025 MMR
 MERCK & CO. INC.
Rash Rash
Descending papular rash that began on baby's cheeks on 8/8/25. Then on 8/9/25 and 8/10/25, rash... Descending papular rash that began on baby's cheeks on 8/8/25. Then on 8/9/25 and 8/10/25, rash descended to baby's upper and lower extremities bilaterally. Spared the torso. Rash has already began to resolve on the cheeks. More
2853623 38 F MI 08/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
Furuncle, Impaired work ability, Localised infection, Pain, Wound Furuncle, Impaired work ability, Localised infection, Pain, Wound
My arm swelled up like a boil and a week and a half later white spots showed up a day later the boil... My arm swelled up like a boil and a week and a half later white spots showed up a day later the boil burst i went to the emergency room 08/08/2025 theybsaid was infected gave mw anitibiotics i called off work 08/09/2025 due to pain and pus, now i have two holes in my shot, no one cleaned tge infection or packed at facility. Im still in pain and going back today 08/11/2025 More
2853624 1 M UT 08/11/2025 HEPA
MMR
VARCEL
 GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
MERCK & CO. INC.
 J4K4X
Y009782
Y015100
Rash; Rash; Rash Rash; Rash; Rash
Rash. Checked in clinic Rash. Checked in clinic
2853625 55 F NY 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 7523j
Lymphadenopathy, Peripheral swelling, Swelling Lymphadenopathy, Peripheral swelling, Swelling
patient stated that her arm and neck swelled as well as lymph node swelling patient stated that her arm and neck swelled as well as lymph node swelling
2853626 12 M TX 08/11/2025 DTAP
MNQ
 GLAXOSMITHKLINE BIOLOGICALS
SANOFI PASTEUR
 Uk330Aa
U8375AA
Wrong product administered; Wrong product administered Wrong product administered; Wrong product administered
Dtap series 6 was given instead of Tdap series 1 Dtap series 6 was given instead of Tdap series 1
2853627 5 F MI 08/11/2025 DTAPIPV
HEP
MMRV
 SANOFI PASTEUR
MERCK & CO. INC.
MERCK & CO. INC.
 U8209CB
x024135
y014438
Extra dose administered, No adverse event; Extra dose administered, No adverse e... Extra dose administered, No adverse event; Extra dose administered, No adverse event; Extra dose administered, No adverse event More
There was no adverse event. Every vaccine the patient received was an extra dose. Patient had a name... There was no adverse event. Every vaccine the patient received was an extra dose. Patient had a name change and it never got merged in database. The database under patient was pulled and showed no vaccines. Discussed the vaccines and lack of them with mother and it was decided to do the vaccinations. It was later discovered that patient was up to date on all vaccines so everything received was and extra dose. According to the CDC there is no harm to be concerned of for the extra dose. Family notified. More
2853628 48 F FL 08/11/2025 UNK
 UNKNOWN MANUFACTURER
 946063
Herpes zoster, Varicella virus test positive Herpes zoster, Varicella virus test positive
PATIENT STATE SHE RECEIVED VACCINE THEN IN 1 WEEK SHE DEVELOPED SHINGLES. SHINGLES RASH ON 2 SIDES O... PATIENT STATE SHE RECEIVED VACCINE THEN IN 1 WEEK SHE DEVELOPED SHINGLES. SHINGLES RASH ON 2 SIDES OF HER KNEE AND ALONG SHIN OF SAME LEG. TESTED WHILE AT URGENT CARE FOR SHINGLES, ANTIGEN TEST WAS POSITIVE, VALTREX PRESCRIBED. DERMOTOLOGIS SEEN AT A LATER DATE WITH CLOBETASOL AND MUPIROCIN PRESCRIBED More
2853629 F VA 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 EK225
Wrong product administered Wrong product administered
Inadvertent administration/ordered a dose of varicella and was inadvertently given shingrix; This no... Inadvertent administration/ordered a dose of varicella and was inadvertently given shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 26-year-old female patient who received Herpes zoster (Shingrix) (batch number EK225, expiry date 10-MAR-2027) for prophylaxis. Co-suspect products included Varicella zoster vaccine (Varicella vaccine) for prophylaxis. On 16-JUN-2025, the patient received the 1st dose of Shingrix. The patient did not receive Varicella vaccine. On 16-JUN-2025, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: Inadvertent administration/ordered a dose of varicella and was inadvertently given shingrix). The outcome of the wrong vaccine administered was not applicable. It was unknown if the reporter considered the wrong vaccine administered to be related to Varicella vaccine. It was unknown if the company considered the wrong vaccine administered to be related to Varicella vaccine. Additional Information: GSK Receipt Date: 14-JUL-2025 The patient was not immune to varicella hence ordered a dose of varicella and was inadvertently given Shingrix, which led wrong vaccine administered. She was supposed to get the varicella vaccine according to reporter. The reporter consented to follow up. More
2853630 30 M OK 08/11/2025 COVID19
COVID19
 MODERNA
MODERNA
 B0003
B0003
Asthenia, Dyspnoea, Hallucination, auditory, Mobility decreased, Palpitations; P... Asthenia, Dyspnoea, Hallucination, auditory, Mobility decreased, Palpitations; Psychotic disorder More
Client states he began to react within 30 minutes of administration. Heart started racing, SOB. Went... Client states he began to react within 30 minutes of administration. Heart started racing, SOB. Went to Hospital 2-3 times. States he spent weeks on the couch unable to get up off of it due to weakness and heart palpations. He also experienced psychosis/mental illness episodes of hearing voices. Client is now able to work and states he is pretty much back to normal. More
✓
2853631 18 M AL 08/11/2025 HEP
HEPA
HPV9
IPV
MMRV
MNQ
TDAP
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
MERCK & CO. INC.
SANOFI PASTEUR
MERCK & CO. INC.
SANOFI PASTEUR
GLAXOSMITHKLINE BIOLOGICALS
 4D333
A3X2K
Y012865
X1C891M
Y015990
U8369BA
3RE73
No adverse event, Product administered to patient of inappropriate age; No adver... No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age; No adverse event, Product administered to patient of inappropriate age More
Patient received Proquad -MMRV at 18 years of age, which is not within acceptable age range for this... Patient received Proquad -MMRV at 18 years of age, which is not within acceptable age range for this combined vaccine. No physical adverse reactions noted or reported. More
2853632 72 F AZ 08/11/2025 PNC20
PNC20
PNC20
 PFIZER\WYETH
PFIZER\WYETH
PFIZER\WYETH
 LX4482
LX4482
LX4482
Fatigue, Headache, Injection site erythema, Injection site rash, Injection site ... Fatigue, Headache, Injection site erythema, Injection site rash, Injection site warmth; Muscle spasms, Muscle tightness, Pain, Pain in extremity, Palpitations; Rash, Skin warm More
High on left arm injected red bump 2? diameter, within several hours arm ached, and rest of body ach... High on left arm injected red bump 2? diameter, within several hours arm ached, and rest of body ached, Tuesday and Wednesday night one thump in the middle of my chest lying down to go to sleep (8/5 and 8/6/2025) Next day rash on upper left back shoulder, and on upper left bicep. Rash warm to the touch. Wednesday rash expanded down my left arm to elbow - warm to touch. Slight headache, generally achey, fatigued. Lower back and outer thigh muscles getting tighter. Had a lower back spasm - taking methocarbimol, 500 mg acetaminophen 2/day, 600 mg ibuprofen 2/day. Hadn?t taken any medication or supplements 2 days prior to getting the prevnar 20 vaccine except for the rosavustatin. More
2853633 45 M LA 08/11/2025 HEPAB
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
2nd dose of Twinrix received late; This non-serious case was reported by a other health professional... 2nd dose of Twinrix received late; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 45-year-old male patient who received HAB (Twinrix) for prophylaxis. Previously administered products included Twinrix (received first dose of Twinrix on 19 Oct 2010 AHABB140AA). On 15-JUL-2025, the patient received the 2nd dose of Twinrix. On 15-JUL-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose of Twinrix received late). The outcome of the drug dose administration interval too long 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: 15-JUL-2025 The patient who received 1st Twinrix vaccine October 19, 2010 and was back on today July 15, 2025 for 2nd dose of Twinrix which might receive which led to Drug dose administration interval too long. They asked when they should have the patient come back for the 3rd dose of Twinrix. More
2853634 FL 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Product preparation issue Product preparation issue
Possible adjuvant administration only; Possible adjuvant administration only; This non-serious case ... Possible adjuvant administration only; Possible adjuvant administration only; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Possible adjuvant administration only) and inappropriate dose of vaccine administered (Verbatim: Possible adjuvant administration only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 15-JUL-2025 The customer asking if they could purchase Shingrix diluent, because they were short 2 diluents. They asked if this was related to the health care professional administering only the Shingrix adjuvant vial, and sales representative said that's what he/she was guessing. The patient had Possible adjuvant administration only which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. More
2853635 F NC 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMVB064A
Product preparation error Product preparation error
A 16-year-old female patient received the powder portion of Menveo reconstituted with normal saline ... A 16-year-old female patient received the powder portion of Menveo reconstituted with normal saline water.; A 16-year-old female patient received the powder portion of Menveo reconstituted with normal saline water.; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB064A, expiry date 31-DEC-2025) for prophylaxis. On 24-JUL-2025, the patient received Menveo. On 24-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: A 16-year-old female patient received the powder portion of Menveo reconstituted with normal saline water.) and inappropriate dose of vaccine administered (Verbatim: A 16-year-old female patient received the powder portion of Menveo reconstituted with normal saline water.). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 24-JUL-2025 Registered Nurse called to report that Menveo lyophilized component was reconstituted using normal saline water instead of the diluent provided, which led to wrong solution used in drug reconstitution and Inappropriate preparation of medication. The reporter wanted to ask if the patient needs to wait 28 days before giving a repeat dose or not. The reporter consented to follow up. More
2853636 11 F KS 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 AMAB064A
Product preparation error Product preparation error
Menveo vaccine reconstituted with non-approved diluent; Menveo vaccine reconstituted with non-approv... Menveo vaccine reconstituted with non-approved diluent; Menveo vaccine reconstituted with non-approved diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB064A, expiry date 31-DEC-2025) for prophylaxis. On 28-JUL-2025, the patient received Menveo. On 28-JUL-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo vaccine reconstituted with non-approved diluent) and inappropriate dose of vaccine administered (Verbatim: Menveo vaccine reconstituted with non-approved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 28-JUL-2025 Reporter requested data on re-vaccination of patient following administration of 2-vial Menveo vaccine reconstituted with non-approved diluent. Menveo reconstituted with non-approved diluent, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. More
2853637 F MD 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
Missed 2nd dose; This non-serious case was reported by a other health professional via call center r... Missed 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 12 months ago). The patient did not receive the 2nd dose of Shingrix. The patient had incomplete course of vaccination (Verbatim: Missed 2nd dose). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK receipt date:28-JUL-2025 It was reported that a patient missed the second dose of Shingrix. The inquiry was made to determine whether a patient can still receive the second dose of Shingrix after 12 months had elapsed since the administration of the first dose. Upon callback to store, spoke to pharmacy on duty who provided patient details. No lot or expiration date of dose 1 was available. Pharmacist states she thinks patient received it at another location. Date of administration of dose 1 also unknown. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. More
2853638 1 F IL 08/11/2025 TDAP
 GLAXOSMITHKLINE BIOLOGICALS
 DY3K7
Product administered to patient of inappropriate age, Wrong product administered Product administered to patient of inappropriate age, Wrong product administered
received the Boostrix vaccine that is usually recommended when they are older, and patient was 22 mo... received the Boostrix vaccine that is usually recommended when they are older, and patient was 22 months old; received Boostrix instead of Daptacel; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 22-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DY3K7, expiry date 14-JUN-2027) for prophylaxis. Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) for prophylaxis. On 29-JUL-2025, the patient received Boostrix. The patient did not receive Daptacel. On 29-JUL-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received the Boostrix vaccine that is usually recommended when they are older, and patient was 22 months old) and wrong vaccine administered (Verbatim: received Boostrix instead of Daptacel). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 29-JUL-2025 The certified medical assistant reported they have a patient that had received the Boostrix vaccine that was usually recommended when they were older and patient was 22 months old, so they were just making sure that there was nothing that they need to do or no contradictions or anything like that with her, giving the vaccine at 22 months old instead of eleven. The patient received Boostrix instead of Daptacel earlier than the recommended age, which led to an inappropriate age at vaccine administration and wrong vaccine administered. More
2853639 4 F TX 08/11/2025 HIBV
 GLAXOSMITHKLINE BIOLOGICALS
 TC3N5
Product preparation issue Product preparation issue
Hiberix only diluent portion was administered; Hiberix only diluent portion was administered; This n... Hiberix only diluent portion was administered; Hiberix only diluent portion was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-year-old female patient who received Hib (Hiberix) (batch number TC3N5, expiry date 17-MAR-2026) for prophylaxis. On 24-JUL-2025, the patient received Hiberix. On 24-JUL-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: Hiberix only diluent portion was administered) and inappropriate dose of vaccine administered (Verbatim: Hiberix only diluent portion was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable. Additional Information: GSK Receipt Date: 30-JUL-2025 The registered nurse reported that the patient administered Hiberix, but only diluent portion was administered, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered More
2853640 NH 08/11/2025 VARZOS
VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
GLAXOSMITHKLINE BIOLOGICALS
UNK
Herpes zoster, Incomplete course of vaccination, Post herpetic neuralgia; Herpes... Herpes zoster, Incomplete course of vaccination, Post herpetic neuralgia; Herpes zoster, Incomplete course of vaccination, Post herpetic neuralgia More
Shingles after first dose; is still experiencing PHN; did not complete the 2 dose series; This non-... Shingles after first dose; is still experiencing PHN; did not complete the 2 dose series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix and the did not receive 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles after first dose), post herpetic neuralgia (Verbatim: is still experiencing PHN) and incomplete course of vaccination (Verbatim: did not complete the 2 dose series). The outcome of the shingles was unknown and the outcome of the post herpetic neuralgia was not resolved and the outcome of the incomplete course of vaccination was not applicable. It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix. It was unknown if the company considered the shingles and post herpetic neuralgia to be related to Shingrix. Additional Information: GSK Receipt Date: 30-JUL-2025 The patient that received 1st dose of Shingrix in the past, did not complete the 2-dose series and the patient had a case of shingles and was still experiencing post herpetic neuralgia (PHN). The reporter asked should the patient receive a 2nd dose and if so, when was the best time to administer 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. More
2853641 F SC 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
got the first back in 2020; This non-serious case was reported by a pharmacist via call center repre... got the first back in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (got the first back in 2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. The patient experienced incomplete course of vaccination (Verbatim: got the first back in 2020). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 31-JUL-2025 Pharmacist wanted to know how to proceed with the second dose of Shingrix after a wife and her husband got the first back in 2020. Healthcare professional mentioned that the patient could have received the first dose in another facility than the one with the zip code provided. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments: US-GSK-US2025098983: More
2853642 NJ 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 UNK
Incomplete course of vaccination Incomplete course of vaccination
was due for the 2nd dose, had not got this in 5 years; This non-serious case was reported by a other... was due for the 2nd dose, had not got this in 5 years; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who did not receive Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose on received in Sep-2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: was due for the 2nd dose, had not got this in 5 years). The outcome of the incomplete course of vaccination was not applicable. Additional Information: GSK Receipt Date: 01-AUG-2025 The patient who had gotten 1st Shingrix vaccine and was due for the 2nd dose, had not got this in 5 years, which led incomplete course of vaccination. The reporter consented to follow up. More
2853643 KS 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 UNK
Extra dose administered Extra dose administered
2 doses 1 year apart; This non-serious case was reported by a other health professional via sales re... 2 doses 1 year apart; This non-serious case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. Previously administered products included Menveo (received 1st dose one year apart). On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 2 doses 1 year apart). The outcome of the extra dose administered was not applicable. Additional Information: GSK Receipt Date: 01-AUG-2025 The reporter reported that they had a patient who received 2 doses of Menveo 1 year apart, which led to extra dose administered The reporter asked were there any significant issues with receiving these within 1 year apart. More
2853644 66 F 08/11/2025 COVID19
 MODERNA
 3046732
Incorrect route of product administration, Injection site indentation, Vaccinati... Incorrect route of product administration, Injection site indentation, Vaccination failure More
created an indent on the injection site; Patient is claiming that the vaccine was given sub-Q rather... created an indent on the injection site; Patient is claiming that the vaccine was given sub-Q rather than intramuscularly; Patient believes that the vaccine was ineffective; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Jul-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use) .5 milliliter. On an unknown date, the patient experienced INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective). At the time of the report, INJECTION SITE INDENTATION (created an indent on the injection site), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient is claiming that the vaccine was given sub-Q rather than intramuscularly) and VACCINATION FAILURE (Patient believes that the vaccine was ineffective) outcome was unknown. For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Subcutaneous use), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient had no medical history, concomitant disease or risk factor. No other vaccines within the past 4 weeks and no relevant medical history were reported as per HCP. According to the HCP, after the vaccination, the patient reported that the vaccine was given subcutaneously instead of intramuscularly and noted an indent at the injection site. The patient believed that the vaccine was ineffective and subsequently requested a second dose of Spikevax. HCP inquired whether administering another dose would be appropriate. It was unknown if the patient experienced any additional symptoms or events. There were no lab data or results available. No treatment medications were reported.; Reporter's Comments: The benefit -risk relationship of product is not affected by this report. More
2853645 78 F 08/11/2025 COVID19
COVID19
COVID19
 MODERNA
MODERNA
MODERNA


Angiogram, Back pain, COVID-19, Ear disorder, Eczema; Eye disorder, Fungal infec... Angiogram, Back pain, COVID-19, Ear disorder, Eczema; Eye disorder, Fungal infection, Gastrointestinal disorder, Pain, Pruritus; Pulmonary mass, Skin reaction More
small nodes were found in lungs and one or two in her trachea; had a fungal infection on hand; GI pr... small nodes were found in lungs and one or two in her trachea; had a fungal infection on hand; GI problems; had a drug reaction on hand. Also one side of hand had eczema; had a problem with eye; taking Bactroban for ear; scalp got extremely itchy/immune response to the vaccine; had a drug reaction on hand. Also one side of hand had eczema; COVID; Last fall after the vaccine had different kinds of pains in back and check and in different places; Last fall after the vaccine had different kinds of pains in back and check and in different places; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand) and GASTROINTESTINAL DISORDER (GI problems) in a 78-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. In 2024, the patient experienced PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places). On an unknown date, the patient experienced PRURITUS (scalp got extremely itchy/immune response to the vaccine), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID). The patient was treated with Mupirocin (Bactroban) for Ear disorder, at an unspecified dose and frequency and Melaleuca alternifolia oil (Tea tree oil) for Eye disorder, at an unspecified dose and frequency. At the time of the report, PRURITUS (scalp got extremely itchy/immune response to the vaccine), PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places), PULMONARY MASS (small nodes were found in lungs and one or two in her trachea), FUNGAL INFECTION (had a fungal infection on hand), GASTROINTESTINAL DISORDER (GI problems), ECZEMA (had a drug reaction on hand. Also one side of hand had eczema), EYE DISORDER (had a problem with eye), EAR DISORDER (taking Bactroban for ear), SKIN REACTION (had a drug reaction on hand. Also one side of hand had eczema) and COVID-19 (COVID) had resolved and BACK PAIN (Last fall after the vaccine had different kinds of pains in back and check and in different places) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Angiogram: small nodes were found in lungs and one or two in trachea. Concomitant medication was not reported. It was stated that patient held off on one her boosters and got covid last spring or summer. She had gotten every single COVID vaccine and booster. Either last fall or the fall before HCP stated she had immune response to the vaccine. Her scalp got extremely itchy which went away on it was own. Last fall after the vaccine she had different kinds of pains in her back and check and in different places. It was also reported that she had gastrointestinal problems, and she skipped the vaccine prior the summer because she had a drug reaction on her hand. Also, one side of her hand had eczema. She had a fungal infection on her hand. She had a problem with her eye and used liquid eye drops. HCP did an IG something at one point because of a reaction to medication but she was not sure what medication. More
2853646 CA 08/11/2025 PNC20
 PFIZER\WYETH
 LN4930
Cellulitis, Erythema, Swelling, Tenderness Cellulitis, Erythema, Swelling, Tenderness
Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness fr... Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jul2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset Jul2025, outcome "recovered" (Jul2025); SWELLING (non-serious) with onset Jul2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset Jul2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow". The event "cellulitis" required emergency room visit. Therapeutic measures taken as a result of cellulitis included antibiotics.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202500159684 same drug/events, different patient; More
2853647 CA 08/11/2025 PNC20
 PFIZER\WYETH
 LN4930
Cellulitis, Erythema, Swelling, Tenderness Cellulitis, Erythema, Swelling, Tenderness
Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness fr... Cellulitis; large swelling; tenderness and redness from shoulder to elbow; tenderness and redness from shoulder to elbow; This is a spontaneous report received from an Other HCP from a sales representative. A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jun2025 as dose 1, single (Lot number: LN4930), in arm (deltoid) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CELLULITIS (medically significant) with onset 30Jun2025, outcome "recovered" (Jul2025); SWELLING (non-serious) with onset 30Jun2025, outcome "recovered" (Jul2025), described as "large swelling"; PAIN IN EXTREMITY (non-serious), ERYTHEMA (non-serious) all with onset 30Jun2025, outcome "recovered" (Jul2025) and all described as "tenderness and redness from shoulder to elbow". The event "cellulitis" required emergency room visit. Therapeutic measures taken as a result of cellulitis included antibiotics.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cellulitis and the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) cannot be excluded. The case will be reassessed once new information is available. 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.,Linked Report(s) : US-PFIZER INC-202500159636 same drug/event, different patient; More
2853649 08/11/2025 COVID19
 PFIZER\BIONTECH
Rash Rash
Their Covid vaccine gave me a rash; This is a spontaneous report received from a Consumer or other n... Their Covid vaccine gave me a rash; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) 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 and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Their Covid vaccine gave me a rash". No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained. More
2853650 F 08/11/2025 TDAP
 SANOFI PASTEUR
Coeliac disease, Rash Coeliac disease, Rash
in the 13 years she received Sanofi's Tdap vaccine, she has developed celiac disease; develop a... in the 13 years she received Sanofi's Tdap vaccine, she has developed celiac disease; develop a rash; Initial information received on 04-Aug-2025 regarding an unsolicited valid serious case received from a consumer/non-hcp 9healthcare professional). This case involves an unknown age female patient who had celiac disease and rash after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine, Suspension for injection, (unknown strength and expiry date) lot number not reported via unknown route in unknown administration site for Immunization. Information regarding batch number corresponding to the one at time of event occurrence is requested. On an unknown date the patient developed celiac disease (coeliac disease) and develop a rash (rash) (unknown latency). Reportedly, A female patient reported a 13-year rash from Sanofi's Tdap vaccine, which she reported as an adverse event. Now, her doctor is considering another Tdap vaccine, but she is concerned about the vaccine's gluten content, as she has developed celiac disease. Action taken was not applicable. It was not reported if the patient received a corrective treatment for both the events. At time of reporting, the outcome was Unknown for both the events. Seriousness Criteria: This event was assessed as medically significant (coeliac disease).; Sender's Comments: Sanofi Company Comment dated 06-Aug-2025,This case involves an unknown age female patient who had celiac disease and rash after receiving Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel]. Further information regarding tolerance, allergic history, medical history, concomitant medication and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed. More
2853653 08/11/2025 MEN
 UNKNOWN MANUFACTURER
 UNK
Malaise Malaise
I almost died from the Meningitis jab; This serious case was reported by a consumer and described t... I almost died from the Meningitis jab; This serious case was reported by a consumer and described the occurrence of near death experience in a patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, an unknown time after receiving Meningococcal B vaccine, the patient experienced near death experience (Verbatim: I almost died from the Meningitis jab) (serious criteria GSK medically significant). The outcome of the near death experience was not reported. The reporter considered the near death experience to be related to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. The company considered the near death experience to be unrelated to Meningococcal B vaccine and Meningococcal B Vaccine Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: Additional Information: GSK Receipt Date: 04-AUG-2025 Consumer reported that almost died from the Meningitis jab as a teenager, but we did not know it at the time. This case has been linked with the caseUS2025AMR103054 and US2025AMR101206, reported by same reporter.; Sender's Comments: A case of Near death experience, on an unknown time after receiving Meningococcal B vaccine, in a patient. Based on the available information a possible causality that the events were caused by GSK Meningococcal B vaccine and Meningococcal B vaccine PRE-FILLED SYRINGE DEVICE cannot be ascertained. Consent for further follow up has not been received US-GSK-US2025AMR101206:Case created for kids US-GSK-US2025AMR103054:Same reporter/kids More
2853654 17 M IA 08/11/2025 MNQ
 NOVARTIS VACCINES AND DIAGNOSTICS
 KX3LM
Expired product administered Expired product administered
maladministration after the expiration date; This non-serious case was reported by a nurse via call ... maladministration after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number KX3LM, expiry date 31-JUL-2025) for prophylaxis. On 04-AUG-2025, the patient received Menveo. On 04-AUG-2025, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: maladministration after the expiration date). The outcome of the expired vaccine used was not applicable. Additional Information: GSK Receipt Date: 04-AUG-2025 The Vaccine Administration Facility was the same as Primary Reporter A registered nurse called to report about the maladministration of a Menveo one vial vaccine after the expiration date which led to expired vaccine used. The registered nurse wanted advice on the situation. More
2853655 M MA 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
Inappropriate schedule of product administration Inappropriate schedule of product administration
Late second dose; This non-serious case was reported by a consumer via call center representative a... Late second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received first dose on MAR-2022). On 05-AUG-2025, the patient received the 2nd dose of Shingrix. On 05-AUG-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable. Additional Information: GSK Receipt Date: 05-AUG-2025 On 5 August 2025, a patient called to get guidance on the Shingrix vaccine series. He mentioned he had the first shingles dose back in March 2022 and received the second dose on 5 August 2025 which led to drug dose administration interval too long The patient wanted to know what about the effectiveness of vaccine. More
2853657 5 F CA 08/11/2025 VARCEL
 MERCK & CO. INC.
 7003883
Rash, Swelling face Rash, Swelling face
Per patient mother patient had swelling to right side of her face and ear , patient had rash the nex... Per patient mother patient had swelling to right side of her face and ear , patient had rash the next morning in various parts of the body. More
2853658 66 F IA 08/11/2025 RSV
 GLAXOSMITHKLINE BIOLOGICALS
 5f5xk
Wrong technique in product usage process Wrong technique in product usage process
While giving the immunization 2 droplets of liquid squirted onto the technician's face. One ne... While giving the immunization 2 droplets of liquid squirted onto the technician's face. One nearby the mouth and one into the mouth. It came out while the needle was retracting. More
2853659 66 F AR 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 24M7E
Rash Rash
Rash appeared under arms a view days after injection. Rash spread to ankles, wrist, and thighs. Rash... Rash appeared under arms a view days after injection. Rash spread to ankles, wrist, and thighs. Rash has spread to legs, buttocks, and stomach. Saw dermatologist which said Rash was from vaccine and prescribed a salve but it did not help.. More
2853660 53 F NV 08/11/2025 VARCEL
 MERCK & CO. INC.
 Z004246
Extra dose administered Extra dose administered
patient was getting her immigration vaccines and daughter was very adament she get the VZV but did n... patient was getting her immigration vaccines and daughter was very adament she get the VZV but did not want her mother to get a titer as suggested from core staff and was willing to pay privately since we did not have 317 and said she needed to get these vaccines asap for immigration. Core nurse and i overlooked that she had a MMR recenty after the vaccine was administered making the VZV invalid. More
2853661 50 F NY 08/11/2025 VARZOS
 GLAXOSMITHKLINE BIOLOGICALS
 97ym7
Contusion, Erythema, Headache, Skin warm, Swelling Contusion, Erythema, Headache, Skin warm, Swelling
having redness, and swelling, and hot to touch, a little bit of bruise in the middle. Been a week an... having redness, and swelling, and hot to touch, a little bit of bruise in the middle. Been a week and tried applying ice. and took tylenol (but for headaches). More
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